Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Surveying bereaved family members could enhance the quality of end-of-life cancer care in inpatient palliative care units (PCUs). We systematically reviewed nationwide postbereavement studies of PCUs in Japan and attempts to develop measures for evaluating end-of-life care from the perspective of bereaved family members. The Care Evaluation Scale (CES) for evaluating the structures and processes of care, and the Good Death Inventory (GDI) for evaluating the outcomes of care were considered suitable methods. ⋯ Feedback from surveys of bereaved family members might help to improve the quality of end-of-life cancer care in inpatient PCUs. However, the effectiveness of feedback procedures remains to be confirmed. Furthermore, there is a need to extend the ongoing evaluation process to home care hospices and general hospitals, including cancer centers, identify the limitations of end-of-life care in all settings, and develop strategies to overcome them.
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Progression-free survival is an important end point in advanced disease settings. Blinded independent central review (BICR) of progression in randomized clinical trials has been advocated to control bias that might result from errors in progression assessments. However, although BICR lessens some potential biases, it does not remove all biases from evaluations of treatment effectiveness. ⋯ We conclude that double-blinded trials with consistent application of measurement criteria are the best means of ensuring unbiased trial results. When such designs are not practical, BICR is not recommended as a general strategy for reducing bias. However, BICR may be useful as an auditing tool to assess the reliability of marginally positive results.
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Multicenter Study
Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma.
To assess the safety and efficacy of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma (mRCC) and explore biomarkers for sunitinib response. ⋯ Sunitinib has substantial antitumor activity in patients with bevacizumab-refractory mRCC and modulates circulating VEGF pathway biomarkers. These data support the hypothesis that sunitinib inhibits signaling pathways involved in bevacizumab resistance. Baseline levels of sVEGFR-3 and VEGF-C may have potential utility as biomarkers of clinical efficacy in this setting.
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Randomized Controlled Trial Multicenter Study Comparative Study
Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial.
In an international, randomized phase III trial, sunitinib demonstrated statistically significant efficacy over interferon alfa (IFN-alpha) as first-line therapy in patients with metastatic renal cell carcinoma (mRCC) (progression-free survival time, 11 v 5 months, respectively; P < .001; objective response rate, 31% v 6%, respectively; P < .001). We report health-related quality-of-life (QOL) results from this trial. ⋯ Sunitinib provides superior QOL compared with IFN-alpha in mRCC patients.
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Review
Survival end point reporting in randomized cancer clinical trials: a review of major journals.
Several publications showed that the standards for reporting randomized clinical trials (RCTs) might not be entirely suitable. Our aim was to evaluate the reporting of survival end points in cancer RCTs. ⋯ A majority of articles failed to provide a complete reporting of survival end points, thus adding another source of uncontrolled variability.