Efficacy and Safety of Paclitaxel versus Cisplatin with Concurrent Radiotherapy in Central India Patients with Locally Advanced Head-and-neck Cancers: A Randomized, Open-label Study

Abstract

ABSTRACT Background: In India, majority of the patients with head-and-neck cancers are diagnosed in the locally advanced stage. The aim of this study was to compare the efficacy and safety of paclitaxel versus cisplatin with concurrent radiotherapy (RT) in patients with locally advanced head-and-neck squamous cell carcinomas (LAHNSCCs). Materials and Methods: This was an open-label, randomized study involving 100 patients with LAHNSCC who were randomly divided into two groups: the first group received paclitaxel (Tax, n = 50, 30 mg/m2/week for 7 weeks) and the second group received cisplatin (Cis, n = 50; 40 mg/m2/week for 7 weeks). Both the groups received concurrent RT in a total dose of 66.6 Gy in 37 fractions of 5 days/week over a period of 7.5 weeks. Results: The complete (46% vs. 36%) and partial (40% vs. 50%) response rates in the Tax + RT group and Cis + RT group were not significantly different (both P > 0.05). Cis + RT resulted in significantly greater Grade I adverse events (AEs) (P < 0.05). While, Grade II, III, and IV AEs were significantly greater with Tax + RT (all P < 0.05). Overall analysis revealed that the use of Cis + RT was associated with a significantly greater number of patients who were free from AEs (P < 0.05). Conclusions Tax + RT and Cis + RT were equi-efficacious in patients with LAHNSCC. However, Cis + RT had a better safety profile.