Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Randomized Controlled Trial Multicenter Study
Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment.
Effective treatment options for patients with metastatic breast cancer resistant to anthracyclines and taxanes are limited. Ixabepilone has single-agent activity in these patients and has demonstrated synergy with capecitabine in this setting. This study was designed to compare ixabepilone plus capecitabine versus capecitabine alone in anthracycline-pretreated or -resistant and taxane-resistant locally advanced or metastatic breast cancer. ⋯ Ixabepilone plus capecitabine demonstrates superior efficacy to capecitabine alone in patients with metastatic breast cancer pretreated or resistant to anthracyclines and resistant to taxanes.
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Many patients with unilateral breast cancer choose contralateral prophylactic mastectomy to prevent cancer in the opposite breast. The purpose of our study was to determine the use and trends of contralateral prophylactic mastectomy in the United States. ⋯ The use of contralateral prophylactic mastectomy in the United States more than doubled within the recent 6-year period of our study. Prospective studies are needed to understand the decision-making processes that have led to more aggressive breast cancer surgery.
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Shared decision making is a tenet of contemporary medicine and oncology practice. How involved elderly patients want to be in making treatment decisions and how physicians perceive patient preferences for such involvement are uncertain. ⋯ For older patients with advanced CRC, preferences for prognostic information and for an active role in treatment decision making are not easily predictable. Physicians' perceptions are often inconsistent with patients' stated preferences. Explicit discussion of preferred decision-making styles may improve patient-physician encounters.
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Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in oncology clinical trials. They frequently are used to help evaluate cancer treatments, as well as for supportive and palliative oncology care. To be most beneficial, these PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. ⋯ At the core of this activity is the formation and application of item banks using item response theory modeling. We also present our work in the fatigue domain, including a short-form measure, as a sample of PROMIS methodology and work to date. Plans for future validation and application of PROMIS measures are discussed.
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In this article, we provide a brief historical review of the development of patient-reported outcome measurement, analysis, and reporting in clinical trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). In doing so, we examine selected lessons learned in furthering the quality of these data and their application to clinical practice. We conclude that sequential institution of key policies within the NCIC CTG and the development of a collective philosophy within the group has enabled the routine incorporation of health-related quality of life into clinical trial protocols according to robust scientific principles; that collection of quality data is possible in a variety of circumstances (although not universally so); that patient-reported data on subjective experiences is likely to be more reliable and valid than conventional toxicity information; and that simple analyses that report group trends as well as individual patient response rates are preferred.