Aims
The aim of this study was to describe the clinical outcomes, demographics, and clinical characteristics of patients with locally advanced, unresectable, stage III non–small cell lung cancer (NSCLC) treated with durvalumab as part of the UK early access programme or post reimbursement.
Materials and methods
CODAK (NCT04667312) was a multicentre, noninterventional, cohort study of patients (N = 114) with locally advanced, unresectable, stage III NSCLC initiated on durvalumab between 1 September 2017 and 31 December 2019 following concurrent or sequential chemoradiotherapy (CRT) in the UK, with retrospective data collection from 10 clinical centres. The primary outcome was the real-world overall survival (rwOS) rate at 12 and 24 months post durvalumab initiation.
Results
Of the 114 patients included, 47 (41.2%) were aged ≥70 years and 67 (58.7%) were male. Median follow-up time from durvalumab initiation was 22 months. The 12-month rwOS rate was 80.2% (95% confidence interval [CI]: 73.1-88.0), and the 24-month rate was 63.0% (54.1-73.4). Median rwOS was 35.9 months (95% CI: 35.9 to not reached [NR]) in the overall cohort. Before durvalumab initiation, 85.1% (97/114) received concurrent CRT and 13.2% (15/114) received sequential CRT (two unknown). In the overall cohort, median real-world progression-free survival was 28.5 months (95% CI: 16.4-NR). The median time to durvalumcab treatment discontinuation was 8.7 months (95% CI: 6.2-11.2). Thirty-three patients (28.9%) discontinued durvalumab treatment due to adverse events (AEs). Pneumonitis/interstitial lung disease (ILD) was the most common AE leading to discontinuation among all patients (19/114 [16.7%]). Eleven patients (9.6%) had at least one interruption due to pneumonitis/ILD.
Conclusion
CODAK provides data from the UK that add to real-world evidence showing that durvalumab following CRT is an effective standard of care for patients with unresectable, stage III NSCLC.
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