KEY POINTS
- JCOG1008 was a multicentre, open-label, randomized phase II/III non-inferiority trial including 261 patients with resected, high-risk locally advanced head and neck squamous cell carcinoma.
- Patients received postoperative radiotherapy with either cisplatin 40 mg/m² weekly for seven cycles or 100 mg/m² every three weeks for three cycles.
- At a median follow-up of 5.6 years, five-year overall survival was 71.2% with weekly cisplatin versus 58.7% with three-weekly cisplatin — hazard ratio 0.76 (95% confidence interval 0.52–1.12; one-sided p=0.0024 for non-inferiority).
- Five-year relapse-free survival was 64.3% versus 53.0%, and local relapse-free survival was 68.8% versus 57.2%, respectively; these differences were numerical rather than statistically conclusive.
- No late adverse event differed by at least 10% between groups. Two treatment-related deaths occurred in the weekly arm and none in the three-weekly arm.
CLINICAL TAKEAWAY
Five-year results support weekly cisplatin at 40 mg/m² as a reasonable alternative to three-weekly high-dose cisplatin for cisplatin-eligible patients receiving postoperative chemoradiotherapy. The evidence is randomized and clinically important, but the Japanese population, relatively wide non-inferiority margin and exclusion of cisplatin-ineligible patients limit universal extrapolation.