Bonner study design1,2
A multicenter, phase III trial of ERBITUX + RT
- This study was an open-label, randomized (1:1), multicenter, controlled clinical trial that compared ERBITUX + RT (n=211) vs RT alone (n=213) in untreated patients (N=424) with locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)
- Primary endpoint was duration of locoregional control
- Secondary endpoint included overall survival. A post-RT neck dissection was recommended for patients with >N1 neck disease. Patients were stratified according to T1-3 vs T4, N0 vs N+, RT fractionation, and KPS (60%-80% vs 90%-100%)
EGFR=epidermal growth factor receptor; KPS=Karnofsky performance status.
Bonner study: Most common adverse reactions1
- 6% of patients (13/208) discontinued ERBITUX due to any adverse reaction in the Bonner study
- ERBITUX-related adverse reactions leading to discontinuation included hypersensitivity reactions, grade 3 acneiform rash, and unspecified reason
*Includes cases also reported as infusion reaction.
†Infusion reaction is defined as any reaction described at any time during the clinical study as “allergic reaction” or “anaphylactoid reaction,” or any reaction occurring on the first day of dosing described as “allergic reaction,” “anaphylactoid reaction,” “fever,” “chills,” “chills and fever,” or “dyspnea.”
‡Based on laboratory measurements, not on reported adverse reactions, the number of subjects with tested samples varied from 205-206 for ERBITUX plus radiation arm; 209-210 for radiation alone.
Cetuximab (ERBITUX®) + RT is a nationally recognized option for the initial treatment of people with select locoregionally advanced SCCHN3,4
National Comprehensive Cancer Network® (NCCN®) recommendation4
Primary systemic therapies recommended by NCCN with concurrent radiation therapy for locoregionally advanced SCCHN4
*Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
†Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
ERBITUX (cetuximab) FDA-approved Indication1
ERBITUX, in combination with radiation therapy, is indicated for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).
- ERBITUX (cetuximab) [package insert]. Indianapolis, IN: Eli Lilly and Company, its subsidiaries or affiliates.
- Bonner JA, et al. N Engl J Med. 2006;354(6):567-578.
- Bonner JA, et al. Lancet Oncol. 2010;11(1):21-28.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Head and Neck Cancers V.2.2017. © National Comprehensive Cancer Network, Inc. 2017. All rights reserved. Accessed May 9, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.