Multicenter phase II study of cetuximab plus docetaxel in 84 patients with recurrent or metastatic, platinum-pretreated SCCHN

Abstract

6048 Background: Cetuximab and docetaxel are both active in squamous cell carcinoma of the head and neck (SCCHN). We investigated the efficacy of cetuximab plus docetaxel as second-line treatment in platinum-pre-treated patients with recurrent and or metastatic SCCHN. Methods: 84 patients were enrolled and received cetuximab (initial dose of 400 mg/m2, followed by subsequent weekly doses of 250 mg/m2) and docetaxel (35 mg/m2 on days 1, 8, 15 of a 4-week cycle) for a maximum of 6 cycles. Patients with stable disease continued to receive cetuximab until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate according to RECIST criteria. Secondary endpoints were response rate in relation to platinum sensitivity, progression-free survival, overall survival, and toxicity. Results: According to RECIST there were 10 PR (12%) and 23 SD (27%), resulting in a disease control rate of 39%. Response to protocol treatment was unrelated to previous platinum sensitivity. Median progression-free survival was 4 months (95% CI, 2.9 to 5.1) and median overall survival was 7 months (95% CI, 5.5 to 8.5). The duration on protocol treatment exceeded 12 months in 6 (8%) patients. Grade III/IV toxicities included gastric perforation (n = 1), pneumonia (n = 7), mucositis and skin toxicities. Conclusions: Cetuximab plus docetaxel was an active second-line treatment regimen with acceptable toxicity in patients with platinum-pretreated SCCHN. The responsiveness was independent of previous platinum sensitivity. [Table: see text]