Bart J Pielkenrood1, Roxanne Gal1, Nicolien Kasperts2, Joost J C Verhoeff2, Marcia M T J Bartels1, Enrica Seravalli2, Yvette M van der Linden3, Evelyn M Monninkhof4, Jorrit-Jan Verlaan5, Joanne M van der Velden2, Helena M Verkooijen6. 1. Division of Imaging and Cancer, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. 2. Departments of Radiotherapy, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. 3. Department of Radiotherapy, Leiden University Medical Center, Leiden, the Netherlands. 4. Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. 5. Departments Orthopedic Surgery, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. 6. Division of Imaging and Cancer, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: h.m.verkooijen@umcutrecht.nl.
Abstract
PURPOSE: Painful bone metastases hamper quality of life (QoL). The aim of this prespecified secondary analysis of the PRESENT trial was to compare change in global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects after conventional radiation therapy (cRT) versus stereotactic body RT (SBRT). METHODS AND MATERIALS: A total of 110 patients were enrolled in the phase 2 randomized controlled VERTICAL trial (NCT02364115) following the "trials within cohorts" design and randomized 1:1 to cRT or SBRT. Patient-reported global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects were assessed by the European Organization for Research and Treatment of Cancer QoL Questionnaire (QLQ) Core 15 Palliative Care and QLQ Bone Metastases 22 modules. Changes in QoL domains over time were compared between patients treated with cRT and SBRT using intention-to-treat (ITT) and per-protocol (PP) linear mixed model analysis adjusting for baseline scores. Proportions of patients in the cRT versus SBRT arm reporting a clinically relevant change in QoL within 3 months were compared using a χ2 test. RESULTS: QoL scores had improved over time and were comparable between groups for all domains in both the ITT and PP analyses, except for functional interference and psychological aspects in the ITT. Functional interference scores had improved more after 12 weeks in the cRT arm than in the SBRT arm (25.5 vs 14.1 points, respectively; effect size [ES] = 0.49, P = .04). Psychosocial aspects scores had improved more after 8 weeks in the cRT arm than in the SBRT arm (12.2 vs 7.3; ES = 0.56, P = .04). No clinically relevant differences between groups at 12 weeks in terms of global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects were observed. CONCLUSIONS: Palliative RT improves QoL. Both SBRT and cRT have a comparable effect on patient-reported QoL outcomes in patients with painful bone metastases. Functional interference and psychological aspects scores improved more in patients treated with cRT versus patients offered SBRT.
PURPOSE: Painful bone metastases hamper quality of life (QoL). The aim of this prespecified secondary analysis of the PRESENT trial was to compare change in global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects after conventional radiation therapy (cRT) versus stereotactic body RT (SBRT). METHODS AND MATERIALS: A total of 110 patients were enrolled in the phase 2 randomized controlled VERTICAL trial (NCT02364115) following the "trials within cohorts" design and randomized 1:1 to cRT or SBRT. Patient-reported global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects were assessed by the European Organization for Research and Treatment of Cancer QoL Questionnaire (QLQ) Core 15 Palliative Care and QLQ Bone Metastases 22 modules. Changes in QoL domains over time were compared between patients treated with cRT and SBRT using intention-to-treat (ITT) and per-protocol (PP) linear mixed model analysis adjusting for baseline scores. Proportions of patients in the cRT versus SBRT arm reporting a clinically relevant change in QoL within 3 months were compared using a χ2 test. RESULTS: QoL scores had improved over time and were comparable between groups for all domains in both the ITT and PP analyses, except for functional interference and psychological aspects in the ITT. Functional interference scores had improved more after 12 weeks in the cRT arm than in the SBRT arm (25.5 vs 14.1 points, respectively; effect size [ES] = 0.49, P = .04). Psychosocial aspects scores had improved more after 8 weeks in the cRT arm than in the SBRT arm (12.2 vs 7.3; ES = 0.56, P = .04). No clinically relevant differences between groups at 12 weeks in terms of global QoL, physical functioning, emotional functioning, functional interference, and psychosocial aspects were observed. CONCLUSIONS: Palliative RT improves QoL. Both SBRT and cRT have a comparable effect on patient-reported QoL outcomes in patients with painful bone metastases. Functional interference and psychological aspects scores improved more in patients treated with cRT versus patients offered SBRT.
Authors: Verónica Cañón; Alfonso Gómez-Iturriaga; Francisco Casquero; Dirk Rades; Arturo Navarro; Olga Del Hoyo; Virginia Morillo; Patricia Willisch; José Luis López-Guerra; Ana Illescas-Vacas; Raquel Ciervide; Lorea Martinez-Indart; Jon Cacicedo Journal: Rep Pract Oncol Radiother Date: 2022-07-29