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首页> 外文期刊>Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer >CALGB 30704 (Alliance): A randomized phase ii study to assess the efficacy of pemetrexed or sunitinib or pemetrexed plus sunitinib in the second-line treatment of advanced non-small-cell lung cancer
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CALGB 30704 (Alliance): A randomized phase ii study to assess the efficacy of pemetrexed or sunitinib or pemetrexed plus sunitinib in the second-line treatment of advanced non-small-cell lung cancer

机译：CALGB 30704（联盟）：一项II期随机研究，评估培美曲塞或舒尼替尼或培美曲塞加舒尼替尼在晚期非小细胞肺癌二线治疗中的疗效

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BACKGROUND:: Second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) improves survival modestly but new strategies are needed. This trial was designed to evaluate an antivascular endothelial growth factor strategy with or without standard chemotherapy in previously treated NSCLC. METHODS:: Patients with stage IIIB/IV NSCLC with performance status 0 to 1 progressive after first-line chemotherapy were eligible for randomization to pemetrexed, sunitinib, or the combination. Patients were stratified by performance status, stage, and sex. Primary objective was 18-week progression-free survival (PFS) rate; secondary objectives included response, overall survival (OS), and toxicity. Target accrual was 225. The study was terminated early because of decreasing accrual rates. RESULTS:: Between April 2008 and September 2011, 130 patients were registered and randomized; of this, 125 patients were treated. Baseline characteristics in the three arms were well balanced. Toxicity was higher in the sunitinib-containing arms. The 18-week PFS rate in the pemetrexed, sunitinib, and combination arms was 54% (95% confidence interval [CI], 40-71), 37% (95% CI, 25-54), and 48% (95% CI, 35-66), respectively (p = 0.25). Median PFS in the pemetrexed, sunitinib, and combination arms in months was 4.9 (2.1-8.8), 3.3 (2.3-4.2), and 3.7 (2.5-5.8), respectively (p = 0.18). There was an overall statistically significant difference in OS between the three arms: median OS in months was 10.5 (8.3-20.2) for pemetrexed, 8.0 (6.8-13.5) for sunitinib, and 6.7 (4.1-10.1) for the combination (p = 0.03). CONCLUSION:: Pemetrexed had a superior toxicity profile to either sunitinib or the combination of pemetrexed and sunitinib. The 18-week PFS rate was not significantly different between the arms. OS was significantly better with pemetrexed alone compared with the two sunitinib-containing arms, with the doublet performing worst for OS.
机译：背景：晚期非小细胞肺癌（NSCLC）的二线化疗可适度提高生存率，但需要新的策略。该试验旨在评估在先前治疗的NSCLC中采用或不采用标准化学疗法的抗血管内皮生长因子策略。方法：一线化疗后表现状态为0到1进行性IIIB / IV期NSCLC的患者，有资格随机分配至培美曲塞，舒尼替尼或其组合。按表现状态，分期和性别对患者进行分层。主要目标是18周无进展生存（PFS）率;次要目标包括反应，总体生存（OS）和毒性。目标应计为225。由于应计率降低，该研究提前终止。结果：在2008年4月至2011年9月之间，共有130名患者被登记并随机分组。其中125例患者接受了治疗。这三个方面的基线特征很均衡。含有舒尼替尼的手臂的毒性较高。培美曲塞，舒尼替尼和联合用药组的18周PFS率分别为54％（95％置信区间[CI]，40-71），37％（95％CI，25-54）和48％（95％） CI，35-66）（p = 0.25）。培美曲塞，舒尼替尼和联合用药组每月的中位PFS分别为4.9（2.1-8.8），3.3（2.3-4.2）和3.7（2.5-5.8）（p = 0.18）。三组之间的OS总体上在统计学上有显着差异：培美曲塞的每月OS中位数为10.5（8.3-20.2），舒尼替尼为8.0（6.8-13.5），联合用药为6.7（4.1-10.1）（p = 0.03）。结论：培美曲塞具有优于舒尼替尼或培美曲塞与舒尼替尼联合使用的毒性。两组之间的18周PFS率无显着差异。与两个舒尼替尼组相比，单独使用培美曲塞治疗的OS明显好得多，而双重治疗对OS的治疗效果最差。

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