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.
- Author:
Jae Jin LEE
1
;
Si Young KIM
;
Imsik SHIN
;
Kyung Sam CHO
;
Hoong Zae JOO
;
Choong YOON
;
Yoon Wha KIM
;
Hwi Joong YOON
Author Information
1. Department of Internal Medicine, Cancer Research Institute, Kyung Hee University College of Medicine, Seoul, Korea. sykim55@chol.com
- Publication Type:Original Article ; Randomized Controlled Trial
- Keywords:
Adjuvant chemotherapy;
5-Fluorouracil;
Stomach neoplasm;
Cisplatin;
Epirubicin;
Leucovorin;
Phase III trial
- MeSH:
Anemia;
Anorexia;
Chemotherapy, Adjuvant*;
Cisplatin*;
Diarrhea;
Disease-Free Survival;
Epirubicin*;
Fluorouracil*;
Follow-Up Studies;
Gastrectomy;
Humans;
Leucovorin*;
Nausea;
Prospective Studies;
Stomach Neoplasms*;
Survival Rate
- From:Cancer Research and Treatment
2004;36(2):140-145
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastirc 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: 10~77 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.
