Evidence map›Paper›PMID 39083190›Full record

Trial reportBreast cancer research and treatment2024

A randomised trial comparing 6-monthly adjuvant zoledronate with a single one-time dose in patients with early breast cancer.

Arif Ali Awan, Carol Stober, Gregory R Pond, Igor Machado, Lucas Clemons, Henry Conter, Demetrios Simos, Sukhbinder Dhesy-Thind, Mihaela Mates, Vikaash Kumar and 6 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Arif Ali AwanDivision of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Carol StoberCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Gregory R PondEscarpment Cancer Research Institute and McMaster University, Hamilton, Canada.
Igor MachadoDivision of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Lucas ClemonsCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Henry ConterWilliam Osler Cancer Centre and Department of Oncology, Brampton, Canada.
Demetrios SimosStronach Regional Cancer Center, Newmarket, Canada.
Sukhbinder Dhesy-ThindEscarpment Cancer Research Institute and McMaster University, Hamilton, Canada.
Mihaela MatesDepartment of Oncology, Cancer Centre of Southeastern Ontario and Queen's University, Kingston, Canada.
Vikaash KumarShakir Rehmatullah Cancer Clinic, Markham Stouffville Hospital, Markham, Canada.
John HiltonDivision of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Marie-France SavardDivision of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Dean FergussonClinical Epidemiology, Ottawa Hospital Research Institute and Departments of Medicine, Surgery, and the School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
Lisa VandermeerCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Mark ClemonsDivision of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. mclemons@toh.ca.
REaCT Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWhile adjuvant bisphosphonate use in early breast cancer (EBC) is associated with improvements in breast cancer-specific outcomes, questions remain around optimal bisphosphonate type, dose and scheduling. We evaluated a single zoledronate infusion in a prospective randomised trial.

methodsPostmenopausal patients with EBC were randomised to receive a single infusion of zoledronate (4 mg IV) or 6-monthly treatment for 3 years. Outcomes measured were; Quality of Life (QoL; EQ-5D-5L), bisphosphonate-related toxicities, including acute phase reactions (APRs), recurrence-free survival (RFS), bone metastasis-free survival (BMFS) and overall survival (OS).

results211 patients were randomized to either a single infusion (n = 107) or six-monthly treatment (n = 104). After 3 years of follow up there were no significant differences between the arms for QoL and most toxicity endpoints. APRs following zoledronate occurred in 81% (171/211) of patients (77.6% in single infusion arm and 84.6% in the 6-monthly group). While the frequency of APRs decreased over 3 years in the 6-monthly arm, they still remain common. Of 34/104 (32.7%) patients who discontinued zoledronate early in the 6-monthly treatment group, the most common reason was APRs (16/34, 47%). At the 3 year follow up, there were no differences between arms for RFS, BMFS or OS.

conclusionA single infusion of zoledronate was associated with increased patient convenience, less toxicity, and lower rates of treatment discontinuation. Despite the common clinical impression that APRs decrease with time, this was not observed when patients were specifically questioned. While the study is not powered for non-inferiority, longer-term follow-up for confirmation of RFS and OS rates is ongoing.

Indexed as

Bone Density Conservation AgentsBreast NeoplasmsQuality of LifeZoledronic AcidAdultAgedAged, 80 and overChemotherapy, AdjuvantDiphosphonatesDrug Administration ScheduleFemaleHumansMiddle AgedNeoplasm StagingProspective StudiesTreatment OutcomeBone Density Conservation AgentsDiphosphonatesZoledronic AcidAdjuvantBisphosphonatesBreast cancerZoledronate

Identifiers

PMID39083190
PMCPMC11522049

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.