Efficacy and Safety of Programmed Death-Ligand 1 Inhibitor Plus Platinum-Etoposide Chemotherapy in Patients With Extensive-Stage SCLC: A Prospective Observational Study

Kenji Morimoto; Tadaaki Yamada; Takayuki Takeda; Shinsuke Shiotsu; Koji Date; Taishi Harada; Nobuyo Tamiya; Yusuke Chihara; Osamu Hiranuma; Takahiro Yamada; Hibiki Kanda; Takayuki Nakano; Yoshie Morimoto; Masahiro Iwasaku; Shinsaku Tokuda; Koichi Takayama

doi:10.1016/j.jtocrr.2022.100353

Efficacy and Safety of Programmed Death-Ligand 1 Inhibitor Plus Platinum-Etoposide Chemotherapy in Patients With Extensive-Stage SCLC: A Prospective Observational Study

JTO Clin Res Rep. 2022 Jun 8;3(7):100353. doi: 10.1016/j.jtocrr.2022.100353. eCollection 2022 Jul.

Authors

Affiliations

¹ Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
² Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
³ Department of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
⁴ Department of Pulmonary Medicine, Kyoto Chubu Medical Center, Kyoto, Japan.
⁵ Department of Medical Oncology, Fukuchiyama City Hospital, Kyoto, Japan.
⁶ Department of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan.
⁷ Department of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan.
⁸ Department of Pulmonary Medicine, Otsu City Hospital, Shiga, Japan.
⁹ Department of Pulmonary Medicine, Matsushita Memorial Hospital, Osaka, Japan.
¹⁰ Department of Respiratory Medicine, Omi Medical Center, Shiga, Japan.

Abstract

Introduction: To date, the efficacy and safety of programmed death-ligand 1 (PD-L1) inhibitor plus platinum-etoposide chemotherapy for patients with extensive-stage SCLC (ES-SCLC), with real-world evidence, stratified on the basis of age and performance status (PS), have not been fully investigated. The aim of this study was to evaluate the efficacy and safety of PD-L1 inhibitor plus platinum-etoposide chemotherapy in patients with ES-SCLC.

Methods: This multicenter prospective study evaluated patients with ES-SCLC who received PD-L1 inhibitor plus platinum-etoposide chemotherapy between September 2019 and October 2021.

Results: A total of 45 patients with ES-SCLC received the aforementioned treatment, including 18 elderly (≥75 y old) patients and six patients with a PS of 2. Multivariate analysis indicated that a PS of 2 was a significant independent prognostic factor for progression-free survival and overall survival (p = 0.008 and p = 0.001, respectively). Of patients with PS of 2 at the initial phase, those that achieved PS improvement during treatment had significantly longer progression-free survival and overall survival than those who did not (p = 0.02 and p = 0.02, respectively). The incidence of adverse events accompanied with treatment discontinuation was significantly higher in the elderly patients than in the non-elderly patients (p = 0.03).

Conclusions: This real-world prospective study found that PD-L1 inhibitor plus platinum-etoposide chemotherapy had limited efficacy in patients with ES-SCLC with a PS of 2, except for cases with improvement of PS during treatment. Owing to the emergence of adverse events and treatment discontinuation, this treatment should be administered with caution in elderly patients with ES-SCLC.

Keywords: Cancer cachexia; Chemoimmunotherapy; Elderly; Extensive-stage small-cell lung cancer; Poor performance status.