Real-world analysis in patients with limited-stage small-cell lung cancer who received durvalumab after concurrent chemoradiotherapy.

Background: The phase III, double-blind, randomized ADRIATIC trial established durvalumab maintenance therapy following platinum-based concurrent chemoradiotherapy (cCRT) as the standard of care for patients with limited-stage small-cell lung cancer (LS-SCLC). However, real-world evidence regarding the efficacy and safety of durvalumab in this patient population remains scarce. We therefore conducted a retrospective real-world analysis to evaluate the clinical effectiveness and safety profile of durvalumab consolidation after cCRT in patients with LS-SCLC. Methods: This retrospective, single-center, real-world cohort study (NCT07050472) enrolled patients with LS-SCLC who received cCRT followed by durvalumab consolidation at Peking University Cancer Hospital between January 1, 2020, and December 31, 2023. The primary endpoint was real-world progression-free survival (rwPFS), defined as the time from the initiation of durvalumab to investigator-confirmed disease progression or all-cause death, whichever occurred first. Secondary endpoints included the 2-year rwPFS rate, 2-year overall survival (OS) rate, duration of durvalumab treatment (DoT), and safety outcomes. Results: A total of 45 eligible patients were included in the analysis. The median age was 57 years, and the majority (93.3%) had stage III disease. Thoracic radiotherapy was administered as 54 Gy in twice-daily fractions in 84.4% of patients and as 45 Gy in twice-daily fractions in 15.6% of patients. Prophylactic cranial irradiation (PCI) was delivered to 68.9% of the study population. At the data cutoff date (June 27, 2025), the median follow-up for rwPFS was 53.6 months [95% confidence interval (CI): 43.5-55.3]. The median DoT of durvalumab was 13.0 months (95% CI: 9.0-not reached). The median rwPFS was 18.6 months (95% CI: 17.6-39.9), with a 2-year rwPFS rate of 46.7% (95% CI: 31.7-60.3%). Median OS was not reached, and the 2-year OS rate was 80.3% (95% CI: 68.9-93.5%). Adverse events (AEs) leading to durvalumab discontinuation occurred in 17.8% of patients. Immune-related AEs (irAEs) were documented in 16 patients (35.6%), with hypothyroidism (6 patients, 13.3%) and pneumonitis (6 patients, 13.3%) being the most common. Two patients (4.4%) developed grade 3 pneumonitis. The overall incidence of radiation pneumonitis was 20%, with no grade 3-4 events reported. All patients were treated with volumetric-modulated arc therapy (VMAT). Conclusions: To our knowledge, this is the first real-world cohort study investigating durvalumab consolidation after cCRT in Chinese patients with LS-SCLC. Our findings demonstrate that this treatment strategy yields favorable clinical effectiveness and a manageable safety profile in routine clinical practice, supporting its role as the standard of care for this patient population.