KEYNOTE-A18

Does pembrolizumab added to chemoradiotherapy and maintenance improve outcomes in high-risk locally advanced cervical cancer?

Population and treatment

Approximately 1,060 patients with high-risk locally advanced cervical cancer.

Intervention vs comparator: Pembrolizumab + chemoradiotherapy then pembrolizumab vs placebo + chemoradiotherapy then placebo.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=KEYNOTE-A18+overall+survival

Results

36-month OS 82.6% vs 74.8%; HR 0.67 (95% CI 0.50–0.90; p=0.004). Earlier grade ≥3 AEs about 78% vs 70%; immune-mediated events 39% vs 17%; later report used different AE definitions.

Overall survival · 36 months

NNT: NCT04221945

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

Toxicity and treatment burden

74.8

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

Approximate landmark NNT 13 at 36 months. Keep analysis cutoffs and adverse-event definitions separate; confirm exact current eligible population.

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

Primary source

Primary publication / authoritative source

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