In the long-term follow-up of a Japanese phase II/III trial (JCOG1008) reported in the Journal of Clinical Oncology, Tahara et al found maintained noninferiority of chemoradiotherapy with weekly vs every-3-week cisplatin for overall survival in patients with postoperative high-risk locally advanced squamous cell carcinoma of the head and neck.
Study Details
In the multicenter trial, 261 patients were randomly assigned to receive chemoradiotherapy with cisplatin at 40 mg/m2 once weekly for seven cycles (n = 129) or cisplatin at 100 mg/m2 once every 3 weeks for three cycles (n = 132). An interim analysis showed that chemoradiotherapy with weekly cisplatin was noninferior in overall survival compared with chemoradiotherapy with 3-weekly cisplatin.
Key Findings
At final analysis, with a median follow-up of 5.6 years, 5-year overall survival was 58.7% in the 3-weekly group and 71.2% in the weekly group (hazard ratio [HR] = 0.76, 95% confidence interval [CI] = 0.52–1.12 [<1.32 noninferiority threshold]), confirming noninferiority of the weekly regimen.
Five-year relapse-free survival was 53.0% in the 3-weekly group vs 64.3% in the weekly group (HR = 0.81, 95% CI = 0.57–1.16). Five-year local relapse-free survival was 57.2% vs 68.8% (HR = 0.79, 95% CI = 0.54–1.14).
No late adverse events of any grade showed more than a 10% difference between the two groups.
The investigators stated: “In conclusion, 5-year follow-up confirmed that chemoradiotherapy with weekly cisplatin is noninferior in [overall survival] to chemoradiotherapy with 3-weekly cisplatin in patients with postoperative high-risk [locally advanced squamous cell carcinoma of the head and neck]. These results further support the use of weekly cisplatin plus radiotherapy as a reasonable alternative for this patient population.”
Makoto Tahara, MD, PhD, of National Cancer Center Hospital East, Kashiwa, Japan, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the National Cancer Center Research and Development Fund and others. For full disclosures of the study authors, visit ascopubs.org.
