- Design
- Randomised phase II/III non-inferiority trial, final long-term analysis
- Population
- 261 patients with high-risk resected locally advanced head and neck squamous cell carcinoma
- Primary outcome
- Overall survival
- Effect
- 5-year OS 71.2% (weekly) vs 58.7% (3-weekly); HR 0.76 (95% CI 0.52–1.12), non-inferior
JCOG1008 randomised 261 patients with high-risk resected locally advanced squamous cell carcinoma of the head and neck to postoperative chemoradiotherapy with cisplatin 100 mg/m² every three weeks for three cycles or 40 mg/m² weekly for seven cycles. The interim analysis had already shown weekly dosing was non-inferior; this is the final analysis at a median 5.6 years.
Five-year overall survival was 58.7% with 3-weekly and 71.2% with weekly cisplatin (HR 0.76, 95% CI 0.52–1.12), within the non-inferiority margin. Relapse-free and local relapse-free survival were numerically better with weekly dosing, and no late adverse event differed by more than 10 percentage points.
The trial was designed to show weekly dosing was not worse, not that it was better, and the higher survival should not be read as superiority. The population was Japanese and postoperative; the result does not directly apply to definitive chemoradiotherapy or to HPV-related oropharyngeal cancer. For Indian head and neck oncology, where weekly cisplatin is commonly chosen because it can be easier to deliver in busy day-care units, the long-term data give firm support to that practice in the postoperative high-risk setting. It was published in June 2026.
- Weekly cisplatin 40 mg/m² with postoperative radiotherapy is a supported alternative to 100 mg/m² every three weeks in high-risk resected disease.
- Do not describe weekly dosing as superior; the trial tested non-inferiority.
- Do not extend the result automatically to definitive chemoradiotherapy.
- Aim to deliver all planned weekly cycles, monitoring renal function and hearing.
- Discuss the regimen choice at the multidisciplinary tumour board.
Why it matters
It gives long-term evidence for the schedule many units already prefer for tolerability and logistics.
Don't overread it
The trial showed weekly cisplatin was not worse; the survival difference does not establish superiority.
The statistics, in plain English
A hazard ratio of 0.76 favours weekly dosing, but the 95% CI (0.52–1.12) crosses 1, so a true benefit is not established. Non-inferiority is shown because the upper limit stays below the pre-set margin of 1.32, meaning weekly dosing is unlikely to be meaningfully worse.
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