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Author Jae Jin Lee, Si Young Kim, Im sik Shin, Kyung Sam Cho, Hoong Zae Joo, Choong Yoon, Yoon Wha Kim, Hwi Joong Yoon
Place of duty Departments of 1Internal Medicine, 2General Surgery and 3Anatomical Pathology, Cancer Research Institute, Kyung Hee University College of Medicine, Seoul, Korea.
Title 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
Publicationinfo Cancer Research and Treatment 2004 Apr; 036(02): 140-145.
Key_word Adjuvant chemotherapy,5-Fluorouracil,Stomach neoplasm,Cisplatin,Epirubicin,Leucovorin,Phase III trial
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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. (Cancer Research and Treatment 2004;36:140-145)