Hepatocellular carcinoma - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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 NCCN Guidelines. Is there a regimen missing from this list? See the main HCC page for current regimens.

2 regimens on this page
2 variants on this page


First-line therapy

Sunitinib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Zhu et al. 2009 (DF/HCC 05-348) 2006-NR Phase II
Cheng et al. 2013 (SUN 1170) 2008-2010 Phase III (E-switch-ic) Sorafenib Inferior OS

Early trial termination of the phase III trial occurred for futility and safety reasons; sunitinib treated patients demonstrated inferior OS and more frequent and severe toxicities. Dosing preserved for historical context.

Targeted therapy

  • 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

  1. 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 verified protocol link to PMC article PubMed NCT00361309
  2. 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

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gallo et al. 1998 (CLIP-1) 1995-1997 Phase III (E-esc) Best supportive care Did not meet primary endpoint of OS
Barbare et al. 2005 (FFCD 9403) 1995-2000 Phase III (E-esc) Best supportive care Did not meet primary endpoint of OS
Doffoël et al. 2008 (FFCD 9402) 1995-2002 Phase III (C) TACE & Tamoxifen Did not meet primary endpoint of OS
Chow et al. 2002 1997-2000 Phase III (E-esc) Placebo Seems to have inferior OS
Verset et al. 2007 2001-2005 Phase III (C) Octreotide LAR & Tamoxifen Did not meet primary endpoint of OS

Hormonotherapy

References

  1. 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 PubMed
  2. Chow PK, Tai BC, Tan CK, Machin D, Win KM, Johnson PJ, Soo KC; Asian-Pacific Hepatocellular Carcinoma Trials Group. High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: a multicenter randomized controlled trial. Hepatology. 2002 Nov;36(5):1221-6. link to original article PubMed
  3. 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 PubMed
  4. 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 PubMed
  5. 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 PubMed