Randomized phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer

被引:55
作者
Socinski, Mark A.
Weissman, Charles
Hart, Lowell L.
Beck, J. Thaddeus
Choksi, Janak K.
Hanson, John P.
Prager, Diane
Monberg, Matthew J.
Ye, Zhishen
Obasaju, Coleman K.
机构
[1] Univ N Carolina, Lineberger Comprehens Canc Ctr, Multidisciplinary Thorac Oncol Program, Chapel Hill, NC 27599 USA
[2] US Oncol, Latham, NY USA
[3] Alamance Reg Med Ctr, Burlington, NC USA
[4] Florida Canc Specialists, Ft Myers, FL USA
[5] Highlands Oncol Grp, Fayetteville, AR USA
[6] St Lukes Hosp, Milwaukee, WI USA
[7] Univ Calif Los Angeles, Med Ctr, Los Angeles, CA 90024 USA
[8] Eli Lilly & Co, Indianapolis, IN 46285 USA
关键词
D O I
10.1200/JCO.2006.07.7016
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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/m(2) plus cisplatin 75 mg/m(2) 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 B-12, and steroid prophylaxis. Results Between December 19, 2002, and May 17, 2004, 78 patients were enrolled onto 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.
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收藏
页码:4840 / 4847
页数:8
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