Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study
Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study
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DOI：
10.1016/s0140-6736(09)61497-5
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发表时间：
2009-10-24
期刊：
影响因子：
168.9
通讯作者：
Belani, Chandra P.
中科院分区：
文献类型：
--
作者：
Ciuleanu, Tudor;Brodowicz, Thomas;Belani, Chandra P.
背景：几项研究显示了培美塞（一种抗叶酸剂）在晚期非小细胞肺癌患者中的疗效、耐受性和给药方便性。我们评估了培美曲塞作为维持治疗在这种疾病的患者。方法这项随机双盲研究在20个国家的83个中心进行。663例IIIB或IV期疾病患者在4个周期的铂类化疗中未发生疾病进展，随机分配（21例患者）接受培美曲塞（500 mg/m2，第1天）加最佳支持治疗（n=441）或安慰剂加最佳支持治疗（n=222），21天为1个周期，直至疾病进展。采用Simon和Pocock最小化方法随机分配治疗。患者和研究者对治疗设盲。所有患者均接受维生素B-12、叶酸和地塞米松治疗。无进展生存期的主要终点和总生存期的次要终点通过意向treat. This研究注册ClinicalTrials.gov，编号NCT00102804.Findings所有随机分配的参与者进行了分析。培美曲塞显著改善了无进展生存期（4.3个月[95% CI 4.1-4.7] vs 2.6个月[1.7-2.8];风险比[HR] 0.50，95% CI 0.42-0.61，p
Background Several studies have shown the efficacy, tolerability, and ease of administration of pemetrexed-an antifolate antineoplastic agent-in patients with advanced non-small-cell lung cancer. We assessed pemetrexed as maintenance therapy in patients with this disease.Methods This randomised double-blind study was undertaken in 83 centres in 20 countries. 663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were randomly assigned (21 ratio) to receive pemetrexed (500 mg/m(2), day 1) plus best supportive care (n=441) or placebo plus best supportive care (n=222) in 21-day cycles until disease progression. Treatment was randomised with the Simon and Pocock minimisation method. Patients and investigators were masked to treatment. All patients received vitamin B-12, folic acid, and dexamethasone. The primary endpoint of progression-free survival and the secondary endpoint of overall survival were analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00102804.Findings All randomly assigned participants were analysed. Pemetrexed significantly improved progression-free survival (4.3 months [95% CI 4.1-4.7] vs 2.6 months [1.7-2.8]; hazard ratio [HR] 0.50, 95% CI 0.42-0.61, p