International journal of clinical oncology · 2026
Treatment sequence after first-line immunotherapy in older adults with advanced NSCLC (NEJ057).
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Kushiro Kohei, Tsukita Yoko, Tozuka Takehiro, Hosokawa Shinobu, Sumi Toshiyuki, Uematsu Mao, Honjo Osamu, Yamaguchi Ou, Kyoyama Hiroyuki, Tsurumi Kyoji, Suzuki Yohei, Ishikawa Daisuke, Yoshimura Naruo, Matsumoto Naoko, Nagashima Hiromi, Kida Ryotaro, Yokouchi Hiroshi, Inomata Minehiko, Kanaji Nobuhiro, Takashina Taichi, Morita Satoshi, Kobayashi Kunihiko, Asahina Hajime
Аннотация
BACKGROUND: Optimal management of older patients with advanced non-small cell lung cancer (NSCLC) following progression on immune checkpoint inhibitors (ICIs) remains uncertain, as large-scale evidence guiding second-line therapy in this population is limited. Thus, we performed this study to evaluate transition rates and clinical outcomes of subsequent treatments in older patients with NSCLC after first-line ICI-based therapy.
METHODS: This multicenter retrospective cohort study included 1245 patients aged ≥ 75 years with advanced or recurrent epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangements-negative NSCLC who received first-line systemic therapy between December 2018 and March 2021 at 58 institutions in Japan. Outcomes included transition rates to second- and third-line therapy, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR).
RESULTS: Of all patients, 354 received ICI plus chemotherapy and 425 received ICI monotherapy. Disease progression occurred in 82% and 77% of patients, respectively. Second-line therapy (most commonly single-agent chemotherapy) was administered to 48% and 31%, respectively. Median PFS with single-agent chemotherapy was 3.7 months in both groups. Median OS was 9.5 and 9.9 months, respectively. ORRs were 11% and 13%, respectively. After progression, 35% and 32% of patients received third-line treatment, which demonstrated limited efficacy. In older patients with advanced NSCLC, transition to second-line therapy after first-line ICI-based treatment was limited. However, the efficacy of single-agent chemotherapy as second-line treatment was comparable to real-world outcomes reported prior to ICIs.
CONCLUSIONS: These findings underscore the importance of providing appropriate second-line treatment for older patients. REGISTRY AND REGISTRATION NO.
OF THE STUDY/TRIAL: UMIN Clinical Trials Registry (UMIN000046700).
METHODS: This multicenter retrospective cohort study included 1245 patients aged ≥ 75 years with advanced or recurrent epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangements-negative NSCLC who received first-line systemic therapy between December 2018 and March 2021 at 58 institutions in Japan. Outcomes included transition rates to second- and third-line therapy, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR).
RESULTS: Of all patients, 354 received ICI plus chemotherapy and 425 received ICI monotherapy. Disease progression occurred in 82% and 77% of patients, respectively. Second-line therapy (most commonly single-agent chemotherapy) was administered to 48% and 31%, respectively. Median PFS with single-agent chemotherapy was 3.7 months in both groups. Median OS was 9.5 and 9.9 months, respectively. ORRs were 11% and 13%, respectively. After progression, 35% and 32% of patients received third-line treatment, which demonstrated limited efficacy. In older patients with advanced NSCLC, transition to second-line therapy after first-line ICI-based treatment was limited. However, the efficacy of single-agent chemotherapy as second-line treatment was comparable to real-world outcomes reported prior to ICIs.
CONCLUSIONS: These findings underscore the importance of providing appropriate second-line treatment for older patients. REGISTRY AND REGISTRATION NO.
OF THE STUDY/TRIAL: UMIN Clinical Trials Registry (UMIN000046700).