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
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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 Res Treat. 2004;36:140-145)
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 Res Treat. 2004;36:140-145)
참고문헌 (25)
- "Annual report on thecause of death statistics,2001" (2002), Daejeon
- "Early gastric cancer:results ingeneral hospital in Japan", 8, pp.308~314 (1984)
- "Extendedlymph node dissection for gastric cancer.", 340, pp.908~914 (1999)
- "Adjuvant therapy aftercurative resection for gastric cancer:Mea-analysis of randomizedtrials", 11, pp.1441~1447 (1993)
- "Adjuvant chemotherapy after curativeresection for gastric cancer in non-asian patients:Revisiting ameta-analysis of randomised trials", 35, pp.1059~1064 (1999)
- "A systemicoverview of chemotherapy effects in gastric cancer", 40, pp.300~326 (2001)
- "A Villar-Grimalt.A randomized trial comparing adjuvant fluorouracil,doxorubicin, and mitomycin with no treatment in operablegastric cancer", 8, pp.1362~1369 (1990)
- "Fluorouracil,doxorubicin,and mitomycin combination versusPELF chemotherapy in advanced gastric cancer:A prospectiverandomized trial of the Italian oncology group for clinicalresearch", 12, pp.2687~2693 (1994)
- "Cisplatin,epirubicin,leucovorin and 5-fluorouracil combination chemotherapyfor advanced gastric cancer:Interim report", 30, pp.907~913 (1998)
- "Adjuvant chemotherapyafter gastric resection in node-positive cancer patients:a multicenter randomised study", 73, pp.549~552 (1996)
- "High-dose folinicacid,5-fluorouracil bolus and continuous infusion in poor- prognosispatients with advanced measurable gastric cancer", 2, pp.231~233 (1991)
- "Adjuvantchemotherapy for resectable gastric cancer:a preliminary report", 57, pp.40~45 (1994)
- "Clinical analysis of patients withgastrectomized stage IV stomach cancer", 31, pp.1120~1128 (1999)
- "A review of chemotherapy in gastriccancer", 34, pp.1576~1586 (1974)
- "Randomized comparisonbetween chemotherapy plus best supportive care withbest supportive care in advancced gastric cancer", 8, pp.163~167 (1997)
- "Randomized clinical trialof adjuvant mitomycin plus tegafur in patients with resectedstage III gastric cancer", 17, pp.3810~3815 (1999)
- "Positive results of adjuvantMMC in resected gastric cancer:a randomized trial on 134patients", 29, pp.340~342 (1993)
- "Adjuvant chemotherapywith FAM versus surgery alone for patients withlocally advanced gastric adenocarcinoma:a Southwest OncologyGroup study", 2, pp.488~494 (1995)
- "Rseults of surgery for gastric cancerand effect of adjuvant mitomycin C on cancer recurrence", 2, pp.213~221 (1977)
- "Extended (D2) lymphadenectomy in gastric cancer: a five year experience", 85, pp.209~215 (2000)
- "Survival benefit of D2 lympadenectomy inpatients with gastric adenocarcinoma", 7, pp.210~217 (2000)
- "Phase II study of a combinationof irinotecan and cisplatin against metastatic gastric cancer", 17, pp.319~323 (1999)
- "Phase II trial of thecombination of paclitaxel and 5-fluorouracil in the treatmentof advanced gastric cancer:a novel,safe,and effective regimen", 22, pp.580~586 (1999)
- "A phase II trial of capecitabine and cisplatinin previous untreated advanced gastric cancer", 20, pp.142~ (2001)
- "Weekly docetaxel andcontinuous infusion 5-fluorouracil in elderly patients with cancerof stomach and distal esophagus", 20, pp.162~ (2001)