Immune checkpoint inhibitors (ICIs) offer longer survival than chemotherapy in advanced non-small cell lung cancer (NSCLC). In subset analyses, ICIs extended survival compared to chemotherapy in patients aged ≥65 years, but the effects in patients aged ≥75 years are controversial. We performed multicenter, collaborative, and retrospective analyses of ICI efficacy and safety in NSCLC patients aged ≥75 years.
We retrospectively studied 434 advanced NSCLC patients who received ICIs from December 2015 to December 2017 at seven centers, and retrospectively applied the G8 screening tool from medical records.
Of 434 patients who received ICIs, 100 were aged ≥75 years (median: 79 years; range: 75–90 years). Five patients with PS 3 were omitted. The histological diagnoses were non-squamous cell carcinoma in 55 (57.9%), squamous cell carcinoma in 40 (42.1%). ICIs were given as a first-line treatment to 20 patients, and as a second- or later-line treatment to 75; 67 (70.5%) patients received nivolumab, and 28 (29.5%) pembrolizumab. The PD-L1 tumor proportion scores (TPS) were <1% in 4 (4.2%), 1-49% in 10 (10.5%), and ≥50% in 26 (27.4%) and unknown in 55 (57.9%). The objective response rate (ORR) was 35.0% (CR: 0, PR: 7, SD: 6, PD: 5, NE: 2), the median progression-free survival (PFS) was 6.1 months [95% confidence interval (CI): 1.6–7.7], and the median survival time (MST) was 8.7 months [95% CI: 7.9–not reached (NR)] for first-line treatment in patients with TPS ≥50%. The ORR was 20.0% (CR: 0, PR: 15, SD: 18, PD: 31, and NE: 11), the PFS was 2.9 months [95% CI: 1.9–4.6], and the MST was 15.5 months [95% CI: 5.5–NR] for second- or later-line treatment. The median G8 score was 11.5 (range: 5.5–15.5). The MST was longer in the G8 high (>11.5) group than the low (≤11.5) group (NR vs. 8.2 months) (p = 0.02). Likewise, the MST was 17.8 months (PS 0–1) vs. 3.1 months (PS 2) (p < 0.01). The grade ≥2 immune-related adverse events incidence was 23.3% (thyroid disease: 4.2%; interstitial lung disease: 10.5%).
Although the observation period is short and the data is immature, ICIs were effective and tolerable for patients aged ≥75 years. PS is a simple and exact parameter, but G8 screening is also useful in judging ICI adequacy for the elderly.
Clinical trial identification
Legal entity responsible for the study
Okayama University Hospital.
Has not received any funding.
T. Kubo: Research Funding: Ono Phamaceuticals. T. Ninomiya: Honoraria: Chugai Pharma and Boehringer Ingelheim. D. Harada: Speakers' Bureau: Kyowa Hakko Kirin,Yakult, AstraZeneca, Lilly Pharma, Bristol Myers Squibbs, Ono Phamaceuticals, Boehringer Ingelheim. E. Ichihara: Honoraria: AstraZeneca, Chugai Pharma, MSD, Lilly Pharma, Boehringer Ingelheim; Research Funding: MSD, Lilly Pharma. K. Ohashi: Honoraria: AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Ono Pharmaceutical; Research Funding: Boehringer Ingelheim, Novartis, Lilly Japan. K. Hotta: Honoraria: AstraZeneca, Nihonkayaku, Chugai Pharma, Novartis, MSD, Lilly Pharma, Bristol Myers Squibbs, Ono Phamaceuticals, Boehringer Ingelheim, Taiho Pharmaceutical; Research Funding: AstraZeneca, Chugai Pharma, Astellas Oncology, Novartis, MSD, Lilly Pharma, Bristol Myers Squibbs, Ono Phamaceuticals, Boehringer Ingelheim. Y. Maeda: Honoraria: Pfizer, Otsuka, Kyowa Hakko Kirin, Eisai, Mochida Pharmaceutical Co. Ltd., Astellas Oncology, Asahi Kasei, Nippon Shinyaku, Yakult, Chugai Pharma, Novartis, BMS UK, Ono Phamaceuticals; Research Funding from Pfizer, Otsuka, Kyowa Hakko Kirin, MSD, Mochida Pharmaceutical Co. Ltd., Eisai, Astellas Oncology, Meiji Seika Kaisha, Asahi Kasei, Nippon Shinyaku, Yakult, BMS UK, Ono Phamaceuticals. K. Kiura: Honoraria: Chugai Pharma, Pfizer, AstraZeneca, Novartis, MSD, Lilly Pharma, Bristol Myers Squibbs, Ono Phamaceuticals, Boehringer Ingelheim, Taiho Pharmaceutical; Research Funding from Chugai Pharma, AstraZeneca, Daiichi Sankyo, Ono Phamaceuticals, Boehringer Ingelheim, Shionogi Pharmaceutical. All other authors have declared no conflicts of interest.