Seminars in oncology
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialDocetaxel versus doxorubicin in patients with metastatic breast cancer who have failed alkylating chemotherapy: a preliminary report of the randomized phase III trial. 303 Study Group.
Three hundred twenty-six patients who had failed prior alkylating agents, given either as adjuvant therapy or therapy for advanced breast cancer or both, were randomly assigned to treatment with up to seven cycles of doxorubicin 75 mg/m2 or docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) 100 mg/m2 given every 3 weeks. The two arms of the study were well-matched for age, performance status, previous therapy, and the nature of the metastatic disease. Forty-seven percent of the docetaxel-treated patients and 49% of the doxorubicin-treated patients were defined as having disease that showed primary or secondary resistance. ⋯ Overall median time to response was 12 weeks with docetaxel and 23 weeks with doxorubicin. Febrile neutropenia, grade 3/4 nausea and vomiting, and cardiotoxicity were significantly more common among the doxorubicin-treated patients, while diarrhea grade 3-4, skin toxicity, neurologic toxicity, fluid retention, and allergy of any grade were significantly more likely in the docetaxel-treated patients. This study demonstrates for the first time the superiority in terms of response rate of a taxoid over an anthracycline in the treatment of advanced breast cancer.
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of paclitaxel or doxorubicin used as single agents in advanced breast cancer: a literature survey.
The anthracyclines are among the most active agents in the treatment of breast cancer. In recent years, the taxoids have produced promising results as single agents in breast cancer. ⋯ Based on the known activity of doxorubicin and the single-agent phase II results of paclitaxel, two phase III randomized trials comparing these drugs as monotherapy in first-line, with crossover on progression, were conducted by the European Organization for Research and Treatment of Cancer and the Intergroup. The preliminary results of these studies were presented at international congresses and will be discussed here.