Difference between revisions of "Hepatocellular carcinoma"
m (Text replacement - "<span style="background:#00CD00; padding:3px 6px 3px 6px; border-color:black; border-width:2px; border-style:solid;">Phase III</span>" to "style="background-color:#00CD00"|Phase III") |
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===References=== | ===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. [http://jco.ascopubs.org/content/26/18/2992.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/26/18/2992.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18565886 PubMed] |
==Bevacizumab & Capecitabine {{#subobject:b24110|Regimen=1}}== | ==Bevacizumab & Capecitabine {{#subobject:b24110|Regimen=1}}== | ||
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===References=== | ===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. [http://www.nature.com/bjc/journal/v102/n6/full/6605580a.html link to original article] '''contains verified protocol''' [ | + | # 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. [http://www.nature.com/bjc/journal/v102/n6/full/6605580a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20160718 PubMed] |
==Bevacizumab, Capecitabine, Oxaliplatin {{#subobject:32787f|Regimen=1}}== | ==Bevacizumab, Capecitabine, Oxaliplatin {{#subobject:32787f|Regimen=1}}== | ||
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===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. Epub 2011 Jan 24. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25889/abstract link to original article] '''contains verified regimen''' [ | + | # 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''' [https://www.ncbi.nlm.nih.gov/pubmed/21264839 PubMed] |
==Bevacizumab & Erlotinib {{#subobject:9afef8|Regimen=1}}== | ==Bevacizumab & Erlotinib {{#subobject:9afef8|Regimen=1}}== | ||
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===References=== | ===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. [http://jco.ascopubs.org/content/27/6/843.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/27/6/843.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19139433 PubMed] |
==Capecitabine (Xeloda) {{#subobject:729cf1|Regimen=1}}== | ==Capecitabine (Xeloda) {{#subobject:729cf1|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[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] | ||
|style="background-color:#00CD00"|Randomized Phase II | |style="background-color:#00CD00"|Randomized Phase II | ||
|[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | |[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | ||
+ | |style="background-color:#ff0000"|Inferior OS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # '''Retrospective:''' Patt YZ, Hassan MM, Aguayo A, Nooka AK, Lozano RD, Curley SA, Vauthey JN, Ellis LM, Schnirer II, Wolff RA, Charnsangavej C, Brown TD. Oral capecitabine for the treatment of hepatocellular carcinoma, cholangiocarcinoma, and gallbladder carcinoma. Cancer. 2004 Aug 1;101(3):578-86. [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] [https://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] [ | + | # 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] [https://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] |
==CapeOx; XELOX {{#subobject:a86027|Regimen=1}}== | ==CapeOx; XELOX {{#subobject:a86027|Regimen=1}}== | ||
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===References=== | ===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. [http://www.nature.com/bjc/journal/v97/n7/full/6603956a.html link to original article] '''contains verified protocol''' [ | + | # 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. [http://www.nature.com/bjc/journal/v97/n7/full/6603956a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17876335 PubMed] |
==Doxorubicin (Adriamycin) {{#subobject:2e9077|Regimen=1}}== | ==Doxorubicin (Adriamycin) {{#subobject:2e9077|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/25/21/3069.long Gish et al. 2007] | |[http://jco.ascopubs.org/content/25/21/3069.long Gish et al. 2007] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
− | | | + | |Nolatrexed |
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===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. [http://jco.ascopubs.org/content/25/21/3069.long link to original article] '''contains verified protocol''' [ | + | # 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''' [https://www.ncbi.nlm.nih.gov/pubmed/17634485 PubMed] |
==Fluorouracil & Folinic acid {{#subobject:7bb459|Regimen=1}}== | ==Fluorouracil & Folinic acid {{#subobject:7bb459|Regimen=1}}== | ||
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===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.karger.com/Article/Abstract/227516 link to original article] [ | + | # 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] [https://www.ncbi.nlm.nih.gov/pubmed/7478436 PubMed] |
==GEMOX {{#subobject:b3749a|Regimen=1}}== | ==GEMOX {{#subobject:b3749a|Regimen=1}}== | ||
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===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''' [ | + | # 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''' [https://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. Epub 2012 Sep 16. [http://www. | + | # '''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.journal-of-hepatology.eu/article/S0168-8278(12)00695-2/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/22989572 PubMed] |
− | == | + | ==Placebo== |
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
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|} | |} | ||
− | ===Regimen | + | ===Regimen=== |
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{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
|'''Study''' | |'''Study''' | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[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)] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | |[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | ||
+ | |style="background-color:#ff0000"|Inferior OS | ||
|- | |- | ||
|[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] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | |[[Hepatobiliary_cancer#Sorafenib_.28Nexavar.29|Sorafenib]] | ||
+ | |style="background-color:#ff0000"|Seems to have inferior OS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===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. [http://www.nejm.org/doi/full/10.1056/NEJMoa0708857 link to original article] '''contains verified protocol''' [ | + | # 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''' [https://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''' [ | + | # 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''' [https://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 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''' [ | + | ## '''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''' [https://www.ncbi.nlm.nih.gov/pubmed/22240282 PubMed] |
==Sorafenib (Nexavar) {{#subobject:b38f69|Regimen=1}}== | ==Sorafenib (Nexavar) {{#subobject:b38f69|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/24/26/4293.long Abou-Alfa et al. 2006] | |[http://jco.ascopubs.org/content/24/26/4293.long Abou-Alfa et al. 2006] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[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)] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Placebo|Placebo]] | |[[Hepatobiliary_cancer#Placebo|Placebo]] | ||
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|[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] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Placebo|Placebo]] | |[[Hepatobiliary_cancer#Placebo|Placebo]] | ||
+ | |style="background-color:#00CD00"|Seems to have superior OS | ||
|- | |- | ||
|[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] | ||
|style="background-color:#ff0000"|Retrospective | |style="background-color:#ff0000"|Retrospective | ||
− | | | + | |style="background-color:#d3d3d3"| |
+ | |style="background-color:#d3d3d3"| | ||
|- | |- | ||
|[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] | ||
|style="background-color:#00CD00"|Randomized Phase II | |style="background-color:#00CD00"|Randomized Phase II | ||
|[[Hepatobiliary_cancer#Capecitabine_.28Xeloda.29|Capecitabine]] | |[[Hepatobiliary_cancer#Capecitabine_.28Xeloda.29|Capecitabine]] | ||
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===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. [http://jco.ascopubs.org/content/24/26/4293.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/24/26/4293.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16908937 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''' [ | + | # 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''' [https://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''' [ | + | # 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''' [https://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 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''' [ | + | ## '''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''' [https://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] [https://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] [ | + | # 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] [https://www.ncbi.nlm.nih.gov/pubmed/23824645 PubMed] |
==Sunitinib (Sutent) {{#subobject:fc4f58|Regimen=1}}== | ==Sunitinib (Sutent) {{#subobject:fc4f58|Regimen=1}}== | ||
Line 352: | Line 337: | ||
===References=== | ===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. [http://jco.ascopubs.org/content/27/18/3027.full link to original article] '''contains verified protocol''' [ | + | # 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. [http://jco.ascopubs.org/content/27/18/3027.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19470923 PubMed] |
=Biliary tract cancer (cholangiocarcinoma/gallbladder)= | =Biliary tract cancer (cholangiocarcinoma/gallbladder)= | ||
− | ==Best supportive care | + | ==Best supportive care== |
{| class="wikitable" style="float:right; margin-left: 5px;" | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
|- | |- | ||
Line 362: | Line 347: | ||
|} | |} | ||
− | ===Regimen | + | ===Regimen=== |
{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
|'''Study''' | |'''Study''' | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
+ | |- | ||
+ | |rowspan=2|[http://annonc.oxfordjournals.org/content/7/6/593.long Glimelius et al. 1996] | ||
+ | |rowspan=2 style="background-color:#00CD00"|Phase III | ||
+ | |[[#FELV|FELv]] | ||
+ | |style="background-color:#ff0000"|Inferior OS | ||
|- | |- | ||
− | |[ | + | |[[Hepatobiliary_cancer#Fluorouracil_.26_Folinic_acid|Fluorouracil & Folinic acid]] |
− | |style="background-color:# | + | |style="background-color:#ff0000"|Inferior OS |
− | |||
|- | |- | ||
|} | |} | ||
Line 377: | Line 367: | ||
===References=== | ===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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org HemOnc.org] |
==Bevacizumab & Erlotinib {{#subobject:CMR1|Regimen=1}}== | ==Bevacizumab & Erlotinib {{#subobject:CMR1|Regimen=1}}== | ||
Line 400: | Line 390: | ||
===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. Epub 2010 Jun 7. [http://jco.ascopubs.org/content/28/21/3491.long link to original article] '''contains verified protocol''' [ | + | # 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/pubmed/20530271 PubMed] |
==Capecitabine (Xeloda) {{#subobject:c7cfeb|Regimen=1}}== | ==Capecitabine (Xeloda) {{#subobject:c7cfeb|Regimen=1}}== | ||
Line 422: | Line 412: | ||
===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] [https://www.ncbi.nlm.nih.gov/pubmed/15274071 PubMed] |
==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ==Capecitabine & Mitomycin {{#subobject:6a9270|Regimen=1}}== | ||
Line 434: | Line 424: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004] | |[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004] | ||
|style="background-color:#00CD00"|Randomized Phase II | |style="background-color:#00CD00"|Randomized Phase II | ||
|[[Hepatobiliary_cancer#Gemcitabine_.26_Mitomycin|Gemcitabine & Mitomycin]] | |[[Hepatobiliary_cancer#Gemcitabine_.26_Mitomycin|Gemcitabine & Mitomycin]] | ||
+ | |style="background-color:#00CD00"|Might have superior ORR | ||
|- | |- | ||
|} | |} | ||
Line 450: | Line 442: | ||
===References=== | ===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''' [ | + | # 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] |
==ECF {{#subobject:57bd6d|Regimen=1}}== | ==ECF {{#subobject:57bd6d|Regimen=1}}== | ||
Line 464: | Line 456: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html Rao et al. 2005] | |[http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html Rao et al. 2005] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[#FELV|FELV]] | |[[#FELV|FELV]] | ||
+ | |style="background-color:#eeee00"|Seems not superior | ||
|- | |- | ||
|} | |} | ||
Line 478: | Line 472: | ||
===References=== | ===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. [http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [ | + | # 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''' [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] |
==FELV {{#subobject:3658a8|Regimen=1}}== | ==FELV {{#subobject:3658a8|Regimen=1}}== | ||
Line 486: | Line 480: | ||
|} | |} | ||
FELV: '''<u>F</u>'''luorouracil , '''<u>E</u>'''toposide, '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid) | FELV: '''<u>F</u>'''luorouracil , '''<u>E</u>'''toposide, '''<u>L</u>'''euco'''<u>V</u>'''orin (Folinic acid) | ||
− | ===Regimen #1 | + | ===Regimen #1 {{#subobject:8e152d|Variant=1}}=== |
{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
|'''Study''' | |'''Study''' | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html Rao et al. 2005] | |[http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html Rao et al. 2005] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#ECF|ECF]] | |[[Hepatobiliary_cancer#ECF|ECF]] | ||
+ | |style="background-color:#eeee00"|Seems not superior | ||
|- | |- | ||
|} | |} | ||
Line 509: | Line 505: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/7/6/593.long Glimelius et al. 1996] | |[http://annonc.oxfordjournals.org/content/7/6/593.long Glimelius et al. 1996] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Best_supportive_care|Best supportive care]] | |[[Hepatobiliary_cancer#Best_supportive_care|Best supportive care]] | ||
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|} | |} | ||
Line 523: | Line 521: | ||
===References=== | ===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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] content property of [http://hemonc.org 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. [http://www.nature.com/bjc/journal/v92/n9/full/6602576a.html link to original article] '''contains verified protocol''' [ | + | # 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''' [https://www.ncbi.nlm.nih.gov/pubmed/15856037 PubMed] |
==Fluorouracil & Folinic acid {{#subobject:7bfb92|Regimen=1}}== | ==Fluorouracil & Folinic acid {{#subobject:7bfb92|Regimen=1}}== | ||
Line 536: | Line 534: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/7/6/593.long Glimelius et al. 1996] | |[http://annonc.oxfordjournals.org/content/7/6/593.long Glimelius et al. 1996] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Best_supportive_care|Best supportive care]] | |[[Hepatobiliary_cancer#Best_supportive_care|Best supportive care]] | ||
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|} | |} | ||
Line 549: | Line 549: | ||
===References=== | ===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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [ | + | # 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. [http://annonc.oxfordjournals.org/content/7/6/593.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/8879373 PubMed] |
==Fluorouracil, Folinic acid, Gemcitabine {{#subobject:eb427f|Regimen=1}}== | ==Fluorouracil, Folinic acid, Gemcitabine {{#subobject:eb427f|Regimen=1}}== | ||
Line 560: | Line 560: | ||
|'''Study''' | |'''Study''' | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
− | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001] | |[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | ||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 580: | Line 573: | ||
===References=== | ===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''' [ | + | # 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] |
==Gemcitabine (Gemzar) {{#subobject:1129f1|Regimen=1}}== | ==Gemcitabine (Gemzar) {{#subobject:1129f1|Regimen=1}}== | ||
Line 592: | Line 585: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Gemcitabine_.26_Cisplatin|Gemcitabine & Cisplatin]] | |[[Hepatobiliary_cancer#Gemcitabine_.26_Cisplatin|Gemcitabine & Cisplatin]] | ||
+ | |style="background-color:#ff0000"|Inferior OS | ||
|- | |- | ||
|} | |} | ||
Line 607: | Line 602: | ||
|'''Study''' | |'''Study''' | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
− | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001] | |[http://jco.ascopubs.org/content/19/20/4089.2.long Gebbia et al. 2001] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | ||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 625: | Line 613: | ||
===References=== | ===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''' [ | + | # 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] |
− | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [ | + | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] |
==Gemcitabine & Cisplatin {{#subobject:af0357|Regimen=1}}== | ==Gemcitabine & Cisplatin {{#subobject:af0357|Regimen=1}}== | ||
Line 638: | Line 626: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 Valle et al. 2010 (ABC-02)] | ||
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Hepatobiliary_cancer#Gemcitabine_.28Gemzar.29|Gemcitabine]] | |[[Hepatobiliary_cancer#Gemcitabine_.28Gemzar.29|Gemcitabine]] | ||
+ | |style="background-color:#00CD00"|Superior OS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===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. [http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [ | + | # 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. [http://www.nejm.org/doi/full/10.1056/NEJMoa0908721 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20375404 PubMed] |
==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}== | ==Gemcitabine & Mitomycin {{#subobject:5dad3c|Regimen=1}}== | ||
Line 667: | Line 657: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004] | |[http://annonc.oxfordjournals.org/content/15/3/478.long Kornek et al. 2004] | ||
|style="background-color:#00CD00"|Randomized Phase II | |style="background-color:#00CD00"|Randomized Phase II | ||
|[[Hepatobiliary_cancer#Capecitabine_.26_Mitomycin|Capecitabine & Mitomycin]] | |[[Hepatobiliary_cancer#Capecitabine_.26_Mitomycin|Capecitabine & Mitomycin]] | ||
+ | |style="background-color:#ff0000"|Might have inferior ORR | ||
|- | |- | ||
|} | |} | ||
Line 683: | Line 675: | ||
===References=== | ===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''' [ | + | # 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] |
==GEMOX-B {{#subobject:119bb0|Regimen=1}}== | ==GEMOX-B {{#subobject:119bb0|Regimen=1}}== | ||
Line 708: | Line 700: | ||
===References=== | ===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. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2809%2970333-X/fulltext link to original article] '''contains verified protocol''' [ | + | # 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. [http://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] |
[[Category:Chemotherapy regimens]] | [[Category:Chemotherapy regimens]] | ||
[[Category:Solid oncology regimens]] | [[Category:Solid oncology regimens]] | ||
[[Category:Gastrointestinal (GI) oncology regimens]] | [[Category:Gastrointestinal (GI) oncology regimens]] |
Revision as of 19:02, 6 November 2016
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38 regimens on this page
48 variants on this page
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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
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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
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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)
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Regimen
Study | Evidence | Comparator | Efficacy |
Abdel-Rahman et al. 2013 | Randomized Phase II | Sorafenib | Inferior OS |
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
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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)
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Regimen
Study | Evidence | Comparator | Efficacy |
Gish et al. 2007 | Phase III | Nolatrexed | Superior OS |
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
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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
Placebo
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Regimen
Study | Evidence | Comparator | Efficacy |
Llovet et al. 2008 (SHARP) | Phase III | Sorafenib | Inferior OS |
Cheng et al. 2008 | Phase III | Sorafenib | Seems to have inferior OS |
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)
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Regimen
Study | Evidence | Comparator | Efficacy |
Abou-Alfa et al. 2006 | Phase II | ||
Llovet et al. 2008 (SHARP) | Phase III | Placebo | Superior OS |
Cheng et al. 2008 | Phase III | Placebo | Seems to have superior OS |
Pinter et al. 2009 | Retrospective | ||
Abdel-Rahman et al. 2013 | Randomized Phase II | Capecitabine | Superior OS |
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
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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
- 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
back to top |
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
- 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 | 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
- 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
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
- 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
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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
- 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
- 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)
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Regimen #1
Study | Evidence | Comparator | Efficacy |
Valle et al. 2010 (ABC-02) | Phase III | Gemcitabine & Cisplatin | 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
- 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
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Regimen
Study | Evidence | Comparator | Efficacy |
Valle et al. 2010 (ABC-02) | Phase III | Gemcitabine | Superior OS |
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
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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
- 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
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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
- 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