Radical treatment of locally advanced head and neck cancer with concurrent chemo radiation-cisplatin versus carboplatin: A randomized comparative phase III trial

摘要

Context: Concurrent chemoradiation with cisplatin is a standard approach for definitive management of locally advanced head and neck squamous cell carcinoma (LAHNSCC). Carboplatin, though a platinum group of drug, is generally well-tolerated compared to cisplatin. Aim: The aim is whether carboplatin can be a substitute of cisplatin with equivalent response and with less toxicity profile. Settings and Design: Single institutional prospective randomized phase III study. Materials and Methods: Between January 2011 and August 2012, 100 patients LAHNSCC with normal comorbidities were included. The patients in Arm A received injection carboplatin (AUC 6) 3 weeks along with external beam radiotherapy (EBRT) dose 66-70 Gy in conventional fractionation and Arm B received injection cisplatin (100 mg/m 2 ) 3 weeks with same EBRT schedule. Detailed clinical examination along with biopsy for residual or recurrent disease, CT scan of head and neck were done to assess the response, toxicities, and disease-free survival (DFS) in follow-up. Statistical Analysis Used: SPSS version 17 used for statistical calculation. For categorical variables, Chi-Square and Fisher Exact tests were used. For continuous variables, independent samples t test were used with 95% CI. Kaplan-Meier survival analysis was used for comparing the DFS. Results: Overall response rate (CR + PR) were 76.9% in Arm A and 63.6% in Arm B (P = 0.06, non-significant). Statistically significant acute skin (P = 0.003), mucosa (P = 0.003), and upper GI (P = Conclusions: It can be concluded that carboplatin is non-inferior in response with statistically significant less toxicities when compared with cisplatin.