Difference between revisions of "Gallbladder cancer"

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(Added adjuvant regimens from biliary tract page which had subsets of gallbladder cancer patients)
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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<big>Note: there is some overlap, especially in the earlier literature, between treatment regimens for gallbladder cancer and those for '''[[pancreatic cancer|pancreatic adenocarcinoma]]''', '''[[periampullary adenocarcinoma]]''', and '''[[cholangiocarcinoma]]; please see those pages for additional regimens.</big>
+
<big>Note: there is some overlap, especially in the earlier literature, between treatment regimens for gallbladder cancer and those for '''[[pancreatic cancer|pancreatic adenocarcinoma]]''', '''[[periampullary adenocarcinoma]]''', and '''[[cholangiocarcinoma]]; please see those pages for additional regimens.'''</big>
  
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=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]
  
 
=Adjuvant therapy=
 
=Adjuvant therapy=
 +
<br />
 +
==Capecitabine monotherapy {{#subobject:f4c3d9|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[Cholangiocarcinoma#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:3a3bdf|Variant=1}}===
 +
{| class="wikitable" style="width: 100%; text-align:center;"
 +
! style="width: 25%" |Study
 +
! style="width: 25%" |[[Levels of Evidence#Evidence|Evidence]]
 +
! style="width: 25%" |Comparator
 +
! style="width: 25%" |[[Levels of Evidence#Efficacy|Efficacy]]
 +
|-
 +
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18)30915-X/fulltext Primrose et al. 2019 (BILCAP)]
 +
| style="background-color:#1a9851" |Phase III (E-esc)
 +
|[[Cholangiocarcinoma#Observation|Observation]]
 +
| style="background-color:#d9ef8b" |Might have superior OS
 +
|}
 +
<nowiki>*</nowiki>79 of 447 enrolled patients (17.7%) had primary gallbladder cancer
 +
 +
====Preceding treatment====
 +
 +
*[[Surgery|Surgical resection]] with macroscopically curative resection
 +
*Chemotherapy start date 8-16 weeks after surgery
 +
 +
====Chemotherapy====
 +
 +
*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> 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. [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]
 +
 +
<br />
 
==Capecitabine & Gemcitabine {{#subobject:17f9f2|Regimen=1}}==
 
==Capecitabine & Gemcitabine {{#subobject:17f9f2|Regimen=1}}==
 
{| class="wikitable" style="float:right; margin-left: 5px;"
 
{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
 
|-
 
|}
 
|}
 +
<nowiki>*</nowiki>25 of 79 enrolled patients (32%) had primary gallbladder cancer
 +
 
====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]
 +
 
 +
<br />
 +
==GemOx {{#subobject:f8c8d9|Regimen=1}}==
 +
{| class="wikitable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[Cholangiocarcinoma#top|back to top]]
 +
|}GemOx: '''<u>Gem</u>'''citabine & '''<u>Ox</u>'''aliplatin
 +
===Regimen {{#subobject:3ghg3f|Variant=1}}===
 +
{| class="wikitable" style="width: 100%; text-align:center;"
 +
! style="width: 25%" |Study
 +
! style="width: 25%" |[[Levels of Evidence#Evidence|Evidence]]
 +
! style="width: 25%" |Comparator
 +
! style="width: 25%" |[[Levels of Evidence#Efficacy|Efficacy]]
 +
|-
 +
|[https://ascopubs.org/doi/full/10.1200/JCO.18.00050 Edeline et al. 2019 (PRODIGE 12-ACCORD 18-UNICANCER GI)]
 +
| style="background-color:#1a9851" |Phase III (E-esc)
 +
|[[Cholangiocarcinoma#Observation|Observation]]
 +
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS
 +
|}
 +
<nowiki>*</nowiki>38 of 194 enrolled patients (20%) had primary gallbladder cancer.
 +
 
 +
====Preceding treatment====
 +
 
 +
*[[Surgery|Surgical resection]] with macroscopically curative resection
 +
 
 +
====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
 +
 
 +
'''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. [https://ascopubs.org/doi/full/10.1200/JCO.18.00050 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30707660 PubMed]
  
 
=Metastatic or unresectable disease, all lines of therapy=
 
=Metastatic or unresectable disease, all lines of therapy=
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===Regimen===
 
===Regimen===
 
{| 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]]
 
|-
 
|-
|rowspan=2|[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
+
| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
|rowspan=2 style="background-color:#1a9851" |Randomized (C)
+
| rowspan="2" style="background-color:#1a9851" |Randomized (C)
 
|1. FUFA
 
|1. FUFA
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
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''No active antineoplastic treatment.''
 
''No active antineoplastic treatment.''
 
===References===
 
===References===
# Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20855823 PubMed]
+
 
 +
#Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20855823 PubMed]
  
 
==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]
  
 
==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)]
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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
 
*[[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]
  
 
==GemOx {{#subobject:c7cmar|Regimen=1}}==
 
==GemOx {{#subobject:c7cmar|Regimen=1}}==
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===Variant #1, 900/80 ("mGEMOX") {{#subobject:b343ca|Variant=1}}===
 
===Variant #1, 900/80 ("mGEMOX") {{#subobject:b343ca|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]]
 
|-
 
|-
|rowspan=2|[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
+
| rowspan="2" |[https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 Sharma et al. 2010]
|rowspan=2 style="background-color:#1a9851" |Randomized (E-esc)
+
| rowspan="2" style="background-color:#1a9851" |Randomized (E-esc)
 
|1. [[#Best_supportive_care|Best supportive care]]
 
|1. [[#Best_supportive_care|Best supportive care]]
 
| style="background-color:#91cf60" |Seems to have superior OS
 
| style="background-color:#91cf60" |Seems to have superior OS
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|}
 
|}
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[Gemcitabine (Gemzar)]] 900 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
*[[Gemcitabine (Gemzar)]] 900 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
*[[Oxaliplatin (Eloxatin)]] 80 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
*[[Oxaliplatin (Eloxatin)]] 80 mg/m<sup>2</sup> IV once per day on days 1 & 8
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===Variant #2, 1000/100, bi-weekly {{#subobject:c652ca|Variant=1}}===
 
===Variant #2, 1000/100, bi-weekly {{#subobject:c652ca|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 173: Line 257:
 
|}
 
|}
 
====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
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===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 192: Line 277:
 
|}
 
|}
 
====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 198: Line 284:
  
 
===References===
 
===References===
# Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20855823 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]
+
#Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. [https://ascopubs.org/doi/full/10.1200/JCO.2010.29.3605 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20855823 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]
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#'''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]
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#'''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]
  
 
[[Category:Gallbladder cancer regimens]]
 
[[Category:Gallbladder cancer regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Hepatobiliary cancers]]
 
[[Category:Hepatobiliary cancers]]

Revision as of 18:38, 25 December 2019

Page editor Section editor
Seifter.jpg
Ari Seifter, MD
University of Illinois at Chicago
Chicago, IL
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Neeta K. Venepalli, MD, MBA
University of Illinois at Chicago
Chicago, IL
21 regimens on this page
26 variants on this page

Note: there is some overlap, especially in the earlier literature, between treatment regimens for gallbladder cancer and those for pancreatic adenocarcinoma, periampullary adenocarcinoma, and cholangiocarcinoma; please see those pages for additional regimens.


Guidelines

ESMO

NCCN

Adjuvant therapy


Capecitabine monotherapy

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Regimen

Study Evidence Comparator Efficacy
Primrose et al. 2019 (BILCAP) Phase III (E-esc) Observation Might have superior OS

*79 of 447 enrolled patients (17.7%) had primary gallbladder cancer

Preceding treatment

  • Surgical resection with macroscopically curative resection
  • Chemotherapy start date 8-16 weeks after surgery

Chemotherapy

21-day cycle for 8 cycles

References

  1. 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

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GemCap: Gemcitabine & Capecitabine

Regimen

Study Evidence
Ben-Josef et al. 2015 (SWOG S0809) Phase II

*25 of 79 enrolled patients (32%) had primary gallbladder cancer

Preceding treatment

Chemotherapy

21-day cycle for 4 cycles

Subsequent treatment

  • Capecitabine & RT

References

  1. 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


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-esc) Observation Did not meet primary endpoint of RFS

*38 of 194 enrolled patients (20%) had primary gallbladder cancer.

Preceding treatment

Chemotherapy

14-day cycle for 12 cycles

References

  1. 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

Metastatic or unresectable disease, all lines of therapy

Best supportive care

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Regimen

Study Evidence Comparator Comparative Efficacy
Sharma et al. 2010 Randomized (C) 1. FUFA Did not meet primary endpoint of OS
2. mGEMOX Seems to have inferior OS

No active antineoplastic treatment.

References

  1. Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article contains protocol PubMed

Capecitabine monotherapy

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Regimen

Study Evidence
Patt et al. 2004 Retrospective

Chemotherapy

21-day cycles

References

  1. 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

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-switch-ic) GEMOX Non-inferior PFS

Chemotherapy

21-day cycle for 8 cycles

References

  1. 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

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GemOx: Gemcitabine & Oxaliplatin
mGEMOX: modified GEMcitabine & OXaliplatin

Variant #1, 900/80 ("mGEMOX")

Study Evidence Comparator Comparative Efficacy
Sharma et al. 2010 Randomized (E-esc) 1. Best supportive care Seems to have superior OS
2. FUFA Not reported

Chemotherapy

21-day cycle for up to 6 cycles

Variant #2, 1000/100, bi-weekly

Study Evidence Comparator Comparative Efficacy
Lee et al. 2011 (SMC 2008-12-024) Phase III (C) E-GEMOX Might have inferior PFS

Chemotherapy

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

21-day cycle for 8 cycles

References

  1. Sharma A, Dwary AD, Mohanti BK, Deo SV, Pal S, Sreenivas V, Raina V, Shukla NK, Thulkar S, Garg P, Chaudhary SP. Best supportive care compared with chemotherapy for unresectable gall bladder cancer: a randomized controlled study. J Clin Oncol. 2010 Oct 20;28(30):4581-6. Epub 2010 Sep 20. link to original article contains protocol PubMed
  2. 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
  3. 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