Famitinib in metastatic renal cell carcinoma： a single center study

• Published in: Chinese medical journal Vol. 126; no. 22; pp. 4277 - 4281
• Main Authors: Zhang, Wen, Zhou, Ai-Ping, Qin, Qiong, Chang, Chun-Xiao, Jiang, Hao-Yuan, Ma, Jian-Hui, Wang, Jin-Wan
• Format: Journal Article
• Language: English
• Published: China Department of Medical Oncology, Cancer Hospital & Institution,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China%Jiangsu Hengrui Medicine Co.Ltd, Lianyungang, Jiangsu 222047,China 20.11.2013
• Subjects: Adult; Aged; Carcinoma, Renal Cell - drug therapy; Female; Humans; Indoles - adverse effects; Indoles - therapeutic use; Kidney Neoplasms - drug therapy; Male; Protein Kinase Inhibitors; Pyrroles - adverse effects; Pyrroles - therapeutic use; Retrospective Studies; Treatment Outcome; Young Adult; 中性粒细胞; 抗肿瘤活性; 癌; 肾细胞; 药物不良反应; 血小板减少; 转移性; 酪氨酸激酶抑制剂; metastatic renal cell carcinoma; famitinib; adverse reaction; efficacy
• ISSN: 0366-6999; 2542-5641
• DOI: 10.3760/cma.j.issn.0366-6999.20131757

Background Famitinib is a novel and potent multitargeting receptor tyrosine kinase inhibitor. The phase I clinical study showed that famitinib was well tolerated and had a broad anti-tumor spectrum. The purpose of this study was to examine the efficacy and safety of famitinib for the treatment of metastatic renal cell carcinoma （mRCC）. Methods The data of famitinib in treating patients with mRCC from the single-center phases I and II clinical trials were analyzed. Famitinib was administered orally at the dose of 13-30 mg once daily until tumor progression, occurrence of intolerable adverse reactions or withdrawal of the informed consent. Results A total of 24 patients with mRCC were treated including 17 patients at a dose of 25 mg once daily, 4 patients at a dose of 27 mg and 1 patient each at a dose of 13 rag, 20 mg and 30 mg, respectively. Twelve （50.0%） patients achieved partial response （PR） and 9 patients achieved stable disease （SD）. Progressive disease was found in 3 （12.5%） patients. The disease control rate was 87.5%. The median follow-up time was 17.6 months; the median progression free survival （PFS） was 10.7 （95% CI 7.0-14.4） months; and the estimated median overall survival （OS） time was 33.0 （95% CI 8.7-57.3） months. The adverse drug reactions mainly included hypertension （54.1%）, hand-foot skin reactions （45.8%）, diarrhea （33.3%）, mucositis （29.2%）, neutropenia （45.8%）, thrombocytopenia （29.2%）, hyperlipidemia （41.7%） and proteinuria （41.7%）. The incidence rate of grades 3 and 4 adverse events was low, mainly including hypertension 12.5%, hand-foot skin reactions 4.2%, neutropenia 4.2%, thrombocytopenia 4.2%, hyperlipidemia 4.2% and proteinuria 12.5%. Conclusions Famitinib has significant anti-tumor activity in mRCC. The common adverse reactions are generally manageable.