전이성 또는 재발성 위암에 대한 저용량 paclitaxel과 cisplatin 복합 화학요법
The low dose paclitaxel as first-line chemotherapy for metastatic or recurrent gastric cancer
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2001년 5월부터 2004년 1월까지 인하대학교 의과대학 부속병원에 내원한 계측 가능병변을 가진 31명의 진행성 위암 환자를 대상으로 고식적 복합화학요법으로서 paclitaxel과 cisplatin 요법을 시행하였다. Paclitaxel의 용량을 135 mg/m2/3wk으로 기존 다른 연구들에서 했던 175～210 mg/m2/3wk의 용량보다는 비교적 적은 용량으로 치료를 시행하여 다음과 같은 결과를 얻었다.총 31명의 환자에서 부분관해 11명(35%), 불변 9명(30%), 진행 11명(35%)으로 35%(95% 신뢰구간, 18%～51%)의 반응율을 얻었다. 전체 환자에서의 생존기간의 중앙값은 8.1개월이었고, 무진행 생존기간의 중앙값은 3.3개월이었다. 총 122회의 복합화학요법을 시행하는 도중에 발생한 부작용은 Grade 3 이상의 호중구 감소증이 11.5%이었고, 이 중 호중구 감소증에 의한 발열이 있었던 환자는 1명으로 치료 기간 중 1차례 발생하였으며 Grade 3의 오심 및 구역, 구토가 4%, Grade 3의 말초 신경병증이 3.3%이었다.향후 135 mg/m2/3wk paclitaxel-cisplatin 복합화학요법의 치료 효과 및 부작용을 보다 정확히 판정하기 위해 향후 기존 175～210 mg/m2/3wk paclitaxel-cisplatin 복합화학요법과의 전향적 무작위 맹검 비교 연구가 필요할 것으로 생각된다.
Abstract
Backgraound : To assess the effect and toxicity of low-dose paclitaxel in patients with metastatic or recurrent gastric cancer with measurable lesions as first-line chemotherapy. Methods : Patients with measurable metastatic or recurrent gastric cancer were eligible in this study. Paclitaxel and cisplatin were intravenously infused for 3h, at a dose of each 135 mg/m2 and 60 mg/m2, every 3 weeks and then this regimen was repeated until intolerable toxicity or disease progression. Objective tumor responses, duration of response, time to disease progression, and toxicity profile were evaluated in this study. Results : Total 31 patients were enrolled in this study between May 2001 and January 2004. Sixteen patients had ECOG performance status (PS) 1, eleven had PS 2 and four had PS 3. A total of 122 cycles (median 3, range 1～12) were administered. Eleven (35%, 11/31) objective partial responses (PR) were observed and the remaining 19 patients showed stable (9 patients, 30%) and progressive disease (11 patients, 35%). The response rate was 35% (95% confidence interval, 18～51%). The estimated median survival was 8.1 months, median response duration was 5.3 months and median progression-free survival was 3.3 months. Severe toxicities were uncommon. There were 14 episodes (11.5%) of grade 3-4 neutropenia. Grade 3 nausea and vomiting occurred in 4%. Grade 3 peripheral neuropathy occurred in 3.3%. Conclusion : This low dose paclitaxel regimen (135 mg/m2) showed comparable results with previously published high-dose paclitaxel regimen (175～250 mg/m2) used in metastatic or recurrent gastric cancer and the toxicity was minimal.
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