Gallbladder cancer

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Neeta K. Venepalli, MD, MBA
University of Illinois at Chicago
Chicago, IL
4 regimens on this page
6 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 & Gemcitabine

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GemCap: Gemcitabine & Capecitabine

Regimen

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

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

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 Seems not superior
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) 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) 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) GEMOX & Erlotinib 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