Oncology Ny
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Docetaxel vs mitomycin plus vinblastine in anthracycline-resistant metastatic breast cancer.
This nonblinded, multicenter, randomized phase III study compares the median time to progression (primary endpoint), response rate, and quality of life, safety, and survival of docetaxel (Taxotere) vs mitomycin (Mutamycin) plus vinblastine (Velban) in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. Patients were randomized to receive an intravenous infusion of either 100 mg/m2 of docetaxel for 1 hour every 3 weeks, or 12 mg/m2 of mitomycin every 6 weeks plus 6 mg/m2 of vinblastine every 3 weeks. This preliminary analysis presents data on 200 patients among 392 patients recruited. ⋯ Based on this preliminary analysis, docetaxel appears to be equally as safe as and more active than mitomycin/ vinblastine in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. These results are subject to cautious interpretation because this analysis was conducted on the first 200 patients who finished the study treatments, and these preliminary results may underestimate response and overstate treatment discontinuation rates. Thus, the final analysis on the entire patient population is necessary to confirm these preliminary findings.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Docetaxel vs doxorubicin in metastatic breast cancer resistant to alkylating chemotherapy.
Single-agent docetaxel (Taxotere) has been shown to be highly active in metastatic breast cancer, with an overall response rate of 47%, median time to progression of 4 months, and survival of 10 months when administered as second-line therapy. These data compare favorably with those reported for doxorubicin (Adriamycin), which has been considered the most active single agent in this setting. This nonblinded, multicenter, randomized phase III study compared the median time to progression, response rate, quality of life, toxicity, and survival after treatment with docetaxel or doxorubicin in patients with metastatic breast cancer in whom previous alkylating chemotherapy failed. ⋯ In addition, doxorubicin produced a higher incidence of grade 3 to 4 thrombocytopenia. Cardiac toxicity led to discontinuation in 7 patients and death in 2 patients in the doxorubicin group; fluid retention led to discontinuation in 1 patient in the docetaxel group. Based on this preliminary analysis, docetaxel was more active and safer than doxorubicin in patients with metastatic breast cancer in whom previous alkylating chemotherapy failed.
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Multicenter Study Clinical Trial
Docetaxel as neoadjuvant chemotherapy in patients with stage III breast cancer.
Optimal management of locally advanced breast cancer (stage III) generally includes a combination of primary chemotherapy followed by surgery (if feasible), and local radiotherapy and adjuvant chemotherapy with or without hormonal therapy. An ongoing phase II study is being performed to evaluate the use of 4 cycles of 100 mg/m2 of docetaxel (Taxotere) administered as a 1-hour intravenous infusion once every 3 weeks followed by surgery, 4 cycles of standard-dose doxorubicin/cyclophosphamide (Cytoxan, Neosar) chemotherapy, and radiation, with and without tamoxifen (Nolvadex) in patients with locally advanced breast cancer. Preliminary results from 33 patients included in this phase II study are reported here. ⋯ One patient with a complete response was confirmed to have a complete pathologic response at the time of surgery. Febrile neutropenia was noted in 8 patients (24%) and in 8 of the 120 treatment cycles (7%) administered. Future trials aimed at increasing the number of pathologic complete responses in patients with stage III breast cancer may require the use of docetaxel in combination with other active agents or the use of dose-dense scheduling schemes.