Abstract
5513 Background: The goal of this study was to investigate the safety and efficacy of cetuximab (Erbitux), an IgG1 monoclonal antibody targeting the EGFR, given in combination with platinum and various doses of 5-FU in pts with recurrent and/or metastatic SCCHN and to evaluate the pharmacokinetic profile of cisplatin and cetuximab. Methods: Main eligibility criteria: Stage III/IV recurrent and/or metastatic SCCHN not suitable for local therapy, no prior palliative chemotherapy (CT) except as part of a multimodal treatment for locally advanced SCCHN, adequate hematologic and biologic functions, and Karnofsky performance status (KPS) ≥ 70. Cetuximab was given at an initial dose of 400 mg/m2, followed by 250 mg/m2 weekly. Pts were randomized to receive either cisplatin 100 mg/m2 (day 2) or carboplatin AUC=5 (day 1). 5-FU was administered as continuous infusion on days 1 during 120 hours at the dose levels of 600, 800 and 1000 mg/m2/day. CT cycles were repeated every 3 weeks. Results: 52 pts (47 male, 5 female) were enrolled (12 pts in 5-FU low dose, 16 pts in medium dose and 24 pts in high dose), median age 55.5 years (33–77) and median KPS 80 (70–100). Typical grade 3/4 adverse events of 5-FU in combination with cisplatin and cetuximab (27 pts), regardless of relationship to the study medication, included neutropenia (48%), asthenia (30%), nausea/vomiting (30%), mucositis (15%), arrhythmia/myocardial infarction (15%), thrombopenia (11%), and dyspnea (11%); in the carboplatin group (25 pts), the most frequent grade 3/4 side effects were neutropenia (36%), asthenia (20%), dyspnea (12%), and thrombopenia (12%). Preliminary efficacy results are available for 47 patients: 2 CR, 21 PR, 16 SD, 7 PD, 1 not assessable. Overall response rate was 48.9% (95% CI: 34.6%–63.2%) disease control rate was 83.0%, (95%CI: 72.2%–93.7%). Conclusions: Cetuximab can be safely combined with therapeutic doses of cis-/carboplatin plus 5-FU. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Merck KGaA
Published Version
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