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

Reury Perng Perng, Chih Hsin Yang, Yuh Min Chen, Gee Chen Chang, Meng Chih Lin, Ruey Kuen Hsieh, Nei Min Chu, Ruay Sheng Lai, Wu Chou Su, Chao Jung Tsao, Te Chun Hsia, Hao Cheng Chen, Chih Hung Chen, Ming Shyan Huang, Jui Long Wang, Ming Lin Ho, Chih Yuan Chung, Chong Jen Yu, Wen Cheng Chang, Han Pin KuoChih Teng Yu, Zhong Zhe Lin, Woei Yau Kao

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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, 150 mg/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.

Original languageEnglish
Pages (from-to)78-84
Number of pages7
JournalLung Cancer
Volume62
Issue number1
DOIs
Publication statusPublished - Oct 1 2008
Externally publishedYes

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Non-Small Cell Lung Carcinoma
Drug Therapy
Exanthema
Taiwan
Disease Progression
Radiotherapy
Erlotinib Hydrochloride
Survival
Proportional Hazards Models
Epidermal Growth Factor Receptor
Protein-Tyrosine Kinases
Disease-Free Survival
Squamous Cell Carcinoma
Adenocarcinoma
Prospective Studies

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy. / Perng, Reury Perng; Yang, Chih Hsin; Chen, Yuh Min; Chang, Gee Chen; Lin, Meng Chih; Hsieh, Ruey Kuen; Chu, Nei Min; Lai, Ruay Sheng; Su, Wu Chou; Tsao, Chao Jung; Hsia, Te Chun; Chen, Hao Cheng; Chen, Chih Hung; Huang, Ming Shyan; Wang, Jui Long; Ho, Ming Lin; Chung, Chih Yuan; Yu, Chong Jen; Chang, Wen Cheng; Kuo, Han Pin; Yu, Chih Teng; Lin, Zhong Zhe; Kao, Woei Yau.

In: Lung Cancer, Vol. 62, No. 1, 01.10.2008, p. 78-84.

Research output: Contribution to journalArticle

Perng, RP, Yang, CH, Chen, YM, Chang, GC, Lin, MC, Hsieh, RK, Chu, NM, Lai, RS, Su, WC, Tsao, CJ, Hsia, TC, Chen, HC, Chen, CH, Huang, MS, Wang, JL, Ho, ML, Chung, CY, Yu, CJ, Chang, WC, Kuo, HP, Yu, CT, Lin, ZZ & Kao, WY 2008, 'High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy', Lung Cancer, vol. 62, no. 1, pp. 78-84. https://doi.org/10.1016/j.lungcan.2008.02.023
Perng, Reury Perng ; Yang, Chih Hsin ; Chen, Yuh Min ; Chang, Gee Chen ; Lin, Meng Chih ; Hsieh, Ruey Kuen ; Chu, Nei Min ; Lai, Ruay Sheng ; Su, Wu Chou ; Tsao, Chao Jung ; Hsia, Te Chun ; Chen, Hao Cheng ; Chen, Chih Hung ; Huang, Ming Shyan ; Wang, Jui Long ; Ho, Ming Lin ; Chung, Chih Yuan ; Yu, Chong Jen ; Chang, Wen Cheng ; Kuo, Han Pin ; Yu, Chih Teng ; Lin, Zhong Zhe ; Kao, Woei Yau. / High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy. In: Lung Cancer. 2008 ; Vol. 62, No. 1. pp. 78-84.
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T1 - High efficacy of erlotinib in Taiwanese NSCLC patients in an expanded access program study previously treated with chemotherapy

AU - Perng, Reury Perng

AU - Yang, Chih Hsin

AU - Chen, Yuh Min

AU - Chang, Gee Chen

AU - Lin, Meng Chih

AU - Hsieh, Ruey Kuen

AU - Chu, Nei Min

AU - Lai, Ruay Sheng

AU - Su, Wu Chou

AU - Tsao, Chao Jung

AU - Hsia, Te Chun

AU - Chen, Hao Cheng

AU - Chen, Chih Hung

AU - Huang, Ming Shyan

AU - Wang, Jui Long

AU - Ho, Ming Lin

AU - Chung, Chih Yuan

AU - Yu, Chong Jen

AU - Chang, Wen Cheng

AU - Kuo, Han Pin

AU - Yu, Chih Teng

AU - Lin, Zhong Zhe

AU - Kao, Woei Yau

PY - 2008/10/1

Y1 - 2008/10/1

N2 - 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, 150 mg/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.

AB - 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, 150 mg/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.

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KW - Carcinoma

KW - Caucasian

KW - Chemotherapy

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KW - Non-small-cell lung

KW - Tyrosine kinase inhibitor (TKI)

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