Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer:a multicenter,randomized,double-blinded,placebo-controlled,phaseⅡclinical trial
- Author:
Xu RUI-HUA
1
;
Shen LIN
;
Wang KE-MING
;
Wu GANG
;
Shi CHUN-MEI
;
Ding KE-FENG
;
Lin LI-ZHU
;
Wang JIN-WAN
;
Xiong JIAN-PING
;
Wu CHANG-PING
;
Li JIN
;
Liu YUN-PENG
;
Wang DONG
;
Ba YI
;
Feng JUE-PING
;
Bai YU-XIAN
;
Bi JING-WANG
;
Ma LI-WEN
;
Lei JIAN
;
Yang QING
;
Yu HAO
Author Information
1. Department of Medical Oncology
- Keywords:
Colorectal cancer;
Famitinib;
Efficacy;
Safety
- From:Chinese Journal of Cancer
2017;36(12):677-685
- CountryChina
- Language:Chinese
-
Abstract:
Background: Metastatic colorectal cancer (mCRC) patients with progressive disease after all available standard therapies need new medication for further treatment. Famitinib is a small-molecule multikinase inhibitor, with promis-ing anticancer activities. This multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial was designed to evaluate the safety and efficacy of famitinib in mCRC. Methods: Famitinib or placebo was administered orally once daily. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), quality-of-life (QoL), and safety. Results: Between July 18, 2012 and Jan 22, 2014, a total of 167 patients were screened, and 154 patients were rand-omized in a 2:1 ratio to receive either famitinib (n = 99) or placebo (n = 55). The median PFS was 2.8 and 1.5 months in the famitinib and placebo groups (hazard ratio = 0.60, 95% confidence interval = 0.41–0.86, P = 0.004). The DCR was 59.8% and 31.4% (P = 0.002) and the ORR was 2.2% and 0.0% (P = 0.540) in the famitinib and placebo groups, respectively. The most frequent grade 3–4 adverse events were hypertension (11.1%), hand-foot syndrome (10.1%), thrombocytopenia (10.1%), and neutropenia (9.1%). Serious adverse events occurred in 11 (11.1%) patients in the famitinib group and 5 (9.1%) in the placebo group (P = 0.788). The median OS of the famitinib and placebo groups was 7.4 and 7.2 months (P = 0.657). Conclusion: Famitinib prolonged PFS in refractory mCRC patients with acceptable tolerability. Trial registration This study was registered on ClinicalTrials.gov (NCT01762293) and was orally presented in the 2015 ASCO-Gastrointestinal Symposium
