RTOG 9501: postoperative concurrent radiotherapy and chemotherapy for high-risk head and neck squamous cell carcinoma
In this American trial, adding cisplatin to postoperative radiotherapy for high-risk head and neck cancer improved local control and disease-free survival but not overall survival, and doubled severe toxicity.
Overview
Phase 3 trial of 459 patients with resected high-risk head and neck squamous cell carcinoma (two or more involved nodes, extracapsular extension or positive margins) randomised to postoperative radiotherapy alone or with concurrent cisplatin.
Locoregional control at two years was 82 versus 72 percent (hazard ratio 0.61) and disease-free survival was improved (hazard ratio 0.78), but overall survival did not differ significantly; grade 3 or worse adverse events were 77 versus 34 percent. Long-term follow-up confirmed benefit only in patients with extracapsular extension or positive margins.
- Two-year locoregional control 82 percent vs 72 percent.
- Grade 3 or greater adverse events 77 percent vs 34 percent.
With EORTC 22931, this trial defines who receives postoperative chemoradiation: patients with extranodal extension or positive margins, not those whose only risk factor is multiple nodes.
- No overall survival benefit in the whole population.
- Different high-risk definitions from the EORTC trial.
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