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Background: Nimotuzumab is ananti-epidermal growth factor receptor monoclonalantibody which can be added to chemoradiotherapy(CRT) to improve efficacy for management oflocally advanced squamous cell carcinoma of thehead and neck (LASCCHN). We prospectivelyevaluated the efficacy and safety of nimotuzumabwith CRT for LASCCHN and compared with CRT alone.Materials and Methods: In this prospective study,29 LASCCHN (Stage III–IVb) patients receivedNimotuzumab plus CRT or CRT alone. Treatmentincluded six cycles of cisplatin (40–50 mg/week)or carboplatin (area under the curve-based),nimotuzumab (200 mg/week), and radiotherapy (60–70Gy). Tumor response was evaluated as per responseevaluation criteria in solid tumors criteria. MoSwas estimated using the Kaplan–Meier method.Toxicity and adverse events (AE's) were assessedas per CTCAE v 4.0. Results: At 24 weeks aftercompletion of treatment, the tumor response rate(complete response, partial response, stabledisease) was 53.3% and 35.7% favoring nimotuzumabarm while progression of disease was 40% and 35.7%in Nimotuzumab plus CRT and CRT groups,respectively. However, the objective response ratewas 57% and 30% in favor of nimotuzumab arm. Atmedian follow-up of 45.5 months, MoS was 33 monthsin Nimotuzumab plus CRT and 27 months in CRTgroup. The 5-year survival rate was 33.3% inNimotuzumab plus CRT versus 7.1% in CRT group.Nimotuzumab was observed to be safe with noadditional AE's such as hypersensitivity,hypomagnesemia, and allergic reaction wasreported. Conclusion: Addition of Nimotuzumab tostandard CRT showed improved survival rate inunresectable, LASCCHN patients without producingadditional toxicity.

south asian journal of cancer

Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study