Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer. ⋯ CPM seems to protect against the development of contralateral breast cancer, and although women who underwent CPM had relatively low all-cause mortality, CPM also was associated with decreased breast cancer mortality.
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Randomized phase II (RPh2) designs are popular in cancer clinical trials because of the smaller sample size requirements when multiple treatments are being evaluated. We reviewed the use of RPh2 designs and give comments on future directions. ⋯ There is a trend of increasing use of RPh2 designs in cancer research. Continued improvement in study design, conduct, analysis, and reporting is required to enhance the quality of RPh2 designs. The accrual rate and success rate of the trials remain low, and therefore, futility stopping rules to terminate ineffective treatment arm(s) should be implemented more frequently. More innovative, flexible RPh2 designs are needed to facilitate the development of effective cancer treatments.
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Randomized Controlled Trial Comparative Study Clinical Trial
Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial.
Axillary lymph node dissection (ALND) as part of surgical treatment for patients with breast cancer is associated with significant morbidity. Sentinel lymph node biopsy (SLNB) is a newly developed method of staging the axilla and has the potential to avoid an ALND in lymph node-negative patients, thereby minimizing morbidity. The aim of this study was to investigate physical and psychological morbidity after SLNB in the treatment of early breast cancer in a randomized controlled trial. ⋯ SLNB in patients undergoing surgery for breast cancer results in a significant reduction in physical and psychological morbidity.
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Multicenter Study Clinical Trial
Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand.
Onycholysis and skin toxicity occur in approximately 30% of patients treated with docetaxel. We investigated the efficacy and safety of an Elasto-Gel (84400 APT Cedex, Akromed, France) frozen glove (FG) for the prevention of docetaxel-induced onycholysis and skin toxicity. ⋯ FG significantly reduces the nail and skin toxicity associated with docetaxel and provides a new tool in supportive care management to improve a patient's quality of life.