Gefitinib (ZD1839) in previously treated advanced non-small-cell lung cancer: experience from a single institution.
BACKGROUND
We conducted an analysis of gefitinib in patients with advanced non-small-cell lung cancer (NSCLC) to assess the antitumor efficacy of this epidermal growth factor receptor tyrosine kinase inhibitor.


METHODS
Our single-center, prospective landmark analysis included 183 patients with advanced NSCLC who received 250 mg of gefitinib orally once daily in an expanded-use program at our institution. Thirty-three of the 183 patients were previously untreated. The patients included in this analysis had all received at least 12 weeks of gefitinib.


RESULTS
The objective tumor response rate was 3.8%, but an additional 53.5% of patients experienced clinically meaningful disease stabilization. Median progression-free survival time was 3.6 months, and median overall survival time was 8.8 months. The 1-year survival rate for the entire cohort was 35%. Predictors of longer survival included female gender, adenocarcinoma or bronchoalveolar carcinoma histology, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Adverse events were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea.


CONCLUSIONS
In this single-center experience, gefitinib demonstrated clinically significant antitumor activity and provided good palliation in a predominantly pretreated group of patients. Our results, which are likely to be reproducible in a community setting, demonstrated a 1-year survival rate of 35% in a cohort of patients who were able to take the drug for at least 12 weeks.
Simon
George R
GR
Thoracic Oncology Program, H. Lee Moffitt Cancer Center Research Institute, Tampa, FL 33612, USA. simongr@moffitt.usf.edu
Ruckdeschel
John C
JC
Williams
Charles
C
Cantor
Alan
A
Chiappori
Alberto
A
Rocha Lima
Caio M
CM
Antonia
Scott
S
Haura
Eric
E
Wagner
Henry
H
Robinson
Lary
L
Sommers
Eric
E
Alberts
Michael
M
Bepler
Gerold
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004815:Epidermal Growth Factor / Q000037:antagonists & inhibitors*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000627:therapeutic use*; D015996:Survival Rate
D000970:Antineoplastic Agents; D011799:Quinazolines; D004815:Epidermal Growth Factor; D000077156:Gefitinib