[Efficacy of gefitinib on advanced non-small cell lung cancer in expanded access program (EAP)].
OBJECTIVE
Gefitinib is a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, and has been used in treating advanced non-small cell lung cancer (NSCLC). This study was to evaluate the efficacy of Gefitinib on advanced NSCLC, and observe adverse events.


METHODS
An open labeled, expanded access program (EAP) was conducted. Pathologically confirmed advanced NSCLC patients who had progressed after systemic chemotherapy or was not suitable for systemic chemotherapy were eligible for this program. Gefitinib (250 mg) was orally administered daily till disease progression or intolerable adverse events developed.


RESULTS
From Sep. 2002 to Mar. 2005, 120 patients were enrolled, and 103 of them were assessable for response. The objective response rate was 18.4% (19/103). The disease control rate was 51.5% (53/103). The median survival time was 6 months (0.5-33 months). Adverse events were generally mild (grade I or II), including skin rash (30.1%), dry skin (12.6%), and diarrhea (25.2%). Two (1.9%) patients developed grade III elevation of serum glutamate pyruvate transaminase (SGPT). No grade IV adverse event occurred.


CONCLUSIONS
Gefitinib is effective in treating advanced NSCLC, and the adverse events are mild.
Zhang
Yang
Y
State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.
Zhang
Li
L
Xu
Fei
F
Wang
Zhi-Qiang
ZQ
Zhao
Hong-Yun
HY
Guan
Zhong-Zhen
ZZ
Xu
Guang-Chuan
GC
Pan
Zhen-Kui
ZK
D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D055815:Young Adult
D000970:Antineoplastic Agents; D011799:Quinazolines; D000410:Alanine Transaminase; D066246:ErbB Receptors; D000077156:Gefitinib