Abstract
Purpose
To gain knowledge about the factors associated with discontinuation of scheduled treatment in elderly men with castration-resistant prostate cancer (CRPC).
Methods
Patients ≥ 70 years with CRPC starting a new line of treatment were included in a prospective cohort study. A geriatric assessment (CGA) was performed at baseline, including comorbidity, mobility, functional/mental/nutritional status, as well as depression. Furthermore, pain intensity, quality of life, ECOG-performance status, and physicians’ and patients’ perception of health were documented. Reasons for and factors associated with discontinuation of scheduled treatment were analysed by univariate and multivariate analysis.
Results
After inclusion of 177 of 300 planned patients, the study was closed due to slow recruitment. 160 patients were eligible for final analysis. Median age was 77.5 years. 46% received chemotherapy, and 54% hormonal treatment. Discontinuation of scheduled treatment occurred in 91 patients (57.6%). The main reasons were progressive disease/death in 63%, adverse events/toxicity in 22%, and withdrawal of consent in 8%. In bivariate analyses, factors associated with discontinuation of treatment were age ≥ 80 years, ECOG PS ≥ 2, compromised/poor health status (physicians’/patients’ assessment), and compromised functional or nutritional status. In multivariate analysis, the only remaining factor independently associated with discontinuation of scheduled treatment was impairment of activities of daily living (ADL < 100 points) (OR = 4.2 for discontinuation; p < 0.05).
Conclusion
Despite limitations due to early termination of the study, our results demonstrate that discontinuation of scheduled treatment was common, and that compromised ADL seems to be a significant risk factor for treatment failure in elderly patients with CRPC.
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Acknowledgements
We thank the following physicians for entering patients into the trial: Dr. med. Haytham Al Akkad, Dr. med. Uwe Behrendt, Manfred Binder, Dr. med. Frank Brands, Dr. med. Horst Brenneis, Dr. med. Ralf Eckert, Dr. med. Rolf H. Eichenauer, Dr. med. Thomas Frangenheim, Jan Franz, Dr. med. Miguel Garcia-Schürmann, Torsten Geyer, Dr. med. Jochen Gleißner, Dr. med. Richard Hansen, Dr. med. Eva Hellmis, Dr. med. Jürgen Jeßberger, Dr. med. Martine Klausmann, Dr. med. Jörg Klier, Prof. Dr. med. Theodor Klotz, PD Dr. med. Frank König, Dipl. Med. Stefan Kowalik, Dr. med. Uwe-Carsten Lock, Dr. med. Frank Meyer, Bernd Möhler, Dr. med. Detlef Müller, Dr. med. Eberhard Mumperow, Christian Nitz, Dr. med. Burkhard Otremba, Dr. med. Michael Peter, Dr. med. Dieter Popp, Dr. med. Michael Prosinger, Dr. med. Sebastian Rau, Dr. med. Wolfgang Rulf, Dr. med. Christoph Rüssel, Dr. med. Axel Schroeder, Dr. med. Matthias Schulze, PD Dr. med. Gernot Seipelt, Dr. med. Jörg Seraphin, Dr. med. Gabriele Simson, Dr. med. Steffen Sturm, Dr. med. Silvio Szymula, Dipl. Med. Jens Telle, Thorsten Werner, Anja Winkel, Dr. med. Jan Wolf, Dr. med. Torsten Woschick, Dr. med. Mark-Oliver Zahn.
Funding
This study was funded by Janssen-Cilag GmbH (Grant number 212082PCR4009).
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Author Friedemann Honecker declares that he has no conflict of interest. Author Ulrich Wedding declares that he has no conflict of interest. Gerd Kallischnigg declares that he has no conflict of interest. Author Axel Schroeder declares that he has no conflict of interest. Author Jörg Klier declares that he has no conflict of interest. Author Thomas Frangenheim declares that he has no conflict of interest. Author Lothar Weißbach declares that he has no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
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Informed consent was obtained from all the individual participants included in the study.
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Honecker, F., Wedding, U., Kallischnigg, G. et al. Risk factors for unplanned discontinuation of scheduled treatment in elderly patients with castration-resistant prostate cancer: results of the IBuTu study. J Cancer Res Clin Oncol 144, 571–577 (2018). https://doi.org/10.1007/s00432-017-2577-1
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DOI: https://doi.org/10.1007/s00432-017-2577-1