A randomized trial comparing four-weekly versus 12-weekly administration of bone-targeted agents (denosumab, zoledronate, or pamidronate) in patients with bone metastases from either breast or castration-resistant prostate cancer.

• DOI: 10.1200/jco.2019.37.15_suppl.11501
• Publication Date: 2020-03-12T15:15:16Z
• Authors: Mark J. Clemons; Michael Ong; Carol Stober; D. Scott Ernst; Christopher M. Booth; Christina M. Canil; Mihaela Mates; Andrew George Rob...; Phillip S. Blanch...; Anil Abraham Joy; John Frederick Hi...; Olexiy Aseyev; Gregory Russell Pond; Brian Hutton; Ahwon Jeong; Lisa Vandermeer; Dean Fergusson
• Keywords: Denosumab; Clinical endpoint; Bone pain

11501 Background: Defining the optimal dosing interval of commonly used bone-targeted agents (BTAs), such as denosumab and bisphosphonates, for patients with bone metastases remains an important clinical question. We performed a pragmatic randomised trial comparing non-inferiority 12- versus 4-weekly BTAs in from breast prostate cancer. Methods: Patients metastases, who were either BTA-naïve, or already receiving, denosumab, pamidronate zoledronate eligible. They to receive their chosen BTA every 4-weeks one year. The primary endpoint was Health related quality life (HRQL) (EORTC-QLQ-C30 Functional Domain - Physical Subdomain). Secondary endpoints included: pain (EORTC-QLQ-BM22 domain), Global Status (EORTC-QLQ-C30), symptomatic skeletal events (SSE) rates time SSEs. Adverse toxicity profiles also compared. Results: Of 263 (60.8% 39.2% prostate), 130 (49.4%) 12-weekly 133 (50.6%) therapy. 138 (52.5%) bone-agent naïve. included; (n=148, 56.3%), (n=63, 24.0%) (n=52, 19.8%). Study-reported outcomes showed no significant difference in; HRQL-physical domain (median [range]: 0 [-86, 40] vs. [-66, 53.3]), 72] [-100, 88]), 66.7] [-83, 33.3]), SSE (N [%]: 24 [18.5%] 22 [16.5%]), 1-year SSE-free rate (median, range; 73.2% [63.6, 80.7] 77.9% [69.1, 84.4]) between arms, respectively. Subgroup analyses naïve pre-treated patients, receiving pamidronate, arms. There reported renal impairment (2.3% 3.0%), hypocalcaemia (1.5% 1.5%) osteonecrosis jaw (0.8% 0.8%). Conclusion: findings this are consistent those previously de-escalating zoledronate. This included de-escalated pamidronate. While results Swiss REDUSE awaited, data presented would suggest that de-escalation all is reasonable treatment option. Clinical information: NCT02721433.