Outcomes after first-line therapy for small cell lung cancer may vary by trial eligibility
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Key takeaways:
- Some outcomes after first-line chemoimmunotherapy appeared better among patients who met eligibility criteria for pivotal clinical trials.
- More research is needed to inform clinical decision-making and regulatory approvals.
Overall treatment outcomes among patients with extensive-stage small cell lung cancer who received first-line chemoimmunotherapy appeared comparable to those reported in pivotal clinical trials, according to study results.
However, outcomes after chemoimmunotherapy may differ between those who meet eligibility criteria for pivotal clinical trials and those who do not, researchers concluded.
“These findings suggest that it may be useful to consider trial-eligibility criteria for clinical decision-making in a clinical practice setting,” Daichi Fujimoto, MD, PhD, of Wakayama Medical University in Japan, and colleagues wrote. “Further studies using high-quality clinical practice data are required to elucidate the association of eligibility criteria with clinical outcomes.”
Chemoimmunotherapy is standard first-line treatment for patients with extensive-stage small cell lung cancer. However, it remains uncertain whether results of pivotal trials can be generalizable to real-world clinical practice, according to study background.
Fujimoto and colleagues conducted a prospective cohort study to compare outcomes after first-line chemoimmunotherapy for extensive-stage small cell lung cancer between patients who met eligibility criteria for prior pivotal phase 3 clinical trials and those who did not.
The analysis included 207 patients (median age, 72 years; range, 46-87; 82% men) treated at 32 hospitals in Japan between Sept. 1, 2019, and Sept. 30, 2020. Approximately one-third (31%) were aged 75 years or older, and the majority (89%) of the cohort had ECOG performance status of 0 or 1.
All patients received first-line therapy with carboplatin, etoposide and the anti-PD-L1 monoclonal antibody atezolizumab (Tecentriq, Genentech).
Two-thirds (64%; n = 132) met eligibility criteria for pivotal trials.
Six-month PFS served as the primary outcome. Secondary outcomes included differences in PFS, OS and safety between trial-eligible and trial-ineligible patients.
Researchers reported a 6-month PFS rate of 38.8% (95% CI, 32.4-45.7).
Results showed better outcomes among trial-eligible patients with regard to median PFS (5.1 months vs. 4.7 months; HR = 0.72; 95% CI, 0.53-0.97) and disease control rate (93% vs. 77%; P=.002). Investigators reported a numerical improvement in median OS among trial-eligible patients, but the difference did not reach statistical significance (15.8 months vs. 13.1 months; HR = 0.73; 95% CI, 0.51-1.07).
Researchers reported numerically higher incidence of adverse events among trial-ineligible patients, but the difference did not reach statistical significance (39% vs. 27%; P = .07).
Additional research that incorporates data from clinical practice settings is necessary to inform clinical decision-making and regulatory approval, Fujimoto and colleagues concluded.
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