진행성 비소세포폐암에 대한 2차 화학요법으로 paclitaxel과 cisplatin의 제 2상 임상연구

Phase II Study of Paclitaxel and Cisplatin as Second-line Chemotherapy in Advanced Non-small Cell Lung Cancer

gemcitabine과 carboplatin으로 치료받은 경력이 있는 진행성 비소세포폐암 환자 25명을 대상으로 2차 화학요법으로 paclitaxel과 cisplatin을 사용하여 다음과 같은 결과를 확인하였다. 전체 25명 중 5명에서 부분반응이 관찰되었으며, 반응군의 반응지속기간은 2~11개월로 중앙값 4.3개월이었다. 전체 환자의 무진행생존 기간은 0~11개월로 중앙값 3.3개월이었으며, 생존기간은 1.3~39개월로 중앙값 7.4개월이었다. 전체 83회의 화학요법 중 WHO 3도의 혈소판감소증이 1회에서만 관찰되었으며, 비혈액학적 부작용도 감내할만 하였다. 이상의 결과 paclitaxel과 cisplatin 복합화학 요법은 진행서 비소세포폐암 환자에서 2차 요법으로 사용하였을 때 부작용이 적으며 효과적인 치료법의 하나로 판단된다.

Background: To evaluate the efficacy and safety of paclitaxel and cisplatin against advanced non-small cell lung cancer (NSCLC) as a second-line chemotherapy. Subjects and Methods: Twenty-five patients were enrolled. The patients received 200 $mg/m^2$ paclitaxel as a 3-hour intravenous infusion and 60 $mg/m^2$ cisplatin as 2D-minute intravenous infusion with vigorous hydration on day 1 every 28 days. The response was assessed every 2 cycles. Results: All 25 patients were assessed for their response and toxicity. Partial responses were observed in 5 patients. The overall response rate was 20%(95% confidence interval, 4%-36%) and the median response duration was 4.5(range, 2-11) months. The median time to progression was 3.3(range, 0-14) months. The median overall survival of all patients was 7.4(range, 1.3-39) months. The hematologic toxicities were minor and easily controlled. Conclusion: The combination chemotherapy of paclitaxel and cisplatin as a second-line treatment has a moderate efficacy with an acceptable toxicity in patients with advanced NSCLC.