Abstract | OBJECTIVES: MATERIALS AND METHODS: This retrospective multi-institutional observational study examined medical records of all consecutive patients with advanced or recurrent NSCLC, who started ICI monotherapy at 15 institutions in Japan between December 2015 and December 2017. Patients who received initial ICI therapy for >1 year without progressive disease were defined as the long-term treatment (LT) group; others were defined as the non-long-term treatment (NLT) group. Primary outcomes included the prognostic factors in the LT group, whereas secondary outcomes included efficacy of ICI rechallenge, safety, and survival outcomes in the overall population. RESULTS: In total, 676 patients were enrolled, and 114 (16.9 %) were assigned to the LT group. The median time interval from the start of initial ICI administration to data cutoff was 34.3 months (range, 24.1-47.8); thus, all surviving patients were followed-up for at least 2 years from the start of initial ICI. Median progression-free survival (PFS) was longer in the LT than in the NLT group (33.6 months vs. 2.7 months; p < 0.001). On multivariate analysis, significantly better PFS was associated with smoking (hazard ratio [HR]=0.36, p = 0.04), and complete response (CR; HR=uncomputable, p < 0.001) in the LT group. Thirty-seven patients (5.5 %) received ICI rechallenge, including 10 in the LT group. Among patients receiving rechallenge treatment, the median PFS was 2.2 months, with no difference between the LT and NLT groups. CONCLUSIONS: In the LT group, smoking and achieving CR were significantly associated with better PFS. Since rechallenge treatment was not effective, careful consideration is required for discontinuing ICI. However, these prognostic factors are helpful in considering candidates for ICI discontinuation. TRIAL REGISTRATION: UMIN ID, UMIN000041403.
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Authors | Shotaro Ito, Hajime Asahina, Osamu Honjo, Hisashi Tanaka, Ryoichi Honda, Satoshi Oizumi, Keiichi Nakamura, Kei Takamura, Fumihiro Hommura, Yasutaka Kawai, Kenichiro Ito, Noriaki Sukoh, Keiki Yokoo, Ryo Morita, Toshiyuki Harada, Taichi Takashina, Tomohiro Goda, Hirotoshi Dosaka-Akita, Hiroshi Isobe, Hokkaido Lung Cancer Clinical Study Group Trial |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 156
Pg. 12-19
(06 2021)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 33872943
(Publication Type: Journal Article, Observational Study)
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Copyright | Copyright © 2021 Elsevier B.V. All rights reserved. |
Topics |
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Humans
- Japan
- Lung Neoplasms
(drug therapy)
- Neoplasm Recurrence, Local
- Prognosis
- Retrospective Studies
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