In an international phase III study of targeted therapy in hepatocellular cancer (HCC), Dr. Josep M. Llovet and colleagues found that sorafenib (Nexavar) helps patients live about 44% longer, compared with patients who did not receive the drug. The researchers randomized 602 patients to treatment with sorafenib, 400 mg twice daily, or placebo, with best supportive care provided in both groups. On interim analysis, they found that sorafenib-treated patients lived a median of 10.7 months vs 7.9 months for placebo recipients. Time to cancer progression was also significantly longer in the treatment group5.5 vs 2.8 months.
"Sorafenib is the first systemic therapy to prolong survival in HCC patients after 30 years of research and more than 100 randomized controlled trials," said Dr. Llovet, who is director of the HCC research program at Mount Sinai School of Medicine in New York. He concluded that the agent is "the new reference standard for systemic therapy of HCC patients."
A 480-patient North American Intergroup trial found that two 25-day courses of arsenic trioxide (Trisenox) consolidation after remission induction significantly improved event-free and overall survival in adults with acute promyelocytic leukemia (APL). At 3 years, overall survival was 86% in the arsenic trioxide-treated arm vs 79% in the standard treatment arm (P = .0346), and event-free survival was 81% vs 66% (P = .0011). The benefit was seen across all risk groups.
The novel therapy "was associated with acceptable and minimal additional toxicity," said Dr. Bayard L. Powell, clinical director of the Comprehensive Cancer Center at Wake Forest University Baptist Medical Center, who reported the results in Chicago. "Relapses were very uncommon in patients who received the planned arsenic trioxide therapy," he added.
Dr. Bernard J. Escudier of the Institut Gustave Roussy, Villejuif, France, presented the results of a randomized controlled double-blind phase III study in renal cell carcinoma (RCC). In this 649-patient comparison of bevacizumab (Avastin)/interferon alfa-2a (Roferon-A) vs placebo/interferon alfa-2a as first-line therapy in metastatic RCC, the investigators concluded that bevacizumab improves progression-free survival when combined with interferon alfa-2a (10.2 vs 5.4 months; hazard ratio [HR] = 0.63; P < .0001). They found no unexpected safety events with the addition of the antiangiogenic agent.
Although at the time of this interim analysis, the median overall survival had not yet been reached in the bevacizumab group, the study revealed a trend in favor of overall survival on this arm, Dr. Escudier noted.
Dr. Ben Slotman, professor and chairman of radiation oncology at VU University Medical Center, Amsterdam, reported on a prospective randomized 286-patient trial of prophylactic cranial irradiation (PCI) vs no PCI in extensive small-cell lung cancer after a response to chemotherapy. This European Organisation for Research and Treatment of Cancer (EORTC) study revealed a significant reduction in the risk of brain metastases, and a significant improvement in both disease-free and overall survival in this patient population. At 1 year, the incidence of symptomatic brain metastases was 14.6% in the PCI group vs 40.4% in the control group (HR = 0.27, P < .001).