Phase II study of gemcitabine and vinorelbine as a combination chemotherapy for the second-line treatment of nonsmall cell lung carcinoma

Eun Joo Lee, EunSil Ha, SangHoon Park, Gyu Young Hur, KiHwan Jung, HyeCheol Jeong, Sung Yong Lee, Je Hyeong Kim, Sang Yeub Lee, Chol Sin, Jae Jeong Shim, Kwang Ho In, Kyung Ho Kang, SeHwa Yoo

Research output: Contribution to journalArticle

Abstract

Backgroud: Lung cancer is the leading cause of cancer deaths in Korea and the number of lung cancer deaths is increasing. The higher response rates, decreased toxicity and improved performance status of the first line treatments have resulted in an increased number of patients becoming candidates for second-line therapy. Several new anti-neoplastic agents, including gemcitabine, docetaxel and paclitaxel, have recently demonstrated second line activity. This phase II study evaluated the efficacy and toxicity of gemcitabine and vinorelbine as combination chemotherapy for Korean patients with NSCLC as a second-line treatment. Methods: Sixty response-evaluable patients were enrolled from December 2000 to July 2003. We conducted a phase II study of a combination gemcitabine and vinorelbine chemotherapy for patients with histologically confirmed NSCLC that was stage IIIB and IV disease at the time of diagnosis, and the disease had progressed onward or the patients had relapsed after first-line platinum-based chemotherapy. They were treated with intravenous gemcitabine 1000mg/m2 and intravenous vinorelbine 25mg/m2 on days 1 and 8. This chemotherapy regimen was repeated every 3 weeks. Results: A total of 215 cycles of treatment were given and the mean number of cycles was 3.6 cycles. All the patients were evaluable for the toxicity profile. The response rate was 10% according to the WHO criteria. The median progression free survival was 3.8 months and the median survival time was 10.1 months. The 1-year survival rate was 32.9%. Grade III and IV neutropenia were seen in 20 (33.3%) and 7 (11.7%) patients, respectively. Conclusion: The combination of gemcitabine and vinorelbine is active and well tolerated as a second-line therapy for patients with advanced nonsmall cell lung carcinoma.

Original languageEnglish
Pages (from-to)510-516
Number of pages7
JournalTuberculosis and Respiratory Diseases
Volume59
Issue number5
Publication statusPublished - 2005 Nov 1

Fingerprint

gemcitabine
Combination Drug Therapy
Carcinoma
Lung
docetaxel
Therapeutics
Drug Therapy
Lung Neoplasms
vinorelbine
Korea
Paclitaxel
Neutropenia
Platinum
Disease-Free Survival
Cause of Death

Keywords

  • Gemcitabine
  • Nonsmall cell lung cancer
  • Phase II study
  • Vinorelbine

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Phase II study of gemcitabine and vinorelbine as a combination chemotherapy for the second-line treatment of nonsmall cell lung carcinoma. / Lee, Eun Joo; Ha, EunSil; Park, SangHoon; Hur, Gyu Young; Jung, KiHwan; Jeong, HyeCheol; Lee, Sung Yong; Kim, Je Hyeong; Lee, Sang Yeub; Sin, Chol; Shim, Jae Jeong; In, Kwang Ho; Kang, Kyung Ho; Yoo, SeHwa.

In: Tuberculosis and Respiratory Diseases, Vol. 59, No. 5, 01.11.2005, p. 510-516.

Research output: Contribution to journalArticle

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title = "Phase II study of gemcitabine and vinorelbine as a combination chemotherapy for the second-line treatment of nonsmall cell lung carcinoma",
abstract = "Backgroud: Lung cancer is the leading cause of cancer deaths in Korea and the number of lung cancer deaths is increasing. The higher response rates, decreased toxicity and improved performance status of the first line treatments have resulted in an increased number of patients becoming candidates for second-line therapy. Several new anti-neoplastic agents, including gemcitabine, docetaxel and paclitaxel, have recently demonstrated second line activity. This phase II study evaluated the efficacy and toxicity of gemcitabine and vinorelbine as combination chemotherapy for Korean patients with NSCLC as a second-line treatment. Methods: Sixty response-evaluable patients were enrolled from December 2000 to July 2003. We conducted a phase II study of a combination gemcitabine and vinorelbine chemotherapy for patients with histologically confirmed NSCLC that was stage IIIB and IV disease at the time of diagnosis, and the disease had progressed onward or the patients had relapsed after first-line platinum-based chemotherapy. They were treated with intravenous gemcitabine 1000mg/m2 and intravenous vinorelbine 25mg/m2 on days 1 and 8. This chemotherapy regimen was repeated every 3 weeks. Results: A total of 215 cycles of treatment were given and the mean number of cycles was 3.6 cycles. All the patients were evaluable for the toxicity profile. The response rate was 10{\%} according to the WHO criteria. The median progression free survival was 3.8 months and the median survival time was 10.1 months. The 1-year survival rate was 32.9{\%}. Grade III and IV neutropenia were seen in 20 (33.3{\%}) and 7 (11.7{\%}) patients, respectively. Conclusion: The combination of gemcitabine and vinorelbine is active and well tolerated as a second-line therapy for patients with advanced nonsmall cell lung carcinoma.",
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T1 - Phase II study of gemcitabine and vinorelbine as a combination chemotherapy for the second-line treatment of nonsmall cell lung carcinoma

AU - Lee, Eun Joo

AU - Ha, EunSil

AU - Park, SangHoon

AU - Hur, Gyu Young

AU - Jung, KiHwan

AU - Jeong, HyeCheol

AU - Lee, Sung Yong

AU - Kim, Je Hyeong

AU - Lee, Sang Yeub

AU - Sin, Chol

AU - Shim, Jae Jeong

AU - In, Kwang Ho

AU - Kang, Kyung Ho

AU - Yoo, SeHwa

PY - 2005/11/1

Y1 - 2005/11/1

N2 - Backgroud: Lung cancer is the leading cause of cancer deaths in Korea and the number of lung cancer deaths is increasing. The higher response rates, decreased toxicity and improved performance status of the first line treatments have resulted in an increased number of patients becoming candidates for second-line therapy. Several new anti-neoplastic agents, including gemcitabine, docetaxel and paclitaxel, have recently demonstrated second line activity. This phase II study evaluated the efficacy and toxicity of gemcitabine and vinorelbine as combination chemotherapy for Korean patients with NSCLC as a second-line treatment. Methods: Sixty response-evaluable patients were enrolled from December 2000 to July 2003. We conducted a phase II study of a combination gemcitabine and vinorelbine chemotherapy for patients with histologically confirmed NSCLC that was stage IIIB and IV disease at the time of diagnosis, and the disease had progressed onward or the patients had relapsed after first-line platinum-based chemotherapy. They were treated with intravenous gemcitabine 1000mg/m2 and intravenous vinorelbine 25mg/m2 on days 1 and 8. This chemotherapy regimen was repeated every 3 weeks. Results: A total of 215 cycles of treatment were given and the mean number of cycles was 3.6 cycles. All the patients were evaluable for the toxicity profile. The response rate was 10% according to the WHO criteria. The median progression free survival was 3.8 months and the median survival time was 10.1 months. The 1-year survival rate was 32.9%. Grade III and IV neutropenia were seen in 20 (33.3%) and 7 (11.7%) patients, respectively. Conclusion: The combination of gemcitabine and vinorelbine is active and well tolerated as a second-line therapy for patients with advanced nonsmall cell lung carcinoma.

AB - Backgroud: Lung cancer is the leading cause of cancer deaths in Korea and the number of lung cancer deaths is increasing. The higher response rates, decreased toxicity and improved performance status of the first line treatments have resulted in an increased number of patients becoming candidates for second-line therapy. Several new anti-neoplastic agents, including gemcitabine, docetaxel and paclitaxel, have recently demonstrated second line activity. This phase II study evaluated the efficacy and toxicity of gemcitabine and vinorelbine as combination chemotherapy for Korean patients with NSCLC as a second-line treatment. Methods: Sixty response-evaluable patients were enrolled from December 2000 to July 2003. We conducted a phase II study of a combination gemcitabine and vinorelbine chemotherapy for patients with histologically confirmed NSCLC that was stage IIIB and IV disease at the time of diagnosis, and the disease had progressed onward or the patients had relapsed after first-line platinum-based chemotherapy. They were treated with intravenous gemcitabine 1000mg/m2 and intravenous vinorelbine 25mg/m2 on days 1 and 8. This chemotherapy regimen was repeated every 3 weeks. Results: A total of 215 cycles of treatment were given and the mean number of cycles was 3.6 cycles. All the patients were evaluable for the toxicity profile. The response rate was 10% according to the WHO criteria. The median progression free survival was 3.8 months and the median survival time was 10.1 months. The 1-year survival rate was 32.9%. Grade III and IV neutropenia were seen in 20 (33.3%) and 7 (11.7%) patients, respectively. Conclusion: The combination of gemcitabine and vinorelbine is active and well tolerated as a second-line therapy for patients with advanced nonsmall cell lung carcinoma.

KW - Gemcitabine

KW - Nonsmall cell lung cancer

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KW - Vinorelbine

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