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Clinical Trial
. 2014 May;50(5):498-505.
doi: 10.1016/j.oraloncology.2013.11.008. Epub 2014 Mar 6.

Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients

B K M Reddy  1 , V Lokesh  2 , M S Vidyasagar  3 , K Shenoy  4 , K G Babu  1 , A Shenoy  1 , T Naveen  1 , Bindhu Joseph  1 , R Bonanthaya  1 , Nanjundappa  1 , P P Bapsy  1 , Loknatha  1 , Jayarama Shetty  4 , Krishna Prasad  4 , C R Tanvir Pasha  1
Affiliations
Clinical Trial

Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients

B K M Reddy et al. Oral Oncol. 2014 May.

Abstract

Objective: Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN).

Methods: This open-label study randomized 92 treatment-naïve patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator's discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60-66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60.

Results: Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100% with CRT + nimotuzumab, 70% with CRT, 76% with RT + nimotuzumab, and 37% with RT. At Month 60, overall survival was 57% with CRT + nimotuzumab, 26% with CRT (P = 0.03), 39% with RT + nimotuzumab, and 26% with RT (P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT (P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT (P = 0.45). Risk of death was 64% lower with CRT + nimotuzumab than with CRT (95%CI: 0.37, 1.56), and 24% lower with RT + nimotuzumab than with RT (95%CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events.

Conclusion: Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.

Keywords: Chemoradiation; Epidermal growth factor receptor; Head and neck cancer; Humanized monoclonal antibody; Nimotuzumab.

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