Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Gemcitabine Plus Vinorelbine as Second-line Chemotherapy of the Patients of Previously Treated Non-small Cell lung Cancer: Phase II Trial

비소세포 폐암 환자의 이차 치료로서 Gemcitabine과 Vinorelbine 혼합 요법의 효과

  • Jang, Pil Soon (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Kang, Hyun Mo (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Lee, Jeong Eun (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Kwon, Seon Jung (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • An, Jin Young (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Lee, Yun Sun (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Jeong, Sung Soo (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Kim, Ju Ock (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute) ;
  • Kim, Sun Young (Department of Internal Medicine, Chungnam National University Hospital, Cancer Research Institute)
  • 장필순 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 강현모 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 이정은 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 권선중 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 안진영 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 이연선 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 정성수 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 김주옥 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소) ;
  • 김선영 (충남대학교 의과대학 내과학교실, 충남대학교병원 암공동연구소)
  • Received : 2005.01.17
  • Accepted : 2005.03.08
  • Published : 2005.04.30
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Abstract

Background : Both gemcitabine and vinorelbine are effective anticancer drugs with mild toxicity on non-small cell lung cancer, and monotherapy of these drugs are effective as a second-line chemotherapy. The aim of this trial was to assess the response and toxicity of a combination of gemcitabine and vinorelbine in patients of previously treated for non-small cell lung cancer. Materials and Methods : 24 patients, initial stage III A/B,IV and previously treated with platinium and taxane based regimens, were enrolled from June 2000 to March 2004. The regimens consisted of vinorelbine $25mg/m^2$ followed by an infusion of gemcitabine $1000mg/m^2$ on day 1 and day 8 every three weeks. This course was repeated more than twice. Results : Twenty-four patients were analyzed for the response, survival rate, and toxicities. The overall response was 17% with a complete remission rate of 4%. The median time-to progression (TTP) was 3.1 months (95%, CI 1-10months), and the survival time was 8.2 months (95%, CI 1-23 months). The grade 3/4 toxicities encountered were neutropenia (12.5%), anemia (0%), thrombocytopenia (0%). Non-hematological 3/4 toxicities were not observed. Conclusion : A combination of gemcitabine and vinorelbine in patients previously treated for non-small cell lung cancer provides a relatively good response rate, and a low toxicity profile. However, further study will be needed to confirm its effectiveness.

배 경 : Gemcitabine, paclitaxel, docetaxel, vinorelbine, irrinotecan 새로운 항종양제의 출현으로 일차 치료의 효과가 증대 되고 있고 재발시에도 좋은 신체 활동도를 보이고 있어서 이차 치료의 대상군도 늘어나는 효과를 보이고 있다. 치료의 필요성은 증대 되고 있지만 현재까지 표준 치료가 확립되지 않은 상황에서 Gemcitabine과 Vinorelbine 모두 독성이 강하지 않아서 혼합 요법이 가능한 장점이 있고 비소세포폐암에 대한 효과도 입증이 되어있어서 본 연구는 반응이 없거나 반응을 보인후에 재발된 진행된 비소세포 폐암에 gemcitabine과 vinorelbine 혼합 요법을 시행하여서 치료 반응률과 생존율 그리고 부작용을 평가하였다. 대상 및 방법 : 2000년 6월부터 2004년 3월까지 충남대학교병원에 내원하여 진행성 비소세포 폐암 IIIA/IIIB, IV로 진단을 받고 일차 항암화학요법치료를 받은 환자중에 초기 치료에 반응이 없거나, 치료에 반응이 있었으나 병이 진행된 환자로 추적 관찰 기간이 6개월 이상인 환자를 대상으로 생존율과 반응률 그리고 독성을 분석하였다. 결 과 : 총 치료 반응률은 17%, 반응 유지기간의 중앙값은 3.1개월(1-10개월)이었고 생존기간의 중앙값은 8.2개월(1-23개월) 그리고 1년 생존율은 35%였다. 항암화학요법에 의한 독성은 3도 이상의 중성구 감소가 12%, 오심과 구토가 12.5% 였다. 결 론 : 일차 치료에 반응이 없거나 재발한 비소세포 폐암환자의 이차 치료로 gemcitabine과 vinorelbine 혼합요법은 효과적이라고 생각되며 향후 3상 연구를 통한 다른 약제와의 비교 연구가 필요하다고 생각된다.

Keywords

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