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

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

The Efficacy and Safety of (Neo)Adjuvant Therapy for Gastric Cancer: A Network Meta-analysis

“…After merging, a total of 37 studies [6,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59] were included in the NMA comparing adjuvant therapy after curative resection (NMA-2), with 14 different radio/chemotherapy regimens. For OS, there were 16 direct comparisons between different regimens with in total n = 10,761 patients (Figure 3).…”

Prognostic and Predictive Factors for the Curative Treatment of Esophageal and Gastric Cancer in Randomized Controlled Trials: A Systematic Review and Meta-Analysis

“…Finally, 97 references were identified on 72 original RCTs. In total, 39 studies reported data on prognostic and/or predictive factors for gastric cancer [3,4,5,6,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53] and 33 studies on esophageal cancer [8,10,11,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,…”

“…Prognostic factors for the curative treatment of gastric cancer identified from overall survival (OS) multivariate analyses in at least one randomized control trial (RCT). In total, there were 32 RCTs contributing to Figure 2 with 27 investigating adjuvant therapy [4,5,6,19,20,21,22,23,24,25,26,27,29,30,31,32,34,35,36,37,39,40,41,42,43,45,49,52,53] and five investigating neoadjuvant therapy [3,28,33,38,51]. The Mandard score was only assessed in patients who received preoperative chemotherapy according to the MAGIC regimen [93].…”

Comparative effectiveness of adjuvant treatments for resected gastric cancer: a network meta-analysis

“…We systematically searched PubMed, EMBASE, the Cochrane Library for RCTs. A total of 3712 articles were considered to be potentially relevant and 11 studies [7][8][9][10][11][29][30][31][32][33][34] meeting the inclusion criteria were included in this meta-analysis. Literature screening process is shown in Fig.…”

“…All the 11 trials contributed to our network meta-analysis of OS, comparing the 7 treatments. HRs were explicitly reported in 9 trials and also could be estimated in 2 trials [31,34]. In Fig.…”