Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.
Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
J Clin Oncol. 2023 Dec 1;41(34):5242-5246. doi: 10.1200/JCO.23.00179. Epub 2023 Sep 1.
JCO 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的 III 期临床试验,旨在评估培美曲塞联合顺铂(PemP)与长春瑞滨联合顺铂(NP)作为 II 期-III 期非鳞状非小细胞肺癌(NSCLC)患者辅助化疗的疗效。在此,我们报告了长期随访的总生存(OS)数据。符合条件的患者被随机分配接受 PemP 或 NP 治疗。主要终点是无复发生存(RFS),次要终点包括 OS。这项分析是使用最后一名患者入组后 5 年收集的数据进行的。在 804 名入组患者中,783 名患者符合条件(NP 组 384 例,PemP 组 389 例)。NP 组的中位 RFS 更新后为 37.5 个月,PemP 组为 43.4 个月,风险比为 0.95(95%CI,0.79 至 1.14)。在中位随访 77.3 个月时,NP 组 3 年和 5 年的 OS 率分别为 84.1%和 75.6%,而 PemP 组为 87.0%和 75.0%,风险比为 1.04(95%CI,0.81 至 1.34)。这项长期随访分析表明,PemP 在 RFS 和 OS 方面与 NP 疗效相当,与历史数据相比,OS 数据是最长的之一。