Mortality during adjuvant treatment of early breast cancer with cyclophosphamide, methotrexate, and fluorouracil
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The interaction of methotrexate and/or cyclophosphamide with the pharmacokinetics of 5-fluorouracil (5-FU) was studied in tumor-bearing WAG/Rij rats. Four groups were formed including treatment with single-agent 5-FU (eight rats); 5-FU plus methotrexate (11 rats); 5-FU plus cyclophosphamide (12 rats); and 5-FU, cyclophosphamide, and methotrexate (13 rats). The area-under-the-plasma-concentration/time curve, total-body clearance, elimination half-life, mean residence time, and steady-state volume of distribution were computed and compared. The mean residence time and elimination half-life of 5-FU increased when methotrexate was included in the combination. The increase was significant (P less than 0.05) for 5-FU, cyclophosphamide, and methotrexate versus 5-FU and cyclophosphamide.
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Thirty-six patients with advanced breast cancer were treated with the regimen of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF). Their response to the combination chemotherapy and their survival were correlated in respect to estrogen-receptor (ER) status. No patient had received any form of hormonal therapy or other chemotherapeutic agents prior to the CMF treatment. Overall response rate, both complete and partial, to chemotherapy was 60% (21/36): 88% in the ER+ group (14/16) and 35% in the ER– group (7/20). Median duration of response was 17 months in ER+ and seven months in the ER–. Median duration of survival was 27 months in ER+ patients and nine months in ER– patients after initiation of chemotherapy. These data suggest ER+ status has a beneficial effect in the responsiveness of advanced breast cancer to CMF chemotherapy and is prognostic of better survival.
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Abstract Twenty‐nine patients with metastatic breast cancer were treated with fluorouracil, adriamycin, cyclophosphamide (FAC), and methotrexate (MTX), with or without leukovorin rescue. Of 24 evaluable patients, one achieved a complete remission and 17 had partial responses. The overall objective response rate was 75%. The median survival from initiation of chemotherapy for the responding patients was 18 months. Four patients (17%) with stable disease had a median survival of 25 months. The addition of MTX to FAC chemotherapy did not improve the therapeutic efficacy of this combination; it did, however, increase the overall toxicity, especially the infectious complications when compared to FAC alone.
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