A phase II study of neoadjuvant bio-chemotherapy with Cetuximab, Paclitaxel, and Cisplatin (CPC) followed by Cetuximab-based concurrent bio-radiotherapy in high-risk locally advanced head and neck cancer - representative of head and neck cancer study grou

[[abstract]]Background: To evaluate the therapeutic efficacy of sequential regimen using cetuximab-based triplet neoadjuvant chemotherapy (NC) followed by concurrent bio-radiotherapy (BRT) in locally advanced head and neck cancer (HNC) patients. Materials and Methods: Eligible criteria included treatment-na??ve patients with histologically confirmed squamous cell carcinoma originated from oral cavity or oropharyngeal area, and the disease staging beyond N2b or T4. The CPC regimen for NC consisted of cetuximab 500 mg/m2, paclitaxel 120 mg/m2, cisplatin 50 mg/m2, every two weeks for five courses. Patients without disease progression would receive cetuximab 500 mg/m2 every two weeks concurrently with radiotherapy for total dose of 70 Gy. Results: Since October 2009 to November 2010, 47 patients were recruited to the study. Of all patients, 93.6% had N2b, N2c or N3 disease. The mean age of the patients was 50.4 years old, and the Eastern Cooperative Oncology Group performance status 0 and 1 was in 31.9% and 68.1%, respectively. The primary lesion was located at oral cavity in 57.4%, and at oropharyngeal area in 42.6% of patients. On intentionto-treat analysis (ITT), the best overall response was partial response (PR) in 30 patients, complete response (CR) in 3, stable disease (SD) in 12. The overall response rate was 70.2%. The best response rate after NC was 48.9%, including PR in 22 and CR in 1. Two patients had progressive disease (PD) before BRT, and among the other 45 patients, two declined to have radiotherapy. Of the 43 patients receiving BRT, two patients discontinued treatment due to treatment-unrelated complication or suggestion of surgical intervention. In the remaining 41 patients, additional 10 and 2 patients achieved PR and CR, respectively. In addition, seven developed PD, and two were not evaluable due to early termination as a consequence of toxicity. The most common grade 3 or 4 adverse events in the NC were neutropenia, while mucositis, anorexia, and dermatitis accounted for the major complications during the BRT. Conclusions: The cetuximab-based sequential regimen showed to be efficient in high-risk locally advanced HNC. CPC regimen was feasible in most patients. However, adequate supportive care is necessary for the toxicity during the period of cetuximab-based radiotherapy