Phase 2 Study of Docetaxel, Cisplatin, and Concurrent Radiation for Technically Resectable Stage III-IV Squamous Cell Carcinoma of the Head and Neck.

Purpose: We investigated the efficacy and safety of weekly low- dose docetaxel and cisplatin therapy concurrent with conventionally fractionated radiation in patients with technically resectable stage III- IV squamous cell carcinoma of the head and neck. Methods and Materials: Between March 2004 and October 2011, we enrolled 117 patients, of whom 116 were analyzable ( 43 had oropharyngeal cancer, 54 had hypopharyngeal cancer, and 19 had laryngeal cancer), and 85 ( 73%) had stage IV disease. Radiation consisted of 66 Gy in 33 fractions. Docetaxel, 10 mg/ m 2, followed by cisplatin, 20 mg/ m 2, administered on the same day were given once a week for 6 cycles. The primary endpoint was overall complete response ( CR) rate after chemoradiation therapy. Human papillomavirus ( HPV) DNA in oropharyngeal cancer was examined by PCR. Results: Of 116 patients, 82 ( 71%) completed treatment per protocol; 102 ( 88%) received the full radiation therapy dose; and 90 ( 78%) and 12 ( 10%) patients received 6 and 5 chemotherapy cycles, respectively. Overall CR rate was 71%. After median follow- up of 50.9 months ( range: 15.6- 113.9 months for surviving patients), 2- year and 4- year overall survival rates were 82% and 68%, respectively. Cumulative 2- year and 4- year local failure rates were 27% and 28%, respectively, whereas distant metastasis rates were 15% and 22%, respectively. HPV status in oropharyngeal cancer was not associated with treatment efficacy. Acute toxicity included grade 3 and 4 infield mucositis in 73% and 5% of patients, respectively, whereas myelosuppression and renal injury were minimal. No patients died of toxicity. Feeding tube dependence in 8% and tracheostomy in 1% of patients were evident at 2 years postchemoradiation therapy in patients who survived without local treatment failure. Conclusions: Local control and survival with this regimen were satisfactory. Although acute toxicity, such as mucositis, was common, late toxicity, such as laryngoesophageal dysfunction, was minimal. Therapy using weekly low- dose docetaxel and cisplatin concurrent with radiation warrants further evaluation. 2015 Elsevier Inc. All rights reserved.