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. 2023 May;12(10):11525-11541.
doi: 10.1002/cam4.5889. Epub 2023 Mar 31.

Real-world data on the efficacy and safety of immune-checkpoint inhibitors in elderly patients with non-small cell lung cancer

Daisuke Morinaga  1 , Hajime Asahina  1 , Shotaro Ito  1 , Osamu Honjo  2 , Hisashi Tanaka  3 , Ryoichi Honda  4 , Hiroshi Yokouchi  5 , Keiichi Nakamura  6 , Kei Takamura  7 , Fumihiro Hommura  8 , Yasutaka Kawai  9 , Kenichiro Ito  10 , Noriaki Sukoh  11 , Keiki Yokoo  12 , Ryo Morita  13 , Toshiyuki Harada  14 , Taichi Takashina  15 , Tomohiro Goda  16 , Hirotoshi Dosaka-Akita  16   17 , Hiroshi Isobe  10 ; Hokkaido Lung Cancer Clinical Study Group Trial
Affiliations

Real-world data on the efficacy and safety of immune-checkpoint inhibitors in elderly patients with non-small cell lung cancer

Daisuke Morinaga et al. Cancer Med. 2023 May.

Abstract

Purpose: Immune-checkpoint inhibitors (ICIs) are effective against advanced non-small cell lung cancer (NSCLC). However, whether the efficacy and safety of ICI treatment in elderly patients are similar to those in younger patients is unclear. This study was designed to address this question.

Methods: We enrolled patients who received ICI monotherapy in Japan between December 2015 and December 2017; those ≥75 years of age comprised the elderly group. We compared the efficacy and safety of ICI monotherapy in elderly patients with those in younger patients and explored prognostic factors in elderly patients.

Results: We enrolled 676 patients; 137 (20.3%) were assigned to the elderly group. The median age of the elderly and younger groups was 78 (range, 75-85) and 66 (range, 34-74) years. The median progression-free survival (4.8 months vs. 3.3 months, p = 0.1589) and median overall survival (12.3 months vs. 13.0 months, p = 0.5587) were similar between the elderly and younger groups. Multivariate analysis revealed that a significantly better OS in the elderly group was associated with better responses to first- or second-line ICI treatment (p = 0.011) and more immune-related adverse events (irAEs) (p = 0.02). IrAEs that led to ICI discontinuation occurred in 34 of 137 patients (24.8%) in the elderly group, and their survival was significantly higher than that in those who did not have irAEs.

Conclusion: ICI is also effective in elderly NSCLC patients, and treatment discontinuation due to irAEs may be a good prognostic marker.

Keywords: elderly patient; immune-checkpoint inhibitor; non-small cell lung cancer.

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Conflict of interest statement

Dr. Hajime Asahina reported receiving lecture fees from Chugai Pharmaceutical. Dr. Osamu Honjo reported lecture fees from Bristol‐Myers Squib K.K. Dr. Hisashi Tanaka reported receiving lecture fees from Chugai Pharmaceutical and Ono Pharmaceutical Co., Ltd during the conduct of the study. Dr. Hiroshi Yokouchi reported receiving lecture fees from AstraZeneca, and grants from Taiho Pharmaceutical, Sanofi, Bristol‐Myers Squibb, MSD, Takeda Pharmaceutical, Daiichi‐Sankyo, and Chugai Pharmaceutical during the conduct of the study. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
PFS and OS in the elderly (≥75 years) and younger (<75 years) groups. Kaplan–Meier curves of (A) PFS and (B) OS according to the patient's age. PFS and OS in the patients with ≥80 years old, 75‐79 years old, <75 years old groups. Kaplan‐Meier curves of (C) PFS and (D) OS according to the patient's age. OS, overall survival; PFS, progression‐free survival.
FIGURE 2
FIGURE 2
Treatment responses in the elderly and younger groups. (A) Best overall response of the elderly group was significantly better than that of the younger group (p = 0.0339). (B) Objective response rate was not significantly different between the two groups (p = 0.1028). CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease.
FIGURE 3
FIGURE 3
PFS in elderly patients according to subgroup analysis. Kaplan–Meier curves for PFS in elderly patients according to (A) sex, (B) smoking history, (C) histology, (D) TNM stage, (E) tumor burden, (F) driver mutation, (G) PD‐L1 expression, (H) performance status, (I) irradiation, (J) prednisolone dosage, (K) number of previous therapies, and (L) best response to ICI treatment. CR, complete response; NE, not evaluable; PD, progressive disease; PFS, progression‐free survival; PR, partial response; PS, performance status; PSL, prednisolone; SD, stable disease; TNM, tumor–node–metastasis.
FIGURE 4
FIGURE 4
OS in elderly patients according to subgroup analysis. Kaplan–Meier curves for OS in elderly patients according to (A) sex, (B) smoking history, (C) histology, (D) TNM stage, (E) tumor burden, (F) driver mutation, (G) PD‐L1 expression, (H) performance status, (I) irradiation, (J) prednisolone dosage, (K) number of previous therapies, and (L) best response to ICI treatment. CR, complete response; NE, not evaluable; OS, overall survival; PD, progressive disease; PFS, progression‐free survival; PR, partial response; PS, performance status; PSL, prednisolone; SD, stable disease; TNM, tumor–node–metastasis.
FIGURE 5
FIGURE 5
PFS and OS in the elderly groups in relation to irAEs. Kaplan–Meier curves for (A) PFS and (B) OS according to the reason for treatment discontinuation (disease progression or irAEs). (C) PFS and (D) OS according to whether patients discontinued treatment due to irAEs. irAEs, immune‐related adverse events; OS, overall survival; PFS, progression‐free survival.
FIGURE 6
FIGURE 6
PFS in patients with/without treatment discontinuation due to irAEs. Kaplan–Meier curves of PFS in elderly patients according whether treatment was discontinued due to (A) pneumonitis, (B) neural irAEs, (C) gastrointestinal irAEs, and (D) endocrine irAEs. irAE, immune‐related adverse event.
FIGURE 7
FIGURE 7
OS in patients with/without treatment discontinuation due to irAEs. Kaplan–Meier curves for OS in elderly patients according to whether treatment was discontinued due to (A) pneumonitis, (B) neural irAEs, (C) gastrointestinal irAEs, and (D) endocrine irAEs. irAE, immune‐related adverse event.
FIGURE 8
FIGURE 8
Relationships between PFS and OS and the NLR. Kaplan–Meier curves for (A) PFS and (B) OS in all patients, (C) PFS and (D) OS in elderly patients, and (E) PFS and (F) OS in younger patients. NLR, neutrophil‐lymphocyte ratio; OS, overall survival; PFS, progression‐free survival.
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