Erlotinib monotherapy for stage IIIB/IV non-small cell lung cancer: A multicenter trial by the Korean Cancer Study Group

Ji Eun Uhm, Byeong Bae Park, Myung Ju Ahn, Jeeyun Lee, Jin Seok Ahn, Sang We Kim, Heung Tae Kim, Jong Seog Lee, Jin Hyung Kang, Jae Yong Cho, Hong Suk Song, Se Hoon Park, Chang Hak Sohn, Sang Won Shin, Jin Hyuck Choi, Keunchil Park

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

BACKGROUND: Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer (NSCLC). In particular, higher response rates have been reported in Asian patients than in Western patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea. PATIENTS AND METHODS: Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status. Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity. RESULTS: A total of 120 patients were enrolled between January 2005 and May 2006. Forty-four patients (36.7%) were female and 72 patients were current or former smoker. Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2% had two or more prior palliative regimens. The overall tumor response rate was 24.2% (95% confidence interval [CI], 16.8-32.8%) with 4 complete responses and 25 partial responses, and the disease control rate was 56.7%. The favorable clinical variables for tumor response were female (P = 0.001), never smokers (P = 0.041), and adenocarcinoma (P = 0.001). The most common adverse event was skin rash (78% of which grade 3 or 4 skin rash occurred in 13.3% of the patients). With a median follow-up of 23.6 months, the median time to progression was 2.7 months (95% CI, 2.2-3.2), and the median overall survival was 12.9 months (95% CI, 6.9-18.8). By multivariate analysis, female and development of skin rash were significantly associated with longer time to progression and overall survival. CONCLUSION: Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology.

Original languageEnglish
Pages (from-to)1136-1143
Number of pages8
JournalJournal of Thoracic Oncology
Volume4
Issue number9
DOIs
Publication statusPublished - 2009 Jan 1

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Non-Small Cell Lung Carcinoma
Multicenter Studies
Neoplasms
Exanthema
Confidence Intervals
Korea
Palliative Care
Epidermal Growth Factor Receptor
Erlotinib Hydrochloride
Adenocarcinoma
Drug Therapy
Survival
Protein-Tyrosine Kinases
Disease Progression
Histology
Multivariate Analysis

Keywords

  • Erlotinib
  • Korean
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Erlotinib monotherapy for stage IIIB/IV non-small cell lung cancer : A multicenter trial by the Korean Cancer Study Group. / Uhm, Ji Eun; Park, Byeong Bae; Ahn, Myung Ju; Lee, Jeeyun; Ahn, Jin Seok; Kim, Sang We; Kim, Heung Tae; Lee, Jong Seog; Kang, Jin Hyung; Cho, Jae Yong; Song, Hong Suk; Park, Se Hoon; Sohn, Chang Hak; Shin, Sang Won; Choi, Jin Hyuck; Park, Keunchil.

In: Journal of Thoracic Oncology, Vol. 4, No. 9, 01.01.2009, p. 1136-1143.

Research output: Contribution to journalArticle

Uhm, JE, Park, BB, Ahn, MJ, Lee, J, Ahn, JS, Kim, SW, Kim, HT, Lee, JS, Kang, JH, Cho, JY, Song, HS, Park, SH, Sohn, CH, Shin, SW, Choi, JH & Park, K 2009, 'Erlotinib monotherapy for stage IIIB/IV non-small cell lung cancer: A multicenter trial by the Korean Cancer Study Group', Journal of Thoracic Oncology, vol. 4, no. 9, pp. 1136-1143. https://doi.org/10.1097/JTO.0b013e3181b270a7
Uhm, Ji Eun ; Park, Byeong Bae ; Ahn, Myung Ju ; Lee, Jeeyun ; Ahn, Jin Seok ; Kim, Sang We ; Kim, Heung Tae ; Lee, Jong Seog ; Kang, Jin Hyung ; Cho, Jae Yong ; Song, Hong Suk ; Park, Se Hoon ; Sohn, Chang Hak ; Shin, Sang Won ; Choi, Jin Hyuck ; Park, Keunchil. / Erlotinib monotherapy for stage IIIB/IV non-small cell lung cancer : A multicenter trial by the Korean Cancer Study Group. In: Journal of Thoracic Oncology. 2009 ; Vol. 4, No. 9. pp. 1136-1143.
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abstract = "BACKGROUND: Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer (NSCLC). In particular, higher response rates have been reported in Asian patients than in Western patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea. PATIENTS AND METHODS: Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status. Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity. RESULTS: A total of 120 patients were enrolled between January 2005 and May 2006. Forty-four patients (36.7{\%}) were female and 72 patients were current or former smoker. Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2{\%} had two or more prior palliative regimens. The overall tumor response rate was 24.2{\%} (95{\%} confidence interval [CI], 16.8-32.8{\%}) with 4 complete responses and 25 partial responses, and the disease control rate was 56.7{\%}. The favorable clinical variables for tumor response were female (P = 0.001), never smokers (P = 0.041), and adenocarcinoma (P = 0.001). The most common adverse event was skin rash (78{\%} of which grade 3 or 4 skin rash occurred in 13.3{\%} of the patients). With a median follow-up of 23.6 months, the median time to progression was 2.7 months (95{\%} CI, 2.2-3.2), and the median overall survival was 12.9 months (95{\%} CI, 6.9-18.8). By multivariate analysis, female and development of skin rash were significantly associated with longer time to progression and overall survival. CONCLUSION: Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology.",
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T1 - Erlotinib monotherapy for stage IIIB/IV non-small cell lung cancer

T2 - A multicenter trial by the Korean Cancer Study Group

AU - Uhm, Ji Eun

AU - Park, Byeong Bae

AU - Ahn, Myung Ju

AU - Lee, Jeeyun

AU - Ahn, Jin Seok

AU - Kim, Sang We

AU - Kim, Heung Tae

AU - Lee, Jong Seog

AU - Kang, Jin Hyung

AU - Cho, Jae Yong

AU - Song, Hong Suk

AU - Park, Se Hoon

AU - Sohn, Chang Hak

AU - Shin, Sang Won

AU - Choi, Jin Hyuck

AU - Park, Keunchil

PY - 2009/1/1

Y1 - 2009/1/1

N2 - BACKGROUND: Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer (NSCLC). In particular, higher response rates have been reported in Asian patients than in Western patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea. PATIENTS AND METHODS: Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status. Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity. RESULTS: A total of 120 patients were enrolled between January 2005 and May 2006. Forty-four patients (36.7%) were female and 72 patients were current or former smoker. Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2% had two or more prior palliative regimens. The overall tumor response rate was 24.2% (95% confidence interval [CI], 16.8-32.8%) with 4 complete responses and 25 partial responses, and the disease control rate was 56.7%. The favorable clinical variables for tumor response were female (P = 0.001), never smokers (P = 0.041), and adenocarcinoma (P = 0.001). The most common adverse event was skin rash (78% of which grade 3 or 4 skin rash occurred in 13.3% of the patients). With a median follow-up of 23.6 months, the median time to progression was 2.7 months (95% CI, 2.2-3.2), and the median overall survival was 12.9 months (95% CI, 6.9-18.8). By multivariate analysis, female and development of skin rash were significantly associated with longer time to progression and overall survival. CONCLUSION: Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology.

AB - BACKGROUND: Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer (NSCLC). In particular, higher response rates have been reported in Asian patients than in Western patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea. PATIENTS AND METHODS: Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status. Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity. RESULTS: A total of 120 patients were enrolled between January 2005 and May 2006. Forty-four patients (36.7%) were female and 72 patients were current or former smoker. Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2% had two or more prior palliative regimens. The overall tumor response rate was 24.2% (95% confidence interval [CI], 16.8-32.8%) with 4 complete responses and 25 partial responses, and the disease control rate was 56.7%. The favorable clinical variables for tumor response were female (P = 0.001), never smokers (P = 0.041), and adenocarcinoma (P = 0.001). The most common adverse event was skin rash (78% of which grade 3 or 4 skin rash occurred in 13.3% of the patients). With a median follow-up of 23.6 months, the median time to progression was 2.7 months (95% CI, 2.2-3.2), and the median overall survival was 12.9 months (95% CI, 6.9-18.8). By multivariate analysis, female and development of skin rash were significantly associated with longer time to progression and overall survival. CONCLUSION: Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology.

KW - Erlotinib

KW - Korean

KW - Non-small cell lung cancer

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