| Title | Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial |
| Authors | Xu, Rui-Hua 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 |
| Affiliation | Sun Yat Sen Univ, Canc Ctr, Dept Med Oncol, State Key Lab Oncol South China,Collaborat Innova, Guangzhou 510060, Guangdong, Peoples R China. Peking Univ, Canc Hosp & Inst, Dept Gastrointestinal Oncol, Key Lab Carcinogenesis & Translat Res,Minist Educ, 52 Fucheng Rd, Beijing 100142, Peoples R China. Nanjing Med Univ, Affiliated Hosp 2, Dept Med Oncol, Nanjing 210011, Jiangsu, Peoples R China. Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Canc Ctr, Wuhan 430030, Hubei, Peoples R China. Fujian Med Univ, Union Hosp, Dept Med Oncol, Fuzhou 350001, Fujian, Peoples R China. Zhejiang Univ, Sch Med, Hosp 2, Dept Surg Oncol, Hangzhou 310009, Zhejiang, Peoples R China. Guangzhou Med Univ Chinese Med, Affiliated Hosp 1, Dept Oncol, Guangzhou 510405, Guangdong, Peoples R China. Chinese Acad Med Sci, Canc Hosp, Dept Med Oncol, Beijing 100021, Peoples R China. Nanchang Univ, Affiliated Hosp 1, Dept Med Oncol, Nanchang 330006, Jiangxi, Peoples R China. First Peoples Hosp Changzhou, Dept Med Oncol, Changzhou 213003, Jiangsu, Peoples R China. Fudan Univ, Canc Hosp, Dept Med Oncol, Shanghai 200032, Peoples R China. China Med Univ, Hosp 1, Dept Med Oncol, Shenyang 110001, Liaoning, Peoples R China. Third Mil Med Univ, Daping Hosp, Canc Ctr, Chongqing 400042, Peoples R China. Third Mil Med Univ, Inst Surg Res, Chongqing 400042, Peoples R China. Tianjin Med Univ, Canc Inst & Hosp, Dept Gastrointestinal Med Oncol, Tianjin 300060, Peoples R China. Huazhong Univ Sci & Technol, Tongji Med Coll, PuAi Hosp, Dept Oncol, Wuhan 430032, Hubei, Peoples R China. Harbin Med Univ, Canc Hosp, Dept Med Oncol, Harbin 150081, Heilongjiang, Peoples R China. Jinan Mil Gen Hosp, Dept Oncol, Jinan 250000, Shandong, Peoples R China. Peking Univ, Hosp 3, Dept Tumor Chemotherapy & Radiol, Beijing 100191, Peoples R China. Guangzhou Med Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, Guangzhou 510120, Guangdong, Peoples R China. Jiangsu Hengrui Med Co Ltd, Dept Clin Med, Lianyungang 222047, Jiangsu, Peoples R China. Nanjing Med Univ, Dept Epidem & Hlth Stat, Nanjing 211166, Jiangsu, Peoples R China. |
| Keywords | Colorectal cancer Famitinib Efficacy Safety ENDOTHELIAL GROWTH-FACTOR RENAL-CELL CARCINOMA QUALITY-OF-LIFE COLON-CANCER ANTITUMOR-ACTIVITY TYROSINE KINASE RAS MUTATIONS IN-VIVO REGORAFENIB BEVACIZUMAB |
| Issue Date | 2017 |
| Publisher | CHINESE JOURNAL OF CANCER |
| Citation | CHINESE JOURNAL OF CANCER. 2017, 36. |
| 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 |
| URI | http://hdl.handle.net/20.500.11897/500316 |
| ISSN | 1000-467X |
| DOI | 10.1186/s40880-017-0263-y |
| Indexed | SCI(E) PubMed |
| Appears in Collections: | 北京肿瘤医院 第三医院 |
