Phase II Study of Irinotecan Plus Cisplatin as First Line therapy in Extensive Small-Cell Lung Cancer

확장기 소세포폐암에서 1차 치료로서 Irinotecan + Cisplatin 복합요법의 임상적 결과

  • Hwang, Ki Eun (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Kim, So Young (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Jung, Jong Hoon (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Park, Seong Hoon (Department of Radiology, College of Medicine, Wonkwang University) ;
  • Park, Jung Hyun (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Kim, Hwi Jung (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Kim, Hak Ryul (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Yang, Sei Hoon (Department of Internal Medicine, College of Medicine, Wonkwang University) ;
  • Jeong, Eun Taik (Department of Internal Medicine, College of Medicine, Wonkwang University)
  • 황기은 (원광대학교 의과대학 내과학교실) ;
  • 김소영 (원광대학교 의과대학 내과학교실) ;
  • 정종훈 (원광대학교 의과대학 내과학교실) ;
  • 박성훈 (원광대학교 의과대학 진단방사선과학교실) ;
  • 박정현 (원광대학교 의과대학 내과학교실) ;
  • 김휘정 (원광대학교 의과대학 내과학교실) ;
  • 김학렬 (원광대학교 의과대학 내과학교실) ;
  • 양세훈 (원광대학교 의과대학 내과학교실) ;
  • 정은택 (원광대학교 의과대학 내과학교실)
  • Received : 2006.05.25
  • Accepted : 2006.07.12
  • Published : 2006.08.30


Background: Irinotecan (topoisomerase I inhibitor) is effective as a monotherapy against small-cell lung cancer(SCLC). Cisplatin is also an important drug against SCLC. A phase II study of irinotecan combined with cisplatin was carried out to evaluate the efficacy and toxicity of this combined regimen as a first line treatment in patients with extensive SCLC. Methods: Thirty-nine patients with previously untreated extensive SCLC were enrolled in this study. Irinotecan $60mg/m^2$ was administered intravenously on days 1, 8 and 15, and in combination with cisplatin $60mg/m^2$ on day 1 and every 28 days thereafter. Four cycles of chemotherapy were given to the patients. Results: The overall response rate was 77% with a complete response (CR) rate of 8%. The median survival time, 1- and 2-year survival rate were 14.8 months, 60.9% and 27.6%, respectively. The median progression free survival time, 6-and 12-month progression free survival rate were 8.4 months, 75% and 18.8%, respectively. The WHO grade 3 or more toxicity encountered were leukopenia (23%), diarrhea (26%). Two patients changed their chemotherapeutic regimen and one patient died from severe diarrhea. Conclusion: The combination of irinotecan and cisplatin is effective as a first line therapy in extensive SCLC is effective, but has severe or fatal diarrhea as toxicity.

연구배경: Toptisomerase I 억제제인 irinotecan 과 소세포폐암 치료의 근간인 cisplatin의 복합화학용법을 확장기 소세포폐암 환자에게 1차 치료법으로 실시하여 반응률, 생존율 및 부작용을 확인하였다. 방 법: 2002년 6월부터 2005년 2월까지 확진된 확장기 소세포폐암 환자 39명에게 irinotecan $60mg/m^2$, 제 1, 8, 15일째 cisplatin $60mg/m^2$ 제1일째에 28일 간격으로 4회 투여하였다. 결 과: 반응률은 77%(완전반응 8%), 중앙생존기간은 14.8개월, 1-및 2-년 생존율은 60.9%, 27.6%였으며, 중앙 무진행생존기간은 8.4개월, 6-및 12-개월 무진행생존율은 75.0%, 18.8%였다. WHO grade 3 이상의 부작용은 백혈구 감소증 23%, 설사 26%였으나, 심한 설사때문에 2명은 치료방법을 바꾸었고, 1명은 사망하였다. 결 론: Irinotecan과 cisplatin 복합화학요법은 확장기 소세포폐암 환자의 1차 치료법으로 유용하며, 부작용으로서 설사에 대해서는 치명적일수 있으므로 심각한 주의가 요망된다.


Supported by : 원광대학교


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