RESUMEN
PURPOSE: To determine whether a combination chemotherapy regimen that contains epirubicin (fluorouracil, epirubicin, and cyclophosphamide [FEC]) is superior to the standard cyclophosphamide, methotrexate, and fluorouracil (CMF) combination in premenopausal women with axillary node-positive operable breast cancer. PATIENTS AND METHODS: The International Collaborative Cancer Group (ICCG) conducted a large randomized trial in which two alternative schedules were used according to participating center: CMF1 versus FEC1 and CMF2 versus FEC2. RESULTS: Seven hundred fifty-nine patients were entered onto the trial. At a median follow-up time of 4.5 years, no significant benefit for the anthracycline-containing regimen was observed in terms of relapse-free (P = .61) or overall survival (P = .13). FEC1 and CMF1 appear to be of similar efficacy, but there is a suggestion that FEC2 may be superior to CMF2, since patients who received FEC2 had improved overall (P = .02) and relapse-free survival (P = .03) rates. Nausea and vomiting and alopecia were more common in the epirubicin-containing regimen (P = .001). CONCLUSION: We conclude that the FEC2 regimen, in which epirubicin replaced the methotrexate in CMF, is the preferable adjuvant chemotherapy regimen for premenopausal patients with operable axillary node-positive breast cancer.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Adulto , Alopecia/inducido químicamente , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Axila , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/cirugía , Quimioterapia Adyuvante , Ciclofosfamida/administración & dosificación , Epirrubicina/administración & dosificación , Femenino , Fluorouracilo/administración & dosificación , Enfermedades Hematológicas/inducido químicamente , Humanos , Metástasis Linfática , Mastectomía , Metotrexato/administración & dosificación , Persona de Mediana Edad , Náusea/inducido químicamente , Premenopausia , Análisis de Regresión , Análisis de Supervivencia , Vómitos/inducido químicamenteRESUMEN
BACKGROUND: It is not yet established whether doses of epirubicin equitoxic to adriamycin are more effective in the treatment of locally advanced or metastatic gastric cancer. PATIENTS AND METHODS: Seventy patients with advanced gastric cancer were randomised to receive fluorouracil (500 mg/m2 days 1-5 every three weeks) or epirubicin (100 mg/m2 every three weeks), with doses escalating to a maximum dose of 700 mg/m2 of fluorouracil or 140 mg/m2 of epirubicin. RESULTS: No patients attained complete response. Partial response was seen in 3 patients in the epirubicin arm (8%) compared with 2 patients in the fluorouracil arm (6%). No statistically significant difference between the two treatments was seen in either response or survival. Severe side effects, particularly alopecia, and nausea and vomiting were more common in the epirubicin arm (45% and 37%, respectively) compared with the fluorouracil arm (12% and 8%, respectively). CONCLUSIONS: Our trial demonstrates that fluorouracil and epirubicin as single agents have comparable but insufficient activity in advanced gastric cancer.