Observational Study on the Interdisciplinary Treatment of Urological Tumors (IBuTu III)
Non-interventional observational study on the relationship between health status and outcome in elderly patients with advanced prostate cancer.
Data technical and statistical support for the implementation of the pilot study "Interdisciplinary treatment of urological tumours - Part 3".
Background
The majority of advanced prostate carcinomas (PCa) are diagnosed in men at the age of almost 70 years. For the treating physicians the therapy decisions in this age group are complex, because aging is a very individual process. In order to be able to treat all patients not only promisingly but also as gently as possible, a geriatric assessment (CGA) should be carried out for old patients with an advanced PCa before therapeutic measures are initiated. So far, little is known about whether the GCA has a valid significance with regard to a possible premature discontinuation of therapy. There is also a lack of information on which instruments are best suited for which disease and for which problem and are of clinical interest. In order to be able to correctly assess the resilience of elderly patients, their psychological and physical functions must be examined using appropriate scales. So far, there are hardly any findings in urological oncology.
Results/ customer benefits
After 177 of 300 planned patients were enrolled, the study was completed due to slow recruitment. 158 patients were suitable for analysis. The mean age was 77.5 years. 46% received chemotherapy and 54% hormone treatment. 91 patients (57.6%) experienced therapy failure. Main reasons were progression/death at 63% and side effects/toxicity at 22%. In the univariate analysis, factors associated with discontinuation of treatment were age ≥80 years, ECOG PS≥2, compromised/poor health (assessment by doctors/patients), and compromised functional or nutritional status. In multivariate analysis, the only factor independently associated with discontinuation of treatment was daily living activities (ADL) < 100 points (OR 3.1 for discontinuation; p<0.05). Despite limitations by the early completion of the study, our results show that compromised ADL is a significant risk factor for treatment failure in elderly patients with CRPC.
Task/ Method
The aim of this study is to identify the characteristics of a CGA that indicate an increased risk of premature discontinuation of therapy in older patients with castration-resistant prostate cancer (CRPC) and are prognostic in nature. Against this background, the observational study will measure functions that help physicians decide on the best treatment for elderly CRPC patients. Patients ≥ 70 years of CRPC starting a new treatment line were included in a prospective cohort study. A geriatric assessment (CGA) was performed that included comorbidity, mobility, functional, mental and nutritional status, and depression. In addition, pain intensity, quality of life, ECOG performance status, and health perceptions of physicians and patients were documented. Factors related to the cessation of treatment failure due to progressive disease, adverse events, or patient withdrawal of consent were analyzed by univariate and multivariate analyses.