Postoperative hyperfractionated IMRT with weekly cisplatin for head and neck cancer: phase IIa trial.

Postoperative chemoradiotherapy (POCRT) is the standard treatment for patients with head and neck squamous cell carcinoma (HNSCC) with high-risk features (positive microscopic margins and/or extranodal extensions). We hypothesized that dose escalation using hyperfractionation in intensity-modulated radiotherapy (HF-IMRT) improves POCRT outcomes; however, no prospective trial has assessed the feasibility of POCRT in HF. Therefore, we evaluated the feasibility of POCRT using HF-IMRT. HNSCC patients with positive microscopic margins and/or extranodal extension following surgery were included. HF-IMRT (73.6 Gy in 64 fractions twice daily) was administered along with cisplatin at 40 mg/m2 once a week for seven cycles during radiotherapy. The primary endpoint was the proportion of patients who completed treatment, which included the planned radiotherapy and the administration of ≥200 mg/m2 of cisplatin. Feasibility was defined as the proportion of patients who completed treatment >60% using a one-sided binomial test. Ten patients were registered between October 2021 and April 2023. One patient was excluded because of tumor recurrence before POCRT. The median follow-up time was 18.2 months, and the proportion of patients who completed treatment was 88.9%. The median total dose of cisplatin was 240 mg/m2. The percentage of patients with grade 3 acute non-hematological adverse events was 77.8%. No patient experienced grade 4 or higher acute adverse events or grade 3 or higher late adverse events. POCRT using HF-IMRT is feasible for achieving adequate cisplatin doses and safe radiotherapy in patients with HNSCC.