Difference between revisions of "Hepatocellular carcinoma - historical"
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Warner-admin (talk | contribs) m (Text replacement - "As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. " to "") |
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− | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only | + | <span id="BackToTop"></span> |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Hepatocellular_carcinoma|main HCC page]] for current regimens. | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div> |
− | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> |
|} | |} | ||
− | |||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
− | =First-line therapy= | + | =First-line therapy for advanced or metastatic disease= |
− | == | + | ==Capecitabine monotherapy {{#subobject:729cf1|Regimen=1}}== |
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#ee6b6e"> |
+ | ===Regimen {{#subobject:34d254|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | ! style="width: 20%" |Study | ||
+ | ! style="width: 20%" |Dates of enrollment | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | ! style="width: 20%" |Comparator | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[http://link.springer.com/article/10.1007/s12032-013-0655-z Abdel-Rahman et al. 2013] | ||
+ | |2010-2011 | ||
+ | | style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ooc) | ||
+ | |[[Hepatocellular_carcinoma#Sorafenib_monotherapy|Sorafenib]] | ||
+ | | style="background-color:#d73027" |Inferior PFS (primary endpoint) | ||
|- | |- | ||
− | |||
|} | |} | ||
− | ===Regimen {{#subobject: | + | ''Note: Neither the primary outcome (progression-free survival) or secondary outcome (overall survival) were met.'' |
− | {| class="wikitable" style="width: | + | <div class="toccolours" style="background-color:#b3e2cd"> |
+ | ====Chemotherapy==== | ||
+ | *[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> PO twice per day on days 1 to 14 | ||
+ | '''21-day cycles''' | ||
+ | </div></div> | ||
+ | ===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. [https://doi.org/10.1002/cncr.20368 link to original article] [https://pubmed.ncbi.nlm.nih.gov/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/s12032-013-0655-z link to original article] [https://pubmed.ncbi.nlm.nih.gov/23824645/ PubMed] | ||
+ | ==Nivolumab monotherapy {{#subobject:10ee99|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #1, weight-based {{#subobject:98564a|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
!style="width: 25%"|Study | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
− | !style="width: 25%"| | + | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] |
− | + | |- | |
+ | |[https://doi.org/10.1016/S0140-6736(17)31046-2 El-Khoueiry et al. 2017 (CheckMate 040)] | ||
+ | |2012-2016 | ||
+ | | style="background-color:#91cf61" |Phase 1/2 (RT) | ||
+ | | style="background-color:#88419d; color:white " |ORR: 20% (95% CI, 15–26) | ||
|- | |- | ||
− | | | + | |} |
− | + | ''Note: This is the dose used in the expansion cohort of this study; patients were required to have ECOG PS 1 or less, and Child-Pugh scores of 6 or less (Child-Pugh A) for the dose expansion. 68% of patients in the dose expansion phase received prior sorafenib therapy.'' | |
− | | style=" | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | | style=" | + | ====Immunotherapy==== |
+ | *[[Nivolumab (Opdivo)]] 3 mg/kg IV once on day 1 | ||
+ | '''14-day cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #2, flat dosing {{#subobject:98582a|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | ! style="width: 20%" |Study | ||
+ | ! style="width: 20%" |Dates of enrollment | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | ! style="width: 20%" |Comparator | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/s1470-2045(21)00604-5 Yau et al. 2021 (CheckMate 459)] |
− | | style="background-color:#1a9851" |Phase | + | |2016-01-11 to 2017-05-24 |
+ | | style="background-color:#1a9851" |Phase 3 (E-switch-ooc) | ||
|[[Hepatocellular_carcinoma#Sorafenib_monotherapy|Sorafenib]] | |[[Hepatocellular_carcinoma#Sorafenib_monotherapy|Sorafenib]] | ||
− | | style="background-color:# | + | | style="background-color:#d9ef8b" |Might have superior OS (primary endpoint)<br>Median OS: 16.4 vs 14.7 mo<br>(HR 0.85, 95% CI 0.72-1.02) |
+ | |- | ||
+ | |} | ||
+ | ''Note: Study included patients with Child-Pugh class B (5-9), hepatitis B and C infections. This study was the basis for the withdrawal of FDA approval for this indication.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Immunotherapy==== | ||
+ | *[[Nivolumab (Opdivo)]] 240 mg IV once on day 1 | ||
+ | '''14-day cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''CheckMate 040:''' El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH 3rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. Epub 2017 Apr 20 [https://doi.org/10.1016/S0140-6736(17)31046-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28434648/ PubMed] [https://clinicaltrials.gov/study/NCT01658878 NCT01658878] | ||
+ | ##'''Update:''' El-Khoueiry AB, Trojan J, Meyer T, Yau T, Melero I, Kudo M, Hsu C, Kim TY, Choo SP, Kang YK, Yeo W, Chopra A, Soleymani S, Yao J, Neely J, Tschaika M, Welling TH, Sangro B. Nivolumab in sorafenib-naive and sorafenib-experienced patients with advanced hepatocellular carcinoma: 5-year follow-up from CheckMate 040. Ann Oncol. 2023 Dec 25:S0923-7534(23)05115-3. Epub ahead of print. [https://doi.org/10.1016/j.annonc.2023.12.008 link to original article] [https://pubmed.ncbi.nlm.nih.gov/38151184/ PubMed] | ||
+ | <!-- #'''Abstract:''' Yau T, Park JW, Finn RS, Cheng A, Mathurin P, Edeline J, Kudo M, Han K, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Begic D, Chen G, Neely J, Anderson J, Sangro B. CheckMate 459: A randomized, multi-center phase 3 study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC). Annals of Oncology. 2019 Sept; 30 (suppl_5): v851-v934. Epub 2019 Sept 27. [https://academic.oup.com/annonc/article/30/Supplement_5/mdz394.029/5577900 link to astract] --> | ||
+ | #'''CheckMate 459:''' Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. Epub 2021 Dec 13. [https://doi.org/10.1016/s1470-2045(21)00604-5 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/34914889/ PubMed] [https://clinicaltrials.gov/study/NCT02576509 NCT02576509] | ||
+ | ==Sunitinib monotherapy {{#subobject:fc4f58|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #1, interrupted sunitinib {{#subobject:d42zfd|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2702235/ Zhu et al. 2009 (DF/HCC 05-348)] | ||
+ | |2006-NR | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | |- | ||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | ==== | + | ====Targeted therapy==== |
*[[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 | ||
− | |||
− | |||
'''42-day cycles''' | '''42-day cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #2, continuous sunitinib {{#subobject:d4c1fd|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.2012.45.8372 Cheng et al. 2013 (SUN 1170)] | ||
+ | |2008-2010 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) | ||
+ | |[[Hepatocellular_carcinoma#Sorafenib_monotherapy|Sorafenib]] | ||
+ | | style="background-color:#d73027" |Inferior OS (primary endpoint)<br>Median OS: 7.9 vs 10.2 mo<br>(HR 1.30, 95% CI 1.13-1.50) | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: Early trial termination of SUN 1170 occurred for futility and safety reasons; sunitinib treated patients demonstrated inferior OS and more frequent and severe toxicities. Dosing preserved for historical context.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Sunitinib (Sutent)]] 37.5 mg PO once per day on days 1 to 28 | ||
+ | '''28-day cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#fff2ae"> | ||
+ | ====Dose and schedule modifications==== | ||
+ | *Dose can be reduced to 25 and 12.5 mg once per day depending on toxicity | ||
+ | </div></div> | ||
===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. [https:// | + | # '''DF/HCC 05-348:''' 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. [https://doi.org/10.1200/JCO.2008.20.9908 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2702235/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19470923/ PubMed] [https://clinicaltrials.gov/study/NCT00361309 NCT00361309] |
− | # '''SUN 1170:''' Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. Epub 2013 Sep 30. [https:// | + | # '''SUN 1170:''' Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. Epub 2013 Sep 30. [https://doi.org/10.1200/jco.2012.45.8372 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24081937/ PubMed] [https://clinicaltrials.gov/study/NCT00699374 NCT00699374] |
==Tamoxifen monotherapy {{#subobject:52e6cb|Regimen=1}}== | ==Tamoxifen monotherapy {{#subobject:52e6cb|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#ee6b6e"> | |
− | + | ===Regimen variant #1, 20 mg/day {{#subobject:djg3ce|Variant=1}}=== | |
− | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | |
− | + | !style="width: 20%"|Study | |
− | ===Regimen {{#subobject: | + | !style="width: 20%"|Dates of enrollment |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | !style="width: | + | !style="width: 20%"|Comparator |
− | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
− | !style="width: | ||
− | !style="width: | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1200/JCO.2005.05.470 Barbare et al. 2005 (FFCD 9403)] |
− | | style="background-color:#1a9851" |Phase | + | |1995-2000 |
− | |[[ | + | | style="background-color:#1a9851" |Phase 3 (E-esc) |
+ | |[[Hepatocellular_carcinoma_-_null_regimens#Best_supportive_care|Best supportive care]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https:/ | + | |[https://doi.org/10.1016/j.ejca.2008.01.004 Doffoël et al. 2008 (FFCD 9402)] |
− | + | |1995-2002 | |
− | + | | style="background-color:#1a9851" |Phase 3 (C) | |
− | + | |[[#TACE_.26_Tamoxifen_999|TACE & Tamoxifen]] | |
− | |||
− | |||
− | | style="background-color:#1a9851" |Phase | ||
− | |[[ | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360361/ Verset et al. 2007] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360361/ Verset et al. 2007] | ||
− | | style="background-color:#1a9851" |Phase | + | |2001-2005 |
− | |Octreotide LAR & Tamoxifen | + | | style="background-color:#1a9851" |Phase 3 (C) |
+ | |[[#Octreotide_LAR_.26_Tamoxifen_999|Octreotide LAR & Tamoxifen]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https:// | + | |} |
− | | style="background-color:#1a9851" |Phase | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | | | + | ====Endocrine therapy==== |
+ | *[[Tamoxifen (Nolvadex)]] 20 mg PO once per day | ||
+ | '''Continued indefinitely''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen variant #2, 40 mg/day {{#subobject:d856de|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/S0140-6736(98)01259-8 Gallo et al. 1998 (CLIP-1)] | ||
+ | |1995-1997 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-esc) | ||
+ | |[[Hepatocellular_carcinoma_-_null_regimens#Best_supportive_care|Best supportive care]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
+ | |- | ||
|} | |} | ||
− | ==== | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[Tamoxifen (Nolvadex)]] | + | ====Endocrine therapy==== |
− | + | *[[Tamoxifen (Nolvadex)]] 40 mg PO once per day | |
+ | '''Continued indefinitely''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # '''CLIP-1:''' Gallo C, Daniele B, Gaeta GB, Perrone F, Pignata S; CLIP | + | # '''CLIP-1:''' Gallo C, Daniele B, Gaeta GB, Perrone F, Pignata S; CLIP. Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial. Lancet. 1998 Jul 4;352(9121):17-20. [https://doi.org/10.1016/S0140-6736(98)01259-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/9800740/ PubMed] |
− | + | # '''FFCD 9403:''' Barbare JC, Bouché O, Bonnetain F, Raoul JL, Rougier P, Abergel A, Boige V, Denis B, Blanchi A, Pariente A, Milan C, Bedenne L. Randomized controlled trial of tamoxifen in advanced hepatocellular carcinoma. J Clin Oncol. 2005 Jul 1;23(19):4338-46. [https://doi.org/10.1200/JCO.2005.05.470 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/15994145/ PubMed] | |
− | # '''FFCD 9403:''' Barbare JC, Bouché O, Bonnetain F, Raoul JL, Rougier P, Abergel A, Boige V, Denis B, Blanchi A, Pariente A, Milan C, Bedenne L. Randomized controlled trial of tamoxifen in advanced hepatocellular carcinoma. J Clin Oncol. 2005 Jul 1;23(19):4338-46. [https:// | + | # Verset G, Verslype C, Reynaert H, Borbath I, Langlet P, Vandebroek A, Peeters M, Houbiers G, Francque S, Arvanitakis M, Van Laethem JL. Efficacy of the combination of long-acting release octreotide and tamoxifen in patients with advanced hepatocellular carcinoma: a randomised multicentre phase III study. Br J Cancer. 2007 Sep 3;97(5):582-8. Epub 2007 Aug 7. [https://doi.org/10.1038/sj.bjc.6603901 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360361/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17687341/ PubMed] |
− | # Verset G, Verslype C, Reynaert H, Borbath I, Langlet P, Vandebroek A, Peeters M, Houbiers G, Francque S, Arvanitakis M, Van Laethem JL. Efficacy of the combination of long-acting release octreotide and tamoxifen in patients with advanced hepatocellular carcinoma: a randomised multicentre phase III study. Br J Cancer. 2007 Sep 3;97(5):582-8. Epub 2007 Aug 7. [https:// | + | # '''FFCD 9402:''' Doffoël M, Bonnetain F, Bouché O, Vetter D, Abergel A, Fratté S, Grangé JD, Stremsdoerfer N, Blanchi A, Bronowicki JP, Caroli-Bosc FX, Causse X, Masskouri F, Rougier P, Bedenne L; Fédération Francophone de Cancérologie Digestive. Multicentre randomised phase III trial comparing Tamoxifen alone or with transarterial Lipiodol Chemoembolisation for unresectable hepatocellular carcinoma in cirrhotic patients (Fédération Francophone de Cancérologie Digestive 9402). Eur J Cancer. 2008 Mar;44(4):528-38. Epub 2008 Jan 31. [https://doi.org/10.1016/j.ejca.2008.01.004 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18242076/ PubMed] |
− | # '''FFCD 9402:''' Doffoël M, Bonnetain F, Bouché O, Vetter D, Abergel A, Fratté S, Grangé JD, Stremsdoerfer N, Blanchi A, Bronowicki JP, Caroli-Bosc FX, Causse X, Masskouri F, Rougier P, Bedenne L; Fédération Francophone de Cancérologie Digestive. Multicentre randomised phase III trial comparing Tamoxifen alone or with transarterial Lipiodol Chemoembolisation for unresectable hepatocellular carcinoma in cirrhotic patients (Fédération Francophone de Cancérologie Digestive 9402). Eur J Cancer. 2008 Mar;44(4):528-38. Epub 2008 Jan 31. [https:// | ||
− | |||
[[Category:Hepatocellular carcinoma regimens]] | [[Category:Hepatocellular carcinoma regimens]] | ||
[[Category:Historical regimens]] | [[Category:Historical regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Hepatobiliary cancers]] | [[Category:Hepatobiliary cancers]] |
Revision as of 11:22, 13 May 2024
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main HCC page for current regimens.
4 regimens on this page
7 variants on this page
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First-line therapy for advanced or metastatic disease
Capecitabine monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Abdel-Rahman et al. 2013 | 2010-2011 | Randomized Phase 2 (E-switch-ooc) | Sorafenib | Inferior PFS (primary endpoint) |
Note: Neither the primary outcome (progression-free survival) or secondary outcome (overall survival) were met.
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
Nivolumab monotherapy
Regimen variant #1, weight-based
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
El-Khoueiry et al. 2017 (CheckMate 040) | 2012-2016 | Phase 1/2 (RT) | ORR: 20% (95% CI, 15–26) |
Note: This is the dose used in the expansion cohort of this study; patients were required to have ECOG PS 1 or less, and Child-Pugh scores of 6 or less (Child-Pugh A) for the dose expansion. 68% of patients in the dose expansion phase received prior sorafenib therapy.
Regimen variant #2, flat dosing
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Yau et al. 2021 (CheckMate 459) | 2016-01-11 to 2017-05-24 | Phase 3 (E-switch-ooc) | Sorafenib | Might have superior OS (primary endpoint) Median OS: 16.4 vs 14.7 mo (HR 0.85, 95% CI 0.72-1.02) |
Note: Study included patients with Child-Pugh class B (5-9), hepatitis B and C infections. This study was the basis for the withdrawal of FDA approval for this indication.
References
- CheckMate 040: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH 3rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. Epub 2017 Apr 20 link to original article contains dosing details in abstract PubMed NCT01658878
- Update: El-Khoueiry AB, Trojan J, Meyer T, Yau T, Melero I, Kudo M, Hsu C, Kim TY, Choo SP, Kang YK, Yeo W, Chopra A, Soleymani S, Yao J, Neely J, Tschaika M, Welling TH, Sangro B. Nivolumab in sorafenib-naive and sorafenib-experienced patients with advanced hepatocellular carcinoma: 5-year follow-up from CheckMate 040. Ann Oncol. 2023 Dec 25:S0923-7534(23)05115-3. Epub ahead of print. link to original article PubMed
- CheckMate 459: Yau T, Park JW, Finn RS, Cheng AL, Mathurin P, Edeline J, Kudo M, Harding JJ, Merle P, Rosmorduc O, Wyrwicz L, Schott E, Choo SP, Kelley RK, Sieghart W, Assenat E, Zaucha R, Furuse J, Abou-Alfa GK, El-Khoueiry AB, Melero I, Begic D, Chen G, Neely J, Wisniewski T, Tschaika M, Sangro B. Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2022 Jan;23(1):77-90. Epub 2021 Dec 13. link to original article contains dosing details in abstract PubMed NCT02576509
Sunitinib monotherapy
Regimen variant #1, interrupted sunitinib
Study | Dates of enrollment | Evidence |
---|---|---|
Zhu et al. 2009 (DF/HCC 05-348) | 2006-NR | Phase 2 |
Regimen variant #2, continuous sunitinib
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Cheng et al. 2013 (SUN 1170) | 2008-2010 | Phase 3 (E-switch-ic) | Sorafenib | Inferior OS (primary endpoint) Median OS: 7.9 vs 10.2 mo (HR 1.30, 95% CI 1.13-1.50) |
Note: Early trial termination of SUN 1170 occurred for futility and safety reasons; sunitinib treated patients demonstrated inferior OS and more frequent and severe toxicities. Dosing preserved for historical context.
Dose and schedule modifications
- Dose can be reduced to 25 and 12.5 mg once per day depending on toxicity
References
- DF/HCC 05-348: 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 dosing details in manuscript link to PMC article PubMed NCT00361309
- SUN 1170: Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. Epub 2013 Sep 30. link to original article PubMed NCT00699374
Tamoxifen monotherapy
Regimen variant #1, 20 mg/day
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Barbare et al. 2005 (FFCD 9403) | 1995-2000 | Phase 3 (E-esc) | Best supportive care | Did not meet primary endpoint of OS |
Doffoël et al. 2008 (FFCD 9402) | 1995-2002 | Phase 3 (C) | TACE & Tamoxifen | Did not meet primary endpoint of OS |
Verset et al. 2007 | 2001-2005 | Phase 3 (C) | Octreotide LAR & Tamoxifen | Did not meet primary endpoint of OS |
Regimen variant #2, 40 mg/day
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gallo et al. 1998 (CLIP-1) | 1995-1997 | Phase 3 (E-esc) | Best supportive care | Did not meet primary endpoint of OS |
References
- CLIP-1: Gallo C, Daniele B, Gaeta GB, Perrone F, Pignata S; CLIP. Tamoxifen in treatment of hepatocellular carcinoma: a randomised controlled trial. Lancet. 1998 Jul 4;352(9121):17-20. link to original article contains dosing details in abstract PubMed
- FFCD 9403: Barbare JC, Bouché O, Bonnetain F, Raoul JL, Rougier P, Abergel A, Boige V, Denis B, Blanchi A, Pariente A, Milan C, Bedenne L. Randomized controlled trial of tamoxifen in advanced hepatocellular carcinoma. J Clin Oncol. 2005 Jul 1;23(19):4338-46. link to original article contains dosing details in abstract PubMed
- Verset G, Verslype C, Reynaert H, Borbath I, Langlet P, Vandebroek A, Peeters M, Houbiers G, Francque S, Arvanitakis M, Van Laethem JL. Efficacy of the combination of long-acting release octreotide and tamoxifen in patients with advanced hepatocellular carcinoma: a randomised multicentre phase III study. Br J Cancer. 2007 Sep 3;97(5):582-8. Epub 2007 Aug 7. link to original article link to PMC article contains dosing details in manuscript PubMed
- FFCD 9402: Doffoël M, Bonnetain F, Bouché O, Vetter D, Abergel A, Fratté S, Grangé JD, Stremsdoerfer N, Blanchi A, Bronowicki JP, Caroli-Bosc FX, Causse X, Masskouri F, Rougier P, Bedenne L; Fédération Francophone de Cancérologie Digestive. Multicentre randomised phase III trial comparing Tamoxifen alone or with transarterial Lipiodol Chemoembolisation for unresectable hepatocellular carcinoma in cirrhotic patients (Fédération Francophone de Cancérologie Digestive 9402). Eur J Cancer. 2008 Mar;44(4):528-38. Epub 2008 Jan 31. link to original article contains dosing details in manuscript PubMed