Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer:a multicenter,randomized,double-blinded,placebo-controlled,phaseⅡclinical trial

摘要:

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

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作者单位: Department of Medical Oncology,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,Guangdong,P.R.China [1] Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Department of Gastrointestinal Oncology,Peking University Cancer Hospital& Institute,No 52,Fucheng Road,Haidian District,Beijing 100142,P.R.China [2] Department of Medical Oncology,Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,Jiangsu,P.R.China [3] Cancer Center of Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei,P.R.China [4] Department of Medical Oncology,Fujian Medical University Union Hospital,Fuzhou 350001,Fujian,P.R.China [5] Department of Surgical Oncology,Second Hospital Affiliated to Zhejiang University School of Medicine,Hangzhou 310009,Zhejiang,P.R.China [6] Department of Oncology,First Affiliated Hospital of Guangzhou Medical University of Chinese Medicine,Guangzhou 510405,Guangdong,P.R.China [7] Department of Medical Oncology,Chinese Academy of Medical Sciences Cancer Hospital,Beijing 100021,P.R.China [8] Department of Medical Oncology,First Affiliated Hospital of Nanchang University,Nanchang 330006,Jiangxi,P.R.China [9] Department of Medical Oncology,First People's Hospital of Changzhou,Changzhou 213003,Jiangsu,P.R.China [10] Department of Medical Oncology,Fudan University Cancer Hospital,Shanghai 200032,P.R.China [11] Department of Medical Oncology,First Hospital of China Medical University,Shen-yang 110001,Liaoning,P.R.China [12] Cancer Center,Daping Hospital and Insti-tute of Surgery Research,Third Military Medical University,Chongqing 400042,P.R.China [13] Department of Gastrointestinal Medical Oncology,Tianjin Medical University Cancer Institute and Hospital,Tianjin 300060,P.R.China [14] Depart-ment of Oncology,PuAi Hospital of Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430032,Hubei,P.R.China [15] Department of Medical Oncology,Harbin Medical University Cancer Hospital,Harbin 150081,Heilongjiang,P.R.China [16] Department of Oncology,Jinan Military General Hos-pital,Jinan 250000,Shandong,P.R.China [17] Department of Tumor Chemother-apy and Radiology,Peking University Third Hospital,Beijing 100191,P.R.China [18] Department of Gastrointestinal Surgery,First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,Guangdong,P.R.China [19] Department of Clinical Medicine,Jiangsu Hengrui Medicine Co.,Ltd,Lianyungang 222047,Jiangsu,P.R.China [20] Department of Epidemic and Health Statistics,Nanjing Medical University,Nanjing 211166,Jiangsu,P.R.China [21]
期刊: 《癌症(英文版)》2017年36卷12期 677-685页 ISTICCA
栏目名称: Original Article
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