How do skeletal morbidity rate and special toxicities affect 12-week versus 4-week schedule zoledronic acid efficacy? A systematic review and a meta-analysis of randomized trials

Santini, Daniele; Galvano, Antonio; Pantano, Francesco; Incorvaia, Lorena; Rizzo, Sérgio; Vincenzi, Bruno; Castellana, Luisa; Giuliana, G; Guadagni, Fiorella; Toia, Francesca; Tonini, Giuseppe; Badalamenti, Giuseppe; Bazan, Viviana

doi:10.1016/j.critrevonc.2019.07.013

Cited by 6 publications

(6 citation statements)

References 18 publications

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“…However, the optimal dosing intervals remain unclear. A randomized controlled trial (RCT) that compared 12-weekly zoledronic acid administration with 4-weekly zoledronic acid administration reported no signi cant difference in the incidence of SREs and a higher incidence of adverse events with 4-weekly zoledronic acid administration [23]. In breast cancer, zoledronic acid is administered every 12 weeks [24], but no speci c dosing interval is speci ed for prostate cancer.…”

Section: Discussionmentioning

confidence: 99%

Cumulative Incidence and Risk Factors for Anti-Resorptive Agent-Related Osteonecrosis of the Jaw during Long-Term Prostate Cancer Management

Tani,

Hatano,

Yoshimura

et al. 2024

Preprint

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Bone-modifying agents (BMA) are extensively used in treating patients with prostate cancer with bone metastases. However, this increases the risk of anti-resorptive agent-related osteonecrosis of the jaw (ARONJ). The safety of long-term BMA administration in clinical practice remains unclear. We aimed to determine the cumulative incidence and risk factors of ARONJ. One hundred and seventy-nine patients with prostate cancer with bone metastases treated with BMA at our institution since 2008 were included in this study. Twenty-seven patients (15%) had ARONJ during the follow-up period (median, 19 months; interquartile range, 9–43 months). The 2-year, 5-year, and 10-year cumulative ARONJ incidence rates were 18%, 27%, and 61%, respectively. Multivariate analysis identified denosumab use as a risk factor for ARONJ, compared with zoledronic acid use (HR 4.64, 95% CI 1.93–11.1). Additionally, BMA use at longer than one-month intervals was associated with a lower risk of ARONJ (HR 0.08, 95% CI 0.01–0.64). Furthermore, six or more bone metastases (HR 3.65, 95% CI 1.13–11.7) and diabetes mellitus (HR 5.07, 95% CI 1.68–15.2) were risk factors for stage 2 or more severe ARONJ. ARONJ should be considered during long-term BMA administration in prostate cancer patients with bone metastases.

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Section: Discussionmentioning

confidence: 99%

Cumulative Incidence and Risk Factors for Anti-Resorptive Agent-Related Osteonecrosis of the Jaw during Long-Term Prostate Cancer Management

Tani,

Hatano,

Yoshimura

et al. 2024

Preprint

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“…As a matter of fact, different results emerged from the ERA-223 [41] and the EORTC 1333/PEACE [42] phase III studies. In these trials, the new radiopharmaceutical's role has been debunked; in fact, to limit the risk of pathological fractures, radium-223 should not be administered together with classical BTAs and abiraterone plus prednisone or enzalutamide [42,43].…”

Section: Bone Targeting Agents In Hormone Sensitive and Castration Re...mentioning

confidence: 99%

“…According to the latest guidelines on skeletal metastases management, ZA should be administered endovenously at the dose of 4 mg every 4 weeks even if 12-weekly schedule does not seem to be inferior to standard administration in terms of reducing the risk of skeletal events [43][44][45]. On the other hand, denosumab should be given subcutaneously every 28 days at the dose of 120 mg. As for ZA, the 12-weekly schedule is an alternative treatment strategy [45].…”

Section: Bone Targeting Agents In Hormone Sensitive and Castration Re...mentioning

confidence: 99%

Bone Targeting Agents in Patients with Prostate Cancer: General Toxicities and Osteonecrosis of the Jaw

et al. 2022

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Introduction: Bone metastases are the most frequent site of secondary localization of prostate cancer (PCa) and are present in about 90% of cases of advanced disease. Consequently, an adequate management of bone involvement is of pivotal importance in the therapeutic approach and skeletal-related events (SREs) need to be closely monitored and promptly assessed and treated. Bone targeting agents (BTAs), consisting in bisphosphonates and denosumab, are an essential part of the treatment of metastatic prostate cancer that accompanies systemic treatments throughout the most part of the history of the disease. Activity and safety of bone targeting agents: These treatments are correlated to better outcomes in terms of reduction of SREs and, in metastatic castration resistant setting, of increased overall survival (OS), but several important adverse events have to be managed and prevented. Of these, osteonecrosis of the jaw (ONJ) is extremely invalidating and should be managed with a special attention. Discussion: The role of BTAs in prostate cancer is pivotal throughout many stages of the disease, but several toxicities should be quickly recognized and treated. We aim at recollecting evidence on clinical benefit of BTAs, common and specific toxicities, and explore the pathophysiology and clinical aspects of osteonecrosis of the jaw. We present a review of the literature to report the role of the different types of bone targeting agents in the management of prostate cancer with bone metastases with a particular focus on common toxicities and ONJ to recollect current evidences on the activity of these compounds and the correct management of their adverse events.

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“…In general clinical practice, high-dose BPs are intravenously administered every 4 weeks after the start of administration; however, recently published studies showed non-inferiority of 12-week versus 4-week schedules of BP administration 22 . The administration interval 23 and the need for switching BPs 24 are still controversial.…”

Section: Scientific Reportsmentioning

confidence: 99%

Quantitative bone single photon emission computed tomography analysis of the effects of duration of bisphosphonate administration on the parietal bone

Hata¹,

Kitao

Sato

et al. 2020

Sci Rep

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Effects of long-term bisphosphonate (BP) administration on the metabolism of healthy bone and the concomitant changes in imaging are unclear. Hence, we aimed to retrospectively investigate the effects of long-term BP administration on the intact parietal bone using the standardised uptake value (SUV) derived from single photon emission computed tomography (SPECT). We enrolled 29 patients who had odontogenic infection, osteoporosis, bone metastasis cancer, or rheumatoid arthritis, and classified them into BP-naïve: A (14 patients) and BP-treated: B, < 4 years (7 patients) and C, ≥ 4 years (8 patients) groups. We measured the maximum bilateral SUV (SUVmax) of the parietal bone using quantitative bone SPECT software. There were significant differences in the duration of BP administration and SUVmax of the parietal bone among the diseases (P < 0.0001 and P = 0.0086, respectively). There was a positive correlation between the duration of BP administration and SUVmax of the parietal bone (rs = 0.65, P = 0.0002). The SUVmax was significantly different between A and B (P = 0.02) and between A and C (P = 0.0024) groups. This is the first report on the correlation between long-term BP administration and the SUVmax of the parietal bone using the quantitative bone SPECT analysis.

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How do skeletal morbidity rate and special toxicities affect 12-week versus 4-week schedule zoledronic acid efficacy? A systematic review and a meta-analysis of randomized trials

Abstract: How do skeletal morbidity rate and special toxicities affect 12-week versus 4-week schedule zoledronic acid efficacy? A systematic review and a metaanalysis of randomized trials

Cited by 6 publications

References 18 publications

Cumulative Incidence and Risk Factors for Anti-Resorptive Agent-Related Osteonecrosis of the Jaw during Long-Term Prostate Cancer Management

Cumulative Incidence and Risk Factors for Anti-Resorptive Agent-Related Osteonecrosis of the Jaw during Long-Term Prostate Cancer Management

Bone Targeting Agents in Patients with Prostate Cancer: General Toxicities and Osteonecrosis of the Jaw

Quantitative bone single photon emission computed tomography analysis of the effects of duration of bisphosphonate administration on the parietal bone

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