High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy.
OBJECTIVE
Erlotinib is the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) which has demonstrated a survival benefit in non-small-cell lung cancer (NSCLC) patients. An open label phase II study was conducted in Taiwanese patients with NSCLC to evaluate its efficacy.


METHODS
Patients with proven stage IIIB/IV NSCLC who had received at least one line of standard chemotherapy or radiotherapy were enrolled into this study. All patients were given oral erlotinib, 150mg/day till disease progression.


RESULTS
From May 2005 to July 2006, 300 patients were entered from 14 hospitals in Taiwan. This analysis was based on 299 patients who received at least one dose of erlotinib. The best response rates were a 29% partial response and 44% stable disease in 273 patients who had response data available. Non-smoking (p=0.033), adenocarcinoma/BAC (p=0.0027), female (p=0.0013), aged less than 65 years (p=0.0115), stage IV (p=0.0492), patients with skin rash (p=0.0216), and a higher grade of skin rash (p=0.003) were significantly correlated with response to treatment. Skin rash was a common adverse event (any grade: 84%, Gr 3-4: 16%). The median time to disease progression was 5.6 months. Cox regression model for progression free survival showed patients most at risk of early progression were males of low performance status having squamous cell carcinoma.


CONCLUSIONS
This was the largest multicenter prospective clinical study of NSCLC in Taiwan. The results demonstrated the excellent response rates, time-to-progression and overall survival of erlotinib in a large population of Taiwanese NSCLC patients who had been previously treated with chemotherapy or radiotherapy.
Perng
Reury-Perng
RP
Chest Department, Taipei Veterans General Hospital, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Yang
Chih-Hsin
CH
Chen
Yuh-Min
YM
Chang
Gee-Chen
GC
Lin
Meng-Chih
MC
Hsieh
Ruey-Kuen
RK
Chu
Nei-Min
NM
Lai
Ruay-Sheng
RS
Su
Wu-Chou
WC
Tsao
Chao-Jung
CJ
Hsia
Te-Chun
TC
Chen
Hao-Cheng
HC
Chen
Chih-Hung
CH
Huang
Ming-Shyan
MS
Wang
Jui-Long
JL
Ho
Ming-Lin
ML
Chung
Chih-Yuan
CY
Yu
Chong-Jen
CJ
Chang
Wen-Cheng
WC
Kuo
Han-Pin
HP
Yu
Chih-Teng
CT
Lin
Zhong-Zhe
ZZ
Kao
Woei-Yau
WY
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011799:Quinazolines / Q000627:therapeutic use*; D016879:Salvage Therapy; D012737:Sex Factors; D012907:Smoking; D013624:Taiwan
D000970:Antineoplastic Agents; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride