JIPANG五年总体生存率分析：培美曲塞或长春瑞滨联合顺铂治疗可切除II-IIIA期非鳞状非小细胞肺癌

SCI

15 September 2023

Five-Year Overall Survival Analysis of the JIPANG Study: Pemetrexed or Vinorelbine Plus Cisplatin for Resected Stage II-IIIA Nonsquamous Non–Small-Cell Lung Cancer

(Journal of Clinical Oncology, IF: 45.3)

Hirotsugu Kenmotsu, Nobuyuki Yamamoto, Toshihiro Misumi, Kiyotaka Yoh, Haruhiro Saito, Shunichi Sugawara, Koji Yamazaki, Kazuhiko Nakagawa, Kenji Sugio, Takashi Seto, Shinichi Toyooka, Hiroshi Date, Tetsuya Mitsudomi, Isamu Okamoto, Kohei Yokoi, Hideo Saka, Hiroaki Okamoto, Yuichi Takiguchi, Toshiaki Takahashi, Masahiro Tsuboi

CORRESPONDENCE TO: h.kenmotsu@scchr.jp

Abstract 摘要

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

临床试验通常包括在不同时间成熟的多个终点。初始报告通常基于主要终点，可能会在关键计划的共同主要或次要终点分析尚不可用时发布。临床试验更新栏目为在JCO或其他地方以外已发表研究的额外结果提供了发表机会，这些研究的主要终点已经报告。

The JIPANG study is an open-label phase III trial evaluating the efficacy of pemetrexed plus cisplatin (PemP) versus vinorelbine plus cisplatin (NP) as adjuvant chemotherapy in patients with stage II-IIIA nonsquamous non–small-cell lung cancer (NSCLC). Here, we report the long follow-up overall survival (OS) data. Eligible patients were randomly assigned to receive either PemP or NP. The primary end point was recurrence-free survival (RFS), and the secondary end point included OS. This analysis was performed using data collected 5 years after the last patient enrollment. Among 804 patients enrolled, 783 patients were eligible (384 for NP and 389 for PemP). The updated median RFS was 37.5 months in the NP arm and 43.4 months in the PemP arm with a hazard ratio of 0.95 (95% CI, 0.79 to 1.14). At a median follow-up of 77.3 months, the OS rates at 3 and 5 years were 84.1% and 75.6% versus 87.0% and 75.0% with a hazard ratio of 1.04 (95% CI, 0.81 to 1.34). This long-term follow-up analysis showed that PemP had similar efficacy to NP in both RFS and OS for this population, with one of the longest OS data compared with the historical data.

JIPANG研究是一项开放标签III期试验，评估培美曲塞加顺铂（PemP）与长春瑞滨加顺铂（NP）治疗II-IIIA期非鳞状非小细胞肺癌（NSCLC）患者辅助化疗的疗效。在此，我们报告长期随访的总生存率（OS）数据。符合条件的患者被随机分配接受PemP或NP。主要终点是无复发生存期（RFS），次要终点包括OS。该分析是使用最后一位患者入组5年后收集的数据进行的。在804名入选患者中，783名患者符合条件（384名为NP，389名为PemP）。NP组和PemP组更新的中位RFS分别为37.5个月和43.4个月，风险比为0.95（95%CI，0.79-1.14）。在77.3个月的中位随访中，NP组和PemP组3年和5年的OS率分别为84.1%和75.6%，87.0%和75.0%，危险比为1.04（95%CI，0.81-1.34）。该长期随访分析表明，PemP在该人群的RFS和OS中具有与NP相似的疗效，是与历史数据相比最长的OS数据之一。