A comparative study of a monoclonal antibody against EGFR (nimotuzumab) used in combination with chemoradiation versus chemoradiation alone in the treatment of locally advanced inoperable squamous cell carcinoma of the head and neck.

Abstract

51 Background: To determine the efficacy, safety and tolerability of concurrent nimotuzumab (monoclonal antibody against epidermal growth factor receptor) used in combination with chemoradiation versus chemoradiation (CRT) alone in advanced inoperable squamous cell carcinoma of the head and neck (SCCHN). Methods: 56 patients were randomly assigned to either of the two treatment arms, nimotuzumab + CRT arm and CRT alone arm. Both arms received concurrent Cisplatin 30 mg/m2 repeated weekly for 6-7 cycles along with external beam radiotherapy 64-70 Gy (200cGy/day for 5 days a week for 6-7 weeks). Nimotuzumab arm additionally received nimotuzumab 200 mg weekly for 6-7 cycles. The patients were followed for 6 months after completion of CRT. The study end points were tumor response evaluation according to the RECIST Criteria version 1.1 and safety analysis using RTOG Acute Radiation Morbidity Scoring Criteria. Patients were evaluated weekly with hematologic tests and for adverse events like mucositis and dermatitis during the CRT. Tumor assessment was performed with clinical and endoscopic methods regularly during the CRT and then at 1 month, 3 months, and 6 months intervals after CRT. One MR imaging was done before starting the CRT to evaluate the baseline tumor characteristics, and another was done after the completion of CRT either at 3 months or 6 months or at both the intervals. Results: 25 patients each were evaluable in both the arms who completed the 6-month study. The overall response rate (complete response + partial response) was 96% in nimotuzumab + CRT arm, whereas it was only 72% in CRT alone arm after 6 months of completion of CRT, which is statistically significant (p value = 0.0206 by Chi Square test). Additionally, nimotuzumab did not potentiate toxicities of CRT, and there was no significant difference in the acute radiation mucositis, dermatitis, or hematological toxicities in both the groups (p value>>0.05). Conclusions: Nimotuzumab can be safely added to the standard CRT treatment for advanced inoperable SCCHN, to achieve better tumor response without potentiating toxicity.