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- Title
Outcomes of Chemoimmunotherapy Among Patients With Extensive-Stage Small Cell Lung Cancer According to Potential Clinical Trial Eligibility.
- Authors
Fujimoto, Daichi; Morimoto, Takeshi; Tamiya, Motohiro; Hata, Akito; Matsumoto, Hirotaka; Nakamura, Atsushi; Yokoyama, Toshihide; Taniguchi, Yoshihiko; Uchida, Junji; Sato, Yuki; Yokoi, Takashi; Tanaka, Hisashi; Furuya, Naoki; Masuda, Takeshi; Sakata, Yoshihiko; Miyauchi, Eisaku; Hara, Satoshi; Saito, Go; Miura, Satoru; Kanazu, Masaki
- Abstract
Key Points: Question: Can the outcomes of pivotal trials conducted among patients with extensive-stage small cell lung cancer (ES-SCLC) be applied in a clinical practice setting? Findings: In this cohort study of 207 patients with ES-SCLC who received chemoimmunotherapy as the first-line treatment, the overall treatment outcome was comparable to that reported in pivotal clinical trials. However, treatment outcomes after chemoimmunotherapy might differ between trial-eligible and trial-ineligible patients. Meaning: These findings suggest that it may be useful to consider trial-eligibility criteria for clinical decision-making in a clinical practice setting; further studies using high-quality clinical practice data are required to elucidate the association of eligibility criteria with clinical outcomes. Importance: Chemoimmunotherapy is the standard first-line therapy for patients with extensive-stage small cell lung cancer (ES-SCLC). However, whether findings from pivotal trials can be extrapolated to the clinical practice setting remains unclear. Objective: To compare treatment outcome gaps following first-line chemoimmunotherapy for patients with ES-SCLC between those who met and did not meet the eligibility criteria used in previous clinical trials. Design, Setting, and Participants: A prospective cohort study was conducted from September 1, 2019, to September 30, 2020, at 32 hospitals in Japan, with at least 12 months of follow-up. Participants included consecutive patients with ES-SCLC who received carboplatin and etoposide with atezolizumab as first-line therapy. Exposures: Patients who met eligibility criteria for pivotal phase 3 clinical trials were considered trial-eligible. Main Outcomes and Measures: The primary outcome was 6-month progression-free survival. The secondary outcomes were differences in progression-free survival, overall survival, and safety according to whether key clinical trial eligibility criteria were met. Results: A total of 207 patients were analyzed (median age, 72 years; range, 46-87 years; 170 [82%] were male). Sixty-four patients (31%) were older adults (age ≥75 years), and most (184 [89%]) had an Eastern Cooperative Oncology Group performance status of 0 or 1. There were 132 (64%) trial-eligible patients. The 6-month progression-free survival rate for all patients was 38.8% (95% CI, 32.4%-45.7%). The median progression-free survival was 5.1 months in trial-eligible patients and 4.7 months in trial-ineligible patients (hazard ratio, 0.72; 95% CI, 0.53-0.97; P =.03). The proportion of patients who achieved disease control was 93% (118 of 127) in trial-eligible patients and 77% (55 of 71) in trial-ineligible patients (P =.002). The median overall survival was 15.8 months in trial-eligible patients and 13.1 months in trial-ineligible patients (hazard ratio, 0.73; 95% CI, 0.51-1.07; P =.10). The rate of severe adverse events was numerically higher among trial-ineligible patients than among trial-eligible patients (39% vs 27%; P =.07). Conclusions and Relevance: In this cohort study, the overall treatment outcome was comparable to that reported in pivotal clinical trials. However, treatment outcomes after chemoimmunotherapy might differ between trial-eligible and trial-ineligible patients. These findings suggest that trial-eligibility criteria may be useful in clinical practice, and further studies using data from clinical practice settings are required to inform regulatory approval and clinical decision-making. This cohort study compares the outcomes of patients with extensive-stage small cell lung cancer who were included in clinical trials with outcomes of patients who were ineligible for those trials.
- Subjects
JAPAN; THERAPEUTIC use of monoclonal antibodies; ETOPOSIDE; DRUG approval; CARBOPLATIN; CONFIDENCE intervals; SMALL cell carcinoma; CANCER chemotherapy; ANTINEOPLASTIC agents; TREATMENT effectiveness; TUMOR classification; DESCRIPTIVE statistics; PROGRESSION-free survival; DECISION making in clinical medicine; IMMUNOTHERAPY; LONGITUDINAL method; PATIENT safety; OVERALL survival
- Publication
JAMA Network Open, 2023, Vol 6, Issue 2, pe230698
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2023.0698