Intermediate results of the prospective randomized controlled trial VOG-01: "Evaluation of the efficacy of neoadjuvant combination hormone therapy in premenopausal patients with ER+ HER2- breast cancer".
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Keywords

ER HER2- breast cancer
neoadjuvant chemotherapy
neoadjuvant hormone therapy
CDK4/6 inhibitors
premenopausal patients

How to Cite

Orlova, R., Topuzov , E., Krivorotko, P., Vakhitova, A., Gluzman, M., & Osidze, . L. (2022). Intermediate results of the prospective randomized controlled trial VOG-01: "Evaluation of the efficacy of neoadjuvant combination hormone therapy in premenopausal patients with ER+ HER2- breast cancer". Voprosy Onkologii, 68(3), 354–361. https://doi.org/10.37469/0507-3758-2022-68-3-354-361

Abstract

To date, the standard of care for neoadjuvant treatment of HER2-negative breast cancer remains chemotherapy with the inclusion of anthracyclines and taxanes in both luminal and triple-negative tumor subtypes. The purpose of this article was to scientifically substantiate the use of combined hormone therapy at the preoperative treatment of premenopausal patients with ER+ HER2- breast cancer. After analyzing the scientific data presented in scientific databases (PubMed, MEDLINE, BMS), as well as studying active clinical trials on the ClinicalTrials.gov, we concluded that most of the studies where hormone therapy was used in the preoperative regimen were conducted in the postmenopausal patient. In this regard, a randomized controlled clinical trial was initiated to study the efficacy and safety of a new method of preoperative treatment in premenopausal women with ER+ HER2- breast cancer, the preliminary results of which will be reported in this article. Currently, the study included 28 patients, of which 13 patients were analyzed who received the neoadjuvant and surgical stages of complex treatment. The research is ongoing.

https://doi.org/10.37469/0507-3758-2022-68-3-354-361
pdf (Русский)

References

DeVita V, Lawrence T, Rosenberg S et al. DeVita, Hellman, and Rosenberg’s Cancer: Principles and Practice of oncology. 8th ed. Philadelphia: J.B. Lippincott, 2008:1634.

Rubens R.D et al. Combined chemotherapy and radiotherapy for locally advanced breast cancer // Eur. J. Cancer. 1980;16(3):351–356.

von Minckwitz G et al. Response-guided neoadjuvant chemotherapy for breast cancer // J. Clin. Oncol. 2013;31(29):3623–3630.

Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer // Cochrane Database Syst. Rev. 2007(2), CD005002.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials // Lancet Oncol. 2018;19(1):27–39.

Gianni L, Baselga J, Eiermann W. et al. European Cooperative Trial in Operable Breast Cancer (ECTO): Improved freedom from progression (FFP) from adding paclitaxel (T) to doxorubicin (A) followed by cyclophosphamide methotrexate and fluorouracil (CMF) // J Clin Oncol. 2005;23(16_suppl):513.

Spring LM, Fell G, Arfe A et al. Pathologic Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-analysis // Clin Cancer Res. 2020;26(12):2838-2848. doi:10.1158/1078-0432.CCR-19-3492

Zhou Q, Yin W, Du Y et al. Prognostic impact of chemotherapy-induced amenorrhea on premenopausal breast cancer: a meta-analysis of the literature // Menopause. 2015;22(10):1091–97. doi:10.1097/GME.0000000000000440

Matthew J. Elliscorresponding author and Cynthia Ma, Letrozole in the neoadjuvant setting: the P024 trial // Breast Cancer Res Treat. 2007;105(Suppl 1):33–43. doi:10.1007/s10549-007-9701-x

Kurosumi M, Takatsuka Y, Watanabe T. Histopathological assessment of anastrozole and tamoxifen as preoperative (neoadjuvant) treatment in postmenopausal Japanese women with hormone receptor-positive breast cancer in the PROACT trial Randomized Controlled Trial // J Cancer Res Clin Oncol. 2008;134(6):715–22. doi:10.1007/s00432-007-0343-5

Семиглазов В.Ф., Семиглазов В.В., Манихас А.Г. и др. Неоадъювантная терапия гормонозависимого рака молочной железы // Злокачественные опухоли. 2012;2(2):6–11 [Semiglazov VF, Semiglazov VV, Manikhas AG et al. Neoadjuvant therapy for hormone-dependent breast cancer // Zlokachestvennye opukholi. 2012;2(2):6–11 (In Russ.)]. doi:10.18027/2224-5057-2012-2-6-11

Cottu P, D'Hondt V, Dureau S et al. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer // Ann Oncol. 2018;29(12):2334-2340. doi:10.1093/annonc/mdy448. PMID: 30307466

Torrisi R, Bagnardi V, Pruneri G. Antitumour and biological effects of letrozole and GnRH analogue as primary therapy in premenopausal women with ER and PgR positive locally advanced operable breast cancer // Br J Cancer. 2007;97(6):802–8. doi:10.1038/sj.bjc.6603947

Kim HJ, Noh WC, Lee ES et al. Efficacy of neoadjuvant endocrine therapy compared with neoadjuvant chemotherapy in pre-menopausal patients with oestrogen receptor-positive and HER2-negative, lymph node-positive breast cancer // Breast Cancer Res. 2020;22:54. doi:10.1186/s13058-020-01288-5

Masuda N, Sagara Y, Kinoshita T. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial Clinical Trial // Lancet Oncol. 2012;13(4):345–52. doi:10.1016/S1470-2045(11)70373-4

Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer, ClinicalTrials.gov Identifier: NCT03628066.

https://clinicaltrials.gov/ct2/show/NCT04753177.

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