Background: In the clinical setting of metastatic castration-resistant prostate cancer the aim of treatment is palliation. Palliation can refer to symptom management or non-curative treatments. Patient-reported outcome is any outcome based on data provided by patients. The aim of this paper is to perform a systematic review of clinical trials including a patient-reported outcome assessment in patients treated with cytotoxic chemotherapy, and to compare their results by traditional medical and patient-reported outcomes assessment.
Methods: In November 2009 a literature search for published studies was undertaken. Selected phase-3 studies were primarily evaluated on the quality of patient-reported outcomes reporting and assessment methodology.
Findings: Health-related quality of life assessment was the most common endpoint, pain control the second one. Results of patient-reported and traditional endpoints analysis are resumed, as well as methodology assessment and quality of patient-reported outcomes reporting. Frequently, methodologic limitations affect patient-reported outcomes assessment in clinical trials, either data analysis, particularly not reporting individual scores of health-related quality of life questionnaires, statistical corrections, limited efforts to avoid missing data, or lacking report of duration of palliative response.
Conclusions: Results of trials can differ if different outcomes, medical or patient-reported, are considered in the analysis. Cytotoxic chemotherapy of metastatic castration-resistant prostate cancer is a challenging issue. A survival benefit is reported only for docetaxel, but this treatment is not always feasible. In all patients, initiation of chemotherapy should be based on patient's preferences within discussion of individual risk and benefit, particularly in patients with extensive asymptomatic and symptomatic metastases.
2010 Elsevier Ltd. All rights reserved.