Assessing the effectiveness of instrumental diagnostics and pathogenetic therapy in patients with benign breast dysplasia
Meskikh E.V., Ashrafyan L.A.
Objective: To assess the effectiveness of instrumental methods of breast examination in the diagnosis of benign breast diseases (BBD) according to the 2024 clinical guidelines. To evaluate the effectiveness of the Indinol Forto medication in patients with mastalgia according to the visual analogue scale (VAS) for pain.
Materials and methods: This paper presents the results of data analysis of 895 female patients aged 20 to 50 years diagnosed with BBD with mastalgia of varying severity. All the patients were examined at the Russian Scientific Center of Roentgen Radiology, Moscow, from January to December 2024. The evaluation of the patients’ condition was based on a comprehensive approach, including clinical examination, VAS pain assessment and instrumental studies (mammography, ultrasound with colour Doppler mapping (CDM) and elastography, MRI with contrast agents, core (trephine) biopsy of breast masses with subsequent histological examination depending on age and indications). The results of instrumental studies were evaluated according to the Breast Imaging Reporting and Data System (BI-RADS) classification on a scale from 1 to 5, including tissue density assessment by the ACR classification (for mammography). Following the results of the study, treatment with Indinol Forto (indolcarbinol) was recommended to patients with BBD with mastalgia of varying severity according to the VAS scale.
Results: Women with BBD aged 20 to 50 years most commonly have high radiological tissue density (ACR types C and D); the cystic component was predominant on breast ultrasound examination. Therapy with indolcarbinol has a positive effect on reducing the intensity of pain syndrome (mastodynia) within 6 months after treatment. There was a decrease in tissue density on mammograms and a decrease in the cystic component on ultrasound examination after completing the course of therapy.
Conclusion: High radiological tissue density and hormonal instability are risk factors for breast cancer. Indolcarbinol is effective as a first-line therapy for patients with cyclic mastalgia in BBD and it is included in the clinical guidelines of the Ministry of Health of the Russian Federation.
Authors’ contributions: Meskikh E.V., Ashrafyan L.A. – developing the research design, obtaining data for analysis, review of publications on the topic of the article, statistical analysis of the obtained data, writing the text of the article.
Conflicts of interest: Authors declare lack of the possible conflicts of interest.
Funding: The study was conducted without sponsorship.
Patient Consent for Publication: The patients provided an informed consent for the publication of their data and associated images.
For citation: Meskikh E.V., Ashrafyan L.A. Assessing the effectiveness of instrumental diagnostics and
pathogenetic therapy in patients with benign breast dysplasia.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (4): 146-156 (in Russian)
https://dx.doi.org/10.18565/aig.2025.103
Keywords
radiological breast density
cystic component on ultrasound examination
breast imaging
density quantification
American College of Radiologists Breast Imaging Reporting and Data System
BI-RADS
benign breast diseases
indolcarbinol
Indinol Forto
References
- Высоцкая И.В., Летягин В.П., Черенков В.Г., Лактионов К.П., Бубликов И.Д. Клинические рекомендации Российского общества онкомаммологов по профилактике рака молочной железы, дифференциальной диагностике, лечению предопухолевых и доброкачественных заболеваний молочных желез. Опухоли женской репродуктивной системы. 2016; 12(3): 43-52. [Vysotskaya I.V., Letyagin V.P., Cherenkov V.G., Bublikov I.D., Laktionov K.P. Clinical guidelines of the Russian Society of Oncomammologists for the prevention of breast cancer, differential diagnosis, treatment of precancerous and benign breast diseases. Tumors of female reproductive system. 2016; 12(3): 43-52. (in Russian)].
- Heer E., Ruan Y., Mealey N., Quan M.L., Brenner D.R. The incidence of breast cancer in Canada 1971-2015: trends in screening-eligible and young-onset age groups. Can. J. Public Health. 2020; 111(5): 787-93. https://dx.doi.org/10.17269/s41997-020-00305-6.
- Xia C., Dong X., Li H., Cao M., Sun D., He S. et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin. Med. J. (Engl.). 2022; 135(5): 584-90. https://dx.doi.org/10.1097/CM9.0000000000002108.
- Jagsi R., Mason G., Overmoyer B.A., Woodward W.A., Badve S., Schneider R.J. et al.; Komen-IBCRF IBC Collaborative in partnership with the Milburn Foundation. Inflammatory breast cancer defined: proposed common diagnostic criteria to guide treatment and research. Breast Cancer Res. Treat. 2022; 192(2): 235-43. https://dx.doi.org/10.1007/s10549-021-06434-x.
- Меских Е.В., Ашрафян Л.А. Патогенетическая терапия доброкачественной дисплазии молочных желез Акушерство и гинекология. 2024; 9: 164-73. [Meskikh E.V., Ashrafyan L.A. Pathogenetic therapy of benign breast dysplasia. Obstetrics and Gynecology. 2024; (9): 164-73 (in Russian)]. https://dx.doi.org/10.18565/aig.2024.238.
- Yeh E.D. Invited commentary: update on mammographic breast density and supplemental screening for breast cancer. Radiographics. 2023; 43(10): e230183. https://dx.doi.org/10.1148/rg.230183.
- Министерство здравоохранения Российской Федерации. Клинические рекомендации. Доброкачественная дисплазия молочной железы. 2024. [Ministry of Health of the Russian Federation. Clinical guidelines. Benign breast dysplasia. 2024. (in Russian)].
- Plu-Bureau G., Lê MG, Sitruk-Ware R., Thalabard J.C. Cyclical mastalgia and breast cancer risk: results of a French cohort study. Cancer Epidemiol. Biomarkers Prev. 2006; 15(6): 1229-31. https://dx.doi.org/10.1158/1055-9965.EPI-05-0745.
- Sinha T. Tumors: benign and malignant. Cancer Ther. Oncol. Int. J. 2018; 10(3): 555790. https://dx.doi.org/10.19080/CTOIJ.2018.10.555790.
- Stachs A., Stubert J., Reimer T., Hartmann S. Benign breast disease in women. Dtsch. Arztebl. Int. 2019; 116(33-34): 565-74. https://dx.doi.org/10.3238/arztebl.2019.0565.
- Bodewes F.T.H., van Asselt A.A., Dorrius M.D., Greuter M.J.W., de Bock G.H. Mammographic breast density and the risk of breast cancer: A systematic review and meta-analysis. Breast. 2022; 66: 62-8. https://dx.doi.org/10.1016/j.breast.2022.09.007.
- Brandt K.R., Scott C.G., Ma L., Mahmoudzadeh A.P., Jensen M.R., Whaley D.H. et al. Comparison of clinical and automated breast density measurements: Implications for risk prediction and supplemental screening. Radiology. 2016; 279(3): 710-9. https://dx.doi.org/10.1148/radiol.2015151261.
- Obeagu E.I., Ahmed Y.A., Obeagu G.U., Bunu U.O., Ugwu O.P.C., Alum E.U. Biomarkers of breast cancer: overview. Int. J. Curr. Res. Biol. Med. 2023; 8(1): 8-16. https://dx.doi.org/10.22192/ijcrbm.2023.08.01.002.
- Magny S.J., Shikhman R., Keppke A.L. Breast Imaging Reporting and Data System. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–.
- Acciavatti R.J., Lee S.H., Reig B., Moy L., Conant E.F., Kontos D. et al. Beyond breast density: risk measures for breast cancer in multiple imaging modalities. Radiology. 2023; 306(3): e222575. https://dx.doi.org/10.1148/radiol.222575.
- Alomaim W., O’Leary D., Ryan J., Rainford L., Evanoff M., Foley S. Subjective versus quantitative methods of assessing breast density. Diagnostics. 2020; 10(5): 331. https://dx.doi.org/10.3390/diagnostics10050331.
- Bissell M.C.S., Kerlikowske K., Sprague B.L., Tice J.A., Gard C.C., Tossas K.Y. et al.; Breast Cancer Surveillance Consortium. Breast Cancer population attributable risk proportions associated with body mass index and breast density by race/ethnicity and menopausal status. Cancer Epidemiol. Biomarkers Prev. 2020; 29(10): 2048-56. https://dx.doi.org/10.1158/1055-9965.EPI-20-0358.
- Edmonds C.E., O'Brien S.R., Conant E.F. Mammographic breast density: current assessment methods, clinical implications, and future directions. Semin. Ultrasound CT MR. 2023; 44(1): 35-45. https://dx.doi.org/10.1053/j.sult.2022.11.001.
- Kataoka M. Mammographic density for personalized breast cancer risk. Radiology. 2023; 306(2): e222129. https://dx.doi.org/10.1148/radiol.222129.
- Mann R.M., Athanasiou A., Baltzer P.A.T., Camps-Herrero J., Clauser P., Fallenberg E.M. et al.; European Society of Breast Imaging (EUSOBI). Breast cancer screening in women with extremely dense breasts recommendations of the European Society of Breast Imaging (EUSOBI). Eur. Radiol. 2022; 32(6): 4036-45. https://dx.doi.org/10.1007/s00330-022-08617-6.
- American College of Radiology (ACR). ACR-BI-RADS®--5th Edition. ACR Breast Imaging Reporting and Data System, Breast Imaging Atlas; BI-RADS. Reston, VA: American College of Radiology; 2014.
- O'Driscoll J., Burke A., Mooney T., Phelan N., Baldelli P., Smith A. et al. A scoping review of programme specific mammographic breast density related guidelines and practices within breast screening programmes. Eur. J. Radiol. Open. 2023; 11: 100510. https://dx.doi.org/10.1016/j.ejro.2023.100510.
- Seely J.M., Peddle S.E., Yang H., Chiarelli A.M., McCallum M., Narasimhan G. et al. Breast density and risk of interval cancers: The effect of annual versus biennial screening mammography policies in Canada. Can. Assoc. Radiol. J. 2022; 73(1): 90-100. https://dx.doi.org/10.1177/08465371211027958.
- Инструкция по медицинскому применению лекарственного препарата ИндинолФорто®. РУ № ЛП 002010. [Instructions for the medical use of the drug Indinol Forto®. RU No. LP 002010. (in Russian)].
- Ашрафян Л.А., Рожкова Н.И., Прокопенко С.П., Меских Е.В., Артымук Н.В., Белоцерковцева Л.Д., Долгушина В.Ф., Коротких Н.В., Кузнецова Л.В., Кукарская И.И., Кононенко Т.С., Марочко Т.Ю., Соколов К.А., Вербицкая Ю.С. Влияние препарата индолкарбинола на течение циклической масталгии на фоне доброкачественной дисплазии молочной железы в условиях рутинной клинической практики (исследование «АФРОДИТА»). Акушерство и гинекология. 2024; 2: 134-42. [Ashrafyan L.A., Rozhkova N.I., Prokopenko S.P., Meskikh E.V., Artymuk N.V., Belotserkovtseva L.D., Dolgushina V.F., Korotkikh N.V., Kuznetsova L.V., Kukarskaya I.I., Kononenko T.S., Marochko T.Yu., Sokolov K.A., Verbitskaya Yu.S. The effect of the indolcarbinol on cyclic mastalgia in benign mammary dysplasia in routine clinical practice (“APHRODITE” study). Obstetrics and Gynecology. 2024; (2): 134-42 (in Russian)]. https://dx.doi.org/10.18565/aig.2024.35.
- Кравченко Е.Н., Набока М.В. Лечение диффузных доброкачественных заболеваний молочной железы. Акушерство и гинекология. 2023; 2: 140-5. [Kravchenko E.N., Naboka M.V. Treatment for diffuse benign breast diseases. Obstetrics and Gynecology. 2023; (2): 140-5. (in Russian)]. https://dx.doi.org/10.18565/aig.2023.25.
- Edward U., Obeagu E.I., Okorie H.M., Vincent C.C.N., Bot Y.S. Studies of serum calcium, inorganic phosphate, and magnesium levels in lactating mothers in Owerri. J. Pharm. Res. Int. 2021; 33(41B): 209-16. https://dx.doi.org/10.9734/JPRI/2021/v33i41B32360.
- Kim E., Lewin A.A. Breast density: Where are we now? Radiol. Clin. North Am. 2024; 62(4): 593-605. https://dx.doi.org/10.1016/j.rcl.2023.12.007.
- Киселев В.И., Сметник В.П., Сутурина Л.В., Селиванов С.П., Рудакова Е.Б., Рахматуллина И.Р., Андреева Е.Н., Фадеева Н.И., Хасанов Р.Ш., Кулагина Н.В., Рожкова Н.И., Артымук Н.В., Гависова А.А., Муйжнек Е.Л., Кузнецов И.Н., Друх В.М. Индолкарбинол (Индинол Форто) – метод мультитаргетной терапии при циклической мастодинии. Акушерство и гинекология. 2013; 7: 56-62. [Kiselev V.I., Smetnik V.P., Suturina L.V., Selivanov S.P., Rudakova E.B., Rakhmatullina I.R., Andreyeva E.N., Fadeyeva N.I., Khasanov R.Sh., Kulagina N.V., Rozhkova N.I., Artymuk N.V., Gavisova A.A., Muizhnek E.L., Kuznetsov I.N., Drukh V.M. Indole carbinol (Indinol Forto) is a multitargeted therapy option for cyclic mastodynia. Obstetrics and Gynecology. 2013; (7): 56-62. (in Russian)].
Received 16.04.2025
Accepted 25.04.2025
About the Authors
Elena V. Meskikh, Dr. Med. Sci., Professor of the Department of X-ray Radiology, Pirogov Russian National Research Medical University, Ministry of Health of Russia;doctor of the highest category, Chief Researcher at X-ray Radiological Laboratory, Russian Scientific Center of Roentgenoradiology, Ministry of Health of Russia,
117997, Russia, Moscow, Profsoyuznaya str., 86, meskihelena@rambler.ru
Lev A. Ashrafyan, Academician of the Russian Academy of Sciences, Professor, Dr. Med. Sci., Head of the Institute of Oncogynecology and Mammology,
Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia,
117997, Russia, Moscow, Ac. Oparina str., 4, levaa2004@yahoo.com, https://orcid.org/0000-0001-6396-4948
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