Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer
| Autor: | Jacques Michel, Angelo Di Leo, Christian Focan, Fernand Ries, S. Beauvois, Stella Dolci, J.M. Nogaret, Philippe Gobert, Martine Piccart, S. Bartholomeus, Alain Tagnon, Marc Beauduin, Françoise Liebens, Jean P. Dufrane, Claude Finet, A. Vindevoghel, Marianne Paesmans, Marie Thérèse Closon-Dejardin, Joseph Kerger, Jean P. Lobelle |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Cyclophosphamide medicine.medical_treatment Breast Neoplasms Gastroenterology Disease-Free Survival Statistics Nonparametric chemistry.chemical_compound Breast cancer Belgium Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Adjuvant therapy Humans Aged Epirubicin Proportional Hazards Models Chemotherapy Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Prognosis Nitrogen mustard Surgery Survival Rate Regimen Methotrexate Oncology chemistry Fluorouracil Chemotherapy Adjuvant Female business medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 19(12) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE: To compare a full-dose epirubicin-cyclophosphamide (HEC) regimen with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) therapy and with a moderate-dose epirubicin-cyclophosphamide regimen (EC) in the adjuvant therapy of node-positive breast cancer. PATIENTS AND METHODS: Node-positive breast cancer patients who were aged 70 years or younger were randomly allocated to one of the following treatments: CMF for six cycles (oral cyclophosphamide); EC for eight cycles (epirubicin 60 mg/m2, cyclophosphamide 500 mg/m2; day 1 every 3 weeks); and HEC for eight cycles (epirubicin 100 mg/m2, cyclophosphamide 830 mg/m2; day 1 every 3 weeks). RESULTS: Two hundred fifty-five, 267, and 255 eligible patients were treated with CMF, EC, and HEC, respectively. Patient characteristics were well balanced among the three arms. One and three cases of congestive heart failure were reported in the EC and HEC arms, respectively. Three cases of acute myeloid leukemia were reported in the HEC arm. After 4 years of median follow-up, no statistically significant differences were observed between HEC and CMF (event-free survival [EFS]: hazards ratio [HR] = 0.96, 95% confidence interval [CI], 0.70 to 1.31, P = .80; distant-EFS: HR = 0.97, 95% CI, 0.70 to 1.34, P = .87; overall survival [OS]: HR = 0.97, 95% CI, 0.65 to 1.44, P = .87). HEC is more effective than EC (EFS: HR = 0.73, 95% CI, 0.54 to 0.99, P = .04; distant-EFS: HR = 0.75, 95% CI, 0.55 to 1.02, P = .06; OS HR = 0.69, 95% CI, 0.47 to 1.00, P = .05). CONCLUSION: This three-arm study does not show an advantage in favor of an adequately dosed epirubicin-based regimen over classical CMF in the adjuvant therapy of node-positive pre- and postmenopausal women with breast cancer. Moreover, this study confirms that there is a dose-response curve for epirubicin in breast cancer adjuvant therapy. |
| Databáze: | OpenAIRE |
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