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
Affiliations
Wanyuan Cui
The 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 Phillips
The 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. Francis
The 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. Anderson
MRC Centre for Reproductive Health, University of Edinburgh, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK
Ann H. Partridge
Department of Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, USA
Sherene Loi
The 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 Loibl
German Breast Group, Martin Behaim Strasse 12, 63263, Neu-Isenburg, Germany; Centre for Haematology and Oncology, Bethanien, Im Prüfling 17, 60389, Frankfurt, Germany
Louise Keogh
Centre for Health Equity, The University of Melbourne, Parkville, VIC, 3010, Australia; Corresponding author.
Background: Detailed 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. Objectives: To determine the barriers to and facilitators of ovarian toxicity assessment in BC trials of anti-cancer drugs. Methods: Semi-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. Results: Saturation 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. Conclusion: Lack 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.
