The tyrosine kinase inhibitor famitinib was associated with a significant improvement in progression-free survival among patients with advanced or metastatic colorectal cancer, according to the results of a phase II study conducted in China.
“Famitinib as a single agent treatment improved the progression-free survival by 1.3 months in patients with advanced/metastatic colorectal cancer,” said presenter Rui-Hua Xu, MD, PhD, of Sun Yat-sen University Cancer Center, Guangzhou, China, at the 2015 ASCO Gastrointestinal Cancers Symposium.
Famitinib is a small molecular, multi-target tyrosine kinase inhibitor that primarily targets VEGFR2, c-KIT, and PDGFR, and acts against angiogenesis. Xu and colleagues designed this study to evaluate the drug’s safety and efficacy in advanced colorectal cancer, the third most frequently diagnosed cancer in China.
The study randomly assigned patients with advanced colorectal cancer 2:1 to famitinib 25 mg (n = 99) or placebo (n = 55) with evaluation of tumor response occurring every 42 days. All patients had failed at least two prior lines of chemotherapy. The primary endpoint was progression-free survival.
Patients assigned to famitinib had a significant improvement in progression-free survival, with a median time to progression of 2.8 months compared with 1.5 months for patients assigned placebo (P = .004). This treatment benefit was consistent across all subgroups of patients analyzed by the researchers.
In addition, patients assigned famitinib had a significantly improved disease control rate compared with patients assigned placebo (59.8% vs 31.4%; P = .0016); however, no difference in overall survival, overall response rate, or in quality of life outcomes were reported between the two arms.
Xu noted though that a trend of prolonged overall survival was observed in a subgroup of patients who previously received had receive 6 or more cycles of first-line chemotherapy or 3 or more cycles of second-line chemotherapy.
The use of famitinib was associated with more adverse events than placebo, including drug-related adverse events leading to discontinuation (13.1% vs 5.5%). The most common adverse events were proteinuria, neutropenia, hypertension, leukopenia, thrombocytopenia, and hand-foot syndrome. However, the rate of drug-related serious adverse events were similar between the two study arms.