培美曲塞联合卡铂与（周疗）紫杉醇联合卡铂一线治疗晚期非鳞状非小细胞肺癌的疗效和安全性的开放标签随机对照试验。
An Open-Label Randomized Controlled Trial Comparing the Efficacy and Safety of Pemetrexed-Carboplatin versus (Weekly) Paclitaxel-Carboplatin as First-Line Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer.
机构信息
Department of Medical Oncology, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, India.
Department of Medical Oncology, Dr. BRAIRCH, All India Institute of Medical Sciences, New Delhi, India,
出版信息
Oncology. 2021;99(6):389-396. doi: 10.1159/000514577. Epub 2021 Mar 18.
BACKGROUND
Before the approval of first-line immune checkpoint inhibitors, platinum doublets were the standard of care in patients with treatment-naïve advanced non-small cell lung cancer (NSCLC) without targetable driver mutations. Pemetrexed-platinum combinations are preferred in non-squamous NSCLC. However, there has been no direct comparison to paclitaxel-carboplatin.
METHODS
This open-label randomized trial was designed to compare pemetrexed-carboplatin with (weekly) paclitaxel-carboplatin in treatment-naïve advanced/metastatic non-squamous NSCLC without driver mutations. Patients received either pemetrexed 500 mg/m2 and carboplatin AUC 5 every 3 weeks, or paclitaxel 80 mg/m2 on day 1, day 8, and day 15 with carboplatin AUC 5 every 4 weeks for 4 cycles. Patients in both arms were allowed to receive pemetrexed maintenance.
RESULTS
A total of 180 patients were enrolled. The study was terminated early; however, at the time of analysis 75.8% of the required events had occurred. Finally, 164 patients were evaluable, 83 in the pemetrexed arm and 81 in the paclitaxel arm. After a median follow-up of 17 months, progression-free survival (PFS) rates at 6 months were not different in the two treatment arms (47.45 vs. 48.64%, p = 0.88). The median PFS values were 5.67 months (95% CI 3.73-7.3) and 5.03 months (95% CI 2.63-7.43) in each arm, respectively (HR 1.13, 95% CI 0.81-1.59, p = 0.44). The median overall survival was also not different: 14.83 months (95% CI 9.5-18.73) and 11.3 (95% CI 8.3-19.7; HR 1.19, 95% CI 0.8-1.78, p = 0.37). All grade toxicities were similar except for alopecia and peripheral neuropathy, which were higher in the paclitaxel arm.
CONCLUSION
Pemetrexed-carboplatin is not superior to (weekly) paclitaxel-carboplatin as the first-line regimen in advanced non-squamous NSCLC in terms of PFS.
背景
在批准一线免疫检查点抑制剂之前，铂类双重化疗是未经治疗的晚期非小细胞肺癌（NSCLC）患者的标准治疗方法，这些患者没有可靶向的驱动突变。培美曲塞联合铂类药物在非鳞状 NSCLC 中更受欢迎。然而，目前还没有与紫杉醇联合卡铂的直接比较。
方法
本开放标签随机试验旨在比较培美曲塞联合卡铂与（每周）紫杉醇联合卡铂在未经治疗的晚期/转移性非鳞状 NSCLC 中，无驱动突变的患者。患者接受培美曲塞 500mg/m2 联合卡铂 AUC5 每 3 周一次，或紫杉醇 80mg/m2 第 1、8 和 15 天，联合卡铂 AUC5 每 4 周一次，共 4 个周期。两组患者均允许接受培美曲塞维持治疗。
结果
共纳入 180 例患者。该研究提前终止；然而，在分析时，所需事件的 75.8%已经发生。最后，164 例患者可评估，培美曲塞组 83 例，紫杉醇组 81 例。中位随访 17 个月后，两组 6 个月无进展生存期（PFS）率无差异（47.45% vs. 48.64%，p=0.88）。两组中位 PFS 值分别为 5.67 个月（95%CI 3.73-7.3）和 5.03 个月（95%CI 2.63-7.43）（HR 1.13，95%CI 0.81-1.59，p=0.44）。中位总生存期也无差异：14.83 个月（95%CI 9.5-18.73）和 11.3 个月（95%CI 8.3-19.7；HR 1.19，95%CI 0.8-1.78，p=0.37）。所有级别毒性相似，除脱发和周围神经病变外，紫杉醇组较高。
结论
培美曲塞联合卡铂在无进展生存期方面并不优于（每周）紫杉醇联合卡铂作为晚期非鳞状 NSCLC 的一线治疗方案。
Zotero 插件