The Absolute Effect

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Melanoma · Medical · Adjuvant stage IIB/C

Population and treatment

790 patients with completely resected stage IIB/C melanoma. Nivolumab 480 mg IV every 4 weeks for 12 months versus placebo.

Reported outcomes

12-month recurrence-free survival 89.0% versus 79.4%; HR 0.42 (95% CI 0.30–0.59; P<0.0001). DMFS HR 0.47 (95% CI 0.30–0.72).

Absolute effect

12-month RFS difference 9.6 percentage points; approximate NNT 11 based on rounded fixed-time rates.

Harms and limitations

Treatment-related grade 3–4 adverse events 10.3% versus 2.3%; one treatment-related death with nivolumab. Initial analysis did not establish OS benefit. Verify current guideline and follow-up context.

Primary source

NCT04099251