Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka, Japan
Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka, Japan.
Int J Gynecol Cancer. 2019 Mar;29(3):474-479. doi: 10.1136/ijgc-2018-000070. Epub 2019 Jan 4.
We conducted a phase II study to investigate the efficacy and toxicities of irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer.
Patients with advanced or recurrent cervical cancer previously treated with platinum based chemotherapy were enrolled. Irinotecan (150 mg/m) was administered intravenously over the course of 90 min on day 1, and S-1 (80 mg/m) was given orally in two divided doses from days 1 to 14 of a 21 day cycle. The primary endpoint of this phase II study was response rate. Secondary endpoints included safety, progression free survival, and overall survival.
A total of 19 patients were enrolled and treated. The response rate was 29.4%. Grade 3-4 hematologic toxicities were observed in three patients (15.7%). The only grade 3-4 non-hematologic toxicity observed was grade 3 diarrhea. The median progression free survival and overall survival were 3 months and 9 months, respectively.
S-1 plus irinotecan in a 3 weekly setting is safe and active in women with advanced or recurrent cervical cancer previously treated with platinum based chemotherapy. Future corroborative clinical studies are warranted.
我们进行了一项 II 期研究，旨在探讨伊立替康联合口服 S-1 治疗晚期或复发性子宫颈癌患者的疗效和毒性。
招募了先前接受过铂类化疗的晚期或复发性宫颈癌患者。伊立替康（150 mg/m）静脉滴注 90 分钟，第 1 天给药，S-1（80 mg/m）每天分两次口服，21 天为一个周期，第 1 至 14 天给药。该 II 期研究的主要终点是缓解率。次要终点包括安全性、无进展生存期和总生存期。
共纳入 19 例患者并进行治疗。缓解率为 29.4%。3 例患者（15.7%）出现 3-4 级血液学毒性。唯一观察到的 3-4 级非血液学毒性是 3 级腹泻。中位无进展生存期和总生存期分别为 3 个月和 9 个月。
在先前接受过铂类化疗的晚期或复发性宫颈癌患者中，S-1 联合伊立替康每 3 周给药方案是安全且有效的。需要进一步的临床研究来证实。
