101. A Phase II Trial of Weekly High-Dose Folinic Acid and 5-Fluorouracil in Combination with Epirubicin as Salvage Chemotherapy in Advanced Breast Cancer
- Author
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Iris Kuss, Ferdinand Ploner, A. K. Kasparek, Marianne Schmid, Renate Moser, Derstvenscheg E, C. Lackner, P. Steindorfer, Hellmut Samonigg, H. Stöger, Thomas Bauernhofer, and M. Wilders-Truschnig
- Subjects
Adult ,Cancer Research ,medicine.medical_specialty ,Nausea ,medicine.medical_treatment ,Leucovorin ,Phases of clinical research ,Salvage therapy ,Breast Neoplasms ,Gastroenterology ,Drug Administration Schedule ,Folinic acid ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Aged ,Epirubicin ,Salvage Therapy ,Chemotherapy ,Leukopenia ,business.industry ,General Medicine ,Middle Aged ,Oncology ,Fluorouracil ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Twenty-five patients with advanced breast cancer (ABC) who had failed from first-line chemotherapy entered into a phase II study employing weekly 5-fluorouracil (FU) 350 mg/m2, folinic acid (FA) 500 mg/m2, and epirubicin (EPI) 35 mg/m2, for a maximum of 18 cycles. Twenty-three patients were evaluable for response. One achieved a complete response and 7 showed a partial response, for an objective response rate of 35%; 7 (31%) patients achieved a stabilization of the disease, while 8 (35%) patients progressed under treatment. The median duration of response was 6 months and median survival amounted to 10.6 months. Side effects were in general mild with grade III leukopenia in 5 patients and grade IV leukopenia in 1 patient. Other toxicity included nausea and vomiting (88%), diarrhea (26%), stomatitis (40%) and alopecia (84%), but all of them mainly restricted to WHO grade I and II. Our results suggest that the combination of high-dose FA, FU, and EPI can be safely administered in the investigated schedule and represents an attractive alternative in the search for second-line therapies that combine effectiveness with acceptable toxicity in the treatment of refractory ABC. more...
- Published
- 1994
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