Evidence map›Paper›PMID 35597179›Full record

ArticleBreast (Edinburgh, Scotland)2022

Understanding the barriers to, and facilitators of, ovarian toxicity assessment in breast cancer clinical trials.

Wanyuan Cui, Kelly-Anne Phillips, Prudence A Francis, Richard A Anderson, Ann H Partridge, Sherene Loi, Sibylle Loibl, Louise Keogh

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast (Edinburgh, Scotland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Fertility in breast cancer survivorship: a scoping review.Journal of cancer survivorship : research and practice · 2026
    Review
  2. Review
  3. Review
  4. Cancer Treatment-Related Ovarian Dysfunction in Women of Childbearing Potential: Management and Fertility Preservation Options.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  5. 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

8 authors at 4 institutions in 4 countries.

Wanyuan CuiThe Sir Peter MacCallum Department of Oncology, The University of Melbourne, 305 Grattan St, Melbourne, 3000, VIC, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.
Kelly-Anne PhillipsThe Sir Peter MacCallum Department of Oncology, The University of Melbourne, 305 Grattan St, Melbourne, 3000, VIC, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia; Breast Cancer Trials Australia New Zealand (BCT-ANZ), Level 4, 175 Scott St, Newcastle, 2300, NSW, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Prudence A FrancisThe Sir Peter MacCallum Department of Oncology, The University of Melbourne, 305 Grattan St, Melbourne, 3000, VIC, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia; Breast Cancer Trials Australia New Zealand (BCT-ANZ), Level 4, 175 Scott St, Newcastle, 2300, NSW, Australia.
Richard A AndersonMRC Centre for Reproductive Health, University of Edinburgh, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK.
Ann H PartridgeDepartment of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA.
Sherene LoiThe Sir Peter MacCallum Department of Oncology, The University of Melbourne, 305 Grattan St, Melbourne, 3000, VIC, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia; Division of Research, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.
Sibylle LoiblGerman Breast Group, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany; Centre for Haematology and Oncology, Bethanien, Im Prüfling 17, 60389, Frankfurt, Germany.
Louise KeoghCentre for Health Equity, The University of Melbourne, Parkville, VIC, 3010, Australia. Electronic address: l.keogh@unimelb.edu.au.
The University of Melbourne · AUCardiovascular Center Bethanien · DEDana-Farber Cancer Institute · USMRC Centre for Reproductive Health · GB

Funding

Medical Research Council MR/W019140/1
6 · The paper itself

Abstract

backgroundDetailed toxicity data are routinely collected in breast cancer (BC) clinical trials. However, ovarian toxicity is infrequently assessed, despite the adverse impacts on fertility and long-term health from treatment-induced ovarian insufficiency.

objectivesTo determine the barriers to and facilitators of ovarian toxicity assessment in BC trials of anti-cancer drugs.

methodsSemi-structured interviews were conducted with purposively selected stakeholders from multiple countries involved in BC clinical trials (clinicians, consumers, pharmaceutical company representatives, members of drug-regulatory agencies). Participants were asked to describe the perceived benefits and barriers to evaluating ovarian toxicity. Interviews were transcribed verbatim, coded in NVivo software and analysed using inductive thematic analysis.

resultsSaturation of the main themes was reached and the final sample size included 25 participants from 14 countries (9 clinicians, 7 consumers, 5 members of regulatory agencies, 4 pharmaceutical company representatives); half were female. The main reported barrier to ovarian toxicity assessment was that the issue was rarely considered. Reasons included that these data are less important than survival data and are not required for regulatory approval. Overall, most participants believed evaluating the impact of BC treatments on ovarian function is valuable. Suggested strategies to increase ovarian toxicity assessment were to include it in clinical trial design guidelines and stakeholder advocacy.

conclusionLack of consideration about measuring ovarian toxicity in BC clinical trials that include premenopausal women suggest that guidelines and stronger advocacy from stakeholders, including regulators, would facilitate its more frequent inclusion in future trials, allowing women to make better informed treatment decisions.

Indexed as

Antineoplastic AgentsBreast NeoplasmsClinical Trials as TopicOvaryFemaleHumansPremenopauseQualitative ResearchResearch DesignAntineoplastic AgentsBreast cancerClinical trialsFertilityMenopauseOvarian insufficiencyQualitative research

Identifiers

PMID35597179
PMCPMC9127191
OpenAlexW4280620970

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.