Cholangiocarcinoma
Page editor | Section editor | ||
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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
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Liver cancer or hepatobiliary cancer comprises cancers that arise within the liver and its hepatocytes (hepatocellular carcinoma) and the biliary tract cancers, which include bile duct cancer/cholangiocarcinoma and gallbladder cancer.
Guidelines
ESMO
- 2016: Valle et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
NCCN
Adjuvant therapy
Capecitabine & Gemcitabine
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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, then Fluorouracil & RT, then Gemcitabine
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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:
Chemoradiotherapy
- Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion throughout radiation therapy
- 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 2
- 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
Gemcitabine and Oxaliplatin
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Edeline et al. (PRODIGE 12-ACCORD 18-UNICANCER GI) | Phase III (C) | Observation | Inferior RFS |
Chemotherapy
· Gemcitabine 1,000 mg/m2 on day 1
· Oxaliplatin 85 mg/m2 infused on day 2
2-week cycle for 12 cycles
Preceding treatment
· Surgical resection with macroscopically curative resection
References
- PRODIGE 12-ACCORD 18-UNICANCER GI: Edeline, J, Benabdelghani M, Bertaut , Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assenat E, François Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardiere C, Lombard-Bohas 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. Journal of Clinical Oncology. 2019 Feb 1. 37 (8):658-667. https://doi. org/10.1200/JCO.18. 00050.
Capecitabine
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Primrose et al (BILCAP) | Phase III (E) | Observation | Superior OS |
Chemotherapy
· Capecitabine (Xeloda) 1250 mg/m² twice daily on days 1–14
21-day cycles x 8 cycles
Preceding treatment
· Surgical resection with macroscopically curative resection
References
- BILCAP: Primrose JN, Fox RP, Palmer DH, Malik HZ, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wason H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma TY, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre,phase 3 study. Lancet. 2019 Mar 25. http://dx.doi.org/10.1016/ S1470-2045(18)30915-X
Gemcitabine
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Ebata et al. 2018 (BCAT) | Phase III (C) | Observation | Seems not superior |
Chemotherapy
· Gemcitabine 1000 mg/m2, administered on days 1, 8 and 15
Every 28 days for six cycles
Preceding treatment[edit | edit source]
· Surgical resection with macroscopically curative resection
References
1. 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. DOI: 10.1002/bjs.10776
Observation
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Ebata et al. 2018 (BCAT) | Phase III (C) | Gemcitabine | 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
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
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
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 & 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
Gemcitabine & Oxaliplatin for biliary tract cancer
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
BGJ (FGFR kinase inhibitor)
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Regimen
Study | Evidence |
---|---|
Jayne et al | Phase II |
Note: studied in advanced or metastatic cholangiocarcinoma containing FGFR2 fusions or other FGFR alterations whose disease had progressed while receiving prior therapy
Targeted therapy
· BGJ398 125 mg once daily for 21 days, then 7 days off
28 day cycle
References
- Javle M, Lowery M, Shroff RT, Heinz Weiss K, Springfeld C, Borad MJ, Ramanathan RK, Goyal L, Sadeghi S, Macarulla T, El-Khoueiry A, Kelley RK, Borbath I, Choo SP, Oh DY, Philip PA, Chen LT, Reungwetwattana T, Cutsem EV, Yeh KH, Ciombor K, Finn RS, Patel A, Sen S, Porter D, Isaacs R, Zhu AX, Abou-Alfa GK, Bekaii-Saab, TB. Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma. 2018 Jan 20. 36 (2); 276-282. DOI: https://doi.org/10.1200/JCO.2017. 75.5009.
Gemcitabine, Cisplatin, S-1
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Sakai et al (KHBO1401-MITSUBA) | Phase III | Gemcitabine and Cisplatin | Seems to have superior OS |
Chemotherapy
· Gemcitabine 1,000 mg/m2 IV on day 1
· Cisplatin 25 mg/m2 IV on day 1
· S-1 80 mg/m2 PO on days 1-7
Every 2 weeks
References
- 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 doi:10.1093/annonc/mdy282.