紫杉醇联合奈达铂治疗晚期食管鳞癌Ⅱ期临床试验结果分析

Phase Ⅱ Study of Paclitaxel and Nedaplatin as Front-line Chemotherapy for Metastatic Esoph-ageal Squamous Cell Carcinoma

目的:观察紫杉醇联合奈达铂方案一线治疗晚期或手术/放疗后转移复发性食管鳞癌患者的疗效和安全性。方法:2008年6月到2010年7月收集39例病理确诊为晚期或手术/放疗后转移复发食管鳞癌患者纳入该项研究给药方案为紫杉醇135～150mg/m^2,d1,3 h静脉滴入;奈达铂80mg/m^2,d2,2 h静脉滴入;每21天为1个周期。近期疗效评估用RECIST疗效评价标准,远期疗效评估采用无进展生存时间(PFS)以及总生存时间(OS),不良反应评估用NCI CTC 3.0标准结果:中位治疗周期为4(1～6)个。其中36例患者可以进行疗效评估,有效率RR为46.2%(18/39),稳定率SD为38.5%(15/39),进展率PD为7.7%(3/39);全组患者中位PFS以及OS分别为7.1个月(95%CI:4.6～9.7个月)和12.4个月(95%CI:9.5～15.3个月);3/4级主要不良反应有粒细胞下降15.4%,贫血7.7%,血小板下降5.1%,恶心10.3%,呕吐5.1%,无治疗相关性死亡。结论:紫杉醇联合奈达铂治疗晚期或手术/放疗后转移复发性食管癌具有较好的疗效且有较好的耐受性。

Abstract Objective： This study aims to assess the efficacy and toxicity of the combination of paclitaxel and nedaplatin as a front-line chemotherapy for patients with metastatic esophageal squamous cell carcinoma （ ESCC ）. Methods： Patients with metastatic ESCC who previously received no palliative chemotherapy were enrolled into a two-center, open-label, single-arm phase Ⅱ study. The patients received 175 mg/m2 paclitaxel over a 3 h infusion on day 1, followed by 80 mg/m2 nedaplatin over a 2 h infusion on day 2. The treatments were done every 3 weeks until a documented disease progression occurs, unacceptable toxicity is reached, or when the patient refused treatment. Results： TA total of 39 patients were enrolled in the intention-to-treat analysis of efficacy and adverse events. Of the 36 patients assessed for efficacy, 2 （ 5.1 % ） had complete responses and 16 patients （ 41.0 % ） had partial responses, giving anoverall response rate of 46.1 %. With a median follow-up period of 13.1 months （ range = 3.3 months to 28.6 months ）, the median progression-free survival and median overall survival for all patients were 7.1 months （ 95 % CI, 4.6 months to 9.7 months ） and 12.4 months （ 95 % CI, 9.5 months to 15.3 months ）, respectively. The toxicities were moderate and manageable. Grade 3 / 4 toxicities included neutropenia （ 15.4 % ）, nausea （ 10.3 % ）, anemia （ 7.7 % ）, thrombocytopenia （ 5.1 %） , vomiting （ 5.1 % ）, and neutropenia fever （ 2.6 % ）. Conclusion： The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.