An open-label, randomized, study of h-R3mAb (nimotuzumab) in patients with advanced (stage III or IVa) squamous cell carcinoma of head and neck (SCCHN): Four-year survival results from a phase IIb study.

5530 Background: h-R3mAb (nimotuzumab) is a humanized monoclonal antibody targeting epidermal growth factor receptor (EGFR). EGFR is over-expressed in >90% squamous cell carcinoma of head and neck (SCCHN). Patients with advanced inoperable SCCHN have poor outcome to radiotherapy (RT) or chemoradiotherapy (CRT) treatment alone. Adding biologically active targeted therapies to RT/CRT might further improve therapeutic outcome with minimal morbidity. Methods: Total of 113 patients with (stage III or IVa), inoperable SCCHN were screened; 92 randomized in 1:1 ratio in two groups; group A received [RT Vs RT+h-R3mAb] and group B received [CRT vs. CRT+h-R3mAb]. Treatment included radiotherapy in total dose 60 -66Gy, h-R3mAb 200mg by I.V infusion over 60 min/ week for 6weeks and in group B, chemotherapy CDDP 50mg/week for 6weeks. Results: Seventy-six patients were evaluable; 36-groupA and 40-groupB. Locoregional response was 100% in CRT+h-R3mAb vs. 70% in CRT and 76% in RT+h-R3mAb vs. 37% in RT. At 48 months follow...