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A phase 2 study of cetuximab in combination with docetaxel in chemotherapy‐refractory/resistant patients with advanced nonsmall cell lung cancer
Author(s) -
Kim Edward S.,
Mauer Ann M.,
William William N.,
Tran Hai T.,
Liu Diane,
Lee Jack J.,
Windt Paul,
Hong Waun K.,
Vokes Everett E.,
Herbst Roy S.
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24148
Subject(s) - medicine , cetuximab , docetaxel , refractory (planetary science) , oncology , chemotherapy , phases of clinical research , lung cancer , cancer , colorectal cancer , physics , astrobiology
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 [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.