Background <p>The survival benefit of combining chemotherapy (chemo) with immune checkpoint inhibitors (ICIs) in older patients with advanced non-small cell lung cancer (NSCLC) remains unclear. We evaluated the lung immune prognostic index (LIPI) as a predictive biomarker in this NEJ057 secondary analysis.</p> Methods <p>This analysis included 600 patients aged ≥ 75&#xa0;years with NSCLC and a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1% enrolled in the NEJ057 study. LIPI was categorized as good, intermediate, or poor based on derived neutrophil-to-lymphocyte ratio and lactate dehydrogenase levels. Overall survival (OS) and progression-free survival (PFS) were assessed using Kaplan–Meier analysis and multivariate Cox proportional hazards models. Subgroup analyses focused on patients with a PD-L1 TPS of 1–49% and intermediate/poor LIPI to evaluate predictive factors for ICI-chemo benefit.</p> Results <p>The survival outcomes of ICI-chemo and ICI-alone varied across different patient characteristics, with LIPI identified as a predictive biomarker. Among patients with a PD-L1 TPS of 1–49% and intermediate/poor LIPI scores, ICI-chemo was associated with significantly longer OS (median: 18.3&#xa0;months [95% confidence interval {CI} 10.7–26.7] vs. 8.6&#xa0;months [95% CI 4.5–12.4], <i>p</i> = 0.007; hazard ratio [HR]: 0.56 [95% CI 0.36–0.86]) and PFS (median: 7.8&#xa0;months [95% CI 6.2–9.7] vs. 3.3&#xa0;months [95% CI 1.5–5.0], <i>p</i> = 0.002; HR: 0.56 [95% CI 0.39–0.81]) compared with ICI-alone. No significant survival benefit was observed in patients with a PD-L1 TPS of ≥ 50% or good LIPI scores.</p> Conclusions <p>LIPI is a useful biomarker for guiding treatment decisions in older patients with NSCLC and a PD-L1 TPS of 1–49%, particularly those with intermediate/poor LIPI scores. Its application might facilitate establishing more personalized strategies and improve outcomes.</p>

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Lung immune prognostic index as a biomarker for predicting the benefit of immune checkpoint inhibitor plus chemotherapy in older patients with non-small cell lung cancer: a secondary analysis of the NEJ057 study

  • Takehiro Tozuka,
  • Yoko Tsukita,
  • Kohei Kushiro,
  • Shinobu Hosokawa,
  • Hitomi Nogawa,
  • Satoshi Arai,
  • Sayo Soda,
  • Daisuke Arai,
  • Kei Takamura,
  • Ryoichi Honda,
  • Kosuke Hamai,
  • Yukiko Namba,
  • Yasutaka Kawai,
  • Takashi Kikuchi,
  • Kensuke Nakazawa,
  • Takayuki Honda,
  • Noriyuki Ebi,
  • Yutaka Yamada,
  • Tomonori Makiguchi,
  • Masahiro Seike,
  • Satoshi Morita,
  • Kunihiko Kobayashi,
  • Hajime Asahina

摘要

Background

The survival benefit of combining chemotherapy (chemo) with immune checkpoint inhibitors (ICIs) in older patients with advanced non-small cell lung cancer (NSCLC) remains unclear. We evaluated the lung immune prognostic index (LIPI) as a predictive biomarker in this NEJ057 secondary analysis.

Methods

This analysis included 600 patients aged ≥ 75 years with NSCLC and a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 1% enrolled in the NEJ057 study. LIPI was categorized as good, intermediate, or poor based on derived neutrophil-to-lymphocyte ratio and lactate dehydrogenase levels. Overall survival (OS) and progression-free survival (PFS) were assessed using Kaplan–Meier analysis and multivariate Cox proportional hazards models. Subgroup analyses focused on patients with a PD-L1 TPS of 1–49% and intermediate/poor LIPI to evaluate predictive factors for ICI-chemo benefit.

Results

The survival outcomes of ICI-chemo and ICI-alone varied across different patient characteristics, with LIPI identified as a predictive biomarker. Among patients with a PD-L1 TPS of 1–49% and intermediate/poor LIPI scores, ICI-chemo was associated with significantly longer OS (median: 18.3 months [95% confidence interval {CI} 10.7–26.7] vs. 8.6 months [95% CI 4.5–12.4], p = 0.007; hazard ratio [HR]: 0.56 [95% CI 0.36–0.86]) and PFS (median: 7.8 months [95% CI 6.2–9.7] vs. 3.3 months [95% CI 1.5–5.0], p = 0.002; HR: 0.56 [95% CI 0.39–0.81]) compared with ICI-alone. No significant survival benefit was observed in patients with a PD-L1 TPS of ≥ 50% or good LIPI scores.

Conclusions

LIPI is a useful biomarker for guiding treatment decisions in older patients with NSCLC and a PD-L1 TPS of 1–49%, particularly those with intermediate/poor LIPI scores. Its application might facilitate establishing more personalized strategies and improve outcomes.