Treatment results of alternating chemoradiotherapy with early assessment for advanced laryngeal cancer: A multi-institutional phase II study.

Objective: To evaluate the efficacy and safety of alternating chemoradiotherapy (ACRT) with early assessment of advanced laryngeal cancer.
Methods: Patients with stage III or IV glottic or supraglottic squamous cell carcinoma were enrolled. ACRT consisted of two cycles of chemotherapy involving 5-fluorouracil and cisplatin (weeks 1 and 6) and radiotherapy (RT; weeks 2 and 7) administered alternately. An early assessment was performed after one cycle of chemotherapy and RT. Patients with a partial response (PR) or a complete response at early assessment continued ACRT. Patients with stable disease (SD) or progressive disease at early assessment discontinued ACRT and underwent salvage surgery. After completion of ACRT, patients who had residual primary tumor and lymph metastasis underwent salvage surgery.
Results: Twenty-eight patients were enrolled in this trial. Median follow-up was 60.0 months. After each cycle of chemotherapy and RT, 24 of the 28 patients (85.7%) were assessed as having a PR at early assessment and continued ACRT, and 4 of 28 patients (14.3%) who were assessed as having SD at early assessment discontinued ACRT and underwent salvage surgery. The estimated 5-year local control and 5-year survival rates were 49.0% and 77.4%, respectively. Larynx preservation was achieved in 17 patients. The estimated 5-year laryngeal preservation rate was 59.4%. Major toxicity included nausea, stomatitis, dermatitis, dysphagia and hemoglobin toxicity. Grade 3 or 4 stomatitis occurred in three patients (10.7%).
Conclusion: The clinical results of ACRT with early assessment of advanced laryngeal cancer patients showed sufficient efficacy and safety.
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