A Prospective Randomised Trial Comparing Neoadjuvant Chemotherapy Followed by Concomitant Chemoradiation versus Concomitant Chemoradiation Alone in Locally Advanced Inoperable Head and Neck Squamous Cell Carcinoma

Introduction: Concurrent chemoradiation is currently the standard of care in LAHNSCC. Neoadjuvant Chemotherapy (NACT) causes tumour downstaging, facilitating organ preservation and has potential to prevent distant metastasis albeit at the cost of increased toxicities. However potential benefit of adding NACT before CTRT in LAHNSCC still remains unclear. Aims and Objectives: This study compared NACT followed by CTRT versus CTRT alone in LAHNSCC in terms of Locoregional response (LRR), Toxicities and Progression Free Survival (PFS). Materials and method: Patients with LAHNSCC of oral cavity, oropharynx, larynx & hypopharynx (AJCC Stage III-IVB), recruited from January 2013 to January 2015 were randomised into two arms (90 each) to receive either NACT (Paclitaxel 175mg/m2 and Carboplatin AUC 5 q 3 weeks 3 cycles) followed by CTRT (Arm A) or CTRT alone (Arm B). EBRT dose was 66–70 Gy in conventional fractionation with three weekly Inj. Cisplatin 100 mg/m2. Results: Median follow up period was 37 months. After NACT, 58.9% of patients achieved PR and CR 7.8%. Response 4 months after treatment showed LRR 56/65 in arm A vs. 53/71 in arm B. Median PFS was 48 months in Arm A vs. 42 months in Arm B; log rank p=0.176. Grade ≥ 3 acute toxicities included myalgia(10%), neutropenia (4.4 %), thrombocytopenia(3.3%) and anemia (3.3%) during NACT. During CTRT more haematotoxicities and mucositis in arm A whereas dermatitis and dysphagia were more in arm B. Regarding late toxicities, grade ≥ 3 neuropathy seen in Arm A. Conclusion: NACT before CTRT is feasible and may be used in LAHNSCC to downstage tumour with no significantly added toxicity.