Second-Line Cabazitaxel Treatment in Castration-Resistant Prostate Cancer Clinical Trials Compared to Standard of Care in CAPRI: Observational Study in the Netherlands |
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| Authors: | Hans M. Westgeest Malou C.P. Kuppen Alphonsus J.M. van den Eertwegh Ronald de Wit Juleon L.L.M. Coenen H.P. van den Berg Niven Mehra Inge M. van Oort Laurent M.C.L. Fossion Mathijs P. Hendriks Haiko J. Bloemendal Addy C.M. van de Luijtgaarden Daan ten Bokkel Huinink A.C.M. van den Bergh Joan van den Bosch Marco B. Polee Nir Weijl Andre M. Bergman Winald R. Gerritsen |
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| Affiliation: | 1. Department of Internal Medicine, Amphia Ziekenhuis, Breda, The Netherlands;2. Institute for Medical Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, The Netherlands;3. Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands;4. Department of Medical Oncology, Erasmus MC Daniel den Hoed Cancer Center, Rotterdam, The Netherlands;5. Department of Internal Medicine, Isala, Zwolle, The Netherlands;6. Department of Internal Medicine, Tergooi Ziekenhuizen, Hilversum, The Netherlands;7. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands;8. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands;9. Department of Urology, Maxima Medisch Centrum, Veldhoven, The Netherlands;10. Department of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands;11. Department of Internal Medicine, Meander Medisch Centrum, Amersfoort, The Netherlands;12. Department of Internal Medicine, Reinier de Graaf Gasthuis and Reinier Haga Prostate Cancer Centre, Delft, The Netherlands;13. Department of Internal Medicine, Diakonessenhuis, Utrecht, The Netherlands;14. Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands;15. Department of Internal Medicine, Albert Schweitzer Ziekenhuis, Dordrecht, The Netherlands;16. Department of Internal Medicine, Medical Center, Leeuwarden, The Netherlands;17. Department of Internal Medicine, MCH-Bronovo Ziekenhuis, ‘s-Gravenhage, The Netherlands;18. Division of Internal Medicine (MOD) and Oncogenomics, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands;19. Institute for Medical Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, The Netherlands;20. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands |
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| Abstract: | BackgroundCabazitaxel has been shown to improve overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients after docetaxel in the TROPIC trial. However, trial populations may not reflect the real-world population. We compared patient characteristics and outcomes of cabazitaxel within and outside trials (standard of care, SOC).Patients and MethodsmCRPC patients treated with cabazitaxel directly after docetaxel therapy before 2017 were retrospectively identified and followed to 2018. Patients were grouped on the basis of treatment within a trial or SOC. Outcomes included OS and prostate-specific antigen (PSA) response.ResultsFrom 3616 patients in the CAPRI registry, we identified 356 patients treated with cabazitaxel, with 173 patients treated in the second line. Trial patients had favorable prognostic factors: fewer symptoms, less visceral disease, lower lactate dehydrogenase, higher hemoglobin, more docetaxel cycles, and longer treatment-free interval since docetaxel therapy. PSA response (≥ 50% decline) was 28 versus 12%, respectively (P = .209). Median OS was 13.6 versus 9.6 months for trial and SOC subgroups, respectively (hazard ratio = 0.73, P = .067). After correction for prognostic factors, there was no difference in survival (hazard ratio = 1.00, P = .999). Longer duration of androgen deprivation therapy treatment, lower lactate dehydrogenase, and lower PSA were associated with longer OS; visceral disease had a trend for shorter OS.ConclusionPatients treated with cabazitaxel in trials were fitter and showed outcomes comparable to registration trials. Conversely, those treated in daily practice showed features of more aggressive disease and worse outcome. This underlines the importance of adequate estimation of trial eligibility and health status of mCRPC patients in daily practice to ensure optimal outcomes. |
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| Keywords: | Address for correspondence: Hans M. Westgeest, MD, Department of Internal Medicine, Amphia Ziekenhuis, Breda, The Netherlands Postdocetaxel Real-world outcomes Registry Trial eligibility Trial population |
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