A chance to give more of what matters. 1.6 years more.
Improvement in median overall survival (OS) for ERBITUX with RT vs RT alone
The BONNER (NCT00004227) study: Significant median OS advantage vs RT alone
1.6 years improvement in median OS
Main outcome measure: Median duration of locoregional control
ERBITUX with RT increased median duration of locoregional control by 0.8 years vs RT alone (2.0 years vs 1.2 years, respectively; HR=0.68 [95% CI: 0.52-0.89]; P=0.005).1
An OS advantage was maintained at 3 and 5 years2,3
ERBITUX with RT improved OS rate at 3 years vs RT alone; 55% vs 45%, respectively (HR not available)2
10% absolute improvement in 3-year survival rate vs RT alone
ERBITUX with RT improved OS rate at 5 years vs RT alone; 45.6% vs 36.4%, respectively (HR=0.73; 95% CI: 0.56-0.95)3
9.2% absolute improvement in 5-year survival rate vs RT alone
BONNER study design1,2
A phase III trial of ERBITUX with RT
This study was an open-label, randomized (1:1), multicenter, controlled clinical trial that compared ERBITUX with RT (n=211) vs RT alone (n=213) in untreated patients (N=424) with locally or regionally advanced SCCHN
The main outcome measure was duration of locoregional control. Another outcome measure was OS
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 (concomitant boost vs once daily vs twice daily), and Karnofsky performance status (KPS) (60%-80% vs 90%-100%)
BID=twice a day; EGFR=epidermal growth factor receptor; QD=once a day.
BONNER study: Most common adverse reactions1
Discontinuation rate2
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
†Adverse reactions occurring in ≥10% of patients in the ERBITUX combination arm and at a higher incidence (≥5%) compared to the radiation-alone arm.
‡Adverse reactions were graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0.
§Includes cases also reported as infusion reaction.
ǁInfusion reaction defined as any event described at any time during the clinical study as “allergic reaction” or “anaphylactoid reaction,” or any event 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 with radiation arm; 209-210 for radiation alone.
#Acneiform rash defined as any event described as “acne,” “rash,” “maculopapular rash,” “pustular rash,” “dry skin,” or “exfoliative dermatitis.”
Bonner JA, et al. N Engl J Med. 2006;354(6):567-578.
Bonner JA, et al. Lancet Oncol. 2010;11(1):21-28.