Induction chemotherapy (CT) with weekly paclitaxel, carboplatin, and cetuximab for squamous cell carcinoma of the head and neck (HN)

Abstract

5520 Background: To further determine the potential efficacy of combining cetuximab with chemotherapy, we conducted a phase II trial with induction CT consisting of 6 weekly cycles of paclitaxel 135 mg/m2, carboplatin auc 2 and cetuximab 400 mg/m2 week 1 then 250 mg/m2 weekly. Methods: Patients (pts) were treatment-naïve with staging T0–4, N2b/c/3, M0; PS 0/1; with any HN primary site; and evaluated for clinico-radiographic complete response (CR). Pathway signaling biomarkers and genomic profiling are planned. Following CT, patients underwent “risk-based” local therapy. Choice of surgery ± postoperative radiotherapy (RT), RT, or concomitant chemoRT was based upon tumor stage and site at diagnosis. Results: Patient entry (2/05–11/05) has concluded with 47 patients (33 m, 14 f), median age 53 years and range 21–78. Two patients are too early for response analysis. Oropharynx was the dominant primary site, N = 42, with staging: Tx N2b - 4, Tx N3 - 1; T1 N2b - 5, T1 N2c - 6, T1 N3 - 3; T2 Nx - 1, T2 N2b - 10, T2 N3 - 3; T3 N2b - 5, T3 N2c - 3, T3 N3 - 1; T4 N2b - 2 and T4 N2c - 3. Toxicity was acceptable. Sixteen (34%) pts had grade 3/4 leukopenia; 22 (47%) grade 3 folliculitis (median 5 cycles of cetuximab administered); and 2 (4%) serious hypersensitivity. All 41 evaluable pts achieved a response in the primary site, 7 (17%) PR and 34 (83%) CR. Forty-three of 44 evaluable patients achieved a nodal response, 31 (70%) PR and 12 (27%) CR. Overall, 11 of 45 (24%) pts were disease-free after CT. At this early point, 3 pts have had 4 tumor recurrences, 2 local and 2 distant. Conclusions: CT administered over 6 wks, with cetuximab, was feasible and highly active with all patients achieving a tumor response. Severe skin rash affected nearly 50% of pts. Preliminary survival data, and correlation of surrogate biomarkers with tumor response are to be presented. Supported by: Bristol Myers Squibb Oncology and Imclone Systems Grant #CS 2004–00011435 WC. [Table: see text]