Clinical lung cancer · 2026
The Impact of Tumor Immune Microenvironment in EGFR-Mutant Non-Small Cell Lung Cancer on the Efficacy of Osimertinib.
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Mizutani Megumi, Matsumoto Yoshiya, Ohe Chisato, Sugimoto Akira, Nagamine Hiroaki, Tani Yoko, Oka Takako, Kaneda Hiroyasu, Yamada Kazuhiro, Watanabe Tetsuya, Asai Kazuhisa, Kimura Tatsuo, Shiohara Masanori, Kohashi Kenichi, Kawaguchi Tomoya
Аннотация
BACKGROUND: The relationship between the tumor microenvironment, comprising programmed cell death-1 ligand-1 (PD-L1), CD8-positive tumor-infiltrating lymphocytes (CD8+TIL), and FOXP3+TIL, in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) and its clinicopathological features and the efficacy of EGFR-tyrosine kinase inhibitors remain poorly understood.
METHODS: Patients treated with osimertinib or afatinib as first-line treatment were included. PD-L1 (clone: 22C3) expression was classified as positive or negative; CD8+TIL and FOXP3+TIL expressions were assessed via immunohistochemistry, and categorized as high or low. Thereafter, tumor immune microenvironment (TIME) was categorized into 4 classes according to PD-L1 and CD8+TIL statuses: class 1, positive/high; class 2, negative/low; class 3, positive/low; and class 4, negative/high.
RESULTS: Among the TIME classes, there were no significant correlations with clinicopathological factors. Progression-free survival (PFS) with osimertinib differed according to the TIME classification (median PFS: 7.6 vs. 17.7 vs. 14.8 vs. 34.0 months for classes 1-4, respectively; P = .0019). PFS was significantly shorter in the FOXP3+TIL-high group than in the low group (median PFS: 8.3 vs. 18.1 months, P = .031). Multivariable analysis showed that high FOXP3+TIL status was independently associated with shorter PFS (HR 2.28, P = .019); class 4 TIME was independently associated with longer PFS (HR 0.28, P = .004).
CONCLUSION: The TIME classification based on PD-L1 and CD8+TIL statuses, as well as FOXP3+TIL status, may help predict the efficacy of osimertinib in EGFR-mutant NSCLC.
METHODS: Patients treated with osimertinib or afatinib as first-line treatment were included. PD-L1 (clone: 22C3) expression was classified as positive or negative; CD8+TIL and FOXP3+TIL expressions were assessed via immunohistochemistry, and categorized as high or low. Thereafter, tumor immune microenvironment (TIME) was categorized into 4 classes according to PD-L1 and CD8+TIL statuses: class 1, positive/high; class 2, negative/low; class 3, positive/low; and class 4, negative/high.
RESULTS: Among the TIME classes, there were no significant correlations with clinicopathological factors. Progression-free survival (PFS) with osimertinib differed according to the TIME classification (median PFS: 7.6 vs. 17.7 vs. 14.8 vs. 34.0 months for classes 1-4, respectively; P = .0019). PFS was significantly shorter in the FOXP3+TIL-high group than in the low group (median PFS: 8.3 vs. 18.1 months, P = .031). Multivariable analysis showed that high FOXP3+TIL status was independently associated with shorter PFS (HR 2.28, P = .019); class 4 TIME was independently associated with longer PFS (HR 0.28, P = .004).
CONCLUSION: The TIME classification based on PD-L1 and CD8+TIL statuses, as well as FOXP3+TIL status, may help predict the efficacy of osimertinib in EGFR-mutant NSCLC.