A Real-World Study on the Effectiveness and Safety of Pembrolizumab Plus Chemotherapy for Nonsquamous NSCLC

Daichi Fujimoto, MD; Satoru Miura, MD, PhD; Kenichi Yoshimura, MD, PhD; Kazushige Wakuda, MD; Yuko Oya, MD; Koji Haratani, MD, PhD; Shoichi Itoh, MD; Takehiro Uemura, MD, PhD; Ryotaro Morinaga, MD, PhD; Takayuki Takahama, MD, PhD; Kazuhisa Nakashima, MD; Motoko Tachihara, MD, PhD; Go Saito, MD; Junko Tanizaki, MD, PhD; Kohei Otsubo, MD, PhD; Satoshi Ikeda, MD; Hirotaka Matsumoto, MD; Satoshi Hara, MD; Akito Hata, MD; Takeshi Masuda, MD, PhD; Nobuyuki Yamamoto, MD, PhD

JTO Clinical and Research Reports (Feb 2022)

A Real-World Study on the Effectiveness and Safety of Pembrolizumab Plus Chemotherapy for Nonsquamous NSCLC

Daichi Fujimoto, MD,
Satoru Miura, MD, PhD,
Kenichi Yoshimura, MD, PhD,
Kazushige Wakuda, MD,
Yuko Oya, MD,
Koji Haratani, MD, PhD,
Shoichi Itoh, MD,
Takehiro Uemura, MD, PhD,
Ryotaro Morinaga, MD, PhD,
Takayuki Takahama, MD, PhD,
Kazuhisa Nakashima, MD,
Motoko Tachihara, MD, PhD,
Go Saito, MD,
Junko Tanizaki, MD, PhD,
Kohei Otsubo, MD, PhD,
Satoshi Ikeda, MD,
Hirotaka Matsumoto, MD,
Satoshi Hara, MD,
Akito Hata, MD,
Takeshi Masuda, MD, PhD,
Nobuyuki Yamamoto, MD, PhD

Affiliations

Daichi Fujimoto, MD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan; Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan
Satoru Miura, MD, PhD: Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan; Corresponding author. Address for correspondence: Satoru Miura, MD, PhD, Department of Internal Medicine, Niigata Cancer Center Hospital, 2-15-3 Kawagishi-cho, Chuo-ku, Niigata 951-8566, Japan.
Kenichi Yoshimura, MD, PhD: Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima, Japan
Kazushige Wakuda, MD: Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan
Yuko Oya, MD: Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
Koji Haratani, MD, PhD: Department of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-Sayama, Japan
Shoichi Itoh, MD: Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan
Takehiro Uemura, MD, PhD: Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University School of Medical Sciences, Nagoya, Japan
Ryotaro Morinaga, MD, PhD: Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Japan
Takayuki Takahama, MD, PhD: Department of Medical Oncology, Kindai Nara Hospital, Ikoma, Japan
Kazuhisa Nakashima, MD: Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine
Motoko Tachihara, MD, PhD: Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Go Saito, MD: Department of Respirology, Chiba University Graduate School of Medicine, Chiba, Japan
Junko Tanizaki, MD, PhD: Department of Medical Oncology, Kishiwada City Hospital, Kishiwada, Japan
Kohei Otsubo, MD, PhD: Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan
Satoshi Ikeda, MD: Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan
Hirotaka Matsumoto, MD: Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan
Satoshi Hara, MD: Department of Respiratory Medicine, Itami City Hospital, Itami, Japan
Akito Hata, MD: Department of Medical Oncology, Kobe Minimally Invasive Cancer Center, Kobe, Japan
Takeshi Masuda, MD, PhD: Department of Respiratory Internal Medicine, Hiroshima University Hospital, Hiroshima, Japan
Nobuyuki Yamamoto, MD, PhD: Internal Medicine III, Wakayama Medical University, Wakayama, Japan

Journal volume & issue: Vol. 3, no. 2
p. 100265

Abstract

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Introduction: The real-world effectiveness of combination treatment with cytotoxic chemotherapy and programmed cell death protein-1 or programmed death-ligand 1 inhibitor for NSCLC, especially for the elderly (aged ≥75 y) or those with poor performance status (≥2), has not been fully elucidated. We investigated the real-world effectiveness and safety of this combination therapy in these populations. Methods: This multicenter retrospective study evaluated patients who are chemo-naïve with advanced NSCLC who received a combination of platinum, pemetrexed, and pembrolizumab between December 2018 and June 2019. This was an updated prespecified secondary analysis with the primary objective of investigating the safety and effectiveness in this cohort. Results: Overall, 299 patients were included. Multivariate analysis identified performance status (0–1) and programmed death-ligand 1 tumor proportion score (≥50%) as significant independent predictors of progression-free survival (p = 0.007, and p = 0.003, respectively). The incidence of severe adverse events (AEs) was higher in the elderly and those with poor performance status than in their younger and good performance status counterparts. A total of 71 patients developed AEs that led to treatment discontinuation, and AE-related treatment discontinuation occurred at a significantly higher rate in older patients (median [range]) (70 [46–82] y) than in younger patients (68 [31–84] y) (p <0.001). Conclusions: Combination treatment with pembrolizumab plus chemotherapy had low real-world effectiveness for poor performance status patients. Severe AEs occurred at a higher rate in the elderly and poor performance status patients, and the AE-related treatment discontinuation rate increased with age. Physicians should be cautious about using this regimen, especially in the elderly and poor performance status patients.

Published in JTO Clinical and Research Reports

ISSN: 2666-3643 (Online)
Publisher: Elsevier
Country of publisher: United States
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.journals.elsevier.com/jto-clinical-and-research-reports/

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