A Phase Ii Study of Concurrent Chemoradiotherapy with Weekly Low-Dose Cisplatin and Docetaxel in Locally Advanced Unresectable Head and Neck Carcinoma

Abstract

ABSTRACT Aim: Concurrent chemoradiotherapy (CRT) with high-dose cisplatin is the standard treatment for patients with locally advanced unresectable head and neck carcinoma. However, improvement of survival outcomes and toxicities is still necessary. This phase II study was designed to assess the efficacy and safety of concurrent CRT with weekly low-dose cisplatin (CDDP) and docetaxel (DOC) in these patients. Methods: Patients with technically unresectable squamous cell carcinoma of head and neck were enrolled in the study between 2004 and 2011. Treatment consisted of conventional radiotherapy, total dose of 60-66Gy/30-33fractions, with weekly administration of CDDP (20mg/m2) and DOC (10mg/m2), total of 6 courses. Adjuvant chemotherapy of 2 courses of TPF (CDDP + DOC + 5-FU) was scheduled to prevent the disease progression after assessment of treatment response. Primary outcome was response rate and secondary outcomes were progression-free survival, overall survival, organ preservation and acute toxicity. This study was analyzed by intention-to-treat (ITT). Results: Thirty-one patients were recruited according to the Simon's two-stage design method. The median age was 62 years (range, 41-74) and the primary site was oropharynx; 11 (35%), hypopharynx; 18 (58%), larynx; 2 (7%). Twenty-four patients (77%) completed chemoradiotherapy as planned, and 9 patients (29%) completed adjuvant TPF chemotherapy. Thirty patients were evaluated for response without 1 early death before post-treatment assessment, and the response rates were CR, 10%; PR, 66.7%; SD, 6.7%; PD, 16.6%. At a median follow-up of 31 months (range, 4.5-113), the median time to progression and overall survival was 13.2 months (95% CI, 7.6-22.4) and 39.9 months (95% CI, 15.7-), respectively. The estimated overall survival with functional larynx at 3 years was 35.5% (95% CI, 20.9-53.4). The most common grade 3 or 4 adverse events during the treatment were lymphocytopenia (100%), mucositis (77%), pain (45%), hyponatremia (32%) and leukocytopenia (13%). Toxicities related to the kidney were minimal and no patients died due to the treatment. Conclusions: This CRT seems to be a very good option for patients with locally advanced unresectable head and neck carcinoma, with favorable survival data and acceptable toxicity. Disclosure: All authors have declared no conflicts of interest.