Pathogenetic therapy of benign breast dysplasia

Meskikh E.V., Ashrafyan L.A.

1) Russian Scientific Center of Roentgen Radiology, Ministry of Health of Russia, Moscow, Russia; 2) N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia, Moscow, Russia; 3) Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, Moscow, Russia

Objective: To evaluate mammographic breast density and determine the relationship of breast density in terms of synergy of radiation diagnostics and long-term pathogenetic therapy (6 months) with indolcarbinol medication in patients with benign breast dysplasia and mastodynia.
Materials and methods: The study included the results of the retrospective analysis of the data obtained from 2500 patients aged 20 to 59 years diagnosed with benign breast dysplasia. All the patients were examined and treated at the Russian Scientific Center of Roentgen Radiology, Moscow from 2021 to 2024. The evaluation of the patients’ condition included clinical examination, pain assessment using visual analog scale and instrumental studies (mammography, color Doppler ultrasonography and elastography, MRI with contrast agents) depending on the age and indications for the study. The results of instrumental examinations 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). The evaluation of the hormonal status and the concomitant diseases of the organs of the female reproductive system was carried out by a gynecologist. The results of the study showed that there were 250 patients with high tissue density, mastalgia and concomitant diseases of the reproductive organs; they were recommended therapy with indolcarbinol (Indinol Forto medication), namely one capsule twice a day for six months.
Results: Mastodynia/mastalgia disappeared in 140/250 (56%) women after six months of taking Indinol Forto. The condition stabilized (mastalgia and mastodynia were absent) in 198/250 (79.2%) patients one year after treatment. There was a one-point decrease in BI-RADS category 6 months after treatment with Indinol Forto in 18% of cases (change of category 3 BI-RADS to category 2 BI-RADS in 7.2% of cases, and category 2 BI-RADS to category 1 BI-RADS in 10.8% of cases); the assessment of tissue density type using the ACR classification showed changes after treatment from type D to type C, and from type C to type B in 25% of cases.
Conclusion: Indinol Forto is an effective medication for the treatment of benign breast dysplasia and can be recommended as a first-line treatment for cyclic mastalgia.

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 interests.
Funding: The study was conducted without sponsorship.
Ethical Approval: This study was approved by the local Ethics Review Board for Clinical Research.
Patient Consent for Publication: The patients provided an informed consent for the publication of their data related to the clinical research.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Meskikh E.V., Ashrafyan L.A. Pathogenetic therapy of benign breast dysplasia.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2024; (9): 164-173 (in Russian)
https://dx.doi.org/10.18565/aig.2024.238

Keywords

breast density
breast imaging
density quantification
breast cancer
breast imaging-reporting and data system (BI-RADS) of the American College of Radiologists
benign breast diseases
indinolcarbinol
Indinol Forto

References

  1. 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.
  2. 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.
  3. Gordon P.B. Breast density and risk of interval cancers. Can. Assoc. Radiol. J. 2022; 73(1): 19-20. https://dx.doi.org/10.1177/08465371211030573.
  4. 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.
  5. 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.
  6. Wolfe J.N., Saftlas A.F., Salane M. Mammographic parenchymal patterns and quantitative evaluation of mammographic densities: a case-control study. AJR Am. J. Roentgenol. 1987; 148(6): 1087-92. https://dx.doi.org/10.2214/ajr.148.6.1087.
  7. Boyd N.F., Byng J.W., Jong R.A., Fishell E.K., Little L.E., Miller A.B. et al. Quantitative classification of mammographic densities and breast cancer risk: results from the Canadian National Breast Screening Study. J. Natl. Cancer Inst. 1995; 87(9): 670-5. https://dx.doi.org/10.1093/jnci/87.9.670.
  8. 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.
  9. Kataoka M. Mammographic density for personalized breast cancer risk. Radiology. 2023; 306(2): e222129. https://dx.doi.org/10.1148/radiol.222129.
  10. 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.
  11. Astley S.M., Harkness E.F., Sergeant J.C., Warwick J., Stavrinos P., Warren R. et al. A comparison of five methods of measuring mammographic density: a case-control study. Breast Cancer Res. 2018; 20(1): 10. https://dx.doi.org/10.1186/s13058-018-0932-z.
  12. 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.
  13. 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.
  14. 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; 2024 Jan–.
  15. 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.
  16. Kim S., Tran T.X.M., Song H., Ryu S., Chang Y., Park B. Mammographic breast density, benign breast disease, and subsequent breast cancer risk in 3.9 million Korean women. Radiology. 2022; 304(3): 534-41. https://dx.doi.org/10.1148/radiol.212727.
  17. Alomaim W., O'Leary D., Ryan J., Rainford L., Evanoff M. et al. Subjective versus quantitative methods of assessing breast density. Diagnostics (Basel). 2020; 10(5): 331. https://dx.doi.org/10.3390/diagnostics10050331.
  18. 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.
  19. 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. Akusherstvo Obstetrics and Gynecology. 2023; (2): 140-5. (in Russian)]. https://dx.doi.org/10.18565/aig.2023.25.
  20. Plu-Bureau G., Thalabard J.C., Sitruk-Ware R., Asselain B., Mauvais-Jarvis P. Cyclical mastalgia as a marker of breast cancer susceptibility: results of a case-control study among French women. Br. J. Cancer. 1992; 65(6): 945-9. https://dx.doi.org/10.1038/bjc.1992.198.
  21. 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 – 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)].
  22. Инструкция по медицинскому применению лекарственного препарата Индинол Форто®. РУ № ЛП 002010. [Instructions for the medical use of the medicinal product Indinol Forto®. RU Nо. LP 002010. (in Russian)].
  23. 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)].

Received 20.09.2024

Accepted 26.09.2024

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

Similar Articles

By continuing to use our site, you consent to the processing of cookies that ensure the proper functioning of the site.