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
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.