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.

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.

• Authors: B K M Reddy, V Lokesh, M S Vidyasagar, K Shenoy, K G Babu, A Shenoy, T Naveen, Bindhu Joseph, R Bonanthaya, Nanjundappa, P P Bapsy, Loknatha, Jayarama Shetty, Krishna Prasad, C R Tanvir Pasha
• Journal: Oral oncology (Oral Oncol) Vol. 50 Issue 5 Pg. 498-505 (May 2014) ISSN: 1879-0593 [Electronic] England
• PMID: 24613543 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014. Published by Elsevier Ltd.

Chemical References

• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• nimotuzumab
• ErbB Receptors

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, metabolism, radiotherapy)
• Combined Modality Therapy
• ErbB Receptors (metabolism)
• Female
• Head and Neck Neoplasms (drug therapy, metabolism, radiotherapy)
• Humans
• Male
• Middle Aged
• Survival Analysis