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Войти в исследования Clinical oncology (Royal College of Radiologists (Great Britain)) · 2026
Risk of Symptomatic Skeletal Events After Discontinuation of Long-term Denosumab in Patients With Bone Metastases: A Retrospective Cohort Study.
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Hara H, Fukase N, Sawada R, Takemori T, Nakamatsu Y, Kuroda R, Akisue T
Аннотация
AIMS: The optimal duration of denosumab (Dmab) therapy for patients with bone metastases remains uncertain, particularly regarding the balance between preventing skeletal-related events and the risk of medication-related osteonecrosis of the jaw (MRONJ) after treatment discontinuation. This study evaluated the incidence and risk factors of symptomatic skeletal events (SSEs) following Dmab discontinuation.
MATERIALS AND METHODS: We retrospectively analysed 178 patients with bone metastases who discontinued Dmab after ≥6 doses and had ≥3 months of follow-up. Incidence, timing, and risk factors of SSEs were assessed using Cox regression. A landmark analysis was performed in patients treated for ≥2 years (n = 152), with SSE-free survival compared between discontinuation and continuation groups, with and without propensity score matching (PSM). Incidence rates of SSEs and MRONJ were compared between patients treated for <2 and ≥2 years.
RESULTS: SSEs occurred in 16.9% of patients, with 77% developing within one year after discontinuation, particularly within six months. Longer Dmab treatment duration was associated with reduced SSE risk (HR, 0.96; 95% CI, 0.93-0.99). The incidence of SSEs was lower in the ≥2-year group compared with the <2-year group (0.044 vs. 0.201 per person-year), whereas MRONJ incidence was higher (0.091 vs. 0.055 per person-year, P < 0.001). In the ≥2-year landmark cohort, the number of prior SSEs was the only independent predictor of subsequent SSEs. After ≥2 years, SSE-free survival was not significantly different between discontinuation and continuation groups after PSM (P = 0.074). Median overall survival from Dmab initiation was 41 months, with 1- and 2-year survival rates of 96% and 72%, respectively.
CONCLUSION: Discontinuation of Dmab after ≥2 years may be a reasonable option for selected patients with stable disease. However, decisions must balance the benefit of reduced SSE risk with the increased likelihood of MRONJ. Patients with a history or greater burden of SSEs remain at increased risk and require close monitoring.
MATERIALS AND METHODS: We retrospectively analysed 178 patients with bone metastases who discontinued Dmab after ≥6 doses and had ≥3 months of follow-up. Incidence, timing, and risk factors of SSEs were assessed using Cox regression. A landmark analysis was performed in patients treated for ≥2 years (n = 152), with SSE-free survival compared between discontinuation and continuation groups, with and without propensity score matching (PSM). Incidence rates of SSEs and MRONJ were compared between patients treated for <2 and ≥2 years.
RESULTS: SSEs occurred in 16.9% of patients, with 77% developing within one year after discontinuation, particularly within six months. Longer Dmab treatment duration was associated with reduced SSE risk (HR, 0.96; 95% CI, 0.93-0.99). The incidence of SSEs was lower in the ≥2-year group compared with the <2-year group (0.044 vs. 0.201 per person-year), whereas MRONJ incidence was higher (0.091 vs. 0.055 per person-year, P < 0.001). In the ≥2-year landmark cohort, the number of prior SSEs was the only independent predictor of subsequent SSEs. After ≥2 years, SSE-free survival was not significantly different between discontinuation and continuation groups after PSM (P = 0.074). Median overall survival from Dmab initiation was 41 months, with 1- and 2-year survival rates of 96% and 72%, respectively.
CONCLUSION: Discontinuation of Dmab after ≥2 years may be a reasonable option for selected patients with stable disease. However, decisions must balance the benefit of reduced SSE risk with the increased likelihood of MRONJ. Patients with a history or greater burden of SSEs remain at increased risk and require close monitoring.