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Clinical Lung Cancer:晚期非鳞状非小细胞肺癌(NSQ-NSCLC)患者化疗后培美曲塞+/-抗VEGF维持的疗效和安全性

2021-11-30 MedSci原创 MedSci原创

研究表明,在NSQ-NSCLC患者中,培美曲塞单药维持用与培美曲塞+抗VEGF维持之间的OS无显著差异,并且双药维持组的不良反应较高。

研究表明,在NSQ-NSCLC患者中,培美曲塞单药维持用与培美曲塞+抗VEGF维持之间的OS无显著差异,并且双药维持组的不良反应较高。


近期,Clinical Lung Cancer杂志上发表了一项合并分析研究结果,目的是晚期非鳞状非小细胞肺癌(NSQ-NSCLC)患者化疗后培美曲塞+/-抗VEGF维持的总生存期(OS)和安全性。



来自4个随机临床试验(PARAMOUNT, PRONOUNCE, PointBreak, JVBL)的NSQ-NSCLC患者接受培美曲塞+/-抗VEGF维持治疗的数据被合并分为两组(A组:培美曲塞单药维持,n=486;B组:培美曲塞+抗VEGF维持组,n=329)。按治疗时间分析两组的OS和治疗相关不良事件(TEAEs)。


大多数患者为腺癌(只用培美曲塞维持治疗,85.0%;培美曲塞+抗VEGF, 81.5%), IV期疾病(仅培美曲塞维持,92.0%;培美曲塞+抗VEGF, 89.4%), ECOG PS为1或2(仅培美曲塞维持,59.7%;培美曲塞+抗VEGF, 54.4%)。大多数患者过去是吸烟者(仅使用培美曲塞维持, 77.6;培美曲塞+抗VEGF 86.3%)。


培美曲塞单药维持组的中位OS为16.1个月(95%CI: 15.2, 18.5),培美曲塞+抗VEGF维持组的中位OS为18.4个月(95%CI: 16.7, 20.3),没有统计学差异(HR: 1.17; 95% CI: 0.95, 1.46, p=0.1417)。培美曲塞单药维持组12、24和36个月的总生存率分别为65.71%、31.36%和26.88%。而培美曲塞+抗VEGF维持组的分别为72.99%, 34.27%, 和14.08%。



亚组分析发现,只有肝转移亚组患者可以从培美曲塞+抗VEGF维持中获益,其他亚组两种维持治疗没有统计学差异。



培美曲塞单药维持组患者中最常见的任何级别TEAE(在整个治疗周期中发生率≥20%)为恶心、疲劳、呕吐、贫血、中性粒细胞减少、便秘、食欲下降、乏力、外周水肿和失眠。最常见的3-5级TEAEs为中性粒细胞减少、贫血、疲劳、呕吐和乏力。


在培美曲塞+抗VEGF维持组中,最常见的TEAE(在整个治疗周期中发病率≥20%)包括疲劳、恶心、贫血、便秘、中性粒细胞减少、血小板减少、食欲下降、鼻出血、呕吐、咳嗽、腹泻、呼吸困难、背痛、头痛、头晕、呼吸困难、脱水、白细胞减少、高血压、蛋白尿、外周水肿和抑郁。大多为1-2级。最常见的3-5级TEAE为血小板减少症、中性粒细胞减少症、贫血、疲劳、白细胞减少症、高血压、呼吸困难。


综上,研究表明,在NSQ-NSCLC患者中,培美曲塞单药维持用与培美曲塞+抗VEGF维持之间的OS无显著差异,并且双药维持组的不良反应较高。但对于肝转移的情况,培美曲塞单药维持用与培美曲塞+抗VEGF维持之间的OS有显著差异,所以对于肝转移患者双药是一种较好的临床选择。


原始出处:
Edward B. Garon , Patrick Peterson , Maria Teresa Rizzo , Jong Seok Kim. Overall Survival and Safety With Pemetrexed/Platinum +/-Anti-VEGF Followed by Pemetrexed +/- Anti-VEGF Maintenance in Advanced Nonsquamous Non-Small-Cell Lung Cancer: A Pooled Analysis of Four Randomized Studies. Clinical Lung Cancer. 2021. DOI: https://doi.org/10.1016/j.cllc.2021.10.010.

 

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    2021-12-02 zll0628
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