Search: A phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma

Andrew X. Zhu, Olivier Rosmorduc, T. R Jeffry Evans, Paul J. Ross, Armando Santoro, Flair Jose Carrilho, Jordi Bruix, Shukui Qin, Paul J. Thuluvath, Josep M. Llovet, Marie Aude Leberre, Markus Jensen, Gerold Meinhardt, Yoon Koo Kang

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma (HCC) in a multicenter, multinational, randomized, phase III trial. Patients and Methods Patients with advanced HCC and underlying Child-Pugh class A cirrhosis, who were naive to systemic treatment (N = 720), were randomly assigned to sorafenib plus either erlotinib (n = 362) or placebo (n = 358). The primary end point was overall survival (OS). Results: Median OS was similar in the sorafenib plus erlotinib and sorafenib plus placebo groups (9.5 v 8.5 months, respectively; hazard ratio [HR], 0.929; P = .408), as was median time to progression (3.2 v 4.0 months, respectively; HR, 1.135; P = .18). In the sorafenib/erlotinib arm versus the sorafenib/placebo arm, the overall response rate trended higher (6.6% v 3.9%, respectively; P = .102), whereas the disease control rate was significantly lower (43.9% v 52.5%, respectively; P = .021). The median durations of treatment with sorafenib were 86 days in the sorafenib/erlotinib arm and 123 days in the sorafenib/placebo arm. In the sorafenib/erlotinib and sorafenib/placebo arms, the rates of treatment-emergent serious AEs (58.0% v 54.6%, respectively) and drug-related serious AEs (21.0% v 22.8%, respectively) were similar. AEs matched the known safety profiles of both agents, but rates of rash/desquamation, anorexia, and diarrhea were higher in the sorafenib/erlotinib arm, whereas rates of alopecia and hand-foot skin reaction were higher in the sorafenib/placebo arm. Withdrawal rates for AEs during cycles 1 to 3 were higher in the sorafenib/erlotinib arm. Conclusion: Adding erlotinib to sorafenib did not improve survival in patients with advanced HCC.

Original languageEnglish
Pages (from-to)559-566
Number of pages8
JournalJournal of Clinical Oncology
Volume33
Issue number6
DOIs
Publication statusPublished - Feb 20 2015

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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