REaCT-Hold BMA was an investigator-initiated study really aiming to evaluate the optimal dosing frequency of bone-modifying agents after more than two years of prior therapy, especially in patients with bone metastases from metastatic breast cancer and castration-resistant prostate cancer. Because this is important because there have been no randomized trial data in this space. So this was an open-label multi-center randomized controlled trial using a non-inferiority design...
REaCT-Hold BMA was an investigator-initiated study really aiming to evaluate the optimal dosing frequency of bone-modifying agents after more than two years of prior therapy, especially in patients with bone metastases from metastatic breast cancer and castration-resistant prostate cancer. Because this is important because there have been no randomized trial data in this space. So this was an open-label multi-center randomized controlled trial using a non-inferiority design. As I said, patients with bone metastasis from metastatic breast or castration-resistant prostate cancer who have been receiving bone therapy for at least two years at a frequency of every four or every 12 weeks as per guideline recommendations were eligible to participate. Participants were randomized one-to-one to either continue the same frequency of dosing or de-escalate to every 24 weeks. The main finding of this study, the primary outcome, which utilized two co-primary endpoints, physical functioning from the EORTC QLQ-C30 subscale and functional interference from the bone metastasis module from EORTC questionnaires. The primary outcome determined was non-inferior, meaning that BMA de-escalation every 24 weeks was non-inferior compared to standard dosing in terms of physical functioning and functional interference. Key secondary endpoints including symptomatic skeletal events and two-year SSE-free survival were not significantly different.
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