Immunotherapy or Chemoimmunotherapy in Older Adults With Advanced Non–Small Cell Lung Cancer

Author:

Tsukita Yoko1,Tozuka Takehiro2,Kushiro Kohei3,Hosokawa Shinobu4,Sumi Toshiyuki5,Uematsu Mao6,Honjo Osamu7,Yamaguchi Ou8,Asao Tetsuhiko9,Sugisaka Jun10,Saito Go11,Shiihara Jun12,Morita Ryo13,Katakura Seigo14,Yasuda Takehiro15,Hisakane Kakeru16,Miyauchi Eisaku1,Morita Satoshi17,Kobayashi Kunihiko8,Asahina Hajime18

Affiliation:

1. Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan

2. Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan

3. Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan

4. Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan

5. Department of Respiratory Medicine, Hakodate Goryoukaku Hospital, Hakodate, Japan

6. Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan

7. Department of Respiratory Medicine, Sapporo Minami-Sanjo Hospital, Sapporo, Japan

8. Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan

9. Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan

10. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan

11. Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan

12. Department of Respiratory Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan

13. Department of Respiratory Medicine, Akita Kousei Medical Center, Akita, Japan

14. Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan

15. Department of Respiratory Medicine, Yokosuka Kyosai Hospital, Yokosuka, Japan

16. Department of Pulmonary Medicine and Medical Oncology, Nippon Medical School Tamanagayama Hospital, Tokyo, Japan

17. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

18. Department of Respiratory Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan

Abstract

ImportanceImmune checkpoint inhibitor (ICI) plus chemotherapy combination treatment (ICI-chemotherapy) is now a standard treatment for non–small cell lung cancer (NSCLC) without targetable oncogene alterations, but there are few data on ICI-chemotherapy for patients 75 years and older.ObjectiveTo inform the choice of first-line drugs in clinical practice and assess the safety and efficacy of ICI-chemotherapy combination treatment in older adult patients with previously untreated advanced NSCLC.Design, Setting, and ParticipantsThis retrospective cohort study included 58 centers in Japan. The cohort consisted of patients 75 years and older with clinical stage IIIB, IIIC, IV, postoperative or radiotherapy recurrent NSCLC. Patients started first-line systemic therapy between December 2018 and March 2021. Those receiving first-line molecular targeted drugs were excluded. The data were analyzed from February 2022 to October 2022.ExposuresSystemic therapy.Main Outcomes and MeasuresThe main outcomes were overall survival (OS), progression-free survival (PFS), and safety.ResultsA total of 1245 patients (median [range] age, 78 [75-95] years; 967 [78%] male) with NSCLC were included in the cohort. Programmed death ligand–1 (PD-L1) expression of less than 1% occurred in 268 tumors (22%); 1% to 49% in 387 tumors (31%); 50% and higher in 410 tumors (33%), and unknown expression in 180 tumors (14%). Median OS was 20.0 (95% CI, 17.1-23.6) months for the 354 patients receiving ICI-chemotherapy (28%); 19.8 (95% CI, 16.5-23.8) months for the 425 patients receiving ICI alone (34%); 12.8 (95% CI, 10.7-15.6) months for the 311 patients receiving platinum-doublet chemotherapy (25%); and 9.5 (95% CI, 7.4-13.4) months for the 155 patients receiving single-agent chemotherapy (12%). After propensity score matching, no differences in OS and PFS were found between the patients receiving ICI-chemotherapy vs ICI alone. Each group consisted of 118 patients. For PD-L1 expression of 1% and higher the OS hazard ratio (HR) was 0.98 (95% CI, 0.67-1.42; P = .90), and the PFS HR was 0.92 (95% CI, 0.67-1.25; P = .59). Significance was also not reached when separately analyzed for lower or higher PD-L1 expression (1%-49% or ≥50%). However, grade 3 or higher immune-related adverse events occurred in 86 patients (24.3%) treated with ICI-chemotherapy and 76 (17.9%) with ICI alone (P = .03).Conclusions and RelevanceIn this study, ICI-chemotherapy combination treatment did not improve survival and increased the incidence of grade 3 and higher immune-related adverse events compared with ICI alone in patients 75 years and older. Based on these results, ICI alone may be recommended for older adult patients with PD-L1–positive NSCLC.

Publisher

American Medical Association (AMA)

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