Difference between revisions of "Hepatocellular carcinoma"
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'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].''' | '''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].''' | ||
− | Is there a regimen missing from this list? | + | Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are [[How_to_contribute|invited to contribute to the site]]. |
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
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− | |<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | |<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} regimens on this page</b></font></div> |
− | <div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | <div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} variants on this page</b></font></div> |
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{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
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===Regimen {{#subobject:51c13b|Variant=1}}=== | ===Regimen {{#subobject:51c13b|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://jco.ascopubs.org/content/26/18/2992.long Siegel et al. 2008] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Bevacizumab (Avastin)]] | + | |} |
+ | ''The dose here was a pre-planned escalation dose.'' | ||
+ | ====Chemotherapy==== | ||
+ | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once on day 1 | ||
'''14-day cycles''' | '''14-day cycles''' | ||
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|} | |} | ||
===Regimen {{#subobject:f3fd07|Variant=1}}=== | ===Regimen {{#subobject:f3fd07|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://www.nature.com/bjc/journal/v102/n6/full/6605580a.html Hsu et al. 2010] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
+ | |- | ||
+ | |} | ||
+ | ====Chemotherapy==== | ||
+ | *[[Bevacizumab (Avastin)]] 7.5 mg/kg IV once on day 1 | ||
+ | *[[Capecitabine (Xeloda)]] 800 mg/m<sup>2</sup> PO BID on days 1 to 14 | ||
− | + | '''21-day cycle for 6 or more cycles depending on response''' | |
− | |||
− | |||
− | '''21-day | ||
===References=== | ===References=== | ||
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|} | |} | ||
===Regimen {{#subobject:231bcb|Variant=1}}=== | ===Regimen {{#subobject:231bcb|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25889/abstract Sun et al. 2011] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Bevacizumab (Avastin)]] 5 mg/kg IV on day 1 | + | |} |
− | **Infusion times for bevacizumab are 75 | + | ====Chemotherapy==== |
− | *[[Capecitabine (Xeloda)]] 825 mg/ | + | *[[Bevacizumab (Avastin)]] 5 mg/kg IV once on day 1 |
− | *[[Oxaliplatin (Eloxatin)]] 130 mg/ | + | **Infusion times for bevacizumab are 75 to 105 minutes for the first dose, which if tolerated could be decreased to 50 to 70 minutes for the second dose, then 20 to 40 minutes for dose 3 and later |
+ | *[[Capecitabine (Xeloda)]] 825 mg/m<sup>2</sup> PO BID on days 1 to 14 | ||
+ | *[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1 | ||
'''21-day cycles''' | '''21-day cycles''' | ||
===References=== | ===References=== | ||
− | # Sun W, Sohal D, Haller DG, Mykulowycz K, Rosen M, Soulen MC, Caparro M, Teitelbaum UR, Giantonio B, O'Dwyer PJ, Shaked A, Reddy R, Olthoff K. Phase 2 trial of bevacizumab, capecitabine, and oxaliplatin in treatment of advanced hepatocellular carcinoma. Cancer. 2011 Jul 15;117(14):3187-92 | + | # Sun W, Sohal D, Haller DG, Mykulowycz K, Rosen M, Soulen MC, Caparro M, Teitelbaum UR, Giantonio B, O'Dwyer PJ, Shaked A, Reddy R, Olthoff K. Phase 2 trial of bevacizumab, capecitabine, and oxaliplatin in treatment of advanced hepatocellular carcinoma. Cancer. 2011 Jul 15;117(14):3187-92. Epub 2011 Jan 24. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25889/abstract link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/21264839 PubMed] |
==Bevacizumab & Erlotinib {{#subobject:9afef8|Regimen=1}}== | ==Bevacizumab & Erlotinib {{#subobject:9afef8|Regimen=1}}== | ||
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|} | |} | ||
===Regimen {{#subobject:112b09|Variant=1}}=== | ===Regimen {{#subobject:112b09|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://jco.ascopubs.org/content/27/6/843.long Thomas et al. 2009] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
+ | |} | ||
+ | ====Chemotherapy==== | ||
*[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15 | ||
− | *[[Erlotinib (Tarceva)]] 150 mg PO once per day | + | *[[Erlotinib (Tarceva)]] 150 mg PO once per day |
'''28-day cycles''' | '''28-day cycles''' | ||
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|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Capecitabine (Xeloda)]] 1000 mg/ | + | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID on days 1 to 14 |
'''21-day cycles''' | '''21-day cycles''' | ||
===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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] | + | # '''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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed] |
# Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. [http://link.springer.com/article/10.1007%2Fs12032-013-0655-z link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] | # Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. [http://link.springer.com/article/10.1007%2Fs12032-013-0655-z link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] | ||
− | ==CapeOx | + | ==CapeOx; XELOX {{#subobject:a86027|Regimen=1}}== |
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
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|} | |} | ||
CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin | CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin | ||
− | <br>XELOX: '''<u>XEL</u>'''oda, '''<u>OX</u>'''aliplatin | + | <br>XELOX: '''<u>XEL</u>'''oda (Capecitabine), '''<u>OX</u>'''aliplatin |
===Regimen {{#subobject:912834|Variant=1}}=== | ===Regimen {{#subobject:912834|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://www.nature.com/bjc/journal/v97/n7/full/6603956a.html Boige et al. 2007] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Capecitabine (Xeloda)]] 1000 mg/ | + | |} |
− | *[[Oxaliplatin (Eloxatin)]] 130 mg/ | + | ====Chemotherapy==== |
+ | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID on days 1 to 14 | ||
+ | *[[Oxaliplatin (Eloxatin)]] 130 mg/m<sup>2</sup> IV over 2 hours once on day 1 | ||
'''21-day cycles''' | '''21-day cycles''' | ||
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|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Doxorubicin (Adriamycin)]] 60 mg/ | + | *[[Doxorubicin (Adriamycin)]] 60 mg/m<sup>2</sup> IV once on day 1 |
'''21-day cycles''' | '''21-day cycles''' | ||
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# Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. [http://jco.ascopubs.org/content/25/21/3069.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17634485 PubMed] | # Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. [http://jco.ascopubs.org/content/25/21/3069.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17634485 PubMed] | ||
− | ==Fluorouracil | + | ==Fluorouracil & Folinic acid {{#subobject:7bb459|Regimen=1}}== |
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
|- | |- | ||
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|} | |} | ||
===Regimen {{#subobject:d1e198|Variant=1}}=== | ===Regimen {{#subobject:d1e198|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://www.karger.com/Article/Abstract/227516 Porta et al. 1995] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Fluorouracil (5-FU)]] 370 mg/ | + | |} |
− | *[[Folinic acid (Leucovorin)]] 200 mg/ | + | ====Chemotherapy==== |
+ | *[[Fluorouracil (5-FU)]] 370 mg/m<sup>2</sup> IV once per day on days 1 to 5 | ||
+ | *[[Folinic acid (Leucovorin)]] 200 mg/m<sup>2</sup> IV once per day on days 1 to 5 | ||
'''28-day cycles''' | '''28-day cycles''' | ||
===References=== | ===References=== | ||
− | # Porta C, Moroni M, Nastasi G, Arcangeli G. 5-Fluorouracil and d,l-leucovorin calcium are active to treat unresectable hepatocellular carcinoma patients: preliminary results of a phase II study. Oncology. 1995 Nov-Dec;52(6):487-91. [http://www.ncbi.nlm.nih.gov/pubmed/7478436 PubMed] | + | # Porta C, Moroni M, Nastasi G, Arcangeli G. 5-Fluorouracil and d,l-leucovorin calcium are active to treat unresectable hepatocellular carcinoma patients: preliminary results of a phase II study. Oncology. 1995 Nov-Dec;52(6):487-91. [http://www.karger.com/Article/Abstract/227516 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/7478436 PubMed] |
==GEMOX {{#subobject:b3749a|Regimen=1}}== | ==GEMOX {{#subobject:b3749a|Regimen=1}}== | ||
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GEMOX: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin | GEMOX: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin | ||
===Regimen {{#subobject:a6a6da|Variant=1}}=== | ===Regimen {{#subobject:a6a6da|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.22532/full Louafi et al. 2007] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
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border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | |} |
− | *[[Oxaliplatin (Eloxatin)]] 100 mg/ | + | ====Chemotherapy==== |
+ | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 2 | ||
'''14-day cycles, given until progression of disease, unacceptable toxicity, or patient choice''' | '''14-day cycles, given until progression of disease, unacceptable toxicity, or patient choice''' | ||
===References=== | ===References=== | ||
− | # Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22532/full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17330837 PubMed] | + | # Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22532/full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17330837 PubMed] |
− | # '''Retrospective:''' Zaanan A, Williet N, Hebbar M, Dabakuyo TS, Fartoux L, Mansourbakht T, Dubreuil O, Rosmorduc O, Cattan S, Bonnetain F, Boige V, Taïeb J. Gemcitabine plus oxaliplatin in advanced hepatocellular carcinoma: A large multicenter AGEO study. J Hepatol. 2013 Jan;58(1):81-8 | + | # '''Retrospective:''' Zaanan A, Williet N, Hebbar M, Dabakuyo TS, Fartoux L, Mansourbakht T, Dubreuil O, Rosmorduc O, Cattan S, Bonnetain F, Boige V, Taïeb J. Gemcitabine plus oxaliplatin in advanced hepatocellular carcinoma: A large multicenter AGEO study. J Hepatol. 2013 Jan;58(1):81-8. Epub 2012 Sep 16. [http://www.sciencedirect.com/science/article/pii/S0168827812006952 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22989572 PubMed] |
==Nolatrexed {{#subobject:5144e3|Regimen=1}}== | ==Nolatrexed {{#subobject:5144e3|Regimen=1}}== | ||
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|} | |} | ||
− | ''This drug was inferior in a randomized clinical trial and does not appear to be in clinical development at this time. | + | ''This drug was inferior in a randomized clinical trial and does not appear to be in clinical development at this time. Included for reference purposes only.'' |
===References=== | ===References=== | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | |[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | ||
− | |||
− | |||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext Cheng et al. 2008] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext Cheng et al. 2008] | ||
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# Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. [http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18650514 PubMed] | # Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. [http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18650514 PubMed] | ||
# Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19095497 PubMed] | # Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19095497 PubMed] | ||
− | ## '''Subset analysis:''' Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jan 10. | + | ## '''Subset analysis:''' Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. Epub 2012 Jan 10. [http://www.ejcancer.com/article/S0959-8049(11)01031-8/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22240282 PubMed] |
==Sorafenib (Nexavar) {{#subobject:b38f69|Regimen=1}}== | ==Sorafenib (Nexavar) {{#subobject:b38f69|Regimen=1}}== | ||
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border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
| | | | ||
− | |||
− | |||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 Llovet et al. 2008 (SHARP)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 Llovet et al. 2008 (SHARP)] | ||
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border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Hepatobiliary_cancer#Placebo|Placebo]] | |[[Hepatobiliary_cancer#Placebo|Placebo]] | ||
− | |||
− | |||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext Cheng et al. 2008] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext Cheng et al. 2008] | ||
Line 340: | Line 377: | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
|[[Hepatobiliary_cancer#Placebo|Placebo]] | |[[Hepatobiliary_cancer#Placebo|Placebo]] | ||
− | |||
− | |||
|- | |- | ||
|[http://theoncologist.alphamedpress.org/content/14/1/70.long Pinter et al. 2009] | |[http://theoncologist.alphamedpress.org/content/14/1/70.long Pinter et al. 2009] | ||
Line 351: | Line 386: | ||
border-style:solid;">Retrospective</span> | border-style:solid;">Retrospective</span> | ||
| | | | ||
− | |||
− | |||
|- | |- | ||
|[http://link.springer.com/article/10.1007%2Fs12032-013-0655-z Abdel-Rahman et al. 2013] | |[http://link.springer.com/article/10.1007%2Fs12032-013-0655-z Abdel-Rahman et al. 2013] | ||
Line 364: | Line 397: | ||
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
*[[Sorafenib (Nexavar)]] 400 mg PO BID | *[[Sorafenib (Nexavar)]] 400 mg PO BID | ||
− | **Dose/schedule changes | + | **Dose/schedule changes due to toxicity include 400 mg PO once per day, 400 mg PO every other day, 200 mg PO BID, 200 mg PO once per day |
'''Given until progression of disease or unacceptable toxicity''' | '''Given until progression of disease or unacceptable toxicity''' | ||
Line 374: | Line 407: | ||
# Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. [http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18650514 PubMed] | # Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. [http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18650514 PubMed] | ||
# Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19095497 PubMed] | # Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2808%2970285-7/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19095497 PubMed] | ||
− | ## '''Subset analysis:''' Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jan 10. | + | ## '''Subset analysis:''' Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. Epub 2012 Jan 10. [http://www.ejcancer.com/article/S0959-8049(11)01031-8/fulltext link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22240282 PubMed] |
− | # '''Retrospective:''' Pinter M, Sieghart W, Graziadei I, Vogel W, Maieron A, Königsberg R, Weissmann A, Kornek G, Plank C, Peck-Radosavljevic M. Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis. Oncologist. 2009 Jan;14(1):70-6. Epub 2009 Jan 14. [http://theoncologist.alphamedpress.org/content/14/1/70.long link to original article] | + | # '''Retrospective:''' Pinter M, Sieghart W, Graziadei I, Vogel W, Maieron A, Königsberg R, Weissmann A, Kornek G, Plank C, Peck-Radosavljevic M. Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis. Oncologist. 2009 Jan;14(1):70-6. Epub 2009 Jan 14. [http://theoncologist.alphamedpress.org/content/14/1/70.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/19144684 PubMed] |
# Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. [http://link.springer.com/article/10.1007%2Fs12032-013-0655-z link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] | # Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. [http://link.springer.com/article/10.1007%2Fs12032-013-0655-z link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] | ||
Line 384: | Line 417: | ||
|} | |} | ||
===Regimen {{#subobject:d4c1fd|Variant=1}}=== | ===Regimen {{#subobject:d4c1fd|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://jco.ascopubs.org/content/27/18/3027.full Zhu et al. 2009] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
Line 391: | Line 428: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
+ | |} | ||
+ | ====Chemotherapy==== | ||
*[[Sunitinib (Sutent)]] 37.5 mg PO once per day on days 1 to 28 | *[[Sunitinib (Sutent)]] 37.5 mg PO once per day on days 1 to 28 | ||
− | **Dose | + | **Dose can be reduced to 25 and 12.5 mg once per day depending on toxicity |
'''42-day cycles''' | '''42-day cycles''' | ||
Line 421: | Line 460: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
− | |[[ | + | |[[#FELV|FELv]]<br> [[Hepatobiliary_cancer#Fluorouracil_.26_Folinic_acid|Fluorouracil & Folinic acid]] |
|- | |- | ||
|} | |} | ||
Line 435: | Line 474: | ||
|[[#toc|back to top]] | |[[#toc|back to top]] | ||
|} | |} | ||
− | ===Regimen | + | ===Regimen {{#subobject:CMV1|Variant=1}}=== |
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://jco.ascopubs.org/content/28/21/3491.long Lubner et al. 2010] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
Line 443: | Line 486: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
+ | |} | ||
+ | ====Chemotherapy==== | ||
*[[Bevacizumab (Avastin)]] 5 mg/kg IV once per day on days 1 & 15 | *[[Bevacizumab (Avastin)]] 5 mg/kg IV once per day on days 1 & 15 | ||
− | *[[Erlotinib (Tarceva)]] 150 mg PO once per day | + | *[[Erlotinib (Tarceva)]] 150 mg PO once per day |
'''28-day cycles, given until progression of disease or unacceptable toxicity''' | '''28-day cycles, given until progression of disease or unacceptable toxicity''' | ||
===References=== | ===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. [http://jco.ascopubs.org/content/28/21/3491.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20530271 PubMed] | + | # 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''' [http://www.ncbi.nlm.nih.gov/pubmed/20530271 PubMed] |
==Capecitabine (Xeloda) {{#subobject:c7cfeb|Regimen=1}}== | ==Capecitabine (Xeloda) {{#subobject:c7cfeb|Regimen=1}}== | ||
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|} | |} | ||
===Regimen {{#subobject:b34ea|Variant=1}}=== | ===Regimen {{#subobject:b34ea|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full Patt et al. 2004] | ||
+ | |<span | ||
style="background:#ff0000; | style="background:#ff0000; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
Line 465: | Line 514: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Retrospective</span> | border-style:solid;">Retrospective</span> | ||
− | + | |- | |
− | *[[Capecitabine (Xeloda)]] 1000 mg/ | + | |} |
+ | ====Chemotherapy==== | ||
+ | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID on days 1 to 14 | ||
'''21-day cycles''' | '''21-day cycles''' | ||
===References=== | ===References=== | ||
− | # 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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] | + | # '''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. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.20368/full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed] |
==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ||
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|- | |- | ||
|} | |} | ||
− | *[[Capecitabine (Xeloda)]] 1000 mg/ | + | ====Chemotherapy==== |
− | *[[Mitomycin (Mutamycin)]] 8 mg/ | + | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO BID on days 1 to 14 |
+ | *[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | ||
− | Supportive medications | + | ====Supportive medications==== |
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | *[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | ||
Line 525: | Line 577: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase III</span> | border-style:solid;">Phase III</span> | ||
− | |[[ | + | |[[#FELV|FELV]] |
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Epirubicin (Ellence)]] 50 mg/ | + | *[[Epirubicin (Ellence)]] 50 mg/m<sup>2</sup> IV once on day 1 |
− | *[[Cisplatin (Platinol)]] 60 mg/ | + | *[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV once on day 1 |
− | *[[Fluorouracil (5-FU)]] 200 mg/ | + | *[[Fluorouracil (5-FU)]] 200 mg/m<sup>2</sup>/day IV continuous infusion on days 1 to 21 |
'''21-day cycles''' | '''21-day cycles''' | ||
Line 538: | Line 590: | ||
# 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. [http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | # 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. [http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] | ||
− | ==FELV | + | ==FELV {{#subobject:3658a8|Regimen=1}}== |
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
|- | |- | ||
Line 560: | Line 612: | ||
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Fluorouracil (5-FU)]] 600 mg/ | + | *[[Fluorouracil (5-FU)]] 600 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' |
− | *[[ | + | *[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' |
− | *[[ | + | *[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given last''' |
'''21-day cycles''' | '''21-day cycles''' | ||
Line 583: | Line 635: | ||
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Fluorouracil (5-FU)]] 500 mg/ | + | *[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given first''' |
− | *[[ | + | *[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over 40 minutes once per day on days 1 to 3, '''given second''' |
− | *[[ | + | *[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 to 3, '''given last''' |
'''21-day cycles''' | '''21-day cycles''' | ||
Line 615: | Line 667: | ||
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Fluorouracil (5-FU)]] 500 mg/ | + | *[[Fluorouracil (5-FU)]] 500 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given first''' |
− | *[[Folinic acid (Leucovorin)]] 60 mg/ | + | *[[Folinic acid (Leucovorin)]] 60 mg/m<sup>2</sup> IV bolus once per day on days 1 & 2, '''given second, 40 minutes after Fluorouracil (5-FU)''' |
'''14-day cycles''' | '''14-day cycles''' | ||
Line 645: | Line 697: | ||
|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Fluorouracil (5-FU)]] 400 mg/ | + | *[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus, then 600 mg/m<sup>2</sup> IV continuous infusion over 22 hours on day 1 |
− | *[[Folinic acid (Leucovorin)]] 100 mg/ | + | *[[Folinic acid (Leucovorin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 1 |
− | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 |
'''21-day cycles''' | '''21-day cycles''' | ||
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|- | |- | ||
|} | |} | ||
+ | ====Chemotherapy==== | ||
+ | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
− | + | '''28-day cycle for 3 to 6 cycles depending on response''' | |
− | |||
− | '''28-day cycle | ||
===Regimen #2 {{#subobject:fcd6f1|Variant=1}}=== | ===Regimen #2 {{#subobject:fcd6f1|Variant=1}}=== | ||
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|- | |- | ||
|} | |} | ||
− | + | ====Chemotherapy==== | |
− | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 |
'''30-day cycles''' | '''30-day cycles''' | ||
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|- | |- | ||
|} | |} | ||
+ | ====Chemotherapy==== | ||
+ | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8, '''given second''' | ||
+ | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 & 8, '''given first''' | ||
− | + | ====Supportive medications==== | |
− | |||
− | |||
− | Supportive medications | ||
*Cisplatin is mixed in a solution of 1 liter of normal saline with 20 mmol potassium chloride, 8 mmol magnesium sulfate | *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 | *After cisplatin, 500 mL normal saline given over 30 minutes | ||
− | '''21-day cycle | + | '''21-day cycle for 4 to 8 cycles depending on response''' |
===References=== | ===References=== | ||
Line 761: | Line 813: | ||
|- | |- | ||
|} | |} | ||
− | *[[Gemcitabine (Gemzar)]] 2000 mg/ | + | ====Chemotherapy==== |
− | *[[Mitomycin (Mutamycin)]] 8 mg/ | + | *[[Gemcitabine (Gemzar)]] 2000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 15 |
+ | *[[Mitomycin (Mutamycin)]] 8 mg/m<sup>2</sup> IV bolus once on day 1 | ||
− | Supportive medications | + | ====Supportive medications==== |
*[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | *[[Dexamethasone (Decadron)]] and [[:Category:Serotonin_5-HT3_antagonists|5-HT3 antagonists]] on the day of IV chemotherapy | ||
Line 779: | Line 832: | ||
GEMOX-B: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin, '''<u>B</u>'''evacizumab | GEMOX-B: '''<u>GEM</u>'''citabine, '''<u>OX</u>'''aliplatin, '''<u>B</u>'''evacizumab | ||
===Regimen {{#subobject:3748a1|Variant=1}}=== | ===Regimen {{#subobject:3748a1|Variant=1}}=== | ||
− | + | {| border="1" style="text-align:center;" !align="left" | |
− | <span | + | |'''Study''' |
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |- | ||
+ | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970333-X/fulltext Zhu et al. 2009] | ||
+ | |<span | ||
style="background:#EEEE00; | style="background:#EEEE00; | ||
padding:3px 6px 3px 6px; | padding:3px 6px 3px 6px; | ||
Line 786: | Line 843: | ||
border-width:2px; | border-width:2px; | ||
border-style:solid;">Phase II</span> | border-style:solid;">Phase II</span> | ||
− | + | |- | |
− | *[[Gemcitabine (Gemzar)]] 1000 mg/ | + | |} |
− | *[[Oxaliplatin (Eloxatin)]] 85 mg/ | + | ====Chemotherapy==== |
− | *[[Bevacizumab (Avastin)]] 10 mg/kg IV once per day on days 1 & 15, given first | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once per day on days 1 & 15, '''given second''' |
+ | *[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> 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''' | '''28-day cycles''' |
Revision as of 00:36, 19 August 2016
Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.
Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.
38 regimens on this page
48 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.
Hepatocellular carcinoma
Bevacizumab (Avastin)
back to top |
Regimen
Study | Evidence |
Siegel et al. 2008 | Phase II |
The dose here was a pre-planned escalation dose.
Chemotherapy
- Bevacizumab (Avastin) 10 mg/kg IV once on day 1
14-day cycles
References
- Siegel AB, Cohen EI, Ocean A, Lehrer D, Goldenberg A, Knox JJ, Chen H, Clark-Garvey S, Weinberg A, Mandeli J, Christos P, Mazumdar M, Popa E, Brown RS Jr, Rafii S, Schwartz JD. Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma. J Clin Oncol. 2008 Jun 20;26(18):2992-8. link to original article contains verified protocol PubMed
Bevacizumab & Capecitabine
back to top |
Regimen
Study | Evidence |
Hsu et al. 2010 | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 7.5 mg/kg IV once on day 1
- Capecitabine (Xeloda) 800 mg/m2 PO BID on days 1 to 14
21-day cycle for 6 or more cycles depending on response
References
- Hsu CH, Yang TS, Hsu C, Toh HC, Epstein RJ, Hsiao LT, Chen PJ, Lin ZZ, Chao TY, Cheng AL. Efficacy and tolerability of bevacizumab plus capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma. Br J Cancer. 2010 Mar 16;102(6):981-6. Epub 2010 Feb 16. link to original article contains verified protocol PubMed
Bevacizumab, Capecitabine, Oxaliplatin
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Regimen
Study | Evidence |
Sun et al. 2011 | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 5 mg/kg IV once on day 1
- Infusion times for bevacizumab are 75 to 105 minutes for the first dose, which if tolerated could be decreased to 50 to 70 minutes for the second dose, then 20 to 40 minutes for dose 3 and later
- Capecitabine (Xeloda) 825 mg/m2 PO BID on days 1 to 14
- Oxaliplatin (Eloxatin) 130 mg/m2 IV over 2 hours once on day 1
21-day cycles
References
- Sun W, Sohal D, Haller DG, Mykulowycz K, Rosen M, Soulen MC, Caparro M, Teitelbaum UR, Giantonio B, O'Dwyer PJ, Shaked A, Reddy R, Olthoff K. Phase 2 trial of bevacizumab, capecitabine, and oxaliplatin in treatment of advanced hepatocellular carcinoma. Cancer. 2011 Jul 15;117(14):3187-92. Epub 2011 Jan 24. link to original article contains verified regimen PubMed
Bevacizumab & Erlotinib
back to top |
Regimen
Study | Evidence |
Thomas et al. 2009 | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 10 mg/kg IV once per day on days 1 & 15
- Erlotinib (Tarceva) 150 mg PO once per day
28-day cycles
References
- Thomas MB, Morris JS, Chadha R, Iwasaki M, Kaur H, Lin E, Kaseb A, Glover K, Davila M, Abbruzzese J. Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. J Clin Oncol. 2009 Feb 20;27(6):843-50. Epub 2009 Jan 12. link to original article contains verified protocol PubMed
Capecitabine (Xeloda)
back to top |
Regimen
Study | Evidence | Comparator |
Abdel-Rahman et al. 2013 | Randomized Phase II | Sorafenib |
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO BID 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
- Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. link to original article PubMed
CapeOx; XELOX
back to top |
CapeOX: Capecitabine, OXaliplatin
XELOX: XELoda (Capecitabine), OXaliplatin
Regimen
Study | Evidence |
Boige et al. 2007 | Phase II |
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO BID on days 1 to 14
- Oxaliplatin (Eloxatin) 130 mg/m2 IV over 2 hours once on day 1
21-day cycles
References
- Boige V, Raoul JL, Pignon JP, Bouché O, Blanc JF, Dahan L, Jouve JL, Dupouy N, Ducreux M; Fédération Francophone de Cancérologie Digestive. Multicentre phase II trial of capecitabine plus oxaliplatin (XELOX) in patients with advanced hepatocellular carcinoma: FFCD 03-03 trial. Br J Cancer. 2007 Oct 8;97(7):862-7. Epub 2007 Sep 18. link to original article contains verified protocol PubMed
Doxorubicin (Adriamycin)
back to top |
Regimen
Study | Evidence | Comparator |
Gish et al. 2007 | Phase III | Nolatrexed |
Chemotherapy
- Doxorubicin (Adriamycin) 60 mg/m2 IV once on day 1
21-day cycles
References
- Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. link to original article contains verified protocol PubMed
Fluorouracil & Folinic acid
back to top |
Regimen
Study | Evidence |
Porta et al. 1995 | Phase II |
Chemotherapy
- Fluorouracil (5-FU) 370 mg/m2 IV once per day on days 1 to 5
- Folinic acid (Leucovorin) 200 mg/m2 IV once per day on days 1 to 5
28-day cycles
References
- Porta C, Moroni M, Nastasi G, Arcangeli G. 5-Fluorouracil and d,l-leucovorin calcium are active to treat unresectable hepatocellular carcinoma patients: preliminary results of a phase II study. Oncology. 1995 Nov-Dec;52(6):487-91. link to original article PubMed
GEMOX
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GEMOX: GEMcitabine, OXaliplatin
Regimen
Study | Evidence |
Louafi et al. 2007 | Phase II |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once on day 1
- Oxaliplatin (Eloxatin) 100 mg/m2 IV over 2 hours once on day 2
14-day cycles, given until progression of disease, unacceptable toxicity, or patient choice
References
- Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taïeb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. link to original article contains verified protocol PubMed
- Retrospective: Zaanan A, Williet N, Hebbar M, Dabakuyo TS, Fartoux L, Mansourbakht T, Dubreuil O, Rosmorduc O, Cattan S, Bonnetain F, Boige V, Taïeb J. Gemcitabine plus oxaliplatin in advanced hepatocellular carcinoma: A large multicenter AGEO study. J Hepatol. 2013 Jan;58(1):81-8. Epub 2012 Sep 16. link to original article PubMed
Nolatrexed
back to top |
Regimen
Study | Evidence | Comparator |
Gish et al. 2007 | Phase III | Doxorubicin |
This drug was inferior in a randomized clinical trial and does not appear to be in clinical development at this time. Included for reference purposes only.
References
- Gish RG, Porta C, Lazar L, Ruff P, Feld R, Croitoru A, Feun L, Jeziorski K, Leighton J, Gallo J, Kennealey GT. Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol. 2007 Jul 20;25(21):3069-75. link to original article contains verified protocol PubMed
Placebo
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Regimen
Study | Evidence | Comparator |
Llovet et al. 2008 (SHARP) | Phase III | Sorafenib |
Cheng et al. 2008 | Phase III | Sorafenib |
No treatment. Included for reference purposes only.
References
- Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. link to original article contains verified protocol PubMed
- Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. link to original article contains verified protocol PubMed
- Subset analysis: Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. Epub 2012 Jan 10. link to original article contains verified protocol PubMed
Sorafenib (Nexavar)
back to top |
Regimen
Study | Evidence | Comparator |
Abou-Alfa et al. 2006 | Phase II | |
Llovet et al. 2008 (SHARP) | Phase III | Placebo |
Cheng et al. 2008 | Phase III | Placebo |
Pinter et al. 2009 | Retrospective | |
Abdel-Rahman et al. 2013 | Randomized Phase II | Capecitabine |
Chemotherapy
- Sorafenib (Nexavar) 400 mg PO BID
- Dose/schedule changes due to toxicity include 400 mg PO once per day, 400 mg PO every other day, 200 mg PO BID, 200 mg PO once per day
Given until progression of disease or unacceptable toxicity
References
- Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. Epub 2006 Aug 14. link to original article contains verified protocol PubMed
- Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. link to original article contains verified protocol PubMed
- Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. link to original article contains verified protocol PubMed
- Subset analysis: Cheng AL, Guan Z, Chen Z, Tsao CJ, Qin S, Kim JS, Yang TS, Tak WY, Pan H, Yu S, Xu J, Fang F, Zou J, Lentini G, Voliotis D, Kang YK. Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to baseline status: Subset analyses of the phase III Sorafenib Asia-Pacific trial. Eur J Cancer. 2012 Jul;48(10):1452-65. Epub 2012 Jan 10. link to original article contains verified protocol PubMed
- Retrospective: Pinter M, Sieghart W, Graziadei I, Vogel W, Maieron A, Königsberg R, Weissmann A, Kornek G, Plank C, Peck-Radosavljevic M. Sorafenib in unresectable hepatocellular carcinoma from mild to advanced stage liver cirrhosis. Oncologist. 2009 Jan;14(1):70-6. Epub 2009 Jan 14. link to original article PubMed
- Abdel-Rahman O, Abdel-Wahab M, Shaker M, Abdel-Wahab S, Elbassiony M, Ellithy M. Sorafenib versus capecitabine in the management of advanced hepatocellular carcinoma. Med Oncol. 2013 Sep;30(3):655. Epub 2013 Jul 4. link to original article PubMed
Sunitinib (Sutent)
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Regimen
Study | Evidence |
Zhu et al. 2009 | Phase II |
Chemotherapy
- Sunitinib (Sutent) 37.5 mg PO once per day on days 1 to 28
- Dose can be reduced to 25 and 12.5 mg once per day depending on toxicity
42-day cycles
References
- Zhu AX, Sahani DV, Duda DG, di Tomaso E, Ancukiewicz M, Catalano OA, Sindhwani V, Blaszkowsky LS, Yoon SS, Lahdenranta J, Bhargava P, Meyerhardt J, Clark JW, Kwak EL, Hezel AF, Miksad R, Abrams TA, Enzinger PC, Fuchs CS, Ryan DP, Jain RK. Efficacy, safety, and potential biomarkers of sunitinib monotherapy in advanced hepatocellular carcinoma: a phase II study. J Clin Oncol. 2009 Jun 20;27(18):3027-35. Epub 2009 May 26. link to original article contains verified protocol PubMed
Biliary tract cancer (cholangiocarcinoma/gallbladder)
Best supportive care
back to top |
Regimen
Study | Evidence | Comparator |
Glimelius et al. 1996 | Phase III | FELv Fluorouracil & Folinic acid |
No antineoplastic treatment. Included for reference purposes only.
References
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed content property of HemOnc.org
Bevacizumab & Erlotinib
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Regimen
Study | Evidence |
Lubner et al. 2010 | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 5 mg/kg IV once per day on days 1 & 15
- Erlotinib (Tarceva) 150 mg PO once per day
28-day cycles, given until progression of disease or unacceptable toxicity
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 PubMed
Capecitabine (Xeloda)
back to top |
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
- 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 |
Kornek et al. 2004 | Randomized Phase II | Gemcitabine & Mitomycin |
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
- 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
ECF
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ECF: Epirubicin, Cisplatin, Fluorouracil
Regimen
Study | Evidence | Comparator |
Rao et al. 2005 | Phase III | FELV |
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
- 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 PubMed
FELV
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FELV: Fluorouracil , Etoposide, LeucoVorin (Folinic acid)
Regimen #1, Rao et al. 2005
Study | Evidence | Comparator |
Rao et al. 2005 | Phase III | ECF |
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 |
Glimelius et al. 1996 | Phase III | Best supportive care |
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
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed content property of HemOnc.org
- Rao S, Cunningham D, Hawkins RE, Hill ME, Smith D, Daniel F, Ross PJ, Oates J, Norman AR. Phase III study of 5FU, etoposide and leucovorin (FELV) compared to epirubicin, cisplatin and 5FU (ECF) in previously untreated patients with advanced biliary cancer. Br J Cancer. 2005 May 9;92(9):1650-4. link to original article contains verified protocol PubMed
Fluorouracil & Folinic acid
back to top |
Regimen
Study | Evidence | Comparator |
Glimelius et al. 1996 | Phase III | Best supportive care |
Chemotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 & 2, given first
- Folinic acid (Leucovorin) 60 mg/m2 IV bolus once per day on days 1 & 2, given second, 40 minutes after Fluorouracil (5-FU)
14-day cycles
References
- Glimelius B, Hoffman K, Sjödén PO, Jacobsson G, Sellström H, Enander LK, Linné T, Svensson C. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996 Aug;7(6):593-600. link to original article contains verified protocol PubMed
Fluorouracil, Folinic acid, Gemcitabine
back to top |
Regimen
Study | Evidence | Comparator |
Gebbia et al. 2001 | Randomized Phase II, <20 per arm | Gemcitabine |
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
- 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 (Gemzar)
back to top |
Regimen #1
Study | Evidence | Comparator |
Valle et al. 2010 (ABC-02) | Phase III | Gemcitabine & Cisplatin |
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 | Comparator |
Gebbia et al. 2001 | Randomized Phase II, <20 per arm | Fluorouracil, Folinic acid, Gemcitabine |
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
- 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
back to top |
Regimen
Study | Evidence | Comparator |
Valle et al. 2010 (ABC-02) | Phase III | Gemcitabine |
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8, given second
- Cisplatin (Platinol) 25 mg/m2 IV over 1 hour once per day on days 1 & 8, given first
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
- 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
back to top |
Regimen
Study | Evidence | Comparator |
Kornek et al. 2004 | Randomized Phase II | Capecitabine & Mitomycin |
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
GEMOX-B
back to top |
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
- 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