Cetuximab monotherapy is active in patients (pts) with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN): Results of a phase II study

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Abstract
5502 Background: Pts with refractory SCCHN have a poor prognosis with few therapeutic options. Cetuximab (Erbitux), an IgG1 monoclonal antibody that binds selectively to EGFR, has shown activity in combination with cisplatin or carboplatin in pts with recurrent/metastatic SCCHN progressing on the same platinum-based regimen (Baselga #900, Kies #925; ASCO 2002). Methods: This multicenter phase II study was designed to investigate the efficacy of cetuximab as monotherapy in pts with platinum-refractory SCCHN. Main inclusion criteria were: stage III/IV recurrent and/or metastatic SCCHN not suitable for local therapy, with documented progression on or within 30 days after 2 to 6 cycles of a platinum-based CT. Cetuximab was given at an initial dose of 400 mg/m2, followed by 250 mg/m2 weekly until disease progression, with the option to switch to the combination of cetuximab with the same platinum that the pts had previously progressed on, after failure to cetuximab monotherapy. Results: 103 pts (84 M, 19 F) were enrolled. Median age was 57 years (23–77), median baseline KPS was 80 (60–100) and median time from diagnosis to study entry was 20 months (3–283). Drug-related adverse events occurring in >10% of pts included: skin rash/acne 80% (1% grade 3), fatigue 24% (4% grade 3), fever/chills 19% (2% grade 3), nail changes 15% (all grade 1–2) and nausea 13% (1% grade 3). There was one treatment-related death due to hypersensitivity reaction in a patient not suitable to receive mechanical ventilation. Preliminary efficacy data (based on investigator assessment) were as follows: 5 CR, 12 PR, 38 SD, 47 PD, 1 not assessable, for an overall objective response rate of 16.5% (95% CI: 9.9%–25.1%). Disease control rate was 53.4% (95% CI: 43.3%–63.3%). Median TTP and median survival were 85 and 175 days, respectively. An independent review of all pre-treatment and on-study imaging assessments is ongoing and will be available at the meeting. Conclusions: Cetuximab as single agent can produce major objective responses in pts with platinum-refractory recurrent/metastatic SCCHN, with acceptable toxicity.

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