Phase II trialA phase II trial of concurrent chemoradiotherapy with weekly docetaxel plus cisplatin treatment for unresectable locally advanced head and neck cancer

PurposeAlthough concurrent chemoradiotherapy (CCRT) is the standard of care for locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN), the optimal CCRT regimen is not yet defined. We conducted a phase II study of weekly docetaxel and cisplatin treatment with concurrent radiotherapy (RT) to investigate the efficacy and toxicity profiles.Material and methodsForty-one patients with locally advanced SCCHN were treated with 20 mg/m2 docetaxel plus 20 mg/m2 cisplatin weekly for 6 cycles, concurrent with RT, between April 2010 and March 2013.ResultsThe mean total doses of docetaxel and cisplatin were 109.3 mg/m2 and 110.7 mg/m2, respectively. The mean total delivered dose of radiation was 67.7 Gy. Thirty-seven patients (90.3%) received 5 or more cycles of treatment. At the 1-month post-CCRT tumor response evaluation, 13 patients (39.9%) achieved a complete response (CR) [95% confidence interval (95% CI), 20.1-56.6]. Thirty-two patients (78.0%) ultimately achieved CR during the post-treatment follow-up period. With a median follow-up of 3.4 years, the 2-year overall survival (OS), disease-free survival (DFS), and distant disease-free survival (DDFS) were 85.4% (95% CI, 74.6-96.2%), 72.8% (95% CI, 59.2-86.4%), and 82.4% (95% CI, 70.7-94.1%), respectively. Overall, grade 3 toxicities occurred in 21 patients (51.2%), most commonly mucositis (39.0%), neutropenia (9.8%), or dysphagia (4.9%). A grade 4 adverse event was observed in only one patient with neutropenia.ConclusionsCCRT with weekly docetaxel and cisplatin shows promising antitumor activity with manageable toxicity profiles for patients with locally advanced SCCHN.