Zhu, Andrew X.Rosmorduc, OlivierEvans, T.R. JeffryRoss, Paul J.Santoro, ArmandoCarrilho, Flair JoséBruix Tudó, JordiQin, ShukuiThuluvath, Paul J.Llovet i Bayer, Josep MariaLeberre, Marie-AudeJensen, MarkusMeinhardt, GeroldKang, Yoon-Koo2017-11-062017-11-062014-02-200732-183Xhttps://hdl.handle.net/2445/117402PURPOSE: 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.8 p.application/pdfeng(c) American Society of Clinical Oncology, 2014Càncer de fetgeQuimioteràpiaAssaigs clínics de medicamentsPlacebosLiver cancerChemotherapyDrug testingPlacebos (Medicine)info:eu-repo/semantics/article6493042017-11-06info:eu-repo/semantics/openAccess25547503