6071 Background: Induction chemotherapy is a treatment option for locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, Docetaxel, Cisplatin, and 5-FU (TPF) followed by Cisplatin with radiotherapy is currently not recommended due to toxicity concerns. The aim of this phase II study was to assess the feasibility of Docetaxel, Cisplatin, and Cetuximab (TPE) followed by Cetuximab with concurrent radiotherapy for LA-SCCHN. Methods: Patients were eligible if they had histologically proven SCC of oropharynx, hypopharynx or larynx, a PS of 0-1, adequate organ function, and no distant metastasis. Induction chemotherapy consisted of Cisplatin 75mg/m2 and Docetaxel 75mg/m2 on day1 and the induction regimen was repeated every 3 weeks up to a total of 3 courses. Cetuximab was administered at an initial dose of 400mg/m2 followed by 250mg/m2 weekly until the end of radiotherapy. Radiotherapy (70Gy/35fr/7w) was started after last administration of Docetaxel. Primary endpoint was the rate of treatment completion. The planned sample size was 55 with one-sided alpha of 0.025 and the power of more than 90% based on the expected and threshold treatment completion rates of 65% and 40%. Results: Between August 2013 and October 2015, 54 patients with a median age of 58 years were eligible and had the study treatment. There were 50 males, hypopharynx/oropharynx/larynx cancer of 28/19/7 cases, and 48 Stage IV disease. Response rate at induction chemotherapy was 72% while that after radiotherapy was 76% . Of 54 patients, 50 (93%) received > 2 courses of induction chemotherapy, and 41 (76%) had the full dose of radiotherapy. The rate of treatment completion was thus 76% (95%CI, 62–87%). The frequency of grade 3-4 neutropenia, febrile neutropenia, and allergy/infusion reaction was 93%, 39%, and 11%, respectively. One treatment-related death was observed. Conclusions: Induction TPE followed by Cetuximab with concurrent radiotherapy was feasible with a promising efficacy. A phase III study to evaluate this treatment strategy is warranted. Clinical trial information: UMIN000009928.
393TiP A phase II trial of nedaplatin, 5-fluorouracil and docetaxel for induction chemotherapy with local advanced squamous cell carcinoma of the head and neck
