A Randomized Study to Evaluate Efficacy and Toxicity Profile of Paclitaxel-carboplatin as Neo-adjuvant Chemotherapy in Locally Advanced Supraglottic and Hypopharyngeal Primaries.

Abstract

This study was conducted in locally advanced supraglottic and hypopharyngeal squamous cell carcinoma patients to ascertain the efficacy and toxicity profile of a two drug combination neo adjuvant chemotherapy (NACT) schedule containing Taxane and Platinum; prior to definitive concurrent chemo-radiotherapy (Def CCRT); sixty patients with stage III, IVA and IVB locally advanced squamous cell cancers of larynx and hypopharynx were randomised to two arms. Thirty patients in study group were treated with NACT with Paclitaxel (175mg/m2) and Carboplatin (AUC 5-7) for 3, 3 weekly cycles; followed by CCRT in the patients who showed at-least a partial response (PR). These patients were compared with the 30 patients of control group who received upfront CCRT. More patients in Study arm developed grade 3 dysphagia (p = 0.001) and mucositis (p = 0.003). Renal, hematogenous and skin toxicities were identical in two arms. At 3months post treatment complete response (CR) at primary site was 83.3% and 66.6% (p = 0.245) in study and control arms respectively. At 6months post treatment; 20 patients (66.6%) in the study group and 17 patients (56.6%) in the control group continued to be in clinic-radiological CR (p = 0.20). NACT with Paclitaxel and Carboplatin is tolerated with manageable toxicities in patients with LAHNSCC (Locally advanced head and neck squamous cell carcinoma), with increased Grade 3 dysphagia and mucositis as compared to patients getting upfront CCRT. A longer follow-up period with a larger sample size is required to further evaluate any statistically significant benefit of adding NACT prior to CCRT.