Yang Zhijun, Chen Dandan, Zhang Jieqing, Yao Desheng, Gao Kun, Wang He, Liu Cui, Yu Jiang, Li Li
Department of Gynecologic Oncology, Affiliated Tumor Hospital of Guangxi Medical University, 71, Hedi Road, Nanning, Guangxi 530021, China; Key Laboratory of High-Incidence-Tumor Prevention & Treatment (Guangxi Medical University), Ministry of Education, China.
Department of Gynecology, The Red Cross Hospital of Yulin, China.
Gynecol Oncol. 2016 May;141(2):231-239. doi: 10.1016/j.ygyno.2015.06.027. Epub 2015 Jun 24.
OBJECTIVE: This study sought to evaluate the toxicity and curative effect of irinotecan plus cisplatin neoadjuvant chemotherapy (NACT) for stage Ib2, IIa2, and IIb cervical cancer patients. METHODS: A total of 219 patients were randomly assigned to two groups: 109 patients were treated with 1-2 cycles of chemotherapy (NACT group), and 110 patients in the control group were treated directly with surgery (DS group). Patients in the NACT group were randomly assigned to two groups: 50 patients were treated with irinotecan plus cisplatin followed by surgery (IP group), and 59 patients were treated with paclitaxel plus cisplatin followed by surgery (TP group). Patients with pathological recurrence risk factors received post-operative radiotherapy. RESULTS: Survival analysis revealed no significant difference in disease-free survival (DFS) or overall survival (OS) between the NACT and DS groups. Analysis of clinicopathologic factors showed that the lymphovascular space invasion (LVSI) and deep stromal invasion rates were significantly lower in the NACT group. Grade 3/4 neutropenia and grade 3/4 diarrhea were both higher in the IP group than in the TP group. DFS and OS were similar in the IP and TP groups. Univariate analysis showed that LVSI was the only factor associated with DFS. CONCLUSION: NACT did not improve overall survival but did reduce the number of patients who received post-operative radiotherapy. NACT consisting of irinotecan plus cisplatin for cervical cancer showed similar efficacy and higher toxicity compared with the use of paclitaxel plus cisplatin, although the toxicity was tolerable.
目的:本研究旨在评估伊立替康联合顺铂新辅助化疗(NACT)对Ib2期、IIa2期和IIb期宫颈癌患者的毒性及疗效。 方法:总共219例患者被随机分为两组:109例患者接受1 - 2周期化疗(NACT组),110例对照组患者直接接受手术(DS组)。NACT组患者又被随机分为两组:50例患者接受伊立替康联合顺铂治疗后行手术(IP组),59例患者接受紫杉醇联合顺铂治疗后行手术(TP组)。有病理复发风险因素的患者接受术后放疗。 结果:生存分析显示,NACT组与DS组在无病生存期(DFS)或总生存期(OS)方面无显著差异。临床病理因素分析表明,NACT组的脉管间隙浸润(LVSI)和深层间质浸润率显著更低。IP组3/4级中性粒细胞减少和3/4级腹泻的发生率均高于TP组。IP组和TP组的DFS和OS相似。单因素分析显示,LVSI是与DFS相关的唯一因素。 结论:NACT并未改善总生存期,但确实减少了接受术后放疗的患者数量。与使用紫杉醇联合顺铂相比,由伊立替康联合顺铂组成的NACT对宫颈癌显示出相似的疗效和更高的毒性,尽管毒性是可耐受的。
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