Revision as of 20:34, 16 January 2020

Page editor		Section editor
	Ari Seifter, MD University of Illinois at Chicago Chicago, IL		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

2016: Valle et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

NCCN

NCCN Guidelines - Hepatobiliary Cancers

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

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

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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

Surgical resection

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

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

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

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
Sharma et al. 2010	Randomized (C)	2. mGEMOX	Seems to have inferior OS

No active antineoplastic treatment.

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. link to original article contains protocol PubMed

Capecitabine monotherapy

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Regimen

Study	Evidence
Patt et al. 2004	Retrospective

3 of 37 patients (8%) had primary gallbladder cancer.

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-switch-ic)	Gemcitabine & Mitomycin	Might have superior ORR

14 of 51 enrolled patients (27%) had primary gallbladder cancer.

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-switch-ic)	GEMOX	Non-inferior PFS

61 of 222 enrolled patients (22%) had primary gallbladder cancer.

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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GC: Gemcitabine & Cisplatin

Regimen

Study	Evidence	Comparator	Comparative Efficacy	Years of study
Valle et al. 2010 (ABC-02)	Phase III (E-esc)	Gemcitabine	Superior OS	2002-2008
Morizane et al. 2019 (FUGA-BT)	Phase III (C)	Gemcitabine & S-1	Seems to have non-inferior OS	2013-2016

In the Valle et al. study, 149 of 410 enrolled patients (36%) had primary gallbladder cancer.

In the Morizane et al. study, 137 of 354 enrolled patients (39%) had primary gallbladder cancer.

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
FUGA-BT: Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. link to original article 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.

13 of 60 patients (22%) had primary gallbladder cancer.

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-switch-ic)	FELV	Did not meet primary endpoint of OS

26 of 114 enrolled patients (23%) had primary gallbladder cancer.

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

10 of 54 patients (19%) included in endpoint analysis had primary gallbladder cancer.

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)

Regimen

Study	Evidence	Comparator	Efficacy
Rao et al. 2005	Phase III (C)	ECF	Did not meet primary endpoint of OS

26 of 54 enrolled patients (48%) had primary gallbladder cancer.

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

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, Gemcitabine

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Regimen

Study	Evidence
Gebbia et al. 2001	Phase II

22 of 40 enrolled patients (55%) had primary gallbladder cancer.

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-de-esc)	Cisplatin & Gemcitabine	Inferior OS

149 of 410 enrolled patients (36%) had primary gallbladder cancer.

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

22 of 40 enrolled patients (55%) had primary gallbladder cancer.

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-esc)	Cisplatin & Gemcitabine	Seems to have superior OS

Although patients with primary gallbladder cancer met eligibility criteria, the relative number of patients enrolled was not reported in the presented abstract.

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-switch-ic)	Capecitabine & Mitomycin	Might have inferior ORR

14 of 51 enrolled patients (27%) had primary gallbladder cancer.

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 & S-1

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GS: Gemcitabine & S-1

Regimen

Study	Evidence	Comparator	Comparative Efficacy	Years of study
Morizane et al. 2019 (FUGA-BT)	Phase III (E-switch-ic)	Gemcitabine & Cisplatin	Seems to have non-inferior OS	2013-2016

137 of 354 enrolled patients (39%) had primary gallbladder cancer.

Chemotherapy

References

FUGA-BT: Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. link to original article 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
Sharma et al. 2010	Randomized (E-esc)	2. FUFA	Not reported

All 81 patients enrolled in this study had primary gallbladder cancer

Chemotherapy

Gemcitabine (Gemzar) 900 mg/m² IV once per day on days 1 & 8
Oxaliplatin (Eloxatin) 80 mg/m² IV once per day on days 1 & 8

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

82 of 268 enrolled patients (31%) had primary gallbladder cancer

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

61 of 222 enrolled patients (22%) had primary gallbladder cancer.

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, 1000/85, bi-weekly

Study	Evidence	Efficacy
Halim et al. 2011	Phase II	ORR: 27.5%

14 of 40 enrolled patients (35%) had primary gallbladder cancer

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 #5, 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

10 of 31 enrolled patients (32%) had primary gallbladder cancer.

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

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
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
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
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

GEMOX-B

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GEMOX-B: GEMcitabine, OXaliplatin, Bevacizumab

10 of 35 enrolled patients (29%) had primary gallbladder cancer.

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

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.

5 of 43 enrolled patients (12%) had primary gallbladder cancer.

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

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 ====Chemotherapy====
@@ Line 294: / Line 294: @@
 #'''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]
+#'''FUGA-BT:''' Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. [https://academic.oup.com/annonc/article-abstract/30/12/1950/5578479 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/31566666 PubMed]
+<br />
+==Cisplatin, Gemcitabine, nab-Paclitaxel {{#subobject:17f9f2|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Regimen {{#subobject:e6a3e3|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[https://jamanetwork.com/journals/jamaoncology/article-abstract/2730639 Shroff et al. 2019 (MDACC 2014-0524)]
+| style="background-color:#91cf61" |Phase II
+|}''Prolonged median PFS and OS vs reported for historical controls treated with gemcitabine-cisplatin alone.''
+''13 of 60 patients (22%) had  primary gallbladder cancer.''
+====Chemotherapy====
+*[[Cisplatin (Platinol)]] 25 mg/m<sup><font size="2">2</font></sup> IV over 60 minutes once per day on days 1 & 8
+*[[Gemcitabine (Gemzar)]] 800 mg/m<sup><font size="2">2</font></sup> IV once per day on days 1 & 8
+*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup><font size="2">2</font></sup> 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] [https://jamanetwork.com/journals/jamaoncology/article-abstract/2730639 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/30998813 PubMed]
+<br />
+==ECF {{#subobject:57bd6d|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}ECF: '''<u>E</u>'''pirubicin, '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil
+===Regimen {{#subobject:f87869|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.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ Rao et al. 2005]
+| style="background-color:#1a9851" |Phase III (E-switch-ic)
+|[[Cholangiocarcinoma#FELV|FELV]]
+| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
+|-
+|}
+''26 of 114 enrolled patients (23%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Epirubicin (Ellence)]] 50 mg/m<sup><font size="2">2</font></sup> IV once on day 1
+*[[Cisplatin (Platinol)]] 60 mg/m<sup><font size="2">2</font></sup> IV once on day 1
+*[[Fluorouracil (5-FU)]] 200 mg/m<sup><font size="2">2</font></sup>/day IV continuous infusion over 21 days, started on day 1 (total dose per cycle: 4200 mg/m<sup><font size="2">2</font></sup>)
+'''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. [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]
+<br />
+==Erlotinib & Bevacizumab {{#subobject:CMR1|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Regimen {{#subobject:CMV1|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917213/ Lubner et al. 2010]
+| style="background-color:#91cf61" |Phase II
+|-
+|}
+''10 of 54 patients (19%) included in endpoint analysis had primary gallbladder cancer.''
+====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. [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]
+<br />
+==FELV {{#subobject:3658a8|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}FELV: '''<u>F</u>'''luorouracil , '''<u>E</u>'''toposide, '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid)
+===Regimen {{#subobject:8e152d|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.ncbi.nlm.nih.gov/pmc/articles/PMC2362051/ Rao et al. 2005]
+| style="background-color:#1a9851" |Phase III (C)
+|[[Cholangiocarcinoma#ECF|ECF]]
+| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
+|-
+|}
+''26 of 54 enrolled patients (48%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Fluorouracil (5-FU)]] 600 mg/m<sup><font size="2">2</font></sup> IV bolus once per day on days 1 to 3, '''given first'''
+*[[Etoposide (Vepesid)]] 120 mg/m<sup><font size="2">2</font></sup> IV over 40 minutes once per day on days 1 to 3, '''given second'''
+*[[Folinic acid (Leucovorin)]] 60 mg/m<sup><font size="2">2</font></sup> IV bolus once per day on days 1 to 3, '''given third'''
+'''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. [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]
+<br />
+==Fluorouracil, Folinic acid, Gemcitabine {{#subobject:eb427f|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Regimen {{#subobject:85fb7b|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001]
+| style="background-color:#91cf61" |Phase II
+|-
+|}
+''22 of 40 enrolled patients (55%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Fluorouracil (5-FU)]] 400 mg/m<sup><font size="2">2</font></sup> IV bolus once on day 1, then 600 mg/m<sup><font size="2">2</font></sup> IV continuous infusion over 22 hours (total dose per cycle: 1000 mg/m<sup><font size="2">2</font></sup>)
+*[[Folinic acid (Leucovorin)]] 100 mg/m<sup><font size="2">2</font></sup> IV over 2 hours once on day 1
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> 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. [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]
+<br />
+==Gemcitabine monotherapy {{#subobject:1129f1|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Variant #1 {{#subobject:b0f450|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.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)]
+| style="background-color:#1a9851" |Phase III (E-de-esc)
+|[[Cholangiocarcinoma#Cisplatin .26 Gemcitabine|Cisplatin & Gemcitabine]]
+| style="background-color:#d73027" |Inferior OS
+|-
+|}
+''149 of 410 enrolled patients (36%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> 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 {{#subobject:fcd6f1|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001]
+| style="background-color:#91cf61" |Phase II
+|-
+|}
+''22 of 40 enrolled patients (55%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> 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. [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]
+<br />
+==Gemcitabine, Cisplatin, S-1 {{#subobject:e0d17a|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}GCS: '''<u>G</u>'''emcitabine, '''<u>C</u>'''isplatin, '''<u>S</u>'''-1
+===Regimen {{#subobject:87f9c7|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://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 Sakai et al. 2018 (KHBO1401-MITSUBA)]
+| style="background-color:#1a9851" |Phase III (E-esc)
+|[[Cholangiocarcinoma#Cisplatin .26 Gemcitabine|Cisplatin & Gemcitabine]]
+| style="background-color:#d9ef8b" |Seems to have superior OS
+|}
+''Although patients with primary gallbladder cancer met eligibility criteria, the relative number of patients enrolled was not reported in the presented abstract.''
+====Chemotherapy====
+*[[Cisplatin (Platinol)]] 25 mg/m<sup><font size="2">2</font></sup> IV once on day 1
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> IV once on day 1
+*[[Tegafur, gimeracil, oteracil (S-1)]] 80 mg/m<sup><font size="2">2</font></sup> 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 [https://academic.oup.com/annonc/article/29/suppl_8/mdy282/5140253 link to abstract]
+<br />
+==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Regimen {{#subobject:42a188|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]]
+|-
+|[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004]
+| style="background-color:#1a9851" |Randomized Phase II (E-switch-ic)
+|[[Cholangiocarcinoma#Capecitabine .26 Mitomycin|Capecitabine & Mitomycin]]
+| style="background-color:#fee08b" |Might have inferior ORR
+|-
+|}
+''14 of 51 enrolled patients (27%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 2000 mg/m<sup><font size="2">2</font></sup> IV over 30 minutes once per day on days 1 & 15
+*[[Mitomycin (Mutamycin)]] 8 mg/m<sup><font size="2">2</font></sup> IV bolus once on day 1
+====Supportive medications====
+*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin 5-HT3 antagonists|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. [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]
+<br />
+==Gemcitabine & S-1 {{#subobject:afbc17|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}GS: '''<u>G</u>'''emcitabine & '''<u>S</u>'''-1
+===Regimen {{#subobject:cb3b9cd|Variant=1}}===
+{| class="wikitable" style="width: 100%; text-align:center;"
+! style="width: 20%" |Study
+! style="width: 20%" |[[Levels of Evidence#Evidence|Evidence]]
+! style="width: 20%" |Comparator
+! style="width: 20%" |[[Levels of Evidence#Comparative efficacy|Comparative Efficacy]]
+! style="width: 20%" |Years of study
+|-
+|[https://academic.oup.com/annonc/article-abstract/30/12/1950/5578479 Morizane et al. 2019 (FUGA-BT)]
+| style="background-color:#1a9851" |Phase III (E-switch-ic)
+|[[Cholangiocarcinoma#Gemcitabine .26 Cisplatin|Gemcitabine & Cisplatin]]
+| style="background-color:#eeee01" |Seems to have non-inferior OS
+|2013-2016
+|-
+|}
+''137 of 354 enrolled patients (39%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]]
+*[[Tegafur, gimeracil, oteracil (S-1)]]
+===References===
 #'''FUGA-BT:''' Morizane C, Okusaka T, Mizusawa J, Katayama H, Ueno M, Ikeda M, Ozaka M, Okano N, Sugimori K, Fukutomi A, Hara H, Mizuno N, Yanagimoto H, Wada K, Tobimatsu K, Yane K, Nakamori S, Yamaguchi H, Asagi A, Yukisawa S, Kojima Y, Kawabe K, Kawamoto Y, Sugimoto R, Iwai T, Nakamura K, Miyakawa H, Yamashita T, Hosokawa A, Ioka T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Combination gemcitabine plus S-1 versus gemcitabine plus cisplatin for advanced/recurrent biliary tract cancer: the FUGA-BT (JCOG1113) randomized phase III clinical trial. Ann Oncol. 2019 Dec 1;30(12):1950-1958. [https://academic.oup.com/annonc/article-abstract/30/12/1950/5578479 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/31566666 PubMed]
@@ Line 319: / Line 610: @@
 |-
 |}
+''All 81 patients enrolled in this study had primary gallbladder cancer''
 ====Chemotherapy====
@@ Line 339: / Line 632: @@
 |-
 |}
+''82 of 268 enrolled patients (31%) had primary gallbladder cancer''
 ====Chemotherapy====
@@ Line 359: / Line 654: @@
 |-
 |}
+''61 of 222 enrolled patients (22%) had primary gallbladder cancer.''
 ====Chemotherapy====
@@ Line 365: / Line 662: @@
 '''21-day cycle for 8 cycles'''
+===Variant #4, 1000/85, bi-weekly {{#subobject:508f1b|Variant=1}}===
+{| class="wikitable" style="width: 75%; text-align:center;"
+! style="width: 33%" |Study
+! style="width: 33%" |[[Levels of Evidence#Evidence|Evidence]]
+! style="width: 33%" |[[Levels of Evidence#Efficacy|Efficacy]]
+|-
+|[https://academic.oup.com/jjco/article/41/2/217/875887 Halim et al. 2011]
+| style="background-color:#91cf61" |Phase II
+|ORR: 27.5%
+|-
+|}
+''14 of 40 enrolled patients (35%) had primary gallbladder cancer''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> IV over 30 minutes once on day 1, '''given first'''
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup><font size="2">2</font></sup> IV over 2 hours once on day 1, '''given second'''
+'''14-day cycles'''
+===Variant #5, 1000/100 ("GEMOX-3") {{#subobject:a8fefg|Variant=1}}===
+{| class="wikitable" style="width: 75%; text-align:center;"
+! style="width: 33%" |Study
+! style="width: 33%" |[[Levels of Evidence#Evidence|Evidence]]
+! style="width: 33%" |[[Levels of Evidence#Efficacy|Efficacy]]
+|-
+|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360533/ Harder et al. 2006]
+| style="background-color:#91cf61" |Phase II
+|ORR: 26% (95% CI 14–44)
+|-
+|}GEMOX-3: '''<u>GEM</u>'''citabine & '''<u>OX</u>'''aliplatin, 3 visits per month
+''10 of 31 enrolled patients (32%) had primary gallbladder cancer.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> IV over 30 minutes once per day on days 1, 8, 15, '''given first'''
+*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup><font size="2">2</font></sup> IV over 2 hours once per day on days 1 & 15, '''given second'''
+'''28-day cycles'''
 ===References===
@@ Line 371: / Line 706: @@
 #'''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]
+#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]
+==GEMOX-B {{#subobject:119bb0|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}GEMOX-B: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin, '''<u>B</u>'''evacizumab
+''10 of 35 enrolled patients (29%) had primary gallbladder cancer.''
+===Regimen {{#subobject:3748a1|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970333-X/fulltext Zhu et al. 2009 (MGH 05-349)]
+| style="background-color:#91cf61" |Phase II
+|-
+|}
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup><font size="2">2</font></sup> IV over 100 minutes once per day on days 1 & 15, '''given second'''
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup><font size="2">2</font></sup> 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. [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]
+==Regorafenib monotherapy {{#subobject:17f9f2|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[Cholangiocarcinoma#top|back to top]]
+|}
+===Regimen {{#subobject:e6a3e3|Variant=1}}===
+{| class="wikitable" style="width: 50%; text-align:center;"
+! style="width: 50%" |Study
+! style="width: 50%" |[[Levels of Evidence#Evidence|Evidence]]
+|-
+|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402964/ Sun et al. 2019]
+| style="background-color:#91cf61" |Phase II
+|}''Only studied in patients with advanced biliary cancer who failed at least 1 line of systemic therapy.''
+''5 of 43 enrolled patients (12%) had primary gallbladder cancer.''
+====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. [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:Gallbladder cancer regimens]]
 [[Category:Disease-specific pages]]
 [[Category:Hepatobiliary cancers]]

Difference between revisions of "Gallbladder cancer"

Revision as of 20:34, 16 January 2020

Guidelines

ESMO

NCCN

Adjuvant therapy

Capecitabine monotherapy

Regimen

Preceding treatment

Chemotherapy

References

Capecitabine & Gemcitabine

Regimen

Preceding treatment

Chemotherapy

Subsequent treatment

References

GemOx

Regimen

Preceding treatment

Chemotherapy

References

Metastatic or unresectable disease, all lines of therapy

Best supportive care

Regimen

References

Capecitabine monotherapy

Regimen

Chemotherapy

References

Capecitabine & Mitomycin

Regimen

Chemotherapy

Supportive medications

References

CapeOx

Regimen

Chemotherapy

References

Cisplatin & Gemcitabine

Regimen

Chemotherapy

Supportive medications

References

Cisplatin, Gemcitabine, nab-Paclitaxel

Regimen

Chemotherapy

References

ECF

Regimen

Chemotherapy

References

Erlotinib & Bevacizumab

Regimen

Chemotherapy

References

FELV

Regimen

Chemotherapy

References

Fluorouracil, Folinic acid, Gemcitabine

Regimen

Chemotherapy

References

Gemcitabine monotherapy

Variant #1

Chemotherapy

Variant #2

Chemotherapy

References

Gemcitabine, Cisplatin, S-1

Regimen

Chemotherapy

References

Gemcitabine & Mitomycin

Regimen

Chemotherapy

Supportive medications

References

Gemcitabine & S-1