Morimoto Kenji, Yamada Tadaaki, Furuya Naoki, Tanaka Hisashi, Yoshimura Akihiro, Oba Tomohiro, Hibino Makoto, Fukuda Takahito, Goto Yasuhiro, Nakao Akira, Ogusu Shinsuke, Okazaki Yuta, Harada Taishi, Ota Takayo, Masubuchi Ken, Mikami Koji, Hata Tae, Matsumoto Shoki, Honda Ryoichi, Date Koji, Chihara Yusuke, Takayama Koichi
Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465, Kajii-cho, Kamigyo-ku, Kyoto, 602-8566, Japan.
Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.
Int J Clin Oncol. 2025 Jul 22. doi: 10.1007/s10147-025-02837-8.
In Japan, chemoimmunotherapy was approved as treatment for advanced or recurrent non-small-cell lung cancer (NSCLC), including for patients with epidermal growth factor receptor (EGFR) mutations, in December 2018. However, the impact of its approval on real-world clinical outcomes among patients with EGFR-mutant NSCLC remains unclear. The aim of our study was to assess that impact.
We retrospectively assessed consecutive patients with advanced or recurrent EGFR-mutant NSCLC who received platinum-based cancer therapy after EGFR-tyrosine kinase inhibitors (TKIs) at 20 institutions in Japan from January 2017 to July 2022.
We evaluated 120 (27.2%) patients before the chemoimmunotherapy approval and 321 (72.8%) after. Overall, no significant differences in progression-free survival (PFS) or overall survival (OS) were observed between the pre- and post-approval groups (p = 0.72 and p = 0.89, respectively). In the subgroup with programmed cell death-ligand 1 (PD-L1) expression ≥ 50%, the post-approval group had a significantly longer PFS (p = 0.007) and OS (p = 0.048) than the pre-approval group. In contrast, in the PD-L1 < 50% cohort, no significant differences in the PFS (p = 0.54) or OS (p = 0.75) were noted between the groups.
The approval of chemoimmunotherapy did not affect treatment outcomes among patients with EGFR-mutant NSCLC who received platinum-based therapy after EGFR-TKIs. However, patients with high levels of PD-L1 expression had improved outcomes post-approval, suggesting potential benefits in this subgroup.
2018年12月，化学免疫疗法在日本被批准用于治疗晚期或复发性非小细胞肺癌（NSCLC），包括表皮生长因子受体（EGFR）突变的患者。然而，其获批对EGFR突变的NSCLC患者实际临床结局的影响仍不清楚。我们研究的目的是评估这种影响。
我们回顾性评估了2017年1月至2022年7月在日本20家机构接受EGFR酪氨酸激酶抑制剂（TKIs）治疗后接受铂类癌症治疗的晚期或复发性EGFR突变NSCLC连续患者。
我们评估了化学免疫疗法获批前的120例（27.2%）患者和获批后的321例（72.8%）患者。总体而言，获批前和获批后组之间在无进展生存期（PFS）或总生存期（OS）方面未观察到显著差异（分别为p = 0.72和p = 0.89）。在程序性细胞死亡配体1（PD-L1）表达≥50%的亚组中，获批后组的PFS（p = 0.007）和OS（p = 0.048）显著长于获批前组。相比之下，在PD-L1<50%的队列中，两组之间在PFS（p = 0.54）或OS（p = 0.75）方面未观察到显著差异。
化学免疫疗法的获批并未影响接受EGFR-TKIs治疗后接受铂类疗法的EGFR突变NSCLC患者的治疗结局。然而，PD-L1表达水平高的患者在获批后的结局有所改善，表明该亚组可能获益。
