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.

医学 德诺苏马布 前列腺癌 临床终点 不利影响 骨痛 内科学 乳腺癌 随机对照试验 骨转移 骨质疏松症 肿瘤科 泌尿科 癌症
作者
Mark Clemons,Michael Ong,Carol Stober,D. Scott Ernst,Christopher M. Booth,Christina M. Canil,Mihaela Mates,Andrew Robinson,Phillip S. Blanchette,Anil A. Joy,John Hilton,Olexiy Aseyev,Gregory R. Pond,Brian Hutton,Ahwon Jeong,Lisa Vandermeer,Dean Fergusson
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:37 (15_suppl): 11501-11501 被引量:11
标识
DOI:10.1200/jco.2019.37.15_suppl.11501
摘要

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

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