Lung cancer · Consolidation after chemoradiotherapy
Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer
| Design | Phase 3, randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Consolidation durvalumab after definitive chemoradiotherapy |
| Control | Placebo |
| Population | 709 patients with stage III unresectable non-small-cell lung cancer who had not progressed after chemoradiotherapy: 473 durvalumab and 236 placebo |
| Follow-up | Median 14.5 months at primary analysis |
| Primary endpoint | Progression-free survival and overall survival |
| Result | Median progression-free survival was 16.8 months (95% CI 13.0 to 18.1) with durvalumab versus 5.6 months (4.6 to 7.8) with placebo — stratified hazard ratio 0.52 (95% CI 0.42 to 0.65, p<0.001). Twelve-month progression-free survival was 55.9% versus 35.3% and 18-month 44.2% versus 27.0%. Safety was similar between groups. |
| Secondary endpoints | Overall survival, time to distant metastasis, response rate, safety |
Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups.
The trial authors, in the published abstract
The stage III patient is managed jointly by respiratory physicians and oncologists, which is why this trial belongs here rather than purely in an oncology reference. Tripling progression-free survival in a group previously facing near-inevitable progression changed the goal of treatment from palliation to cure for some. Pneumonitis after chemoradiotherapy plus immunotherapy is the toxicity respiratory physicians see.
Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med 2017 Nov 16;377(20):1919-1929.