Details

Autor(en) / Beteiligte

• Rui-Hua Xu
• Lin Shen
• Ke-Ming Wang
• Gang Wu
• Chun-Mei Shi
• Ke-Feng Ding
• Li-Zhu Lin
• Jin-Wan Wang
• Jian-Ping Xiong
• Chang-Ping Wu
• Jin Li
• Yun-Peng Liu
• Dong Wang
• Yi Ba
• Jue-Ping Feng
• Yu-Xian Bai
• Jing-Wang Bi
• Li-Wen Ma
• Jian Lei
• Qing Yang
• Hao Yu

Titel

Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized,double.blinded, placebo.controlled, phase II clinical trial

Ist Teil von

• 癌症：英文版, 2017, Vol.36 (12), p.677-685

Erscheinungsjahr

2017

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• 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