何义富, 季楚舒, 胡冰, 胡长路, 徐腾云, 范平生, 陈曼萍. 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[J]. 中国肿瘤临床, 2012, 39(18): 1379-1381，1389. DOI: 10.3969/j.issn.1000-8179.2012.18.012
引用本文: 何义富, 季楚舒, 胡冰, 胡长路, 徐腾云, 范平生, 陈曼萍. 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[J]. 中国肿瘤临床, 2012, 39(18): 1379-1381，1389. DOI: 10.3969/j.issn.1000-8179.2012.18.012
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Yifu HE, Chushu JI, Bing HU, Zhanglu HU, Tengyun XU, Pingsheng FAN, Manping CHEN. Phase Ⅱ Study of Paclitaxel and Nedaplatin as Front-line Chemotherapy for Metastatic Esoph-ageal Squamous Cell Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2012, 39(18): 1379-1381，1389. DOI: 10.3969/j.issn.1000-8179.2012.18.012
Citation: Yifu HE, Chushu JI, Bing HU, Zhanglu HU, Tengyun XU, Pingsheng FAN, Manping CHEN. Phase Ⅱ Study of Paclitaxel and Nedaplatin as Front-line Chemotherapy for Metastatic Esoph-ageal Squamous Cell Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2012, 39(18): 1379-1381，1389. DOI: 10.3969/j.issn.1000-8179.2012.18.012
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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

    摘要
  • 摘要:
      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/m2, d1, 3 h静脉滴入; 奈达铂80mg/m2, 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.

     

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