Cholangiocarcinoma

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29 regimens on this page 35 variants on this page

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

• Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. PubMed

NCCN

• NCCN Guidelines - Hepatobiliary Cancers

All lines of therapy

Best supportive care

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Regimen

Study	Evidence	Comparator	Efficacy
Glimelius et al. 1996	Phase III	FELv	Inferior OS
		Fluorouracil & Folinic acid	Inferior OS

No antineoplastic treatment. Included for reference purposes only.

References

1. 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 BID on days 1 to 14

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

Capecitabine & Mitomycin

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Regimen

Study	Evidence	Comparator	Efficacy
Kornek et al. 2004	Randomized Phase II	Gemcitabine & Mitomycin	Might have superior ORR

Chemotherapy

• Capecitabine (Xeloda) 1000 mg/m² PO BID 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

1. 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	Gemcitabine	Superior OS

Chemotherapy

• Cisplatin (Platinol) 25 mg/m² IV over 1 hour 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

1. 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	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 on days 1 to 21

21-day cycles

References

1. 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, given until progression of disease or unacceptable toxicity

References

1. 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 #1

Study	Evidence	Comparator	Efficacy
Rao et al. 2005	Phase III	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 last

21-day cycles

Regimen #2

Study	Evidence	Comparator	Efficacy
Glimelius et al. 1996	Phase III	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 last

21-day cycles

References

1. 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
2. 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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Regimen

Study	Evidence	Comparator	Efficacy
Glimelius et al. 1996	Phase III	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

1. 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, then 600 mg/m² IV continuous infusion over 22 hours on day 1
• 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

1. 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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Regimen #1

Study	Evidence	Comparator	Efficacy
Valle et al. 2010 (ABC-02)	Phase III	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

Regimen #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

1. 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
2. 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	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

1. 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 & Oxaliplatin

Gemcitabine & Oxaliplatin for biliary tract cancer

GEMOX-B

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GEMOX-B: GEMcitabine, OXaliplatin, Bevacizumab

Regimen

Study	Evidence
Zhu et al. 2009	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 last
• Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15, given first

28-day cycles

References

1. 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