Long-Term Follow-Up of JCOG1008, a Randomized Phase II/III Trial of Chemoradiotherapy Comparing 3-Weekly Cisplatin With Weekly Cisplatin in Postoperative Head and Neck Cancer

Five-year follow-up of the phase 2/3 JCOG1008 trial (n=261) confirmed that weekly cisplatin (40 mg/m2, seven cycles) is noninferior to the 3-weekly schedule (100 mg/m2, three cycles) in postoperative chemoradiotherapy for high-risk locally advanced squamous cell carcinoma of the head and neck. At a median follow-up of 5.6 years, 5-year overall survival was 71.2% in the weekly arm versus 58.7% in the 3-weekly arm (HR 0.76; 95% CI 0.52-1.12 against a prespecified noninferiority margin of 1.32). The trial was designed as a noninferiority study, so the numerically better result for the weekly schedule does NOT establish its superiority. Relapse-free survival was numerically better in the same arm, and no late adverse event differed between arms by more than 10 percentage points.