A study in Japan involving patients with extensive-stage small cell lung cancer (ES-SCLC) indicated that pivotal clinical trial outcomes were comparable to those of patients receiving chemoimmunotherapy in the clinical practice setting. However, the study investigators also determined that clinical trial eligibility criteria may be relevant to outcomes. Results of this study were reported in JAMA Network Open.
“Our findings suggest that the positive results among trial-eligible patients may not apply to patients with ES-SCLC who are ineligible for such trials,” the study investigators wrote in their report.
In this prospective cohort study, patients with ES-SCLC were categorized for analyses by whether or not they met eligibility criteria for prior clinical trials. Patients were treated with carboplatin and etoposide with atezolizumab in the first-line setting. The study had a primary outcome of 6-month progression-free survival (PFS), with secondary outcomes related to differences in PFS, overall survival (OS), and safety based on status regarding whether patients met criteria for clinical trial eligibility. Analyses involved different sets of possible eligibility criteria, but in those described here, the presence of untreated asymptomatic brain metastasis was considered trial eligible.
The study had a total of 207 patients, with a median age of 72 years (range, 46 to 87). Nearly one-third (31%) of patients were aged 75 years and older, 89% of patients had Eastern Cooperative Oncology Group performance status scores of 0 or 1, and 64% were trial eligible.
Overall, the 6-month PFS rate was 38.8% (95% CI, 32.4%-45.7%). Patients who were trial eligible had a median PFS of 5.1 months, compared with 4.7 months for those who were trial ineligible (hazard ratio [HR], 0.72; 95% CI, 0.53-0.97; P =.03).
Disease control was achieved in 93% of trial-eligible patients, compared with 77% of trial-ineligible patients (P =.002). Trial-eligible patients had a median OS of 15.8 months, whereas median OS for trial-ineligible patients was 13.1 months (HR, 0.73; 95% CI, 0.51-1.07; P =.10). There was not a significant difference in rates of severe adverse events between trial-eligible and trial-ineligible patients, but there was a numerically higher rate of these for trial-ineligible patients (39%), compared with the rate for trial-eligible patients (27%; P =.07).
The study investigators considered results in this study to be similar to those seen in pivotal clinical trials for outcomes overall, but they noted that outcomes following chemoimmunotherapy may show differences based on whether patients meet trial-eligibility criteria. “Trial-eligibility criteria should be considered in clinical practice, and further studies using clinical practice data are required to inform regulatory approval and clinical decision-making,” the study investigators concluded in their report.
Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Fujimoto D, Morimoto T, Tamiya M, et al. Outcomes of chemoimmunotherapy among patients with extensive-stage small cell lung cancer according to potential clinical trial eligibility. JAMA Netw Open. 2023;6(2):e230698. doi:10.1001/jamanetworkopen.2023.0698