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  • Title: Five-day infusion of fluorouracil and vinorelbine for advanced breast cancer patients treated previously with anthracyclines.
    Author: Pieńkowski T, Jagiello-Gruszfeld A.
    Journal: Int J Clin Pharmacol Res; 2001; 21(3-4):111-7. PubMed ID: 12067140.
    Abstract:
    Vinorelbine has proven to be effective in pretreated metastatic breast cancer patients. In particular, no cross-resistance with anthracyclines has been demonstrated. Protracted 5-fluorouracil infusion presents a better pharmacological profile than its bolus administration. The aim of this study was to investigate the efficacy and toxicity of the combination of these two antitumor drugs in patients with metastatic breast cancer who had been previously treated with anthracycline-containing regimens. From February 1998 to January 2000, 65 patients were enrolled into the study The most important inclusion criteria were as follows: Karnofsky 70-100, measurable or evaluable disease and normal renal, hepatic, bone marrow and cardiac function. Mean age was 48 years (range: 31-70). Fourteen of the 65 women had already received more than one chemotherapy line. Twenty-three patients had previously been treated with taxanes. Sites of involvement were the lungs in 50% of the patients, the liver in 37%, soft tissue in 72%, bone in 58% and other sites in 32%. Treatment consisted of vinorelbine 25 mg/m2 administered on days 1 and 6 every 21 days and 5-fluorouracil 700 mg/m2/day for 5 consecutive days. The total number of cycles was 340 (mean: five cycles). The treatment was well tolerated. Febrile neutropenia was observed in 4.6% of patients. Fourteen percent of patients experienced grade 3 or 4 neutropenia, and 3% experienced grade 3 thrombocytopenia. Grade 3 stomatitis was observed in 9.2% of patients, grade 3 neurologic toxicity was observed in 1.5%, and grade 3 cardiotoxicity in 4.6%. Grade 3 site reaction occurred in 3% of patients. Sixty patients were evaluated for response. One patient (1.7%) attained complete clinical response and 28 (46.7%) attained partial response. In 22 patients (36.6%) stable disease was documented and nine patients (15%) progressed while on treatment. Median time to progression was 24 weeks, median duration of response was 35 weeks and median overall survival was 41 weeks. Vinorelbine with 5-day infusion of 5-fluorouracil presented high therapeutic activity in breast cancer patients previously treated with anthracyclines, with acceptable toxicity.
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