N Engl J Med ; We compared docetaxel with vinorelbine for the adjuvant treatment of early breast cancer. Full Text of Background We randomly assigned women with axillary-node—positive or high-risk node-negative cancer to receive three cycles of docetaxel or vinorelbine, followed by in both groups three cycles of fluorouracil, epirubicin, and cyclophosphamide.
The primary end point was recurrence-free survival. Full Text of Methods Recurrence-free survival at three years was better with docetaxel than with vinorelbine 91 percent vs. Docetaxel was associated with more adverse effects than was vinorelbine. Trastuzumab was not associated with decreased left ventricular ejection fraction or cardiac failure. Full Text of Results Adjuvant treatment with docetaxel, as compared with vinorelbine, improves recurrence-free survival in women with early breast cancer.
International Standard Randomised Controlled Trial number, ISRCTN Full Text of Discussion Adjuvant postoperative treatment has markedly reduced rates of death due to breast cancer. Trastuzumab Herceptin, Roche is a humanized monoclonal antibody against the HER2 protein. When administered with chemotherapy, it improves survival in advanced HER2-positive breast cancer. The risk of cardiac dysfunction with trastuzumab treatment increases with the use of anthracyclines.
Ryan dating eva joensuu trastuzumab with docetaxel, vinorelbine, ryan dating eva joensuu, carboplatin, or paclitaxel has resulted in the highest pooled response rates to date in the treatment of breast cancer. In this study, trastuzumab was administered before other cardiotoxic therapies and concomitantly with potentially synergistic chemotherapy for only nine weeks ryan dating eva joensuu test the hypothesis that such a schedule would limit cardiotoxicity and maintain efficacy.
Women eligible for the study were less than 66 years of age, had a World Health Organization performance status of 0 or 1, and had undergone breast surgery with axillary-node dissection or sentinel-node biopsy for invasive breast carcinoma. We required determination of steroid hormone—receptor status and HER2 expression by immunohistochemistry, according to the guidelines of each institution.
Participants were randomly assigned centrally and with computer-assisted blinding to a study group within 12 weeks after surgery. The staging workup included isotope bone scanning; chest radiography or computed tomography CT ; and CT or ultrasonography of the upper abdomen. Criteria for exclusion were distant metastases, pregnancy, severe hypertension, and cardiac disease including cardiac failure of any degree, ryan dating eva joensuu requiring regular medication, and myocardial infarction within the previous 12 months.
Patients were ineligible if they had a serum bilirubin level above the upper limit of normal, an alanine or aspartate aminotransferase level greater than 1. An ethics committee at Helsinki University Central Hospital approved the study. Study participants provided written informed consent. Figure 1 Figure 1 The Design of the Trial.
CISH denotes chromogenic in situ hybridization, and FEC a regimen of fluorouracil, epirubicin, and cyclophosphamide. Randomization was stratified according to HER2 status positive vs. Permuted blocks were used to randomly assign all participants to receive three cycles of either docetaxel or vinorelbine. Docetaxel Taxotere, Sanofi-Aventis was given at a dose of mg per square meter of body-surface area as a one-hour intravenous infusion on day 1 of each day cycle.
Vinorelbine Navelbine, Pierre Fabre was administered at a dose of 25 mg per square meter as a 5-tominute intravenous infusion on days 1, 8, and 15 of the day cycles. After the completion of docetaxel or vinorelbine treatment, three cycles of a regimen consisting of intravenous fluorouracil at a dose of mg per square meter, epirubicin at a dose of 60 mg per square meter, and cyclophosphamide at a dose of mg per square meter, each administered on day 1 of a day cycle FECwere given.
The vinorelbine infusion on day 15 was omitted from the third cycle to allow the initiation of FEC at a full dose without delay. The duration of the chemotherapy regimen ryan dating eva joensuu 18 weeks. Women who had verified HER2-positive cancer were randomly assigned to receive or not to receive trastuzumab. Nine trastuzumab infusions were administered at one-week intervals; the first infusion was given ryan dating eva joensuu day 1 of the first docetaxel or vinorelbine cycle.
The first dose was 4 mg per kilogram of body weight and the subsequent doses 2 mg per kilogram, administered over periods of 90 and 30 minutes, respectively. Trastuzumab was infused before docetaxel or vinorelbine. No trastuzumab was given during FEC administration. The primary end point was recurrence-free survival, defined as the time from the date of randomization to the date of detection with histologic or cytologic confirmation or with radiologic evidence of local, distant, or contralateral invasive breast cancer or death, whichever occurred first.
Secondary end ryan dating eva joensuu included adverse effects, the effect of treatment on the left ventricular ejection fraction, the time to distant recurrence, and overall survival, defined as time from randomization to death from any cause. Patients assigned sex nettsteder for gratis naantali docetaxel received ryan dating eva joensuu 7.
Use of prophylactic antibiotics or granulocyte colony-stimulating factors was not recommended unless one or more episodes of febrile neutropenia or severe infection occurred. Radiotherapy was given after the completion of chemotherapy according to each institution's guidelines, but it was required after breast-conserving surgery. Tamoxifen at a dose of 20 mg per day was administered to patients with estrogen-receptor—positive or progesterone-receptor—positive tumors; this treatment was to be continued for five years.
Chemotherapy doses were reduced by 20 percent in cases of persistent hematologic toxic effects or grade 3 or 4 nonhematologic toxic effects, defined according to the National Cancer Institute Common Toxicity Criteria version 2. When either docetaxel or vinorelbine was discontinued because of adverse effects, the cycles not given were replaced by an equal number of cycles of FEC.
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