tolerability of durvalumab following sequential CRT (sCRT).
Methods: Patients with stage III, unresectable NSCLC and no progression following platinum-based, sCRT were enrolled to receive durvalumab (1500 mg intravenously) every 4 weeks for up to 24 months. The primary endpoint was the incidence of grade 3/4 adverse events possibly related to treatment (PRAEs) occurring within 6 months. Secondary endpoints included investigator-assessed
progression-free survival (PFS; RECIST v1.1) and overall survival (OS).
Results: Overall, 117 patients were enrolled (59.8% with PS >0, 65.8% aged ≥65 years, and 37.6% with stage IIIA disease). Median treatment duration was 32.0 weeks; 37.6% of patients remained on treatment at data cut-off (July 15, 2021). Grade 3/4 AEs occurred in 18.8% of patients. Five patients had grade 3/4 PRAEs within 6 months (incidence: 4.3%; 95% CI: 1.4–9.7), including two pneumonitis
cases. Two patients (1.7%) had grade 5 AEs of any cause. Survival data maturity
was limited. Median PFS was 10.9 months (95% CI: 7.3–15.6) and 12-month PFS and OS rates were 49.6% and 84.1%, respectively.
Conclusions: Durvalumab following sCRT had a comparable safety profile to that observed with durvalumab following cCRT in PACIFIC and showed encouraging preliminary efficacy in a frailer population.
|Journal||Journal of Thoracic Oncology|
|Publication status||Accepted/In press - 18 Jul 2022|
Research Beacons, Institutes and Platforms
- Manchester Cancer Research Centre