MIAMI BEACHDrugs that block epidermal growth factor receptor (EGFR) tyrosine kinase activity may represent a new option for patients whose non-small-cell lung cancer (NSCLC) has progressed despite standard chemotherapy, Jose Baselga, MD, reported at the Molecular Targets and Cancer Therapeutics meeting (abstract 630A).
The meeting was sponsored by the American Association for Cancer Research, National Cancer Institute, and European Organization for Research and Treatment of Cancer.
Dr. Baselga, of Vall D’Hebron University Hospital, Barcelona, Spain, reported phase II data from a multicenter, international, randomized, double-blind, parallel-group study of two different dosages of the investigational EGFR tyrosine kinase inhibitor ZD-1839 (Iressa) as salvage monotherapy for patients with advanced NSCLC.
"Early on in the phase I trials of ZD1839, we saw some responses in various tumor types including NSCLC. Since there are few options for these patients, we proceeded to the phase II trial," Dr. Baselga said.
The investigators enrolled 210 patients with advanced NSCLC whose disease had progressed despite one or two chemotherapy regimens. The study objectives were to evaluate the objective tumor response rate and the safety profiles of two doses of ZD1839.
Secondary objectives included estimating disease-related symptom improvement using the 7-item lung cancer subscale from the FACT-L questionnaire and to estimate disease control rates, defined as responses plus stable disease. Patients were not selected by tumor EGFR status.
Patients were randomized to receive oral ZD1839 at 250 mg or 500 mg once daily. Tumors were assessed every 4 weeks after the start of treatment for the first 4 months, then every 8 weeks. Of 210 patients enrolled, 208 were evaluable for response, with a minimum follow-up of 4 months.