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Long-term safety of monthly zoledronic acid therapy beyond 1 year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study.

ABSTRACT: Malignant bone disease can cause significant morbidity. Monthly zoledronic acid (ZOL) reduces skeletal complications; however, limited data are available regarding long-term safety. We aimed to assess efficacy and safety of ZOL beyond 1 year of treatment. We prospectively evaluated 73 patients; breast cancer (n = 29), castrate-resistant prostate cancer (n = 13), multiple myeloma (n = 31) from 2006 to 2008 in 19 cancer centres. All patients were diagnosed with bone disease and had completed 1-2 years of monthly ZOL (4 mg) and received a further 1-2 years of therapy following contemporary guidelines for managing risks of osteonecrosis of the jaw (ONJ) and renal toxicity. Overall rates of skeletal-related events (SREs), renal impairment and ONJ were assessed. Over the additional 1 year of treatment, only 5.5% (n = 4) of patients developed a new SRE. The overall Kaplan-Meier estimate for SRE incidence after 48 weeks on study was 6.75% (95 CI: 2.5-17.3). Although 51% of patients reported serious adverse events, only two cases were suspected as ZOL related. No patients had confirmed ONJ. The observed incidence of new renal impairment was 11% (none due to ZOL). Our study confirms the benefit over risk of continuing monthly ZOL for at least 2 years in patients with advanced cancer involving bone.

SUBMITTER: Khalafallah AA

PROVIDER: S-EPMC5901400 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Long-term safety of monthly zoledronic acid therapy beyond 1 year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study.

Khalafallah A A AA Slancar M M Cosolo W W Abdi E E Chern B B Woodfield R J RJ Copeman M C MC

European journal of cancer care 20170130 2

Malignant bone disease can cause significant morbidity. Monthly zoledronic acid (ZOL) reduces skeletal complications; however, limited data are available regarding long-term safety. We aimed to assess efficacy and safety of ZOL beyond 1 year of treatment. We prospectively evaluated 73 patients; breast cancer (n = 29), castrate-resistant prostate cancer (n = 13), multiple myeloma (n = 31) from 2006 to 2008 in 19 cancer centres. All patients were diagnosed with bone disease and had completed 1-2 y ...[more]

PMID: 28134499

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Project description:ObjectivesTo gain insight in the safety of direct active rehabilitation without immobilisation in patients undergoing reverse total shoulder arthroplasty without subscapularis reattachment, measured by the occurrence of complications until 1-year follow up. Next, to explore improvement in shoulder function and in patient-reported outcome measures.DesignAn international multicentre prospective cohort safety study.SettingPatients indicated for reverse total shoulder arthroplasty, visiting the orthopaedics outpatient clinic at two hospitals in the Netherlands and one hospital in Curaçao between January 2019 and July 2021, were selected.Participants100 patients (68% female, mean age 74±7.0 years) undergoing unilateral primary shoulder replacement were included if: ≥50 years, diagnosed with shoulder osteoarthritis, rotator cuff arthropathy or avascular necrosis, and selected for reverse total shoulder arthroplasty. A sling was used for only 1 day, followed by a progressive active rehabilitation for ≥12 weeks with no precautions.Main outcome measuresComplications, range of motion and patient-reported outcome measures (Oxford Shoulder Score, Pain Numeric Rating Scale and EuroQol-5D for quality of life). Patients were evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.ResultsIn total, 17 complications were registered (17.0%) including five (5.0%) categorised as potentially related to the rehabilitation strategy: one dislocation, one acromion fracture and three cases with persistent pain. Anteflexion, abduction and external rotation, pain scores and the Oxford Shoulder Score all improved significantly (p<0.05) at all time points compared with preoperative. Quality of life improved significantly from 3 months onwards. These secondary outcomes improved further until 1 year postoperatively.ConclusionDirect active rehabilitation after reverse total shoulder arthroplasty seems to be safe and effective. Potentially, this approach will lead to less dependent patients and faster recovery. Larger studies, preferably including a control group, should corroborate our results.Trial registration numberNL7656.

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Dataset Information

Long-term safety of monthly zoledronic acid therapy beyond 1 year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study.

Publications

Long-term safety of monthly zoledronic acid therapy beyond 1 year in patients with advanced cancer involving bone (LoTESS): A multicentre prospective phase 4 study.

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