期刊
CANCER
卷 115, 期 8, 页码 1713-1722出版社
JOHN WILEY & SONS INC
DOI: 10.1002/cncr.24148
关键词
Cetuximab; NSCLC; EGFR; chemotherapy-refractory; docetaxel
类别
资金
- ImClone Systems Incorporated
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/m(2) initial; 250 mg/m(2) thereafter). Docetaxel was administered every 3 weeks (75 mg/m(2)). 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 [Cl], 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;115:1713-22. (C) 2009 American Cancer Society.
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