Immunotherapy added to radiotherapy did not help early lung cancer

Design

Phase 3, open-label, randomised, superiority; stopped early for futility

Population

402 patients with inoperable early-stage (T1-T3N0M0) NSCLC; median age 72.8

Primary outcome

Overall survival

Effect

Hazard ratio 1.04 (95% CI 0.69-1.58); two-year survival 82% both arms; grade 3+ AEs 12% vs 3%

SWOG/NRG S1914, an open-label phase 3 trial at 146 US institutions, randomised 402 patients with inoperable early-stage (T1-T3N0M0, 7 cm or less) non-small-cell lung cancer and a recurrence risk factor to stereotactic body radiotherapy with or without neoadjuvant, concurrent and adjuvant atezolizumab, with overall survival as the primary endpoint.

Accrual was stopped early for futility. With longer follow-up the overall survival hazard ratio was 1.04 (95% CI 0.69 to 1.58), and two-year survival was 82% in both arms. Grade 3 or higher adverse events were more common with atezolizumab (12% vs 3%), including two fatal respiratory events.

This is the first fully reported cooperative-group phase 3 test of immunotherapy in this setting, and it was negative: adding atezolizumab to SBRT did not extend survival and added toxicity. It applies to inoperable early-stage disease treated with SBRT, not to resected disease or advanced-stage immunotherapy, where benefit is established.

• Adding atezolizumab to stereotactic radiotherapy did not improve survival in inoperable early-stage NSCLC.
• The overall survival hazard ratio was 1.04, and two-year survival was 82% in both arms.
• Accrual stopped early for futility.
• Grade 3 or higher toxicity was higher with atezolizumab (12% vs 3%), with two fatal respiratory events.
• The result does not apply to resected disease or to advanced-stage immunotherapy.

Why it matters

It checks the assumption that immunotherapy benefit in advanced lung cancer extends to early-stage radiotherapy.

Don't overread it

This applies to inoperable early-stage SBRT only, not to resected disease or established advanced-stage immunotherapy.

The statistics, in plain English

A hazard ratio of 1.04 with a confidence interval crossing 1.0 means no survival difference; stopping early for futility indicates the planned benefit was very unlikely to emerge.

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