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  • 1
    ISSN: 1573-7217
    Keywords: advanced breast cancer ; mitoxantrone ; fluorouracil ; leucovorin combination
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary A phase II study to test the toxicity and the efficacy of a weekly combination of Mitoxantrone, 5-Fluorouracil and L-Leucovorin (MFL) was carried out in 43 patients with metastatic breast cancer. Chemotherapy consisted of mitoxantrone 4 mg/m2, 5-fluorouracil 375 mg/m2, and L-leucovorin 100 mg/m2 on day 1, weekly. Patient characteristics were: median age 53 years (range 36–65); estrogen receptor (ER) status was known in 26 patients and of these 15 (57.7%) patients were ER-positive and 11 (42.3%) ER-negative. Of the 43 patients, 25 (58.1%) and 18 (41.9%) patients had received prior adjuvant chemotherapy and prior adjuvant endocrine treatment, respectively. MFL was administered to 22 (51.1%) patients as first line chemotherapy for advanced disease, while 21 (48.9%) patients had received 1 to 2 cytotoxic regimens for metastatic disease. The dominant sites of metastases were: soft tissue in 11 (25.5%) patients, bone in 8 (18.6%) patients and viscera in 24 (55.9%). All patients were assessable for toxicity: only 8 patients experienced WHO grade 3 leukopenia. Thrombocytopenia, diarrhea, stomatitis, and nausea/vomiting were negligible. Anemia and alopecia were not observed. Thirty-nine patients were assessable for response: overall response rate was 28.2% (complete response 7.7% and partial response 20.5%). Median duration of response was 12 months (range 6–34). Patients with no prior anthracyclines had a 42.1% response rate compared to 15% in patients who had received anthracyclines. Median overall survival of the 43 patients was 6 months (range 1–34). Weekly MFL is a well-tolerated and a moderately effective regimen for the treatment of metastatic breast cancer.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-7217
    Keywords: advanced breast cancer ; chemotherapy ; elderly patients
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary We have carried out a phase II trial to evaluate the efficacy and toxicity of a combination therapy consisting of mitoxantrone 10 mg/sqm i.v. on day 1, levo-leucovorin 250 mg/sqm administered over 2 hours and 5-fluorouracil 500 mg/sqm i.v. push after the first hour of levo-leucovorin infusion, on days 15–16 (MFL) in patients aged more than 65 years. 24 patients with advanced breast cancer entered the study: 16 aged 65–70 yrs, 4 patients 70–75 yrs, and 4 〉 75 yrs. Median PS was 1 (range 0–2); sites of metastases were: bone 14 patients, viscera 14 patients, soft tissue 11 patients, and CNS 1 patient. A median number of 6 cycles (range 3–9) was administered. All patients were evaluable for response and toxicity; partial response was obtained in 12 (50%) patients (95% C.I 30–70), stable disease was observed in 9 patients (37.5%), while 3 patients (12.5%) progressed. Median progression-free survival and survival were 9 months (range 2–14) and 14 months (range 5–36), respectively. Toxicity was generally mild and the most frequently observed side-effects were WHO gr. 1–2 leukopenia in 6/24 (25%) patients and gr. 1–2 emesis in 10/24 (41.6%) pts. 1 patient pretreated with doxorubicin cumulative dose of 240 mg/sqm showed clinical signs of congestive heart failure (NYHA grade 1) after the fifth cycle of treatment. MFL is a well tolerated regimen and could represent a safe and effective treatment in older advanced breast cancer patients.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1573-7217
    Keywords: advanced breast cancer ; drugs combination ; salvage chemotherapy ; single-agent
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Metastatic breast cancer remains an incurable disease and the median overall survival has not significantly improved over the past two decades. Aims of the present randomized phase II trial were to analyse activity and toxicity of chemotherapies with single agent or with combination regimens in previously treated patients with advanced breast cancer. Ninety-nine eligible patients were randomized to receive the following chemotherapies: Arm A – 30 mg/m2 i.v. weekly; Arm B – leucovorin 100 mg/m2 i.v. followed by 5-fluorouracil 370 mg/m2 i.v. days 1→5, q 28 days; Arm C – mitoxantrone 12 mg/m2 i.v. only day 1 + leucovorin 100 mg/m2 i.v. followed by 5-fluorouracil 370 mg/m2 i.v. days 1→3, q 28 days. Patients characteristics are comparable in the three groups. The median number of chemotherapy courses administered was 7, 6 and 5 in arm A, B and C, respectively. Objective responses were 24%, 30% and 21% and the median duration of responses were 2, 2.5 and 5.5 months in the arm A, B and C, respectively. Median overall survivals were 9.5, 9 and 9 months in the three arms. No difference was noted comparing the survivals of responding or non responding patients. General toxicity was not mild, with 27.5% of patients experiencing WHO grade 3–4 toxicities. Our results are similar in the three groups of patients and comparable to those reported by other authors. Chemotherapy applied to patients with second or subsequent recurrence allow objective responses in a small percentage of patients. Moreover responders have a negligible prolongation of survival.
    Type of Medium: Electronic Resource
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