Sugiyama T, Nishida T, Kumagai S, Nishio S, Fujiyoshi K, Okura N, Yakushiji M, Hiura M, Umesaki N
Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume City, Japan.
Br J Cancer. 1999 Sep;81(1):95-8. doi: 10.1038/sj.bjc.6690656.
To evaluate the response rate and toxicity of the combination of irinotecan (CPT-11) and cisplatin in a neoadjuvant setting, a phase II study was conducted regarding the regimen of this combination in patients with locally advanced cervical cancer. Eligibility included patients with previously untreated stage Ib2, IIb, or IIIb squamous cell carcinoma with good performance status. CPT-11 (60 mg m(-2)) was administered intravenously on days 1, 8 and 15, followed by cisplatin (60 mg m(-2)) given intravenously on day 1. Treatment was repeated every 4 weeks for a total of two or three cycles. Among 23 eligible patients (median age: 59 years), three showed complete response (13%), 15 showed partial response (65%), for an overall response rate of 78% (95% confidence interval 58-90%). Stable disease was observed in four cases (17%) and progressive disease in one (4%). The median time to failure and median survival time have not yet been reached. Of the 52 treatment cycles administered, diarrhoea and grade 3 or 4 neutropenia were observed in 10% and 75% respectively. There were no therapy-related deaths. The combination of CPT-11 with cisplatin is a promising regimen for neoadjuvant chemotherapy in locally advanced cervical cancer. The toxicities of this regimen are well tolerated.
为了评估伊立替康（CPT-11）与顺铂联合用于新辅助治疗时的缓解率及毒性，针对该联合方案在局部晚期宫颈癌患者中的应用开展了一项II期研究。入选标准包括既往未接受过治疗、体能状态良好的Ib2期、IIb期或IIIb期鳞状细胞癌患者。CPT-11（60 mg m(-2)）于第1、8和15天静脉给药，随后顺铂（60 mg m(-2)）于第1天静脉给药。每4周重复治疗一次，共进行两或三个周期。在23例符合条件的患者（中位年龄：59岁）中，3例显示完全缓解（13%），15例显示部分缓解（65%），总缓解率为78%（95%置信区间58-90%）。4例（17%）观察到病情稳定，1例（4%）出现疾病进展。失败的中位时间和中位生存时间尚未达到。在52个治疗周期中，分别有10%和75%的患者出现腹泻和3级或4级中性粒细胞减少。无治疗相关死亡。CPT-11与顺铂联合是局部晚期宫颈癌新辅助化疗的一种有前景的方案。该方案的毒性耐受性良好。
