Difference between revisions of "Cholangiocarcinoma"
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=Guidelines= | =Guidelines= | ||
==[http://www.esmo.org/ ESMO]== | ==[http://www.esmo.org/ ESMO]== | ||
− | * '''2016:''' Valle et al. [https://www.esmo.org/Guidelines/Gastrointestinal-Cancers/Biliary-Cancer Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] | + | |
+ | *'''2016:''' Valle et al. [https://www.esmo.org/Guidelines/Gastrointestinal-Cancers/Biliary-Cancer Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] | ||
==[https://www.nccn.org/ NCCN]== | ==[https://www.nccn.org/ NCCN]== | ||
+ | |||
*[https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf NCCN Guidelines - Hepatobiliary Cancers] | *[https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf NCCN Guidelines - Hepatobiliary Cancers] | ||
+ | |||
+ | ==[https://ascopubs.org/ ASCO]== | ||
+ | |||
+ | *[https://ascopubs.org/doi/full/10.1200/JCO.18.02178 Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline April 2019] | ||
=Adjuvant therapy= | =Adjuvant therapy= | ||
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|} | |} | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery|Surgical resection]] with macroscopically curative resection | *[[Surgery|Surgical resection]] with macroscopically curative resection | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | *[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
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===References=== | ===References=== | ||
− | # '''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30915-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30922733 PubMed] | + | |
+ | #'''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30915-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30922733 PubMed] | ||
==Capecitabine & Gemcitabine {{#subobject:17f9f2|Regimen=1}}== | ==Capecitabine & Gemcitabine {{#subobject:17f9f2|Regimen=1}}== | ||
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|} | |} | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery#Surgical_resection|Surgical resection]] | *[[Surgery#Surgical_resection|Surgical resection]] | ||
+ | |||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Capecitabine (Xeloda)]] 750 mg/m<sup>2</sup>/day PO twice per day on days 1 to 14 | *[[Capecitabine (Xeloda)]] 750 mg/m<sup>2</sup>/day PO twice per day on days 1 to 14 | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
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'''21-day cycle for 4 cycles''' | '''21-day cycle for 4 cycles''' | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
+ | |||
*Capecitabine & RT | *Capecitabine & RT | ||
===References=== | ===References=== | ||
− | # '''SWOG S0809:''' Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. Epub 2015 May 11. [https://ascopubs.org/doi/full/10.1200/JCO.2014.60.2219 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4534524/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25964250 PubMed] | + | |
+ | #'''SWOG S0809:''' Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. Epub 2015 May 11. [https://ascopubs.org/doi/full/10.1200/JCO.2014.60.2219 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4534524/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25964250 PubMed] | ||
==Gemcitabine monotherapy {{#subobject:f8c8d9|Regimen=1}}== | ==Gemcitabine monotherapy {{#subobject:f8c8d9|Regimen=1}}== | ||
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|} | |} | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery|Surgical resection]] with macroscopically curative resection | *[[Surgery|Surgical resection]] with macroscopically curative resection | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | + | |
+ | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
'''28-day cycle for 6 cycles''' | '''28-day cycle for 6 cycles''' | ||
− | === References === | + | ===References=== |
− | # '''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10776 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29405274 PubMed] | + | |
+ | #'''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10776 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29405274 PubMed] | ||
==Gemcitabine, then Fluorouracil & RT, then Gemcitabine {{#subobject:f8c8d9|Regimen=1}}== | ==Gemcitabine, then Fluorouracil & RT, then Gemcitabine {{#subobject:f8c8d9|Regimen=1}}== | ||
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''Note: this study was in pancreatic cancer but in practice it is extrapolated to cholangiocarcinoma. Reported efficacy is based on the 2011 update.'' | ''Note: this study was in pancreatic cancer but in practice it is extrapolated to cholangiocarcinoma. Reported efficacy is based on the 2011 update.'' | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery#Surgical_resection|Surgical resection]] | *[[Surgery#Surgical_resection|Surgical resection]] | ||
+ | |||
====Chemotherapy, part 1==== | ====Chemotherapy, part 1==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
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====Chemotherapy, part 2==== | ====Chemotherapy, part 2==== | ||
+ | |||
*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion throughout radiation therapy | *[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion throughout radiation therapy | ||
+ | |||
====Radiotherapy==== | ====Radiotherapy==== | ||
+ | |||
*Concurrent [[External_beam_radiotherapy|radiation therapy]], 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed. | *Concurrent [[External_beam_radiotherapy|radiation therapy]], 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed. | ||
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====Chemotherapy, part 3==== | ====Chemotherapy, part 3==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
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===References=== | ===References=== | ||
− | # '''RTOG 9704:''' Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18319412 PubMed] | + | |
− | ## '''Update:''' Regine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the US Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. Epub 2011 Mar 10. [https://link.springer.com/article/10.1245%2Fs10434-011-1630-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3548408/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/21499862 PubMed] | + | #'''RTOG 9704:''' Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18319412 PubMed] |
+ | ##'''Update:''' Regine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the US Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. Epub 2011 Mar 10. [https://link.springer.com/article/10.1245%2Fs10434-011-1630-6 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3548408/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/21499862 PubMed] | ||
==GemOx {{#subobject:f8c8d9|Regimen=1}}== | ==GemOx {{#subobject:f8c8d9|Regimen=1}}== | ||
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|} | |} | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery|Surgical resection]] with macroscopically curative resection | *[[Surgery|Surgical resection]] with macroscopically curative resection | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | + | |
− | *[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV once on day 2 | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 |
+ | *[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV once on day 2 | ||
'''14-day cycle for 12 cycles''' | '''14-day cycle for 12 cycles''' | ||
===References=== | ===References=== | ||
− | # '''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://ascopubs.org/doi/full/10.1200/JCO.18.00050 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30707660 PubMed] | + | |
+ | #'''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://ascopubs.org/doi/full/10.1200/JCO.18.00050 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30707660 PubMed] | ||
==Observation== | ==Observation== | ||
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''No antineoplastic treatment after surgery.'' | ''No antineoplastic treatment after surgery.'' | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
+ | |||
*[[Surgery#Surgical_resection|Surgical resection]] with macroscopically curative resection | *[[Surgery#Surgical_resection|Surgical resection]] with macroscopically curative resection | ||
===References=== | ===References=== | ||
− | # '''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10776 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29405274 PubMed] | + | |
− | # '''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://ascopubs.org/doi/full/10.1200/JCO.18.00050 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30707660 PubMed] | + | #'''BCAT:''' Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. [https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10776 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29405274 PubMed] |
− | # '''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30915-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30922733 PubMed] | + | #'''PRODIGE 12-ACCORD 18-UNICANCER GI:''' Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. [https://ascopubs.org/doi/full/10.1200/JCO.18.00050 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30707660 PubMed] |
+ | #'''BILCAP:''' Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30915-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30922733 PubMed] | ||
=Metastatic disease, all lines of therapy= | =Metastatic disease, all lines of therapy= | ||
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===References=== | ===References=== | ||
− | # Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org HemOnc.org] | + | |
+ | #Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org HemOnc.org] | ||
==Capecitabine monotherapy {{#subobject:c7cfeb|Regimen=1}}== | ==Capecitabine monotherapy {{#subobject:c7cfeb|Regimen=1}}== | ||
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|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
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===References=== | ===References=== | ||
− | # '''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed] | + | |
+ | #'''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [https://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed] | ||
==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ||
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|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
*[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | *[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | ||
====Supportive medications==== | ====Supportive medications==== | ||
+ | |||
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | *[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | ||
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===References=== | ===References=== | ||
− | # Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [http://annonc.oxfordjournals.org/content/15/3/478.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14998852 PubMed] | + | |
+ | #Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [http://annonc.oxfordjournals.org/content/15/3/478.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14998852 PubMed] | ||
==CapeOx {{#subobject:cf9acc|Regimen=1}}== | ==CapeOx {{#subobject:cf9acc|Regimen=1}}== | ||
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===Regimen {{#subobject:1ef938|Variant=1}}=== | ===Regimen {{#subobject:1ef938|Variant=1}}=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
− | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
− | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
− | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://academic.oup.com/annonc/article/30/5/788/5345557 Kim et al. 2019 (SMC 2011-05-070)] | |[https://academic.oup.com/annonc/article/30/5/788/5345557 Kim et al. 2019 (SMC 2011-05-070)] | ||
Line 317: | Line 353: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
*[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV once on day 1 | *[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV once on day 1 | ||
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===References=== | ===References=== | ||
− | # '''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed] | + | |
+ | #'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed] | ||
==Cisplatin & Gemcitabine {{#subobject:af0357|Regimen=1}}== | ==Cisplatin & Gemcitabine {{#subobject:af0357|Regimen=1}}== | ||
Line 344: | Line 382: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8, '''given first''' | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8, '''given first''' | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8, '''given second''' | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8, '''given second''' | ||
====Supportive medications==== | ====Supportive medications==== | ||
+ | |||
*Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate | *Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate | ||
*After cisplatin, 500 mL normal saline given over 30 minutes | *After cisplatin, 500 mL normal saline given over 30 minutes | ||
Line 354: | Line 394: | ||
===References=== | ===References=== | ||
− | # '''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] | + | |
+ | #'''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] | ||
==Cisplatin, Gemcitabine, nab-Paclitaxel {{#subobject:17f9f2|Regimen=1}}== | ==Cisplatin, Gemcitabine, nab-Paclitaxel {{#subobject:17f9f2|Regimen=1}}== | ||
Line 372: | Line 413: | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8 | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 & 8 | ||
*[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
Line 379: | Line 421: | ||
===References=== | ===References=== | ||
− | # '''MDACC 2014-0524:''' Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: a phase 2 clinical trial. JAMA Oncol. 2019 Apr 18. [Epub ahead of print] [https://jamanetwork.com/journals/jamaoncology/article-abstract/2730639 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30998813 PubMed] | + | |
+ | #'''MDACC 2014-0524:''' Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: a phase 2 clinical trial. JAMA Oncol. 2019 Apr 18. [Epub ahead of print] [https://jamanetwork.com/journals/jamaoncology/article-abstract/2730639 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30998813 PubMed] | ||
==ECF {{#subobject:57bd6d|Regimen=1}}== | ==ECF {{#subobject:57bd6d|Regimen=1}}== | ||
Line 402: | Line 445: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Epirubicin (Ellence)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Epirubicin (Ellence)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV once on day 1 | ||
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===References=== | ===References=== | ||
− | # Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | + | |
+ | #Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | ||
==Erlotinib & Bevacizumab {{#subobject:CMR1|Regimen=1}}== | ==Erlotinib & Bevacizumab {{#subobject:CMR1|Regimen=1}}== | ||
Line 426: | Line 471: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Erlotinib (Tarceva)]] 150 mg PO once per day | *[[Erlotinib (Tarceva)]] 150 mg PO once per day | ||
*[[Bevacizumab (Avastin)]] 5 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 5 mg/kg IV once per day on days 1 & 15 | ||
Line 432: | Line 478: | ||
===References=== | ===References=== | ||
− | # Lubner SJ, Mahoney MR, Kolesar JL, Loconte NK, Kim GP, Pitot HC, Philip PA, Picus J, Yong WP, Horvath L, Van Hazel G, Erlichman CE, Holen KD. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study. J Clin Oncol. 2010 Jul 20;28(21):3491-7. Epub 2010 Jun 7. [http://jco.ascopubs.org/content/28/21/3491.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917213/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/20530271 PubMed] | + | |
+ | #Lubner SJ, Mahoney MR, Kolesar JL, Loconte NK, Kim GP, Pitot HC, Philip PA, Picus J, Yong WP, Horvath L, Van Hazel G, Erlichman CE, Holen KD. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study. J Clin Oncol. 2010 Jul 20;28(21):3491-7. Epub 2010 Jun 7. [http://jco.ascopubs.org/content/28/21/3491.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917213/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/20530271 PubMed] | ||
==FELV {{#subobject:3658a8|Regimen=1}}== | ==FELV {{#subobject:3658a8|Regimen=1}}== | ||
Line 454: | Line 501: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' | *[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' | ||
*[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' | *[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' | ||
Line 473: | Line 521: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' | *[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' | ||
*[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' | *[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' | ||
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===References=== | ===References=== | ||
− | # Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org HemOnc.org] | + | |
− | # Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | + | #Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org HemOnc.org] |
+ | #Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. [https://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | ||
==Fluorouracil & Folinic acid {{#subobject:7bfb92|Regimen=1}}== | ==Fluorouracil & Folinic acid {{#subobject:7bfb92|Regimen=1}}== | ||
Line 503: | Line 553: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given first''' | *[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given first''' | ||
*[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given second, 40 minutes after Fluorouracil (5-FU)''' | *[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given second, 40 minutes after Fluorouracil (5-FU)''' | ||
Line 509: | Line 560: | ||
===References=== | ===References=== | ||
− | # Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] | + | |
+ | #Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] | ||
==Fluorouracil, Folinic acid, Gemcitabine {{#subobject:eb427f|Regimen=1}}== | ==Fluorouracil, Folinic acid, Gemcitabine {{#subobject:eb427f|Regimen=1}}== | ||
Line 526: | Line 578: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 600 mg/m<sup>2</sup> IV continuous infusion over 22 hours (total dose per cycle: 1000 mg/m<sup>2</sup>) | *[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus once on day 1, then 600 mg/m<sup>2</sup> IV continuous infusion over 22 hours (total dose per cycle: 1000 mg/m<sup>2</sup>) | ||
*[[Folinic acid (Leucovorin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 1 | *[[Folinic acid (Leucovorin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 1 | ||
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===References=== | ===References=== | ||
− | # Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [http://jco.ascopubs.org/content/19/20/4089.2.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11600613 PubMed] | + | |
+ | #Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [http://jco.ascopubs.org/content/19/20/4089.2.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11600613 PubMed] | ||
==Gemcitabine monotherapy {{#subobject:1129f1|Regimen=1}}== | ==Gemcitabine monotherapy {{#subobject:1129f1|Regimen=1}}== | ||
Line 554: | Line 608: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
Line 568: | Line 623: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
Line 573: | Line 629: | ||
===References=== | ===References=== | ||
− | # Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [http://jco.ascopubs.org/content/19/20/4089.2.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11600613 PubMed] | + | |
− | # '''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] | + | #Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. [http://jco.ascopubs.org/content/19/20/4089.2.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/11600613 PubMed] |
+ | #'''ABC-02:''' Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. [https://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] | ||
==Gemcitabine, Cisplatin, S-1 {{#subobject:e0d17a|Regimen=1}}== | ==Gemcitabine, Cisplatin, S-1 {{#subobject:e0d17a|Regimen=1}}== | ||
Line 595: | Line 652: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | ||
− | *[[Tegafur, gimeracil, oteracil (S-1)]] 80 mg/m<sup>2</sup> PO once per day on days 1 to 7 | + | *[[Tegafur, gimeracil, oteracil (S-1)]] 80 mg/m<sup>2</sup> PO once per day on days 1 to 7 |
'''14-day cycles''' | '''14-day cycles''' | ||
===References=== | ===References=== | ||
− | # '''Abstract:''' Sakai D, Kanai M , Kobayashi S, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Ishioka C, Sho M, Takeyama Y, Fujimoto J, Toyoda M, Shimizu J, Goto T, Yoshimura K, Hatano E, Nagano H, Ioka T. Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). Annals of Oncology 29 (Supplement 8): viii205–viii270, 2018 [https://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 link to abstract] | + | |
+ | #'''Abstract:''' Sakai D, Kanai M , Kobayashi S, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Ishioka C, Sho M, Takeyama Y, Fujimoto J, Toyoda M, Shimizu J, Goto T, Yoshimura K, Hatano E, Nagano H, Ioka T. Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). Annals of Oncology 29 (Supplement 8): viii205–viii270, 2018 [https://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 link to abstract] | ||
==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}== | ==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}== | ||
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|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 2000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 15 | *[[Gemcitabine (Gemzar)]] 2000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 15 | ||
*[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | *[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | ||
====Supportive medications==== | ====Supportive medications==== | ||
+ | |||
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | *[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | ||
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===References=== | ===References=== | ||
− | # Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [http://annonc.oxfordjournals.org/content/15/3/478.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14998852 PubMed] | + | |
+ | #Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. [http://annonc.oxfordjournals.org/content/15/3/478.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/14998852 PubMed] | ||
==Gemcitabine & nab-Paclitaxel {{#subobject:fbd698|Regimen=1}}== | ==Gemcitabine & nab-Paclitaxel {{#subobject:fbd698|Regimen=1}}== | ||
Line 651: | Line 713: | ||
''Note: this regimen was intended for ECOG PS 0 to 2, and Child-Pugh score less than 8.'' | ''Note: this regimen was intended for ECOG PS 0 to 2, and Child-Pugh score less than 8.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 125 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 125 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | ||
Line 657: | Line 720: | ||
===References=== | ===References=== | ||
− | # Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. nab-Paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma: a phase 2 clinical trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. [https://jamanetwork.com/journals/jamaoncology/article-abstract/2698042 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30178032 PubMed] | + | |
+ | #Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. nab-Paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma: a phase 2 clinical trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. [https://jamanetwork.com/journals/jamaoncology/article-abstract/2698042 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30178032 PubMed] | ||
==GemOx {{#subobject:a99e6e|Regimen=1}}== | ==GemOx {{#subobject:a99e6e|Regimen=1}}== | ||
Line 668: | Line 732: | ||
===Variant #1, 1000/85, bi-weekly {{#subobject:508f1b|Variant=1}}=== | ===Variant #1, 1000/85, bi-weekly {{#subobject:508f1b|Variant=1}}=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
− | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
− | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://academic.oup.com/jjco/article/41/2/217/875887 Halim et al. 2011] | |[https://academic.oup.com/jjco/article/41/2/217/875887 Halim et al. 2011] | ||
− | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
|ORR: 27.5% | |ORR: 27.5% | ||
|- | |- | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once on day 1, '''given first''' | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once on day 1, '''given first''' | ||
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second''' | *[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given second''' | ||
Line 685: | Line 750: | ||
===Variant #2, 1000/100, bi-weekly {{#subobject:a8fecb|Variant=1}}=== | ===Variant #2, 1000/100, bi-weekly {{#subobject:a8fecb|Variant=1}}=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
− | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
− | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
− | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70301-1/fulltext Lee et al. 2011 (SMC 2008-12-024)] | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70301-1/fulltext Lee et al. 2011 (SMC 2008-12-024)] | ||
Line 697: | Line 762: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 2 | *[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 2 | ||
Line 704: | Line 770: | ||
===Variant #3, 1000/100, 2 weeks out of 3 {{#subobject:a6c33cb|Variant=1}}=== | ===Variant #3, 1000/100, 2 weeks out of 3 {{#subobject:a6c33cb|Variant=1}}=== | ||
{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
− | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
− | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
− | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://academic.oup.com/annonc/article/30/5/788/5345557 Kim et al. 2019 (SMC 2011-05-070)] | |[https://academic.oup.com/annonc/article/30/5/788/5345557 Kim et al. 2019 (SMC 2011-05-070)] | ||
Line 716: | Line 782: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 1 | *[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV once on day 1 | ||
Line 723: | Line 790: | ||
===Variant #4, 1000/100 ("GEMOX-3") {{#subobject:a8fefg|Variant=1}}=== | ===Variant #4, 1000/100 ("GEMOX-3") {{#subobject:a8fefg|Variant=1}}=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
− | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
− | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ Harder et al. 2006] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ Harder et al. 2006] | ||
− | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
− | |ORR: 26% (95% CI 14–44) | + | |ORR: 26% (95% CI 14–44) |
|- | |- | ||
|} | |} | ||
GEMOX-3: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin, 3 visits per month | GEMOX-3: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin, 3 visits per month | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, '''given first''' | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, '''given first''' | ||
*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given second''' | *[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given second''' | ||
Line 740: | Line 808: | ||
===References=== | ===References=== | ||
− | # Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H. Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer. 2006 Oct 9;95(7):848-52. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16969352 PubMed] | + | |
− | # Halim A, Ebrahim MA, Saleh Y. A phase II study of outpatient biweekly gemcitabine-oxaliplatin in advanced biliary tract carcinomas. Jpn J Clin Oncol. 2011 Feb;41(2):217-24. [https://academic.oup.com/jjco/article/41/2/217/875887 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21062755 PubMed] | + | #Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H. Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer. 2006 Oct 9;95(7):848-52. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16969352 PubMed] |
− | # '''SMC 2008-12-024:''' Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. Epub 2011 Dec 20. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70301-1/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22192731 PubMed] | + | #Halim A, Ebrahim MA, Saleh Y. A phase II study of outpatient biweekly gemcitabine-oxaliplatin in advanced biliary tract carcinomas. Jpn J Clin Oncol. 2011 Feb;41(2):217-24. [https://academic.oup.com/jjco/article/41/2/217/875887 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21062755 PubMed] |
− | # '''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed] | + | #'''SMC 2008-12-024:''' Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. Epub 2011 Dec 20. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70301-1/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22192731 PubMed] |
+ | #'''SMC 2011-05-070:''' Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. [https://academic.oup.com/annonc/article/30/5/788/5345557 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30785198 PubMed] | ||
==GEMOX-B {{#subobject:119bb0|Regimen=1}}== | ==GEMOX-B {{#subobject:119bb0|Regimen=1}}== | ||
Line 761: | Line 830: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | |||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once per day on days 1 & 15, '''given second''' | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once per day on days 1 & 15, '''given second''' | ||
*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given third''' | *[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 & 15, '''given third''' | ||
Line 768: | Line 838: | ||
===References=== | ===References=== | ||
− | # '''MGH 05-349:''' Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. Epub 2009 Nov 20. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970333-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19932054 PubMed] | + | |
+ | #'''MGH 05-349:''' Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. Epub 2009 Nov 20. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970333-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19932054 PubMed] | ||
==Pembrolizumab monotherapy {{#subobject:e0d17a|Regimen=1}}== | ==Pembrolizumab monotherapy {{#subobject:e0d17a|Regimen=1}}== | ||
Line 786: | Line 857: | ||
''Note: KEYNOTE-016 was an expansion to a CRC-specific trial.'' | ''Note: KEYNOTE-016 was an expansion to a CRC-specific trial.'' | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
+ | |||
*[[Pembrolizumab (Keytruda)]] 10 mg/kg IV once on day 1 | *[[Pembrolizumab (Keytruda)]] 10 mg/kg IV once on day 1 | ||
Line 791: | Line 863: | ||
===References=== | ===References=== | ||
− | # '''KEYNOTE-016:''' Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. [http://science.sciencemag.org/content/357/6349/409.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/ link to PMC article] '''contains verified protocol in supplement''' [https://www.ncbi.nlm.nih.gov/pubmed/28596308 PubMed] | + | |
+ | #'''KEYNOTE-016:''' Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. [http://science.sciencemag.org/content/357/6349/409.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/ link to PMC article] '''contains verified protocol in supplement''' [https://www.ncbi.nlm.nih.gov/pubmed/28596308 PubMed] | ||
==Regorafenib monotherapy {{#subobject:17f9f2|Regimen=1}}== | ==Regorafenib monotherapy {{#subobject:17f9f2|Regimen=1}}== | ||
Line 808: | Line 881: | ||
''Only studied in patients with advanced biliary cancer who failed at least 1 line of systemic therapy.'' | ''Only studied in patients with advanced biliary cancer who failed at least 1 line of systemic therapy.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Regorafenib (Stivarga)]] 120 mg PO once per day on days 1 to 21 | + | |
+ | *[[Regorafenib (Stivarga)]] 120 mg PO once per day on days 1 to 21 | ||
'''28-day cycles''' | '''28-day cycles''' | ||
===References=== | ===References=== | ||
− | # Sun W, Patel A, Normolle A, Patel K, Ohr J, Lee JJ, Bahary N, Chu E, Streeter N, Drummond S. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy‐refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer. 2019 Mar 15;125(6):902-909. Epub 2018 Dec 18. [https://onlinelibrary.wiley.com/doi/abs/10.1002/cncr.31872 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402964/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/30561756 PubMed] | + | |
+ | #Sun W, Patel A, Normolle A, Patel K, Ohr J, Lee JJ, Bahary N, Chu E, Streeter N, Drummond S. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy‐refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer. 2019 Mar 15;125(6):902-909. Epub 2018 Dec 18. [https://onlinelibrary.wiley.com/doi/abs/10.1002/cncr.31872 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402964/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/30561756 PubMed] | ||
[[Category:Cholangiocarcinoma regimens]] | [[Category:Cholangiocarcinoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Hepatobiliary cancers]] | [[Category:Hepatobiliary cancers]] |
Revision as of 00:33, 10 July 2019
Page editor | Section editor | ||
---|---|---|---|
Candice Schwartz, MD University of Illinois at Chicago Chicago, IL |
Neeta K. Venepalli, MD, MBA University of Illinois at Chicago Chicago, IL |
29 regimens on this page
35 variants on this page
|
Note: there is some overlap, especially in the earlier literature, between treatment regimens for cholangiocarcinoma and those for pancreatic adenocarcinoma, periampullary adenocarcinoma, and gallbladder cancer; please see those pages for additional regimens.
Guidelines
ESMO
- 2016: Valle et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
NCCN
ASCO
Adjuvant therapy
Capecitabine monotherapy
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Primrose et al. 2019 (BILCAP) | Phase III (E) | Observation | Might have superior OS |
Preceding treatment
- Surgical resection with macroscopically curative resection
Chemotherapy
- Capecitabine (Xeloda) 1250 mg/m2 PO twice per day on days 1 to 14
21-day cycle for 8 cycles
References
- BILCAP: Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. link to original article PubMed
Capecitabine & Gemcitabine
back to top |
GemCap: Gemcitabine & Capecitabine
Regimen
Study | Evidence |
---|---|
Ben-Josef et al. 2015 (SWOG S0809) | Phase II |
Preceding treatment
Chemotherapy
- Capecitabine (Xeloda) 750 mg/m2/day PO twice per day on days 1 to 14
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycle for 4 cycles
Subsequent treatment
- Capecitabine & RT
References
- SWOG S0809: Ben-Josef E, Guthrie KA, El-Khoueiry AB, Corless CL, Zalupski MM, Lowy AM, Thomas CR Jr, Alberts SR, Dawson LA, Micetich KC, Thomas MB, Siegel AB, Blanke CD. SWOG S0809: A phase II intergroup trial of adjuvant capecitabine and gemcitabine followed by radiotherapy and concurrent capecitabine in extrahepatic cholangiocarcinoma and gallbladder carcinoma. J Clin Oncol. 2015 Aug 20;33(24):2617-22. Epub 2015 May 11. link to original article link to PMC article contains verified protocol PubMed
Gemcitabine monotherapy
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Ebata et al. 2018 (BCAT) | Phase III (E) | Observation | Seems not superior |
Preceding treatment
- Surgical resection with macroscopically curative resection
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1, 8, 15
28-day cycle for 6 cycles
References
- BCAT: Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. link to original article PubMed
Gemcitabine, then Fluorouracil & RT, then Gemcitabine
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Regine et al. 2008 (RTOG 9704) | Phase III (E) | Fluorouracil & RT | Seems not superior (*) |
Note: this study was in pancreatic cancer but in practice it is extrapolated to cholangiocarcinoma. Reported efficacy is based on the 2011 update.
Preceding treatment
Chemotherapy, part 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
21-day course, followed in 1 to 2 weeks by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion throughout radiation therapy
Radiotherapy
- Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
6-week course, followed in 3 to 5 weeks by:
Chemotherapy, part 3
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycle for 3 cycles
References
- RTOG 9704: Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. link to original article contains verified protocol PubMed
- Update: Regine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the US Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. Epub 2011 Mar 10. link to original article link to PMC article PubMed
GemOx
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GemOx: Gemcitabine & Oxaliplatin
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI) | Phase III (E) | Observation | Seems not superior |
Preceding treatment
- Surgical resection with macroscopically curative resection
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once on day 1
- Oxaliplatin (Eloxatin) 85 mg/m2 IV once on day 2
14-day cycle for 12 cycles
References
- PRODIGE 12-ACCORD 18-UNICANCER GI: Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. link to original article PubMed
Observation
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Ebata et al. 2018 (BCAT) | Phase III (C) | Gemcitabine | Seems not superior |
Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI) | Phase III (C) | GemOx | Seems not superior |
No antineoplastic treatment after surgery.
Preceding treatment
- Surgical resection with macroscopically curative resection
References
- BCAT: Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. link to original article PubMed
- PRODIGE 12-ACCORD 18-UNICANCER GI: Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assénat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardière C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. Epub 2019 Feb 1. link to original article PubMed
- BILCAP: Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. Epub 2019 Mar 25. Erratum in: Lancet Oncol. 2019 Apr 2. link to original article PubMed
Metastatic disease, all lines of therapy
Best supportive care
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Glimelius et al. 1996 | Phase III (C) | 1. FELV | Inferior OS |
2. Fluorouracil & Folinic acid | Inferior OS |
No antineoplastic treatment. Included for reference purposes only.
References
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed content property of HemOnc.org
Capecitabine monotherapy
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Regimen
Study | Evidence |
---|---|
Patt et al. 2004 | Retrospective |
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
21-day cycles
References
- Retrospective: Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. link to original article PubMed
Capecitabine & Mitomycin
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Kornek et al. 2004 | Randomized Phase II (E) | Gemcitabine & Mitomycin | Might have superior ORR |
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
- Mitomycin (Mutamycin) 8 mg/m2 IV bolus once on day 1
Supportive medications
- Dexamethasone (Decadron) and 5-HT3 antagonists on the day of IV chemotherapy
28-day cycles
References
- Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. link to original article contains verified protocol PubMed
CapeOx
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CapeOx: Capecitabine & Oxaliplatin
XELOX: XELoda (Capecitabine) & OXaliplatin
Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Kim et al. 2019 (SMC 2011-05-070) | Phase III (E) | GEMOX | Non-inferior PFS |
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
- Oxaliplatin (Eloxatin) 130 mg/m2 IV once on day 1
21-day cycle for 8 cycles
References
- SMC 2011-05-070: Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. link to original article contains protocol PubMed
Cisplatin & Gemcitabine
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Valle et al. 2010 (ABC-02) | Phase III (E) | Gemcitabine | Superior OS |
Chemotherapy
- Cisplatin (Platinol) 25 mg/m2 IV over 60 minutes once per day on days 1 & 8, given first
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8, given second
Supportive medications
- Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate
- After cisplatin, 500 mL normal saline given over 30 minutes
21-day cycle for 4 to 8 cycles depending on response
References
- ABC-02: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. link to original article contains verified protocol PubMed
Cisplatin, Gemcitabine, nab-Paclitaxel
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Regimen
Study | Evidence |
---|---|
Shroff et al. 2019 (MDACC 2014-0524) | Phase II |
Prolonged median PFS and OS vs reported for historical controls treated with gemcitabine-cisplatin alone.
Chemotherapy
- Cisplatin (Platinol) 25 mg/m2 IV over 60 minutes once per day on days 1 & 8
- Gemcitabine (Gemzar) 800 mg/m2 IV once per day on days 1 & 8
- Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 mg/m2 IV once per day on days 1 & 8
21-day cycle
References
- MDACC 2014-0524: Shroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: a phase 2 clinical trial. JAMA Oncol. 2019 Apr 18. [Epub ahead of print] link to original article PubMed
ECF
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ECF: Epirubicin, Cisplatin, Fluorouracil
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rao et al. 2005 | Phase III (E) | FELV | Seems not superior |
Chemotherapy
- Epirubicin (Ellence) 50 mg/m2 IV once on day 1
- Cisplatin (Platinol) 60 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 200 mg/m2/day IV continuous infusion over 21 days, started on day 1 (total dose per cycle: 4200 mg/m2)
21-day cycles
References
- Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. link to original article contains verified protocol link to PMC article PubMed
Erlotinib & Bevacizumab
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Regimen
Study | Evidence |
---|---|
Lubner et al. 2010 | Phase II |
Chemotherapy
- Erlotinib (Tarceva) 150 mg PO once per day
- Bevacizumab (Avastin) 5 mg/kg IV once per day on days 1 & 15
28-day cycles
References
- Lubner SJ, Mahoney MR, Kolesar JL, Loconte NK, Kim GP, Pitot HC, Philip PA, Picus J, Yong WP, Horvath L, Van Hazel G, Erlichman CE, Holen KD. Report of a multicenter phase II trial testing a combination of biweekly bevacizumab and daily erlotinib in patients with unresectable biliary cancer: a phase II Consortium study. J Clin Oncol. 2010 Jul 20;28(21):3491-7. Epub 2010 Jun 7. link to original article contains verified protocol link to PMC article PubMed
FELV
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FELV: Fluorouracil , Etoposide, LeucoVorin (Folinic acid)
Variant #1, 500/120/60
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Glimelius et al. 1996 | Phase III (E) | Best supportive care | Superior OS |
Chemotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 3, given first
- Etoposide (Vepesid) 120 mg/m2 IV over 40 minutes once per day on days 1 to 3, given second
- Folinic acid (Leucovorin) 60 mg/m2 IV bolus once per day on days 1 to 3, given third
21-day cycles
Variant #2, 600/120/60
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rao et al. 2005 | Phase III (C) | ECF | Seems not superior |
Chemotherapy
- Fluorouracil (5-FU) 600 mg/m2 IV bolus once per day on days 1 to 3, given first
- Etoposide (Vepesid) 120 mg/m2 IV over 40 minutes once per day on days 1 to 3, given second
- Folinic acid (Leucovorin) 60 mg/m2 IV bolus once per day on days 1 to 3, given third
21-day cycles
References
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed content property of HemOnc.org
- Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. link to original article contains verified protocol link to PMC article PubMed
Fluorouracil & Folinic acid
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FUFA: 5-FU (Fluorouracil) & Folinic Acid
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Glimelius et al. 1996 | Phase III (E) | Best supportive care | Superior OS |
Chemotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 & 2, given first
- Folinic acid (Leucovorin) 60 mg/m2 IV bolus once per day on days 1 & 2, given second, 40 minutes after Fluorouracil (5-FU)
14-day cycles
References
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed
Fluorouracil, Folinic acid, Gemcitabine
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Regimen
Study | Evidence |
---|---|
Gebbia et al. 2001 | Phase II |
Chemotherapy
- Fluorouracil (5-FU) 400 mg/m2 IV bolus once on day 1, then 600 mg/m2 IV continuous infusion over 22 hours (total dose per cycle: 1000 mg/m2)
- Folinic acid (Leucovorin) 100 mg/m2 IV over 2 hours once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycles
References
- Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. link to original article contains verified protocol PubMed
Gemcitabine monotherapy
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Variant #1
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Valle et al. 2010 (ABC-02) | Phase III (E) | Cisplatin & Gemcitabine | Inferior OS |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycle for 3 to 6 cycles depending on response
Variant #2
Study | Evidence |
---|---|
Gebbia et al. 2001 | Phase II |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
30-day cycles
References
- Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M. Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol. 2001 Oct 15;19(20):4089-91. link to original article contains verified protocol PubMed
- ABC-02: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. link to original article contains verified protocol PubMed
Gemcitabine, Cisplatin, S-1
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GCS: Gemcitabine, Cisplatin, S-1
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Sakai et al. 2018 (KHBO1401-MITSUBA) | Phase III (E) | Cisplatin & Gemcitabine | Seems to have superior OS |
Chemotherapy
- Cisplatin (Platinol) 25 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once on day 1
- Tegafur, gimeracil, oteracil (S-1) 80 mg/m2 PO once per day on days 1 to 7
14-day cycles
References
- Abstract: Sakai D, Kanai M , Kobayashi S, Eguchi H, Baba H, Seo S, Taketomi A, Takayama T, Yamaue H, Ishioka C, Sho M, Takeyama Y, Fujimoto J, Toyoda M, Shimizu J, Goto T, Yoshimura K, Hatano E, Nagano H, Ioka T. Randomized phase III study of gemcitabine, cisplatin plus S-1 (GCS) versus gemcitabine, cisplatin (GC) for advanced biliary tract cancer (KHBO1401-MITSUBA). Annals of Oncology 29 (Supplement 8): viii205–viii270, 2018 link to abstract
Gemcitabine & Mitomycin
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Kornek et al. 2004 | Randomized Phase II (E) | Capecitabine & Mitomycin | Might have inferior ORR |
Chemotherapy
- Gemcitabine (Gemzar) 2000 mg/m2 IV over 30 minutes once per day on days 1 & 15
- Mitomycin (Mutamycin) 8 mg/m2 IV bolus once on day 1
Supportive medications
- Dexamethasone (Decadron) and 5-HT3 antagonists on the day of IV chemotherapy
28-day cycles
References
- Kornek GV, Schuell B, Laengle F, Gruenberger T, Penz M, Karall K, Depisch D, Lang F, Scheithauer W. Mitomycin C in combination with capecitabine or biweekly high-dose gemcitabine in patients with advanced biliary tract cancer: a randomised phase II trial. Ann Oncol. 2004 Mar;15(3):478-83. link to original article contains verified protocol PubMed
Gemcitabine & nab-Paclitaxel
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NG: Nab-Paclitaxel & Gemcitabine
Regimen
Study | Evidence |
---|---|
Sahai et al. 2018 | Phase II |
Note: this regimen was intended for ECOG PS 0 to 2, and Child-Pugh score less than 8.
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1, 8, 15
- Paclitaxel, nanoparticle albumin-bound (Abraxane) 125 mg/m2 IV once per day on days 1, 8, 15
28-day cycles
References
- Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. nab-Paclitaxel and gemcitabine as first-line treatment of advanced or metastatic cholangiocarcinoma: a phase 2 clinical trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. link to original article contains protocol PubMed
GemOx
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GemOx: Gemcitabine & Oxaliplatin
GEMOX: GEMcitabine & OXaliplatin
Variant #1, 1000/85, bi-weekly
Study | Evidence | Efficacy |
---|---|---|
Halim et al. 2011 | Phase II | ORR: 27.5% |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once on day 1, given first
- Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours once on day 1, given second
14-day cycles
Variant #2, 1000/100, bi-weekly
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Lee et al. 2011 (SMC 2008-12-024) | Phase III (C) | GEMOX & Erlotinib | Might have inferior PFS |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once on day 1
- Oxaliplatin (Eloxatin) 100 mg/m2 IV once on day 2
14-day cycles
Variant #3, 1000/100, 2 weeks out of 3
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Kim et al. 2019 (SMC 2011-05-070) | Phase III (C) | XELOX | Non-inferior PFS |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Oxaliplatin (Eloxatin) 100 mg/m2 IV once on day 1
21-day cycle for 8 cycles
Variant #4, 1000/100 ("GEMOX-3")
Study | Evidence | Efficacy |
---|---|---|
Harder et al. 2006 | Phase II | ORR: 26% (95% CI 14–44) |
GEMOX-3: GEMcitabine & OXaliplatin, 3 visits per month
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, given first
- Oxaliplatin (Eloxatin) 100 mg/m2 IV over 2 hours once per day on days 1 & 15, given second
28-day cycles
References
- Harder J, Riecken B, Kummer O, Lohrmann C, Otto F, Usadel H, Geissler M, Opitz O, Henss H. Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. Br J Cancer. 2006 Oct 9;95(7):848-52. link to PMC article contains verified protocol PubMed
- Halim A, Ebrahim MA, Saleh Y. A phase II study of outpatient biweekly gemcitabine-oxaliplatin in advanced biliary tract carcinomas. Jpn J Clin Oncol. 2011 Feb;41(2):217-24. link to original article contains verified protocol PubMed
- SMC 2008-12-024: Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. Epub 2011 Dec 20. link to original article contains protocol PubMed
- SMC 2011-05-070: Kim ST, Kang JH, Lee J, Lee HW, Oh SY, Jang JS, Lee MA, Sohn BS, Yoon SY, Choi HJ, Hong JH, Kim MJ, Kim S, Park YS, Park JO, Lim HY. Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial. Ann Oncol. 2019 May 1;30(5):788-795. link to original article contains protocol PubMed
GEMOX-B
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GEMOX-B: GEMcitabine, OXaliplatin, Bevacizumab
Regimen
Study | Evidence |
---|---|
Zhu et al. 2009 (MGH 05-349) | Phase II |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 100 minutes once per day on days 1 & 15, given second
- Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours once per day on days 1 & 15, given third
- Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15, given first
28-day cycles
References
- MGH 05-349: Zhu AX, Meyerhardt JA, Blaszkowsky LS, Kambadakone AR, Muzikansky A, Zheng H, Clark JW, Abrams TA, Chan JA, Enzinger PC, Bhargava P, Kwak EL, Allen JN, Jain SR, Stuart K, Horgan K, Sheehan S, Fuchs CS, Ryan DP, Sahani DV. Efficacy and safety of gemcitabine, oxaliplatin, and bevacizumab in advanced biliary-tract cancers and correlation of changes in 18-fluorodeoxyglucose PET with clinical outcome: a phase 2 study. Lancet Oncol. 2010 Jan;11(1):48-54. Epub 2009 Nov 20. link to original article contains verified protocol PubMed
Pembrolizumab monotherapy
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Regimen
Study | Evidence |
---|---|
Le et al. 2017 (KEYNOTE-016) | Phase II, <20 pts of this subtype |
Note: KEYNOTE-016 was an expansion to a CRC-specific trial.
Immunotherapy
- Pembrolizumab (Keytruda) 10 mg/kg IV once on day 1
14-day cycle for up to 2 years
References
- KEYNOTE-016: Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. link to original article link to PMC article contains verified protocol in supplement PubMed
Regorafenib monotherapy
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Regimen
Study | Evidence |
---|---|
Sun et al. 2019 | Phase II |
Only studied in patients with advanced biliary cancer who failed at least 1 line of systemic therapy.
Chemotherapy
- Regorafenib (Stivarga) 120 mg PO once per day on days 1 to 21
28-day cycles
References
- Sun W, Patel A, Normolle A, Patel K, Ohr J, Lee JJ, Bahary N, Chu E, Streeter N, Drummond S. A phase 2 trial of regorafenib as a single agent in patients with chemotherapy‐refractory, advanced, and metastatic biliary tract adenocarcinoma. Cancer. 2019 Mar 15;125(6):902-909. Epub 2018 Dec 18. link to original article link to PMC article PubMed