(HealthDay News) — Cabozantinib results in significantly longer overall and progression-free survival than placebo among patients with advanced hepatocellular carcinoma, according to a study published in the July 5 issue of the New England Journal of Medicine.
Ghassan K. Abou-Alfa, M.D., from Memorial Sloan Kettering Cancer Center in New York City, and colleagues randomized 707 patients with advanced hepatocellular carcinoma in a 2-to-1 ratio to receive cabozantinib or matching placebo. Participants had received previous treatment with sorafenib and had disease progression after one or more systemic treatments for hepatocellular carcinoma.
The trial showed significantly longer overall survival with cabozantinib than placebo at the second planned interim analysis. The researchers found that the median overall survival was 10.2 and 8.0 months with cabozantinib and placebo, respectively (hazard ratio for death, 0.76). Median progression-free survival was 5.2 and 1.9 months with cabozantinib and placebo, respectively (hazard ratio for disease progression or death, 0.44); the objective response rates were 4 and <1 percent, respectively. Grade 3 or 4 adverse events occurred in 68 and 36 percent of patients in the cabozantinib and placebo groups, respectively. The most common high-grade events were palmar-plantar erythrodysesthesia, hypertension, increased aspartate aminotransferase level, fatigue, and diarrhea, which were all more common with cabozantinib.
“Among patients with previously treated advanced hepatocellular carcinoma, treatment with cabozantinib resulted in longer overall survival and progression-free survival than placebo,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Exelixis, which manufactures cabozantinib and funded the study.