Shimada Rie, Tsukahara Kiyoaki, Takase Soichiro, Okamoto Isaku, Sato Hiroki, Katsube Yasuaki, Maruyama Ryo, Shimizu Akira
Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
Jpn Clin Med. 2018 Jan 29;9:1179670717749231. doi: 10.1177/1179670717749231. eCollection 2018.
The use of generic drugs has been increasing. However, studies of the safety of generic cisplatin (CDDP) for the treatment of head and neck cancer (HNC) have not been reported. This study investigated the treatment completion rates and incidence of CDDP-related adverse events in patients with advanced HNC treated with concurrent chemoradiotherapy (CRT) using generic CDDP. This study included 72 patients who received concurrent CRT using generic CDDP. The number of courses of CDDP was 3 in 45 patients, 2 in 19 patients, and 1 in 8 patients. During 154 courses of 80 mg/m generic CDDP, grade 3/4 leukopenia in 21 (14%), neutropenia in 18 (12%), and hypochromia in 8 (5%) cases were reported. Grade 2 elevated serum creatinine occurred in 4 cases (3%), but no grade 3/4 elevated serum creatinine was reported. These results suggest that CRT using generic CDDP is well tolerated in patients with HNC.
仿制药的使用一直在增加。然而，关于仿制药顺铂（CDDP）治疗头颈部癌（HNC）安全性的研究尚未见报道。本研究调查了使用仿制药CDDP同步放化疗（CRT）治疗的晚期HNC患者的治疗完成率及CDDP相关不良事件的发生率。本研究纳入了72例接受仿制药CDDP同步CRT的患者。45例患者的CDDP疗程为3个，19例患者为2个，8例患者为1个。在154个疗程的80mg/m仿制药CDDP治疗期间，报告了21例（14%）3/4级白细胞减少、18例（12%）中性粒细胞减少和8例（5%）低色素血症。4例（3%）出现2级血清肌酐升高，但未报告3/4级血清肌酐升高。这些结果表明，HNC患者对使用仿制药CDDP的CRT耐受性良好。
