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Pemetrexed联合顺铂或卡铂一线治疗广泛期小细胞肺癌II期随机临床试验

2009-08-19 17:03:26 作者：新特药房来源：中国新持药网浏览次数：126 文字大小：【大】【中】【小】

简介： 英文原文：　　　 Randomized PhaseIITrialofPemetrexedCombinedWithEitherCisplatinorCarboplatin in Untreated Extensive-Stage Small-Cell Lung Cancer Mark A. Socinski, Charles Weis ...

关键字：培美曲塞 Pemetrexed 小细胞肺癌

英文原文：　　　
Randomized PhaseIITrialofPemetrexedCombinedWithEitherCisplatinorCarboplatin in Untreated Extensive-Stage Small-Cell Lung Cancer

Mark A. Socinski, Charles Weissman, Lowell L. Hart, J. Thaddeus Beck, Janak K. Choksi, John P. Hanson, Diane Prager, Matthew J. Monberg, Zhishen Ye, Coleman K. Obasaju Journal of Clinical Oncology, Vol 24, No 30 (October 20), 2006: pp. 4840-4847

PURPOSE: Given the activity and tolerability of pemetrexed/platinum combinations in non–small-cell lung cancer, and the success of novel therapeutic strategies employed in recent extensive-stage small-cell lung cancer (ES-SCLC) trials, a randomized phase II trial was initiated to evaluate the use of cisplatin or carboplatin plus pemetrexed in previously untreated ES-SCLC.

PATIENTS AND METHODS: Patients were randomly assigned to receive pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or pemetrexed plus carboplatin area under the concentration curve 5. Treatment was administered once every 21 days for a maximum of six cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis.

RESULTS: Between December 19, 2002, and May 17, 2004, 78 patients were enrolledonto this multicenter trial. Median age was 63 years (range, 46 to 82 years) for cisplatin/pemetrexed and 66 years (range, 47 to 75 years) for carboplatin/pemetrexed. Median survival time (MST) for cisplatin/pemetrexed was 7.6 months, with a 1-year survivorship of 33.4% and a response rate of 35% (95% CI, 20.6% to 51.7%). The MST for carboplatin/pemetrexed was 10.4 months, with a 1-year survivorship of 39.0% and a response rate of 39.5% (95% CI, 24.0 to 56.6). Median time to progression for cisplatin/pemetrexed was 4.9 months and for carboplatin/pemetrexed was 4.5 months. Median dose-intensity (actual/planned dose) was 98.94% for cisplatin and 99.95% for pemetrexed in the cisplatin/pemetrexed group and 93.21% for carboplatin and 98.50% for pemetrexed in the carboplatin/pemetrexed group. Grade 3/4 hematologic toxicities included neutropenia (15.8% v 20.0%) and thrombocytopenia (13.2% v 22.9%) in the cisplatin/pemetrexed and carboplatin/pemetrexed treatment groups, respectively.
CONCLUSION: Pemetrexed/platinum doublets had activity and appeared to be well-tolerated in first-line ES-SCLC.

参考译文：　
Pemetrexed联合顺铂或卡铂一线治疗广泛期小细胞肺癌的II期随机临床试验
目的：
鉴于Pemetrexed联合铂类药物治疗非小细胞肺癌安全、有效，新近进行广泛期小细胞肺癌的II期随机临床试验引入了这一新的治疗方案,目的是评估Pemetrexed联合顺铂或卡铂在未经治疗的广泛期小细胞肺癌治疗中的应用。　
患者和方法：患者随机分成两组，分别接受培美曲塞 500 mg/m2 加顺铂 75 mg/m2（以下简称顺铂组）和培美曲塞加卡铂面积浓度曲线＜5（以下简称卡铂组）治疗。给药方法为每21天为1周期，每周期给一次最大剂量药物，共6周期。所有患者同时给予叶酸、维生素B12，类固醇预防治疗。

结果：
从2002年12月19日到2004年5月17日，共78名患者参加这项多中心试验。顺铂加培美曲塞组中位年龄63岁（年龄范围从46-82岁），卡铂加培美曲塞组中位年龄66岁（范围从47-75岁）。前组中位生存期为7.6个月，1年生存率为33.4%,有效率为35％。后组中位生存期为10.4个月，1年生存率为39％，有效率39.5％，顺铂组中位进展期为4.9个月，卡铂组为4.5个月，中位最大剂量（实际应用/计划剂量）在顺铂组，顺铂剂量为计划剂量的98.94%，培美曲塞99.95%；卡铂组卡铂为93.21%，培美曲塞98.50%。两组3~4级血液毒性反应包括中性粒细胞减少症发生率分别为15.8%和20.0%，血小板减少症发生率分别为13.2%和22.9%。
　　
结论：培美曲塞联合铂类药物一线治疗小细胞肺癌有效且耐受良好