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Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy

  • Clinical trial
  • Published:
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Abstract

Purpose

Sexual dysfunction is an important concern of premenopausal women with early breast cancer. We investigated predictors of sexual problems in two randomized controlled trials.

Methods

A subset of patients enrolled in TEXT and SOFT completed global and symptom-specific quality-of-life indicators, CES-Depression and MOS-Sexual Problems measures at baseline, six, 12 and 24 months. Mixed models tested the association of changes in treatment-induced symptoms (baseline to 6 months), depression at 6 months, and age at randomization with changes in sexual problems over 2 years.

Results

Sexual problems increased by 6 months and persisted at this level. Overall, patients with more severe worsening of vaginal dryness, sleep disturbances and bone or joint pain at 6 months reported a greater increase in sexual problems at all time-points. Depression scores were significantly associated with sexual problems in the short-term. All other symptoms had a smaller impact on sexual problems. Age was not associated with sexual problems at any time-point.

Conclusion

Among several key symptoms, vaginal dryness, sleep disturbance, and bone and joint pain significantly predicted sexual problems during the first 2 years. Early identification of these symptoms may contribute to timely and tailored interventions.

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Data availability

The data on which these analyses are based forms part of the clinical trials database of the International Breast Cancer Study Group, and as such is available for use on application in accordance with IBCSG data sharing policy.

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Acknowledgements

We thank the patients, physicians, nurses and trial coordinators who participated in the SOFT and TEXT clinical trials. The trials were coordinated by the International Breast Cancer Study Group (IBCSG), in collaboration with the Breast International Group (BIG), BIG cooperative groups, and US National Cancer Institute, National Clinical Trials Network cooperative groups.

Funding

SOFT and TEXT receive financial support for trial conduct from Pfizer, the International Breast Cancer Study Group, the US National Cancer Institute, the Breast Cancer Research Foundation (16-185, 17-187, 18-003), Ipsen, TerSera. Pfizer and Ipsen provided drug supply.

Support for the coordinating group, IBCSG: Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research (SAKK), Cancer Research Switzerland, Oncosuisse, Cancer League Switzerland, Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK). Grant support of cooperative groups: Breast Cancer Trials Australia & New Zealand [NHMRC 351161, 510788 and 1105058]; Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom (NCRI-BCSG—ICR-CTSU Partnership) [Cancer Research UK CRUKE/03/022, CRUKE/03/023, A15955; National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical Research Centre; and National Institute for Health Research/Cambridge Biomedical Research Centre; Alliance for Clinical Trials in Oncology [US NIH U10CA180821]; SWOG [US NIH CA32102]; ECOG-ACRIN Cancer Research Group [US NIH CA21115, CA16116]; NRG Oncology [US NIH grant numbers U10CA180868, U10CA180822, UG1CA189867]; Canadian Cancer Trials Group [US NIH CA077202; and Canadian Cancer Society Research Institute 015469, 021039].

Author information

Authors and Affiliations

  1. International Breast Cancer Study Group (IBCSG) Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland

    Karin Ribi, Aron Goldhirsch, Alan S. Coates & Jürg Bernhard

  2. IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA

    Weixiu Luo, Anita Giobbie-Hurder, Richard D. Gelber & Meredith M. Regan

  3. University of Calgary and Canadian Cancer Trials Group, Calgary, AB, Canada

    Barbara A. Walley

  4. Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA

    Harold J. Burstein

  5. Box Hill and Maroondah Hospitals, Monash University, Clayton, VIC, Australia

    Jacquie Chirgwin

  6. Breast Cancer Trials Australia & New Zealand, University of Newcastle, Callaghan, Australia

    Jacquie Chirgwin, Andre van der Westhuizen & Prudence A. Francis

  7. Norther Indiana Cancer Research Consortium, South Bend, USA

    Rafat H. Ansari

  8. Allan Blair Cancer Center, Regina, SK, Canada

    Muhammed Salim

  9. Calvary Mater Newcastle Hospital, Waratah, NSW, Australia

    Andre van der Westhuizen

  10. The Tweed Hospital, Griffith University Gold Coast, Tweed Heads, NSW, Australia

    Ehtesham Abdi

  11. Peter MacCallum Cancer Center, St Vincent’s Hospital, University of Melbourne, Melbourne, Australia

    Prudence A. Francis

  12. BCCA-Vancouver Cancer Center, Vancouver, BC, Canada

    Stephen Chia

  13. Auckland City Hospital, Auckland, New Zealand

    Vernon J. Harvey

  14. The University of Chicago Medical Center, Chicago, IL, USA

    Gini F. Fleming

  15. Institute of Oncology of Southern Switzerland, Geneva University Hospitals, Swiss Group for Clinical Cancer Research (SAKK), Lugano Viganello, Switzerland

    Olivia Pagani

  16. Hospital of Prato-AUSL Toscana Centro and International Breast Cancer Study Group, Prato, Italy

    Angelo Di Leo

  17. IEO, European Institute of Oncology IRCCS, Milan, Italy

    Marco Colleoni

  18. Harvard Medical School, Harvard University, Boston, MA, USA

    Richard D. Gelber & Meredith M. Regan

  19. Harvard TH Chan School of Public Health, Frontier Science and Technology Research Foundation, Boston, MA, USA

    Richard D. Gelber

  20. MultiMedica, Milan, Italy

    Aron Goldhirsch

  21. University of Sydney, Sydney, Australia

    Alan S. Coates

  22. Bern University Hospital, Inselspital, Bern, Switzerland

    Jürg Bernhard

Authors
  1. Karin Ribi
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  2. Weixiu Luo
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  3. Barbara A. Walley
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  4. Harold J. Burstein
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  5. Jacquie Chirgwin
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  6. Rafat H. Ansari
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  7. Muhammed Salim
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  8. Andre van der Westhuizen
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  9. Ehtesham Abdi
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  10. Prudence A. Francis
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  11. Stephen Chia
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  12. Vernon J. Harvey
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  13. Anita Giobbie-Hurder
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  14. Gini F. Fleming
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  15. Olivia Pagani
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  16. Angelo Di Leo
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  17. Marco Colleoni
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  18. Richard D. Gelber
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  19. Aron Goldhirsch
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  20. Alan S. Coates
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  21. Meredith M. Regan
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  22. Jürg Bernhard
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Contributions

Karin Ribi, Weixiu Luo, Prue Francis, Gini F. Fleming, Olivia Pagani, Barbara A. Wallley Richard D. Gelber, Aron Goldhirsch, Alan S. Coates, Meredith M. Regan, Jürg Bernhard—Conception and design. Barbara A. Walley, Harold J. Burstein, Michael J. Naughton, Jacquie Chirgwin, Rafat H. Ansari, Muhammed Salim, Andre van der Westhuizen, Ehtesham Abdi, Prudence A. Francis, Daniel R. Budman, Stephen Chia, Hagen Kennecke, Vernon J. Harvey, Anita Giobbie-Hurder, Gini F. Fleming, Olivia Pagani, Angelo Di Leo, Marco Colleoni, Richard D. Gelber, Aron Goldhirsch, Alan S. Coates, Meredith M. Regan—Collection and assembly of data. Barbara A. Walley, Harold J. Burstein, Michael J. Naughton, Jacquie Chirgwin, Rafat H. Ansari, Muhammed Salim, Andre van der Westhuizen, Ehtesham Abdi, Prudence A. Francis, Daniel R. Budman, Stephen Chia, Hagen Kennecke, Vernon J. Harvey, Anita Giobbie-Hurder, Gini F. Fleming, Olivia Pagani, Angelo Di Leo, Marco Colleoni, Richard D. Gelber, Aron Goldhirsch, Alan S. Coates, Meredith M. Regan—provision of study materials or patients. Karin Ribi, Weixiu Luo, Alan S. Coates, Richard D. Gelber, Meredith M. Regan, Jürg Bernhard—Data analysis and interpretation. All authors—Manuscript writing and final approval of manuscript.

Corresponding author

Correspondence to Karin Ribi.

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Conflict of interest

KR, WL, BAW, HJB, JC, RHA, MS, AvW, EA, VJH, AGH, OP, AG, ASC, and JB have nothing to disclose. PAF reports personal fees from AstraZeneca, personal fees from Novartis, outside the submitted work; and Presentation of SOFT and TEXT trial results for Pfizer and Ipsen at overseas meeting without receiving honorarium. SC reports grants from NCIC, during the conduct of the study. GFF reports personal fees from Up To Date and Vaniam Group, non-financial support from Corcept, other from Merck, Syndax, 47 Inc, Sanofi, Astex EMD Sereno, Roche/Genentech, Syros, Tesaro, Iovance, Sanofi, Ssermonix, Incyte, Compugen and Abbvie, outside the submitted work. AD reports personal fees from AstraZeneca, personal fees from Bayer, personal fees from Celgene, personal fees from Daichii-Sankyo, personal fees from Eisai, personal fees from Genentech, personal fees from Genomic Health, personal fees from Ipsen, personal fees from Lilly, grants and personal fees from Novartis, grants and personal fees from Pfizer, personal fees from Pierre Fabre, personal fees from Roche, personal fees from Seattle Genetics, outside the submitted work. MC reports personal fees from AstraZeneca, personal fees from Pierre Fabre, personal fees from Pfizer, personal fees from Novartis, personal fees from OBI Pharma, personal fees from Puma Biotechnology, personal fees from Celldex, outside the submitted work. RDG reports grants from Pfizer, grants from Ipsen, grants from AstraZeneca, during the conduct of the study; grants from Roche, grants from Merck, grants from Celgene, grants from Ferring, grants from Novartis, outside the submitted work. MMR reports grants and non-financial support from Pfizer, non-financial support and other from Ipsen, during the conduct of the study; grants and non-financial support from Research funding to the IBCSG (and/or provision of drug supply for clinical trials) from Novartis, Pfizer, Ipsen, TerSera, Merck, Ferring, Pierre Fabre, Roche, AstraZeneca, grants from Bayer, grants and personal fees from Bristol-Myers Squibb, outside the submitted work.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Ethics committees and appropriate national health authorities from each center approved the protocol, and all patients provided written informed consent as part of the informed consent for the main trial. This manuscript does not contain any individual person’s data in any form.

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Trial Registration: clinicaltrials.gov NCT00066703 (TEXT) and NCT00066690 (SOFT).

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Ribi, K., Luo, W., Walley, B.A. et al. Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy. Breast Cancer Res Treat 181, 347–359 (2020). https://doi.org/10.1007/s10549-020-05622-5

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  • DOI: https://doi.org/10.1007/s10549-020-05622-5

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