A dose finding study for the combination of epidoxorubicin and vinorelbine, delivered every two weeks with G-CSF support, in advanced breast cancer.
The aim of this study was to find the maximum tolerated dose of epidoxorubicin as part of a regimen with vinorelbine at the dose of 25 mg/m2 on days 1 and 5, every 2 weeks in patients with advanced breast cancer. The optimal dose intensity of the two drugs was supported by administration of granulocyte colony stimulating factor (G-CSF) on days 7-12. Patients were treated with epidoxorubicin at three different dose levels (50-65-80 mg/m2 on day 1 of each cycle). No dose limiting toxicity was observed in the first three patients (treated at the dose of 50 mg/m2). We observed one case of dose limiting toxicity out of the 6 patients treated with 65 mg/m2 and 3/3 cases among patients treated with 80 mg/m2. We conclude that 65 mg/m2 is the maximum tolerated dose of epidoxorubicin in this regimen, which is also able to maintain adequate dose intensities.
Pronzato
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Dept. of Medical Oncology, St. Andrea Hospital, La Spezia, Italy.
Tognoni
A
A
Pensa
F
F
Vaira
F
F
Vigani
A
A
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D014747:Vinblastine; D000077235:Vinorelbine