Cancer Res Treat.  2004 Apr;36(2):140-145.

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

• Lee JJ
• Kim SY
• Shin I
• Cho KS
• Joo HZ
• Yoon C
• Kim YW
• Yoon HJ

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.

Keyword

Adjuvant chemotherapy; 5-Fluorouracil; Stomach neoplasm; Cisplatin; Epirubicin; Leucovorin; Phase III trial

MeSH Terms

Anemia
Anorexia
Chemotherapy, Adjuvant*
Cisplatin*
Diarrhea
Disease-Free Survival
Epirubicin*
Fluorouracil*
Follow-Up Studies
Gastrectomy
Humans
Leucovorin*
Nausea
Prospective Studies
Stomach Neoplasms*
Survival Rate
Cisplatin
Epirubicin
Fluorouracil
Leucovorin

Figure

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  Fig. 1 The therapeutic plans in two groups by randomization.

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  Fig. 2 Overall survival of all patients.

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  Fig. 3 Overall survival according to PELF and 5-FU group.

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  Fig. 4 Disease-free survival according to PELF and 5-FU group.

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