A Comparative Evaluation of Mycobacterium w Vaccine Based Immunotherapy plus Concomitant Chemoradiation versus Concomitant Chemoradiation alone in Locally Advanced Head and Neck Cancer

Materials and Methods: Sixty LAHNC patients were randomly assigned to either radical radiotherapy, 64 Gy/32 fractions over 6.2 weeks plus intravenous cisplatin 40 mg/m 2 weekly for six doses (CCRT arm) or intradermal Mw vaccine 0.2 ml weekly for six doses plus CCRT (MwCCRT arm) to equal number of patients. Primary end points taken were in the form of the response rate along with toxicity profile and locoregional control after 6 month follow up in two groups. Results: All patients in each arm completed the planned treatment. The complete response rate was observed to be 70% versus 63.3% (p =0.752), no evidence of disease (NED) at six month of follow was seen in 63.3% versus 53.3% in MwCRT and CRT arms (p =0.612) respectively. Grade 2 skin and mucosal toxicity observed were 40% versus 83.3% (p=0.033) and 40% versus 83.3% (p=0.033) in MwCCRT arm and CCRT arm respectively. Grade 3 skin and mucosal toxicity were 13.3% and 10% in CCRT arm only, respectively. Conclusion: This study on Indian locally advanced head and neck squamous cell carcinoma patients suggests that the use of weekly Mw vaccine plus weekly cisplatin is safe and MwCCRT may be superior to CCRT alone in terms of better response rate, higher locoregional control with lesser toxicities.