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| |  Sorafenib Plus Doxorubicin May Offer Better Time to Progression Than Doxorubicin Alone in Advanced Hepatocellular Carcinoma: Presented at ICACT By Shazia Qureshi PARIS, FRANCE -- February 8, 2008 -- Sorafenib plus doxorubicin appears to offer longer time to progression compared with doxorubicin monotherapy in patients with advanced hepatocellular carcinoma, according to a study reported here at the 19th International Congress on Anti-Cancer Treatment (ICACT). In addition, patients receiving the combination have longer overall survival and progression-free survival times than do patients on doxorubicin, results of the randomised, double-blind, placebo-controlled, phase 2 study. The findings were presented on February 7 by lead author Ghassan Abou-Alfa, MD, Medical Oncologist, Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, and Assistant Professor of Medicine, Cornell University, New York, New York. "This trial supports the growing body of evidence of the activity of sorafenib in advanced hepatocellular carcinoma," Dr. Abou-Alfa noted. The study included 96 patients with a median age of 65 years; 76% were men. Enrolment criteria were advanced hepatocellular carcinoma as well as a Child-Pugh score of A (indicating a prognosis of 100% at 1 year and 85% at 2 years), no prior systemic therapy. Eastern Cooperative Oncology Group performance status was 0 or 1 (indicating they were fully active) in 91% of patients. Patients received doxorubicin therapy intravenously at a dose of 60 mg/m2 every 21 days. In addition, 47 patients were randomised to oral sorafenib at a dose of 400 mg twice daily, and 49 to placebo twice daily. Treatment duration was 18 weeks, which corresponded to 6 cycles of doxorubicin therapy. After that, patients could continue receiving sorafenib or placebo until disease progression. Results showed a median time to progression of 8.6 months in patients receiving sorafenib and 4.8 months in patients on placebo. Median overall survival was 13.7 months in the sorafenib patients and 6.5 months in the placebo patients. Median progression-free survival was 6.9 months and 2.8 months, respectively. One patient in the sorafenib group experienced grade 3/4 left ventricular dysfunction. Fatigue and neutropenia were the most commonly reported grade 3/4 adverse effects, and these occurred equally in both groups of patients. "This randomised study showed encouraging time to progression and overall survival outcomes for sorafenib plus doxorubicin," Dr. Abou-Alfa concluded. "Any synergistic role between sorafenib and doxorubicin needs to be further defined." Funding for this study was provided by Bayer Corporation.
[Presentation title: Phase II (PhII), Randomized, Double-Blind Study of Sorafenib Plus Doxorubicin (S+D) Versus Placebo Plus Doxorubicin (P+D) in Patients (pts) With Advanced Hepatocellular Carcinoma (AHCC). Abstract OR 9]
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