5-氟尿嘧啶、亚叶酸钙和顺铂治疗晚期胰腺癌的随机试验。

Randomized trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer.

作者信息

Huguier M, Barrier A, Valinas R, Flahault A, Adloff M, Pezet D, Jaeck D, Millat B

机构信息

Department of Surgery, Hôpital Tenon, 4 rue de la Chine 75020, Paris, France.

出版信息

Hepatogastroenterology. 2001 May-Jun;48(39):875-8.

PMID:11462946

Abstract

BACKGROUND/AIMS: Phase II trials of combined 5 fluorouracil, leucovorin and cisplatin have demonstrated an 18-28% response rate in advanced pancreatic carcinomas. We investigated the effect of this chemotherapy regime on patients' survival.

METHODOLOGY

Patients included gave informed consent. They had an advanced and proven pancreatic adenocarcinoma. The trial was multicentric, prospective and randomized. It compared a 5-day course of leucovorin (200 mg/m2/day), 5-fluorouracil (375 mg/m2/day) and cisplatin (15 mg/m2/day) repeated every 21 days (23 patients) with a control group (22 patients). The main end points were survival time (Kaplan-Meier and log-rank methods) a[not readable: see text]side effects of chemotherapy.

RESULTS

Association of leucovorin, 5-fluorouracil and cisplatin failed to demonstrate any advantage of this regimen compared with supported care alone. Median survival times were 8.6 months (SD +/- 1.8) and 7.0 months (SD +/- 0.6), respectively. The modulation of 5-fluorouracil by leucovorin and cisplatin was well tolerated with moderate toxic effects.

CONCLUSIONS

This multicentric trial failed to demonstrate any advantage of the evaluated chemotherapy regime in the palliative treatment of cancer of the exocrine pancreas. Other trials including gemcitabine and/or radiotherapy are needed in advanced pancreatic adenocarcinoma.

摘要

背景/目的：5-氟尿嘧啶、亚叶酸钙和顺铂联合的II期试验已证明晚期胰腺癌的缓解率为18%-28%。我们研究了这种化疗方案对患者生存的影响。

方法

纳入的患者均签署了知情同意书。他们患有晚期且经证实的胰腺腺癌。该试验为多中心、前瞻性和随机试验。它比较了每21天重复一次的为期5天的亚叶酸钙（200mg/m²/天）、5-氟尿嘧啶（375mg/m²/天）和顺铂（15mg/m²/天）疗程（23例患者）与对照组（22例患者）。主要终点是生存时间（Kaplan-Meier法和对数秩检验法）以及化疗的副作用。