Academic Journal
Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
| العنوان: | Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer |
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| المؤلفون: | Arif Awan, Terry Ng, Henry Conter, William Raskin, Carol Stober, Demetrios Simos, Greg Pond, Sukhbinder Dhesy-Thind, Mihaela Mates, Vikaash Kumar, Dean Fergusson, Brian Hutton, Deanna Saunders, Lisa Vandermeer, Mark Clemons |
| المصدر: | Journal of Bone Oncology, Vol 26, Iss , Pp 100343- (2021) |
| بيانات النشر: | Elsevier, 2021. |
| سنة النشر: | 2021 |
| المجموعة: | LCC:Diseases of the musculoskeletal system LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: | Breast cancer, Zoledronate, Adjuvant bisphosphonate, Diseases of the musculoskeletal system, RC925-935, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: | Background: Adjuvant zoledronate is widely used in patients with early stage breast cancer (EBC), but its optimal duration and dosing interval is still unknown. While a single-dose of zoledronate can improve bone density for many years, a proper evaluation of its effects on breast cancer-related outcomes would require a large trial. In this pilot study we evaluated the feasibility of performing such a trial. Methods: Eligible patients with EBC were randomised to receive either one dose of zoledronate or 7 doses (6-monthly dosing for 3 years). Feasibility was assessed by a combination of primary outcomes including: activation of at least 6 Ontario sites within a year, active participation (i.e. approaching eligible patients for study participation) of at least half of the medical oncologists, and enrolment of at least 100 patients across all sites within 9 months of the sixth site being activated. Results: All 6 sites were activated within 1 year and of 47 medical oncologists, 27 (57%) approached patients. Between November 2018 and April 2020, 211 eligible patients were randomised, 106 (50.2%) to a single dose of zoledronate and 105 (49.8%) to 6-monthly dosing. Baseline characteristics of randomised patients included; median age 59 (range 36–88), ER and/or PR positive (85%), Her2 positive (23%), menopausal status (premenopausal [19%], perimenopausal [6.7%] and postmenopausal [74%]) and 74% received neo/adjuvant chemotherapy. Conclusions: All study feasibility endpoints were met in this trial comparing alternative schedules for adjuvant zoledronate. We will now seek funding for performing a larger efficacy trial.Trial registration: NCT03664687. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2212-1374 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2212137420300981; https://doaj.org/toc/2212-1374 |
| DOI: | 10.1016/j.jbo.2020.100343 |
| URL الوصول: | https://doaj.org/article/9cbee11243204b0a8c3c062e7a1485a9 |
| رقم الانضمام: | edsdoj.9cbee11243204b0a8c3c062e7a1485a9 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 22121374 |
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| DOI: | 10.1016/j.jbo.2020.100343 |