Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Clinical Trial
Phase II and pharmacologic study of docetaxel as initial chemotherapy for metastatic breast cancer.
Because docetaxel (Taxotere, RP 56976; Rhone-Poulenc Rorer, Antony, France) appeared to be active against breast cancer in phase I trials, we performed this phase II study. ⋯ Docetaxel is active for metastatic breast cancer. Neutropenia and fluid retention are dose-limiting. The AUC did not predict toxicity, but caution is warranted when treating patients with liver dysfunction. An understanding of the pathophysiology of the fluid retention may facilitate prevention. Frequent HSR may warrant prophylactic premedication.
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To evaluate the prognostic significance of ipsilateral breast tumor recurrence (IBTR) with respect to the subsequent development of distant metastasis. ⋯ It appears that early IBTR is a significant predictor for distant metastases. Whether early breast tumor relapse is a marker for or cause of distant metastases remains a controversial and unresolved issue. Implications for adjuvant systemic therapy at the time of breast relapse are discussed.
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Alternatives to the standard design for conducting phase I trials are proposed with increasing frequency. This study was undertaken to determine how phase I trials are currently conducted and to provide a basis for evaluation of evolving methodology. ⋯ This summary of phase I trials recently conducted at M.D. Anderson Cancer Center confirms the need for alternative methods, provides baseline information against which alternatively conducted trials can be compared, and demonstrates some practical clinical trial issues not generally considered when alternative methods are proposed.
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Comparative Study Clinical Trial
Trade-offs between survival and breast preservation for three initial treatments of ductal carcinoma-in-situ of the breast.
To assess the trade-offs between survival and breast preservation of currently accepted approaches for ductal carcinoma-in-situ (DCIS) of the breast. ⋯ BCS with or without radiation compared with mastectomy as initial management of DCIS of the breast trades a slight decrease in survival rates for the value of breast preservation. This model should aid clinicians in matching treatments to their patients' preferences.