Gefitinib (ZD1839) monotherapy as a salvage regimen for previously treated advanced non-small cell lung cancer.
OBJECTIVE
A worldwide compassionate-use program has enabled >42,000 patients with advanced non-small cell lung cancer (NSCLC) to receive gefitinib treatment. Here we report the outcome of gefitinib therapy in patients who enrolled in the "Iressa" Expanded Access Program at the Samsung Medical Center.


METHODS
Patients with advanced or metastatic NSCLC who had progressed after prior systemic chemotherapy and for whom no other treatment option was available were eligible to receive gefitinib treatment as part of the Expanded Access Program. A post hoc assessment of potential prognostic factors for response and survival was performed by multivariate analysis.


RESULTS
All 111 evaluable patients had stage IV disease; most patients had a baseline performance status of 2 [n = 52 (47%)] or 3 [n = 18 (16%)] and had received >/=2 prior chemotherapy regimens (56%). The objective response rate was 26%, the disease control rate (measured over >/=8 weeks) was 40%, and the 1-year survival rate was 44%. Adenocarcinoma histology was associated with better response and disease control rates, and a performance status of 0-2 was also associated with a better disease control rate. Both of these factors, as well as female gender, were significantly associated with longer survival. Gefitinib was well tolerated; the most common adverse event was grade 1 skin rash.


CONCLUSIONS
Gefitinib demonstrated significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients with poor prognosis.
Park
Jinny
J
Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Park
Byung Bae
BB
Kim
Jee Youn
JY
Lee
Se-Hoon
SH
Lee
Soon Il
SI
Kim
Ho Young
HY
Kim
Jung Han
JH
Park
Se Hoon
SH
Lee
Kyung-Eun
KE
Park
Joon Oh
JO
Kim
Kihyun
K
Jung
Chul Won
CW
Park
Young Suk
YS
Im
Young-Hyuck
YH
Kang
Won Ki
WK
Lee
Mark H
MH
Park
Keunchil
K
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D011799:Quinazolines / Q000494:pharmacology*; D016879:Salvage Therapy; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib