Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer.
dc.contributor.author | Ross, P J | |
dc.contributor.author | Nicolson, Marianne | |
dc.contributor.author | Cunningham, David | |
dc.contributor.author | Valle, Juan W | |
dc.contributor.author | Seymour, M T | |
dc.contributor.author | Harper, P | |
dc.contributor.author | Price, T | |
dc.contributor.author | Anderson, Heather | |
dc.contributor.author | Iveson, T | |
dc.contributor.author | Hickish, T | |
dc.contributor.author | Lofts, Fiona J | |
dc.contributor.author | Norman, A | |
dc.date.accessioned | 2009-09-07T15:24:59Z | |
dc.date.available | 2009-09-07T15:24:59Z | |
dc.date.issued | 2002-04-15 | |
dc.identifier.citation | Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. 2002, 20 (8):1996-2004 J. Clin. Oncol. | en |
dc.identifier.issn | 0732-183X | |
dc.identifier.pmid | 11956258 | |
dc.identifier.doi | 10.1200/JCO.2002.08.105 | |
dc.identifier.uri | http://hdl.handle.net/10541/80153 | |
dc.description.abstract | PURPOSE: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) (ECF) with the combination of mitomycin, cisplatin, and PVI 5-FU (MCF) in previously untreated patients with advanced esophagogastric cancer. PATIENTS AND METHODS: Five hundred eighty patients with adenocarcinoma, squamous carcinoma, or undifferentiated carcinoma were randomized to receive either ECF (epirubicin 50 mg/m(2) every 3 weeks, cisplatin 60 mg/m(2) every 3 weeks and PVI 5-FU 200 mg/m(2)/d) or MCF (mitomycin 7 mg/m(2) every 6 weeks, cisplatin 60 mg/m(2) every 3 weeks, and PVI 5-FU 300 mg/m(2)/d) and analyzed for survival, response, toxicity, and quality of life (QOL). RESULTS: The overall response rate was 42.4% (95% confidence interval [CI], 37% to 48%) with ECF and 44.1% (95% CI, 38% to 50%) with MCF (P =.692). Toxicity was tolerable, and there were only two toxic deaths. ECF resulted in more grade 3/4 neutropenia and grade 2 alopecia, but MCF caused more thrombocytopenia and plantar-palmar erythema. Median survival was 9.4 months with ECF and 8.7 months with MCF (P =.315); at 1 year, 40.2% (95% CI, 34% to 46%) of ECF and 32.7% (95% CI, 27% to 38%) of MCF patients were alive. Median failure-free survival was 7 months with both regimens. Global QOL scores were better with ECF at 3 and 6 months. CONCLUSION: This study confirms response, survival, and QOL benefits of ECF observed in a previous randomized study. The equivalent efficacy of MCF was demonstrated, but QOL was superior with ECF. ECF remains one of the reference treatments for advanced esophagogastric cancer. | |
dc.language.iso | en | en |
dc.subject | Oesophageal Cancer | en |
dc.subject | Stomach Cancer | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject.mesh | Cisplatin | |
dc.subject.mesh | Epirubicin | |
dc.subject.mesh | Esophageal Neoplasms | |
dc.subject.mesh | Female | |
dc.subject.mesh | Fluorouracil | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Male | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Mitomycins | |
dc.subject.mesh | Proportional Hazards Models | |
dc.subject.mesh | Quality of Life | |
dc.subject.mesh | Stomach Neoplasms | |
dc.subject.mesh | Survival Analysis | |
dc.title | Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. | en |
dc.type | Article | en |
dc.contributor.department | Department of Medicine and Gastrointestinal Unit, Royal Marsden Hospital, London and Sutton, Surrey, United Kingdom. | en |
dc.identifier.journal | Journal of Clinical Oncology | en |
html.description.abstract | PURPOSE: We report the results of a prospectively randomized study that compared the combination of epirubicin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) (ECF) with the combination of mitomycin, cisplatin, and PVI 5-FU (MCF) in previously untreated patients with advanced esophagogastric cancer. PATIENTS AND METHODS: Five hundred eighty patients with adenocarcinoma, squamous carcinoma, or undifferentiated carcinoma were randomized to receive either ECF (epirubicin 50 mg/m(2) every 3 weeks, cisplatin 60 mg/m(2) every 3 weeks and PVI 5-FU 200 mg/m(2)/d) or MCF (mitomycin 7 mg/m(2) every 6 weeks, cisplatin 60 mg/m(2) every 3 weeks, and PVI 5-FU 300 mg/m(2)/d) and analyzed for survival, response, toxicity, and quality of life (QOL). RESULTS: The overall response rate was 42.4% (95% confidence interval [CI], 37% to 48%) with ECF and 44.1% (95% CI, 38% to 50%) with MCF (P =.692). Toxicity was tolerable, and there were only two toxic deaths. ECF resulted in more grade 3/4 neutropenia and grade 2 alopecia, but MCF caused more thrombocytopenia and plantar-palmar erythema. Median survival was 9.4 months with ECF and 8.7 months with MCF (P =.315); at 1 year, 40.2% (95% CI, 34% to 46%) of ECF and 32.7% (95% CI, 27% to 38%) of MCF patients were alive. Median failure-free survival was 7 months with both regimens. Global QOL scores were better with ECF at 3 and 6 months. CONCLUSION: This study confirms response, survival, and QOL benefits of ECF observed in a previous randomized study. The equivalent efficacy of MCF was demonstrated, but QOL was superior with ECF. ECF remains one of the reference treatments for advanced esophagogastric cancer. |