Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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The Efficacy of ZD1839 ($Iressa^{TM}$) in Patients with Advanced Non-small Cell Lung Cancer which has Progressed After Previous Chemotherapy

표준 항암화학요법에 실패한 진행성 비소세포폐암에서 ZD1839 ($Iressa^{TM}$)의 효과

  • Lee, Seung Whan (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Kim, Duck Ryung (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Lee, Sang Dae (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Lee, Jong Sin (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Park, Yeon Hee (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Ryoo, Baek-Yeol (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Kim, Heung Tae (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Park, Sunhoo (Department of pathology, Korea Cancer Center Hospital) ;
  • Kim, Bong Seog (Department of Internal Medicine, Seoul Veterans Hospital) ;
  • Kim, Cheol Hyeon (Department of Internal Medicine, Korea Cancer Center Hospital) ;
  • Lee, Jae Cheol (Department of Internal Medicine, Korea Cancer Center Hospital)
  • Received : 2004.03.26
  • Accepted : 2004.07.01
  • Published : 2004.08.30
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Abstract

Background : The role of second-line chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC) is known to be limited. Recently, ZD1839, the small molecule epidermal growth factor receptor-tyrosine kinase inhibitor, has been developed and has shown anti-tumor activity in patients with solid malignant tumors including lung cancer. We evaluated the response rate and toxicities of ZD1839 in patients with advanced NSCLC which has progressed after previous chemotherapy. Patients and Methods : We examined 83 patients with advanced NSCLC treated with ZD1839 for more than 1 month in Korea Cancer Center Hospital during the period from January 2002 to September 2003. All the patients were enrolled in the international expanded access program (EAP) with ZD1839 by AstraZeneca. The administered dose of ZD1839 was 250 mg once daily. Chest radiography and laboratory tests were followed-up. We evaluated the response rate, median survival, and toxicity after treatment. Results : Median age of the patients was 59 years (range 33-76). The most predominant cell type was adenocarcinoma and the most stage of the patients was IV. ECOG performance status was as follows; grade 0-1 in 10, grade 2 in 42, and grade 3 in 31 patients. Partial response was achieved in 12 patients (14.5%). Median overall survival was 9.2 (range 1.3-21.6+) months and median time to progression was 3.1 (range 1-21.2+) months. The most common adverse effect of ZD1839 was skin eruption which developed in 25 patients (25.8%). Significantly higher response rate and survival was found in patients with adenocarcinoma or good performance status. Conclusion : ZD1839 showed modest activity and tolerable toxicity in the treatment for patients with NSCLC which has progressed after previous chemotherapy.

배 경 : 비소세포폐암에서 2차 항암화학요법에 대한 치료반응과 역할은 아직 정립되어 있지 못한 실정이다. 한편, 최근 개발된 ZD1839는 상피세포성장인자 수용체 억제제로서 악성 고형 종양, 특히 비소세포폐암에서 항종양효과를 보이는 것으로 알려져 있다. 저자들은 기존의 표준 항암화학요법에 실패한 진행성 비소세포폐암 환자들을 대상으로 ZD1839를 투여하여 그 반응 및 안전성을 평가하고자 하였다. 대상 및 방법 : 원자력병원에서 비소세포폐암으로 조직학적 진단을 받고 임상 병기 IIIB 이상인 환자들 중에서 1차 이상의 항암화학요법을 시행 받은 후 치료실패로 판정된 환자들을 대상으로 2002년 1월부터 2003년 9월까지 ZD1839를 투여 하였다. 투여 용량은 하루 250 mg이었고, 반응 및 부작용을 평가하기 위해 1개월 간격으로 흉부 방사선 검사 및 외래 추적 검사를 실시하였다. 이 환자들 중 반응 및 독성의 평가가 가능하였던, 1개월 이상 투여 받은 83명의 환자들을 대상으로 하였다. 환자들의 중앙 연령은 59(33-76)세였고, 임상 병기는 IIIB가 12명, IV가 71명이었으며, ECOG 전신수행상태는 0-1이 10명, 2는 42명, 3은 31명이었다. ZD1839 투여일수는 중앙값이 90일이었다. 결 과 : ZD1839 투여 후 부분 반응은 12명(14.5%), 불변은 31명(37.3%), 진행은 40명(48.2%)이었고, 전체 생존기간과 병의 진행까지 기간의 중앙값은 각각 9.2 개월과 3.1 개월이었다. ZD1839의 부작용으로는 피부 발진을 보인 환자가 25명(25.8%)으로 가장 많았으며, 구토 및 설사를 보인 환자가 15(15.5%), 비정상적 간효소수치 상승 및 혈소판 감소를 보인 환자가 각각 1명(1.03%)이었다. Performance status 0, 1인 전신 상태와 선암종을 가진 환자군에서 반응률 및 생존률이 통계적으로 유의한 증가를 보였다. 결 론 : 기존의 항암화학요법에 실패한 일부 진행성 비소세포폐암 환자들에서 ZD1839 투여는 비교적 높은 반응률을 보였으며 부작용은 비교적 경미하였다. 향후 보다 대규모의 연구 결과에 대한 추시가 필요할 것으로 생각된다.

Keywords

References

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