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Background <p>In Japan, chemoimmunotherapy was approved as treatment for advanced or recurrent non-small-cell lung cancer (NSCLC), including for patients with <i>epidermal growth factor receptor</i> (<i>EGFR</i>) mutations, in December 2018. However, the impact of its approval on real-world clinical outcomes among patients with <i>EGFR</i>-mutant NSCLC remains unclear. The aim of our study was to assess that impact.</p> Methods <p>We retrospectively assessed consecutive patients with advanced or recurrent <i>EGFR-</i>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.</p> Results <p>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 &lt; 50% cohort, no significant differences in the PFS (p = 0.54) or OS (p = 0.75) were noted between the groups.</p> Conclusions <p>The approval of chemoimmunotherapy did not affect treatment outcomes among patients with <i>EGFR</i>-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.</p>

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Real-world treatment outcomes before and after chemoimmunotherapy approval in EGFR-mutant NSCLC after EGFR-TKI failure: a Japanese cohort study

  • 期刊论文

  • 发表日期：

    2025年7月22日

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  • Kenji Morimoto,
  • Tadaaki Yamada,
  • Naoki Furuya,
  • Hisashi Tanaka,
  • Akihiro Yoshimura,
  • Tomohiro Oba,
  • Makoto Hibino,
  • Takahito Fukuda,
  • Yasuhiro Goto,
  • Akira Nakao,
  • Shinsuke Ogusu,
  • Yuta Okazaki,
  • Taishi Harada,
  • Takayo Ota,
  • Ken Masubuchi,
  • Koji Mikami,
  • Tae Hata,
  • Shoki Matsumoto,
  • Ryoichi Honda,
  • Koji Date,
  • Yusuke Chihara,
  • Koichi Takayama

摘要

Background

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.

Methods

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.

Results

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.

Conclusions

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.