随机 III 期临床试验：顺铂、表阿霉素、亚叶酸钙、5-氟尿嘧啶（PELF）联合方案对比 5-氟尿嘧啶单药作为可切除 III 期胃癌辅助化疗。

Randomized phase III trial of cisplatin, epirubicin, leucovorin, 5-fluorouracil (PELF) combination versus 5-fluorouracil alone as adjuvant chemotherapy in curative resected stage III gastric cancer.

机构信息

Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea.

出版信息

Cancer Res Treat. 2004 Apr;36(2):140-5. doi: 10.4143/crt.2004.36.2.140. Epub 2004 Apr 30.

DOI:10.4143/crt.2004.36.2.140

PMID:20396554

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2855100/

Abstract

PURPOSE

The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastric cancer, was compared with 5-fluorouracil (5-FU) administration alone. This paper reports the results of a prospective randomized comparison of the two regimens, PELF and 5-FU.

METHODS

From August 1996 to July 1999, 54 patients were selected subsequent to being diagnosed with stage III cancer after a curative resection for gastric cancer. The patients were stratified according to stage IIIA/IIIB and subtotal/total gastrectomy, and then they were randomized into each treatment group, i.e. the PELF or 5-FU alone groups.

RESULTS

54 assessable patients were enrolled in this study: 28 received PELF and 26 received 5-FU alone. 12 patients relapsed in each group and the median follow-up duration was 42 months (range: 10 approximately 77 months). The overall survival rate and disease-free survival rate (DFS) were not significantly different between two groups, (5-year survival of PELF vs. 5-FU: 57% vs. 64%, 5-year DFS: 54% vs. 51%). The PELF combination was more toxic in terms of anemia, anorexia, nausea and diarrhea than the 5-FU.

CONCLUSIONS

This study showed that the PELF combination, as an adjuvant therapy for gastric cancer after a curative resection, was a less effective treatment, and it had more toxic effects than the 5-FU.

摘要

目的

与单独使用氟尿嘧啶（5-FU）相比，顺铂、表柔比星、亚叶酸和 5-氟尿嘧啶（PELF）联合用于根治性切除术后胃癌的辅助化疗。本文报告了两种方案（PELF 和 5-FU）的前瞻性随机比较结果。

方法

从 1996 年 8 月到 1999 年 7 月，选择了 54 名经根治性胃切除术后诊断为 III 期癌症的患者。根据 IIIA/IIIB 期和胃大部/全胃切除术对患者进行分层，然后将他们随机分为每组治疗组，即 PELF 或 5-FU 单独组。

结果

这项研究纳入了 54 名可评估的患者：28 名患者接受了 PELF 治疗，26 名患者接受了 5-FU 单独治疗。每组有 12 名患者复发，中位随访时间为 42 个月（范围：10-77 个月）。两组的总生存率和无病生存率（DFS）无显著差异，（PELF 与 5-FU 的 5 年生存率：57% vs. 64%，5 年 DFS：54% vs. 51%）。与 5-FU 相比，PELF 联合方案在贫血、厌食、恶心和腹泻方面毒性更大。