A phase 2 study of cetuximab in combination with docetaxel in chemotherapy‐refractory/resistant patients with advanced nonsmall cell lung cancer

BACKGROUND: Cetuximab in combination with docetaxel was examined in chemotherapy‐refractory/resistant patients with advanced nonsmall‐cell lung cancer (NSCLC) to determine response rate, survival, safety, and pharmacokinetics (PK). METHODS: Patients had evidence of epidermal growth factor receptor (EGFR) expression (≥1 +) and tumor progression during or disease recurrence within 3 months after chemotherapy. Cetuximab was administered weekly (400 mg/m2 initial; 250 mg/m2 thereafter). Docetaxel was administered every 3 weeks (75 mg/m2). A response in 3 of the first 21 patients was required to continue accrual to the target sample size of 50 patients. RESULTS: Confirmed responses included 1 complete response (1.8%), 10 partial responses (18.2%), and 20 with stable disease (36.4%). The response rate was 20% (95% confidence interval [CI], 10.4% to 33.0%) and median time to disease progression was 104 days. There were no differences in PK parameters of docetaxel alone or with cetuximab. The most common grade 3 of 4 adverse events were leukopenia (27.3%) and acne (21.8%). Four patients (7.3%) discontinued due to allergic reaction. The median overall survival (OS) was 7.5 months with a 1‐year survival of 35%. CONCLUSIONS: Cetuximab in combination with docetaxel was well tolerated. The response rate supports more definitive evaluation of this combination in the second‐line setting. Cancer 2009. © 2009 American Cancer Society. Cetuximab in combination with docetaxel was examined in chemotherapy‐refractory and/or resistant patients with advanced nonsmall‐cell lung cancer (NSCLC) to determine response rate, survival, safety, and pharmacokinetics (PK). Cetuximab in combination with docetaxel was well tolerated, and the response rate supports more definitive evaluation of this combination in the second‐line setting.