Maarten J van der Doelen1,2, Irma M Oving3, Dirk N J Wyndaele4, Jean-Paul van Basten5, Frederiek Terheggen6, Addy C M van de Luijtgaarden7, Wim J G Oyen8,9,10, W Dick van Schelven11, Franchette van den Berkmortel12, Niven Mehra13, Marcel J R Janssen14, Judith B Prins15, Winald R Gerritsen13, José A E Custers15, Inge M van Oort16. 1. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. Maarten.vanderDoelen@radboudumc.nl. 2. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands. Maarten.vanderDoelen@radboudumc.nl. 3. Department of Medical Oncology, Ziekenhuisgroep Twente, Almelo, Netherlands. 4. Department of Nuclear Medicine, Catharina Hospital, Eindhoven, The Netherlands. 5. Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands. 6. Department of Medical Oncology, Bravis Hospital, Roosendaal, The Netherlands. 7. Department of Medical Oncology, Reinier de Graaf Gasthuis and Reinier Haga Prostate Cancer Center, Delft, The Netherlands. 8. Department of Radiology and Nuclear Medicine, Rijnstate Hospital, Arnhem, The Netherlands. 9. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 10. Department of Nuclear Medicine, Humanitas Clinical and Research Center, Milan, Italy. 11. Department of Nuclear Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands. 12. Department of Medical Oncology, Zuyderland Medical Center, Sittard, The Netherlands. 13. Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. 14. Department of Radiology and Nuclear Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. 15. Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands. 16. Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
BACKGROUND: Radium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223. METHODS: Primary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). A trajectory analysis was performed to explore HR-QoL patterns over time. RESULTS: In total, 122 patients were included for analysis. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels. CONCLUSIONS: Patients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation. CLINICAL TRIAL REGISTRATION NUMBER: NCT04995614.
BACKGROUND: Radium-223 is a registered treatment option for symptomatic bone metastatic castration-resistant prostate cancer (mCRPC). Aim of this multicenter, prospective observational cohort study was to evaluate health-related quality of life (HR-QoL), psychological distress and fatigue in mCRPC patients treated with radium-223. METHODS: Primary endpoint was cancer-specific and bone metastases-related HR-QoL, as measured by the EORTC QLQ-C30 and BM-22 questionnaires. Secondary endpoints were psychological distress and fatigue, evaluated by the HADS and CIS-Fatigue questionnaires. Outcomes were analyzed for the total cohort and between subgroups (1-3 versus 4-5 versus 6 radium-223 injections). A trajectory analysis was performed to explore HR-QoL patterns over time. RESULTS: In total, 122 patients were included for analysis. Baseline HR-QoL, pain intensity, psychological distress and fatigue were worse in patients who did not complete radium-223 therapy. In patients who completed therapy, stabilization of HR-QoL was perceived and psychological distress and fatigue remained stable, whereas clinically meaningful and statistically significant deterioration of HR-QoL, psychological distress and fatigue over time was observed in patients who discontinued radium-223 therapy. Trajectory analysis revealed that HR-QoL deterioration over time was more likely in patients with baseline opioid use, low hemoglobin and high alkaline phosphatase levels. CONCLUSIONS: Patients who discontinued radium-223 therapy showed worse HR-QoL, psychological distress and fatigue at baseline and more frequent deterioration of HR-QoL, psychological distress and fatigue over time when compared to patients who completed therapy. Specific attention with regard to HR-QoL during follow-up is indicated in patients with opioid use, low hemoglobin and high alkaline phosphatase levels before radium-223 therapy initiation. CLINICAL TRIAL REGISTRATION NUMBER: NCT04995614.
Authors: Peter Hoskin; Oliver Sartor; Joe M O'Sullivan; Dag Clement Johannessen; Svein I Helle; John Logue; David Bottomley; Sten Nilsson; Nicholas J Vogelzang; Fang Fang; Mona Wahba; Anne-Kirsti Aksnes; Christopher Parker Journal: Lancet Oncol Date: 2014-10-17 Impact factor: 41.316
Authors: Kelly Chipperfield; Jane Fletcher; Jeremy Millar; Joanne Brooker; Robin Smith; Mark Frydenberg; Sue Burney Journal: Psychooncology Date: 2013-03-11 Impact factor: 3.894
Authors: Christopher Parker; Steven E Finkelstein; Jeff M Michalski; Joe M O'Sullivan; Øyvind Bruland; Nicholas J Vogelzang; Robert E Coleman; Sten Nilsson; Oliver Sartor; Rui Li; Monica A Seger; David Bottomley Journal: Eur Urol Date: 2016-06-22 Impact factor: 20.096
Authors: C Parker; S Nilsson; D Heinrich; S I Helle; J M O'Sullivan; S D Fosså; A Chodacki; P Wiechno; J Logue; M Seke; A Widmark; D C Johannessen; P Hoskin; D Bottomley; N D James; A Solberg; I Syndikus; J Kliment; S Wedel; S Boehmer; M Dall'Oglio; L Franzén; R Coleman; N J Vogelzang; C G O'Bryan-Tear; K Staudacher; J Garcia-Vargas; M Shan; Ø S Bruland; O Sartor Journal: N Engl J Med Date: 2013-07-18 Impact factor: 91.245