Clinical and economic feasibility of a three-month goserelin formulation in breast cancer treatment

Cover Page

Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Hormone receptor-positive (luminal) subtypes account for up to 70 % of all breast cancer (BC) cases. Endocrine therapy is the mainstay of treatment for luminal BC. Ovarian function suppression is a type of endocrine therapy that significantly impacts treatment outcomes. Pharmacological ovarian suppression using gonadotropin-releasing hormone agonists, including goserelin, has become firmly established in routine clinical practice. Until recently, monthly drug formulations were preferred in BC treatment, in contrast to prostate cancer therapy. However, numerous comparative efficacy studies have demonstrated that the 3-month long-acting goserelin 10.8 mg formulation is non-inferior to the monthly formulation. Furthermore, it ensures higher patient adherence due to fewer clinic visits and contributes to improved BC outcomes. Additionally, the use of goserelin 10.8 mg enhances the quality of medical care, provides budget savings, and optimizes healthcare system resources.

About the authors

Olga O. Gordeeva

Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency

Author for correspondence.
Email: gordeeva.oo@yandex.ru
ORCID iD: 0009-0000-3757-5025
Russian Federation, 1a Malaya Pirogovskaya St., Moscow 119435

References

  1. Giaquinto A.N., Sung H., Miller K. et al. Breast cancer statistics, 2022. CA Cancer J Clin 2022;72(6):524–41. doi: 10.3322/caac.21754
  2. Luo L., Zhang Y., Zhan L. et al. Ovarian escape in premenopausal breast cancer: challenges and strategies for optimizing hormone suppression. Cancer Treat Rev 2025;139:102970. doi: 10.1016/j.ctrv.2025.102970
  3. Fornier M.N., Modi Sh., Panageas K. et al. Incidence of chemotherapy-induced, long-term amenorrhea in patients with breast carcinoma age 40 years and younger after adjuvant anthracycline and taxane. Cancer 2005;104:1575–9. doi: 10.1002/cncr.2138
  4. Kim H.A., Won Lee J., Jin Nam S. et al. Adding ovarian suppression to tamoxifen for premenopausal breast cancer: a randomized phase III trial. J Clin Oncol 2020;38:434–43. doi: 10.1200/JCO.19.00126
  5. The state of oncological care for the population of Russia in 2022. Ed. by A.D. Kaprin, V.V. Starinskiy, A.O. Shakhzadova. Moscow: MNIOI im. P.A. Gertsena – filial FGBU “NMIC radiologii” Minzdrava Rossii, 2022. 239 p. (In Russ.).
  6. Orrantia-Borunda E., Anchondo-Nuñez E., Evelia Acuña-Aguilar L. et al. Subtypes of breast cancer. In: Breast Cancer. Brisbane: Exon Publications, 2022. Chapter 3. Available at: https://www.ncbi.nlm.nih.gov/books/NBK583808/. doi: 10.36255/exon-publications-breast-cancer-subtypes
  7. Klijn J.G.M., de Jong F.H. Treatment with luteinising hormone releasing hormone analogue (Buserelin) in premenopausal patients with metastatic breast cancer. Lancet 1982;1(8283):1213–6. doi: 10.1016/s0140-6736(82)92339-x
  8. Robertson J.F., Blamey R.W. The use of gonadotrophin-releasing hormone (GnRH) agonists in early and advanced breast cancer in pre- and perimenopausal women. Eur J Cancer 2003;39:861–9.
  9. Chen N., Audi Blotta D., Jeong Kim H. et al. Efficacy of goserelin in ovarian function suppression and preservation for pre- and perimenopausal breast cancer patients: a systematic review. Ther Adv Med Oncol 2025;17:17588359251319696. doi: 10.1177/17588359251319696
  10. Arboleda B., Bartsch R., de Azambuja E. et al. Ovarian function suppression: a deeper consideration of the role in early breast cancer and its potential impact on patient outcomes: a consensus statement from an international expert panel. Oncologist 2022;27:722–31. doi: 10.1093/oncolo/oyac101
  11. Folkerd E.J., Lønning P.E., Dowsett M. Interpreting plasma estrogen levels in breast cancer: caution needed. J Clin Oncol 2014;32:1396–400.
  12. Dowsett M., Lønning P., Davidson N. Incomplete estrogen suppression with gonadotropin-releasing hormone agonists may reduce clinical efficacy in premenopausal women with early breast cancer. J Clin Oncol 2016;34:1580–3. doi: 10.1200/JCO.2015.62.3728
  13. Burstein H.J., Lacchetti C., Anderson H. et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO Clinical Practice Guideline focused update. J Clin Oncol 2019;37:423–38. doi: 10.1200/JCO.18.01160
  14. Fleege N.M.G., Li Y., Kidwell K. et al. Ovarian function suppression in premenopausal women with concurrent endocrine therapy use. Clin Breast Cancer 2023;23:454–60. doi: 10.1016/j.clbc.2023.03.009
  15. Demers L.M., Hankinson S., Haymond S. et al. Measuring estrogen exposure and metabolism: workshop recommendations on clinical issues. J Clin Endocrinol Metab 2015;100:2165–70. doi: 10.1210/jc.2015-1040
  16. Santen R.J., Demers L., Ohorodnik S. et al. Superiority of gas chromatography/tandem mass spectrometry assay (GC/MS/MS) for estradiol for monitoring of aromatase inhibitor therapy. Steroids 2007;72:666–71. doi: 10.1016/j.steroids.2007.05.003
  17. Lee J.S., Ettinger B., Stanczyk F. et al. Comparison of methods to measure low serum estradiol levels in postmenopausal women. J Clin Endocrinol Metab 2006;91:3791–7. doi: 10.1210/jc.2005-2378
  18. Hillebrand J.J., Wickenhagen W.V., Heijboer A.C. Improving science by overcoming laboratory pitfals with hormone measurements. J Clin Endocrinol Metab 2021;106:e1504–e12.
  19. Ball L.J., Palesh O., Kriegsfeld L.J. The pathophysiologic role of disrupted circadian and neuroendocrine rhythms in breast carcinogenesis. Endocr Rev 2016;37:450–66.
  20. Eisen A., Fletcher G.G., Gandhi S. et al. Optimal systemic therapy for early breast cancer in women: a clinical practice guideline. Curr Oncol 2015;22:S67–81. doi: 10.3747/co.22.2320
  21. Gnant M., Mlineritsch B., Stoeger H. et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol 2011;12:631–41. doi: 10.1016/S1470-2045(11)70122-X
  22. Kaufmann M., Untch M., Volz J. et al. A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer – GABG-IV B-93. Eur J Cancer 2007;43:2351–8. doi: 10.1016/j.ejca.2007.08.014
  23. Paluch-Shimon S., Cardoso F., Partridge A.H. et al. ESO-ESMO fifth international consensus guidelines for breast cancer in young women (BCY5). Ann Oncol 2022;33:1097–118. doi: 10.1016/j.annonc.2022.07.007
  24. Kim HJ., Lee J., Lee S. et al. Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: an ASTRRA study report. Eur J Cancer 2021;151:190–200. doi: 10.1016/j.ejca.2021.04.012
  25. McCann K.E., Pistilli B., Bellet M. et al. Selection of appropriate biomarkers to monitor effectiveness of ovarian function suppression in pre-menopausal patients with ER+ breast cancer. NPJ Breast Cancer 2024;10(1):8. doi: 10.1038/s41523-024-00614-w
  26. Swain S.M., Jeong J.H., Wolmark N. Amenorrhea from breast cancer therapy – not a matter of dose. N Engl J Med 2010;363(23):2268–70.
  27. Francis P.A., Pagani O., Fleming G.F. et al. Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer. Ann Oncol 2026:S0923-7534(26)00888-4.
  28. Cardoso F., Paluch-Shimon S., Schumacher-Wulf E. et al. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). Breast 2024;76:103756. doi: 10.1016/j.breast.2024.103756
  29. Tyulyandin S.A., Artamonova E.V., Zhigulev A.N. et al. Breast cancer. RUSSCO clinical guidelines, part 1.2. Zlokachestvennye opukholi = Malignant Neoplasms 2025;15(3s2):35–83. (In Russ.).
  30. Molinelli C., Sini G., Canepa M. et al. Ovarian suppression: early menopause and late effects. Curr Treat Options Oncol 2024;25(4):523–42. doi: 10.1007/s11864-024-01190-8
  31. Moore H.C.F., Unger J.M., Phillips K.A. et al. Final analysis of the prevention of early menopause study (POEMS)/SWOG Intergroup S0230. JNCI J Natl Cancer Inst 2019;111(2):210–3.
  32. Lambertini M., Derchi L., Cinquini M. et al. Temporary ovarian suppression during chemotherapy to preserve ovarian function and fertility in breast cancer patients: a GRADE approach for evidence evaluation and recommendations by the Italian Association of Medical Oncology. Eur J Cancer 2017;1990(71): 25–33. doi: 10.1016/j.ejca.2016.10.034
  33. Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women. Available at: https://clinicaltrials.gov/study/NCT00322348.
  34. Noguchi S., Kim H.J., Jesena A. et al. Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer. Breast Cancer 2016;23(5):771–9.
  35. Masuda N., Iwata H., Rai Y. et al. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer. Breast Cancer Res Treat 2011;126(2):443–51.
  36. Blotta D.A., Gomes R., Faroni L. et al. Efficacy of ovarian function suppression of 3-monthly versus monthly GnRH agonist as endocrine therapy for premenopausal breast cancer patients. J Clin Oncol 2023;41:527. doi: 10.1200/JCO.2023.41.16_suppl.527
  37. Wu H., Bian L., Xie J. et al. Goserelin 3-monthly depot is noninferior to goserelin monthly depot in the treatment of breast cancer: a real-world evidence study. ESMO Open 2023;8(Suppl 4):101335.
  38. Wang Y., Chen N., Zhang Q. et al. Real-world effectiveness of goserelin 10.8-mg compared to goserelin 3.6-mg in premenopausal and perimenopausal Chinese patients with hormone receptor positive breast cancer: a cohort study. J Nat Cancer Center 2025;5(3):180–7. doi: 10.1016/j.jncc.2025.02.001
  39. El Zawawy S.F., Khedr G. Efficacy and feasibility of long acting every three months goserelin for premenopausal breast cancer patients during COVID pandemic. Ann Oncol 2022;33:S631
  40. McCann K.E., Osman N., Cannon J. et al. Goserelin 3-month depot shows non-inferiority to the monthly formulation in U.S. patients with premenopausal breast cancer: a real-world evidence study. Breast Cancer Res Treat 2025;211(2):409–19. doi: 10.1007/s10549-025-07656-z
  41. McCann K.E., Osman N., Cannon J. et al. Treatment patterns of goserelin 3.6 mg once every 4 weeks and 10.8 mg once every 12 weeks in women with breast cancer: a real-world analysis of patients in the United States. JCO Oncol Pract 2025;21(5): 385–94. doi: 10.1200/OP.24.00655
  42. Reis P.C.A., Gomes R., Faroni L. et al. Three-monthly gonadotropin-releasing hormone agonist for ovarian function suppression in premenopausal breast cancer: a systematic review and meta-analysis. J Clin Oncol 2026;44(16 Suppl):542. doi: 10.1200/JCO.2026.44.16_suppl.542
  43. LeVasseur N., St-Pierre F., Gandhi S. et al. Overview of long-acting GnRH agonists in premenopausal breast cancer patients: survivorship challenges and management. Curr Oncol 2024;31(8):4209–24. doi: 10.3747/co31080315

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

Copyright (c) 2026 ABV-Press

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: серия ПИ № ФС 77 - 36991 от  21.07.2009.