NRG/RTOG 1016
In HPV-positive oropharyngeal cancer, is cetuximab non-inferior to cisplatin with definitive radiotherapy?
Trial design and population
Registry: undefined.
Key results
Five-year OS 84.6% with cisplatin vs 77.9% with cetuximab; cetuximab-vs-cisplatin HR 1.45 (95% CI 1.03–2.05), p=0.0163. Cetuximab failed the prespecified non-inferiority criterion.
Outcome visualization
Five-year overall survival · 5 years · 84.6
Bars scale to the larger reported value. Median survival values are time-to-event summaries, not fixed-time absolute event risks.
Absolute Effect
Endpoint/time horizon: Five-year overall survival · 5 years · 84.6.
NNT: Not calculated from median survival or hazard ratios; calculate only from defensible fixed-time absolute risks.
NNH: Not calculated unless a fixed-time excess-harm risk difference is available. Cetuximab is not an efficacy-equivalent de-escalation substitute in cisplatin-eligible patients. Individualize alternatives for cisplatin-ineligible patients.
Safety, burden and QoL
Cetuximab is not an efficacy-equivalent de-escalation substitute in cisplatin-eligible patients. Individualize alternatives for cisplatin-ineligible patients.
QoL and discontinuation percentages are not asserted where not verified from the full primary report; complete source-table audit remains a QC item.
Subgroups, maturity and limitations
https://pubmed.ncbi.nlm.nih.gov/30449625/
Distinguish prespecified from exploratory subgroups, immature from mature endpoints, and superiority from non-inferiority. Historical comparators may not represent all current treatment sequences.
Current-practice context · 21 October 2026
Verify current guidelines, regulatory status, biomarker requirements, prior treatment, comorbidities and patient goals before applying these historical trial results. Clinical freshness and full QoL/toxicity source review remain open where noted.