ADRIATIC

Does consolidation durvalumab improve survival after chemoradiotherapy in limited-stage SCLC?

Population and treatment

730 randomized across three arms; primary comparison durvalumab vs placebo after definitive concurrent chemoradiotherapy.

Intervention vs comparator: Durvalumab consolidation vs placebo.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=ADRIATIC+durvalumab+limited-stage+SCLC

Results

Median OS 55.9 vs 33.4 months; HR 0.73 (98.321% CI 0.54–0.98; p=0.01). Median PFS 16.6 vs 9.2 months; HR 0.76 (97.195% CI 0.59–0.98; p=0.02). Grade 3–4 AEs 24.4% vs 24.2%; discontinuation 16.4% vs 10.6%.

Overall survival · Median (not fixed-time)

NNT: NCT03703297

NNH not calculated without a defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

33.4

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

Applies to limited-stage SCLC without progression after concurrent chemoradiotherapy. Do not calculate NNT from median OS; fixed-time OS and QoL review needed.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.