[Efficacy of gefitinib on Chinese patients with locally advanced or metastatic non-small cell lung cancer: a clinical trial].
OBJECTIVE
Gefitinib, a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, has been approved to be used in treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in many countries. This study, a multicenter clinical trial, was designed to evaluate the efficacy of gefitinib on Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy, and explore its safety.


METHODS
A total of 159 pathologically-confirmed NSCLC patients were enrolled. Gefitinib was orally administered 250 mg once daily until disease progression or the occurrence of intolerable toxicity.


RESULTS
The objective response rate was 27.0%; the disease control rate was 54.1%. The median progression-free survival time was 97 days; the median overall survival time was 10.0 months; the 1-year survival rate was 44%. The most common drug-related adverse events were rash (44.0%), pruritus (15.7%), and diarrhea (10.1%), and most of them were grade 1-2 events with no need of further treatment.


CONCLUSIONS
Gefitinib is effective and safe in treating Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy.
Guan
Zhong-Zhen
ZZ
Skate Key Laboratory of Oncology in Southern China, Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, P. R. China. zzguan@21cn.com
Zhang
Li
L
Li
Long-Yun
LY
Jiang
Guo-Liang
GL
Liu
Xu-Yi
XY
Chu
Da-Tong
DT
Zhao
Hong-Yun
HY
Li
Wei
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011537:Pruritus / Q000139:chemically induced; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate
D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib