Open AccessFamitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double‐blinded, placebo‐controlled, phase II clinical trial
Author(s) -
Xu RuiHua,
Shen Lin,
Wang KeMing,
Wu Gang,
Shi ChunMei,
Ding KeFeng,
Lin LiZhu,
Wang JinWan,
Xiong JianPing,
Wu ChangPing,
Li Jin,
Liu YunPeng,
Wang Dong,
Ba Yi,
Feng JuePing,
Bai YuXian,
Bi JingWang,
Ma LiWen,
Lei Jian,
Yang Qing,
Yu Hao
Publication year - 2017
Publication title -
cancer communications
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.119
H-Index - 53
ISSN - 2523-3548
DOI - 10.1186/s40880-017-0263-y
Subject(s) - medicine , placebo , clinical endpoint , hazard ratio , adverse effect , neutropenia , colorectal cancer , gastroenterology , randomized controlled trial , phases of clinical research , progression free survival , surgery , clinical trial , confidence interval , cancer , chemotherapy , pathology , alternative medicine
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 promising 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 randomized 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