Premium
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
Author(s) -
Khalafallah A.A.,
Slancar M.,
Cosolo W.,
Abdi E.,
Chern B.,
Woodfield R.J.,
Copeman M.C.
Publication year - 2018
Publication title -
european journal of cancer care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 67
eISSN - 1365-2354
pISSN - 0961-5423
DOI - 10.1111/ecc.12638
Subject(s) - medicine , zoledronic acid , osteonecrosis of the jaw , incidence (geometry) , prostate cancer , breast cancer , cancer , adverse effect , prospective cohort study , multiple myeloma , surgery , oncology , osteoporosis , bisphosphonate , physics , optics
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 ( SRE s), 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.