Prospective Study to Compare Efficacy of Conventional Chemoradiotherapy with Hypofractionated Chemoradiotherapy in Locally Advanced Carcinoma of Oropharynx.

ABSTRACT

AIMS: Chemoradiotherapy is the standard treatment for advanced Oropharyngeal squamous cell carcinoma (OPSCC). Upcoming hypofractionation has led to better compliance and non-inferior results in various sites such as breast and prostate cancer etc.  This study prospectively compared a dose-intensified schedule in advanced OPSCC with standard hypofractionation. MATERIALS AND METHODS: Patients with advanced stage III and IV OPSCC suitable for radical chemoradiotherapy were eligible. Patients were alternatively allocated to both the treatment arms. Arm A planned to receive 64 Gy in 25 fractions (#) with concurrent cisplatin and Arm B received standard fractionation 70 Gy in 35 # with concurrent cisplatin. All patients completed a median follow up of 6 to 18 months.  The primary end point was acute toxicity (less than 3 months) and late toxicity at 1 year. Secondary end point was disease free survival and overall survival at 1 year. RESULTS: 44 patients in arm A and 49  patients in arm B were recruited over 18 months. 34 patients completed full-dose radiotherapy in both arms. Maximum acute toxicity in arm A in terms of skin reaction was Grade II in 47.05% cases and mucositis grade II in 67.6% cases. In arm B grade II skin toxicity was seen in 47.1% and mucositis grade II was seen in 79.4 % cases. Ryle's tube dependency was seen in 38.2 % cases in arm A and 50% in arm B.  Complete response rate at 3 months was equivalent in both arms in Arm A (100%), and in Arm B (96.7%). Disease free survival (DFS), Overall survival (OS) at 3 month, 6 months, and 12 months was comparable. CONCLUSIONS: 64 Gy in 25 fractions with concomitant chemotherapy is tolerable in patients with equivalent results and better compliance. Shorter fractionation schedule is more acceptable and we look forward for more randomized control trials.