Evidence map›Paper›PMID 28134499›Full record

Trial reportEuropean journal of cancer care2018

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.

A A Khalafallah, M Slancar, W Cosolo, E Abdi, B Chern, R J Woodfield, M C Copeman

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyObservational Study
In one paragraph

Trial report in European journal of cancer care, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 38% of its field
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

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. 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

7 authors at 6 institutions in 2 countries.

A A KhalafallahLaunceston General Hospital, Launceston, TAS., Australia.ORCID http://orcid.org/0000-0002-2399-3311
M SlancarHaematology & Oncology Clinics of Australia - Southport, Southport, Qld, Australia.
W CosoloJohn Fawkner Cancer Trial Centre, Coburg, Vic., Australia.
E AbdiGriffith University, The Tweed Hospital, Tweed Heads, NSW, Australia.
B ChernRedcliffe Hospital, Redcliffe, Qld, Australia.
R J WoodfieldNovartis Pharmaceuticals Australia Pty Ltd, North Ryde, NSW, Australia.
M C CopemanManly Hospital, Manly, NSW, Australia.
Cancer Trials Australia · AUGriffith University · AUManly Hospital · AUNovartis (Switzerland) · CHRedcliffe Hospital · AUUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AgedAged, 80 and overBone Density Conservation AgentsBone DiseasesDiphosphonatesFemaleHumansImidazolesKaplan-Meier EstimateLongitudinal StudiesMaleMiddle AgedNeoplasmsProspective StudiesZoledronic AcidBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic Acidbone metastasislong-term safetyosteonecrosis of the jawrenal impairmentzoledronic acid

Identifiers

PMID28134499
PMCPMC5901400
OpenAlexW2579930291

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.