High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy

Received 8 January 2008; received in revised form 18 February 2008; accepted 24 February 2008. published online 23 April 2008.

Summary

Purpose

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.

Keywords: Carcinoma, Non-small-cell lung, Epidermal growth factor receptor (EGFR), Erlotinib, Asian, Caucasian, Chemotherapy, Tyrosine kinase inhibitor (TKI)

a Chest Department, Taipei Veterans General Hospital, School of Medicine, National Yang-Ming University, Taipei, Taiwan

b Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan

c Department of Internal Medicine, Taichung Veterans General Hospital, Taiwan

d Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaoshiung, Taiwan

e Department of Internal Medicine, Mackay Memorial Hospital, Taiwan

f Department of Internal Medicine, Koo Foundation Sun Yat-Sen Cancer Center, Taiwan

g Department of Medicine, Kaohsiung Veterans General Hospital, Taiwan

h Department of Internal Medicine, National Cheng Kung University Hospital, Taiwan

i Department of Internal Medicine, Chi-Mei Medical Center, Taiwan

j Department of Internal Medicine, China Medical University Hospital, Taiwan

k Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

l Department of Thoracic Medicine, Chang Gung Memorial Hospital, Linkou, Taiwan

m Department of Internal Medicine, Kaohsiung Medical University Hospital, Taiwan

n Department of Internal Medicine, Chunghua Christian Hospital, Taiwan

o Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

p Department of Internal Medicine, Tri-Service General Hospital, Taiwan

Corresponding author at: Chest Department, Taipei Veterans General Hospital, No. 201, Section 2, Shih-Pai Road, Taipei 112, Taiwan, R.O.C. Tel.: +886 2 28763466; fax: +886 2 28763466.

1 These authors contributed equally to the present study.

PII: S0169-5002(08)00109-8

doi:10.1016/j.lungcan.2008.02.023

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