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Clinical Trial
. 2009 Oct 1;27(28):4787-92.
doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.

Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer

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Clinical Trial

Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer (V体育官网)

Mark A Socinski et al. J Clin Oncol. .

Abstract

Purpose: Following a phase II trial in which pemetrexed-platinum demonstrated similar activity to that of historical etoposide-platinum controls, a phase III study was conducted to compare pemetrexed-carboplatin with etoposide-carboplatin for the treatment of extensive-stage small-cell lung cancer (ES-SCLC). VSports手机版.

Patients and methods: Chemotherapy-naive patients with ES-SCLC and an Eastern Cooperative Oncology Group performance status of zero to 2 were randomly assigned to receive pemetrexed-carboplatin (pemetrexed 500 mg/m(2) on day 1; carboplatin at area under the serum concentration-time curve [AUC] 5 on day 1) or etoposide-carboplatin (etoposide 100 mg/m(2) on days 1 through 3; carboplatin AUC 5 on day 1) every 3 weeks for up to six cycles. The primary objective of the study was noninferiority of pemetrexed-carboplatin overall survival with a 15% margin V体育安卓版. .

Results: Accrual was terminated with 908 of 1,820 patients enrolled after results of a planned interim analysis. In the final analysis, pemetrexed-carboplatin was inferior to etoposide-carboplatin for overall survival (median, 8. 1 v 10. 6 months; hazard ratio [HR],1. 56; 95% CI, 1. 27 to 1. 92; log-rank P < . 01) and progression-free survival (median, 3. 8 v 5. 4 months; HR, 1 V体育ios版. 85; 95% CI, 1. 58 to 2. 17; log-rank P < . 01). Objective response rates were also significantly lower for pemetrexed-carboplatin (31% v 52%; P < . 001). Pemetrexed-carboplatin had lower grade 3 to 4 neutropenia, febrile neutropenia, and leukopenia than etoposide-carboplatin; grade 3 to 4 thrombocytopenia was comparable between arms and anemia was higher in the pemetrexed-carboplatin arm. .

Conclusion: Pemetrexed-carboplatin is inferior for the treatment of ES-SCLC VSports最新版本. Planned translational research and pharmacogenomic analyses of tumor and blood samples may help explain the study results and provide insight into new treatment strategies. .

Trial registration: ClinicalTrials V体育平台登录. gov NCT00363415. .

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