The impact of p53 protein expression on the achievement of complete pathomorphism in neoadjuvant drug therapy for early HER2-positive breast cancer (results of a retrospective single-center study)

Kuts I.N., Titov K.S., Karseladze D.A., Zakurdaev E.I., Lebedev S.S., Lebedinsky I.N., Chizhikov N.P., Tatarova A.V., Roshchin F.Yu.

1) S.P. Botkin Moscow Multidisciplinary Research and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; 2) Peoples’ Friendship University of Russia named after Patrice Lumumba, Moscow, Russia; 3) Russian Medical Academy of Continuous Professional Education, Moscow, Russia

Background: Neoadjuvant therapy (NAT) is currently the gold standard for the treatment of early HER2-positive breast cancer (BC). However, only patients who achieve a complete pathological response (pCR) benefit from overall survival and progression-free survival (OS and PFS). The question of which patients should begin treatment with neoadjuvant therapy (NAT) and which should be treated initially with surgery remains a matter of debate.
Objective: Determination of the role of tumor p53 expression in achieving pCR after NAT in patients with early HER2-positive breast cancer by review prepared histological biopsy specimens for p53 expression determination, followed by a logistic regression analysis of the resulting database to calculate the relationship between achieving complete pathological response and the presence of p53 expression.
Materials and methods: A retrospective analysis of the medical records of 50 patients who received combination or comprehensive treatment for early (cT1-3N0-2M0) HER2-positive breast cancer in the General Oncology Department, S.P. Botkin Moscow Multidisciplinary Research and Clinical Center of the Moscow Healthcare Department, over a 4-year period from 2021 to 2024. All patients were assessed for p53 protein expression in preoperative biopsy specimens using immunohistochemistry assay. The presence or absence of p53 protein expression was analyzed and correlated with the achievement of pCR.
Results: The presence of p53 protein expression significantly increases the likelihood of achieving a complete pathological response (pCR=1). OR=9.33 indicates that patients with p53 expression have a 9-fold higher chance of pCR than patients without it. The result is statistically significant (p=0.0024), confirming the role of p53 protein expression as a strong predictor of response to NAT.
Conclusion: p53 protein expression is a significant predictor of achieving a complete pathological response (RCB = 0) after effective NAT. 

For citations: Kuts I.N., Titov K.S., Karseladze D.A., Zakurdaev E.I., Lebedev S.S., Lebedinsky I.N., Chizhikov N.P., Tatarova A.V., Roshchin F.Yu. 
The impact of p53 protein expression on the achievement of complete pathomorphism in neoadjuvant drug therapy for early HER2-positive breast cancer (results of a retrospective single-center study). Pharmateca. 2025;32(9):144-150. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2025.9.144-150

Authors’ contribution: Titov K.S., Lebedinsky I.N., Lebedev S.S. – data collection, editing. Kuts I.N. – data collection, writing. Karseladze D.A., Tatarova A.V., Zakurdaev E.I., Chizhikov N.P. – data collection. Roshchin F.Yu. – statistical analysis.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The work was performed without external funding.
Ethical Approval: Minutes No. 10 of the Meeting of the Independent Ethics Committee of the S.P. Botkin Moscow Multidisciplinary Research and Clinical Center of the Moscow Healthcare Department, dated September 11, 2025.
Patient Consent for Publication: The retrospective design of the study did not require informed consent from patients for statistical processing of anonymized data for subsequent publication.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.

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About the Authors

Ivan N. Kuts, Oncologist, Oncosurgical Department No. 71 (General Oncology), S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0000-0003-1516-6110 (corresponding author)
Konstantin S. Titov, Dr. Sci. (Med.), Professor, Leading Researcher, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department; Professor, Department of Oncology and Roentgenology named after V.P. Kharchenko, Medical Institute of the Peoples’ Friendship University of Russia named after Patrice Lumumba, Moscow, Russia; ORCID: http://orcid.org/0000-0003-4460-9136, SPIN-code: 7795-6512, AuthorID: 921470
Dmitry A. Karseladze, Cand. Sci. (Med.), Research Fellow, Surgeon, Oncosurgical Department No. 71 (General Oncology), S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Depaetment, Moscow, Russia; ORCID: https://orcid.org/0000-0002-9877-1078
Evgeny I. Zakurdaev, Cand. Sci. (Med.), Pathologist, Pathology Department, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0000-0001-8613-9609
Ivan N. Lebedinsky, Cand Sci. (Med.), Senior Researcher, Head of Oncosurgical Department No. 71 (General Oncology), S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; ОRCID: https://orcid.org/0000-0001-7735-1106
Sergey S. Lebedev, Dr. Sci. (Med.), Associate Professor, Deputy Chief Physician for Oncology, Leading Researcher, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department; Professor, Department of Surgery, Faculty of Surgery, Russian Medical Academy of Continuous Professional Education, Moscow, Russia; ОRCID: https://orcid.org/0000-0001-5366-1281
Nikita P. Chizhikov, Pathologist, Head of the Pathology Department, S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0009-0004-0584-8657
Angelina V. Tatarova, Surgeon, Oncosurgical Department No. 71 (General Oncology), S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Healthcare Department, Moscow, Russia; ORCID: https://orcid.org/0009-0005-3865-0046
Fedor Yu. Roshchin, Statistical Consultant, Independent Specialist, Moscow, Russia; ORCID: https://orcid.org/0009-0004-0477-7690

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