Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Phase II Study of Gemcitabine and Vinorelbine as a Combination Chemotherapy for the Second-Line Treatment of Nonsmall Cell Lung Carcinoma

비소세포 폐암 환자의 2차 치료로서 Gemcitabine과 Vinorelbine의 병합 요법의 효과

  • Lee, EunJoo (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Ha, EunSil (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Park, SangHoon (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Hur, GyuYoung (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Jung, KiHwan (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Jeong, HyeCheol (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Lee, SungYong (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Kim, JeHyeong (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Lee, SangYeub (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Sin, Chol (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Shim, JaeJeong (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • In, KwangHo (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Kang, KyungHo (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University) ;
  • Yoo, SeHwa (Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, College of Medicine, Korea University)
  • 이은주 (고려대학교 의과대학 내과학교실) ;
  • 하은실 (고려대학교 의과대학 내과학교실) ;
  • 박상훈 (고려대학교 의과대학 내과학교실) ;
  • 허규영 (고려대학교 의과대학 내과학교실) ;
  • 정기환 (고려대학교 의과대학 내과학교실) ;
  • 정혜철 (고려대학교 의과대학 내과학교실) ;
  • 이승룡 (고려대학교 의과대학 내과학교실) ;
  • 김제형 (고려대학교 의과대학 내과학교실) ;
  • 이상엽 (고려대학교 의과대학 내과학교실) ;
  • 신철 (고려대학교 의과대학 내과학교실) ;
  • 심재정 (고려대학교 의과대학 내과학교실) ;
  • 인광호 (고려대학교 의과대학 내과학교실) ;
  • 강경호 (고려대학교 의과대학 내과학교실) ;
  • 유세화 (고려대학교 의과대학 내과학교실)
  • Received : 2005.06.16
  • Accepted : 2005.09.16
  • Published : 2005.11.30
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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 antineoplastic 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 $1000mg/m^2$ and intravenous vinorelbine $25mg/m^2$ 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.

배 경 : 새로운 항암제의 사용으로 비소세포 폐암에서 1차 항암 치료의 효과는 많이 향상 되었지만 많은 환자에서 치료 중 혹은 치료 후에 폐암이 진행하거나 재발되고 있다. 최근 환자의 체력 및 영양 상태의 향상으로 폐암의 진행 및 재발 후에도 신체 수행 상태(performance status)가 양호하여 2차 항암 치료의 대상 환자가 늘어나는 추세이다. 그러나 아직까지 표준화된 2차 항암 치료가 없는 실정으로 gemcitabine과 vinorelbine의 병합 요법은 비교적 다른 기전의 독성을 보여 병합 요법으로서의 가능성을 높여 주었다. 이에 저자들은 1차 항암 요법에 반응을 보이지 않거나 재발한 진행성 비소세포 폐암 환자를 대상으로 gemcitabine과 vinorelbine 병합 요법을 시행하여 치료 반응율, 생존율 및 독성에 대해 연구하였다. 대상 및 방법 : 2000년 12월부터 2003년 7월까지 고려대학교 의료원에 내원하여 비소세포 폐암으로 확진 받은 환자 중 진단 당시 IIIB, IV병기로 platinum을 기반으로 docetaxel 혹은 paclitaxel의 2제 복합 항암 요법을 1차 치료로 시행한 환자 중 진행하거나 재발한 환자들을 대상으로 gemcitabine과 vinorelbine 병합 요법의 치료 반응율, 생존율 및 독성을 분석하였다. 결 과 : Vinorelbine과 gemcitabine 병합 항암화학 요법은 총 215회가 시행 되었고, 환자당 시행된 평균값은 3.6회였다. 주요 반응에 해당하는 관해율은 10%였다. 1년 생존율은 32.9% 였으며, 생존 중앙값은 10.1개월이었다. 관해 지속 기간 중앙값은 3.8개월이었다. 대부분에서 경도의 오심과 구토, 탈모증이 관찰되었으며 WHO grade 3의 오심, 구토는 2예(3%)였으며, grade 4의 오심, 구토는 없었다. Grade 3 백혈구 감소가 33.3%, grade 4가 11.7%로 비교적 흔히 발생하였다. 호중구 감소가 동반된 폐렴으로 사망이 1예 보고되었다. 결 론 : Platinum을 기반으로 하는 1차 항암 치료 후 재발하거나 진행한 비소세포 폐암 환자에서 gemcitabine과 vinorelbine 병합 항암 요법은 비교적 효과적이고 안전한 항암 치료법으로 사료된다.

Keywords

References

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