(HealthDay News) – For patients with metastatic colorectal cancer that has progressed after standard therapies, treatment with regorafenib significantly improves overall survival and progression-free survival compared with placebo, according to a study presented at the American Society of Clinical Oncology’s annual Gastrointestinal Cancers Symposium, held from January 19 to 21 in San Francisco.
Axel Grothey, MD, of the Mayo Clinic in Rochester, MN, and colleagues investigated the efficacy and safety of regorafenib in an international phase III trial involving 760 patients with metastatic colorectal cancer that had progressed after all standard therapies. Patients were randomly allocated to receive either regorafenib (505 patients) or placebo (255 patients), plus best supportive care, until progression, death, or unacceptable toxicity.
The investigators found that, based on a pre-planned formal interim analysis, median overall survival was significantly improved with regorafenib (6.4 months) compared with placebo (5.0 months). For regorafenib and placebo, respectively, the median progression-free survival was 1.9 and 1.7 months, the overall response rate was 1.6 and 0.4%, and the disease control rate was 44 and 15%. The most frequent adverse events (grade 3 or higher) seen with regorafenib were hand-foot skin reaction, fatigue, diarrhea, hyperbilirubinemia, and hypertension.
“Tumors that progress after first-, second-, and even third-line treatment have developed elaborate mechanisms and pathways that enable them to resist chemotherapy and sustain their growth. Using a multi-targeted drug alone, without chemotherapy, is a novel approach for overcoming some of the tumor’s defenses and sparing patients the side effects of additional chemotherapy,” Grothey said in a statement.
Several of the study authors disclosed financial relationships with pharmaceutical companies, including Bayer, which manufactures regorafenib.