Cetuximab prolongs survival in patients with locoregionally advanced squamous cell carcinoma of head and neck: A phase III study of high dose radiation therapy with or without cetuximab

• DOI: 10.1200/jco.2004.22.90140.5507
• Publication Date: 2017-04-05T07:17:42Z
• Authors: J. A. Bonner; P. M. Harari; J. Giralt; N. Azarnia; R. B. Cohen; D. Raben; C. Jones; M. S. Kies; J. Baselga; K. K. Ang
• Keywords: Regimen; Concomitant

5507 Background: The majority of head and neck cancers overexpress the epidermal growth factor receptor (EGFR), which is associated with aggressive tumor behavior poor clinical outcome. Preclinical in vitro vivo model systems demonstrate radiosensitization following molecular inhibition EGFR signaling. Promising phase I/II results were achieved when radiation was combined blocking antibody, cetuximab, patients locoregionally advanced squamous cell carcinoma (SCC) (H&N). This III international trial designed to examine impact combining cetuximab high dose on locoregional disease control survival locally H&N cancer. Methods: Patients SCC oropharynx, hypopharynx or larynx measurable eligible enroll. stratified by Karnofsky score 60–80 vs. 90–100, node positive negative, T1–3 T4, fractionation regimen (once-a-day twice-a-day concomitant boost), randomized receive either alone for 6–7 weeks, plus weekly cetuximab. Following completion treatment, followed physical examination radiographic imaging every 4 months 2 years, then 6 up 5 years. Results: From 04/99 03/02, 424 this USA (61%), Europe (28%), other countries. Median age 57; 80% male; 69% had KPS 90–100; 60% oropharyngeal, 25% laryngeal, 15% hypopharyngeal primary tumors. two treatment arms well balanced regard patient characteristics stratification factors. also respect fractions received, use post-radiotherapy dissection, secondary cancer therapy. Minimum median durations follow-up 24 38 months, respectively. times, three-year rates derive from Kaplan-Meier estimates. Survival selected safety are as follows: overall toxicity profile dominated classic known effects radiation, although some additional attributed Locoregional assessment ongoing. Conclusions: addition demonstrated a statistically significant prolongation survival. benefit minimal enhancement curative-intent These corroborate promising preclinical earlier supporting blockade combination H&N. Furthermore, should be explored common epithelial malignancies demonstrating overexpression. Author Disclosure Employment Leadership Consultant Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration ImClone Systems