Email this article The amount of surgery in patients with early breast cancer and complete clinical response to neoadjuvant systemic therapy
- Authors: Amirov N.S.1, Krivorotko P.V.1, Mortada V.V.1, Donskikh R.V.1, Pesotskiy R.S.1, Emelyanov A.S.1, Tabagua T.T.1, Gigolaeva L.P.1, Yerechshenko S.S.1, Komyakhov A.V.1, Nikolaev K.S.1, Zernov K.Y.1, Zhiltsova E.K.1, Bondarchuk Y.I.1, Enaldieva D.A.1, Bessonov A.A.2, Artemyeva A.S.1, Novikov S.N.1, Busko E.A.1,3, Semiglazova T.Y.1, Semiglazov V.F.1, Belyaev A.M.1,4
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Affiliations:
- National Medical Research Center of Oncology named after N.N. Petrov
- Leningrad Regional Clinical Oncology Center
- Saint Petersburg State University
- North-Western State Medical University named after I.I. Mechnikov
- Issue: Vol 15, No 1 (2023)
- Pages: 63-71
- Section: Original research
- URL: https://journals.eco-vector.com/vszgmu/article/view/112622
- DOI: https://doi.org/10.17816/mechnikov112622
- ID: 112622
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Abstract
BACKGROUND: Neoadjuvant systemic therapy for triple-negative and HER2-positive breast cancer can achieve a complete pathologic response in approximately 60% of patients. Pathological complete response to neoadjuvant systemic therapy is a predictive factor consistent with a positive prognosis which can be accurately determined by percutaneous vacuum aspiration biopsy.
AIM: To evaluate the amount of surgery in the group of patients with triple-negative and HER2-positive early breast cancer whose complete pathologic response was confirmed by vacuum aspiration biopsy and who did not undergo standard surgery.
MATERIALS AND METHODS: The following single-centre study has been conducted in the Russian Federation. Women aged 18 years old and older with unicentric (cT1-2N0-1M0 by classification TNM) triple-negative or HER2-positive breast cancer with complete clinical response after neoadjuvant systemic therapy according to imaging diagnostic methods. The patients underwent vacuum aspiration biopsy on the mammary gland under ultrusound control with standard amount of surgical intervention on the axillary region. In case when no invasive or in situ disease was detected, no further breast surgery was performed and the patients underwent standard radiation therapy. The survival with no tumor relapse in the ipsilateral mammary gland was assessed as the primary endpoint. The study is registered on сlinicaltrials.gov, NCT04293796.
RESULTS: Between June 2020 and May 2022, twenty-seven (84.4%) patients (all women; mean age 47.5 (32–68) years) were enrolled in the study and underwent visually controlled vacuum aspiration biopsy. The average initial tumor size was 20.5 (7–35) mm. 7 (25.9%) patients initially had metastases in the axillary lymph nodes confirmed by puncture biopsy; 15 (55.6%) patients had HER2-positive breast cancer, and 12 (44.4%) had triple-negative breast cancer. A study of vacuum aspiration biopsy samples showed that 6 (22.2%) patients had a residual tumor, and 21 (77.8%) patients achieved complete pathologic response (95% confidence interval 53.2 to 81.4). At a median follow-up of 12.4 months, there were no tumor relapses in the ipsilateral mammary gland in 21 patients with complete pathologic response confirmed by vacuum aspiration biopsy after neoadjuvant systemic therapy, as well as other relapses or progression of the disease.
CONCLUSIONS: The patients with a complete pathologic response, which is confirmed by the vacuum aspiration biopsy method, who refused to perform surgery on the mammary gland do not demonstrate worse results with a short period of observation. However, additional prospective clinical studies are needed.
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About the authors
Nikolay S. Amirov
National Medical Research Center of Oncology named after N.N. Petrov
Email: amirovn17@gmail.com
ORCID iD: 0000-0002-2421-3284
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Petr V. Krivorotko
National Medical Research Center of Oncology named after N.N. Petrov
Email: dr.krivorotko@mail.ru
ORCID iD: 0000-0002-4898-9159
SPIN-code: 2448-7506
Scopus Author ID: 36600762900
MD, Dr. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Viktoria V. Mortada
National Medical Research Center of Oncology named after N.N. Petrov
Email: vika-gukova@mail.ru
ORCID iD: 0000-0002-1982-5710
SPIN-code: 3871-8774
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Roman V. Donskikh
National Medical Research Center of Oncology named after N.N. Petrov
Email: rdonskih@rambler.ru
ORCID iD: 0000-0002-9391-5327
SPIN-code: 5111-8211
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Roman S. Pesotskiy
National Medical Research Center of Oncology named after N.N. Petrov
Email: shipmeback@gmail.com
ORCID iD: 0000-0002-2573-2211
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Alexander S. Emelyanov
National Medical Research Center of Oncology named after N.N. Petrov
Email: ae28111992@yandex.ru
ORCID iD: 0000-0002-0528-9937
SPIN-code: 6312-4894
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Tengiz T. Tabagua
National Medical Research Center of Oncology named after N.N. Petrov
Email: tedo8308@mail.ru
ORCID iD: 0000-0003-1471-9473
SPIN-code: 4466-6316
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Larisa P. Gigolaeva
National Medical Research Center of Oncology named after N.N. Petrov
Email: gigosha532@gmail.com
ORCID iD: 0000-0001-7654-4336
SPIN-code: 3521-7448
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Sergey S. Yerechshenko
National Medical Research Center of Oncology named after N.N. Petrov
Email: dr.ereschenko@gmail.com
ORCID iD: 0000-0002-5090-7001
SPIN-code: 5957-9137
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Alexander V. Komyakhov
National Medical Research Center of Oncology named after N.N. Petrov
Email: komyahov@yandex.ru
ORCID iD: 0000-0002-6598-1669
SPIN-code: 8286-4406
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Kirill S. Nikolaev
National Medical Research Center of Oncology named after N.N. Petrov
Email: kirill.nikolaev87@gmail.com
ORCID iD: 0000-0003-3377-6369
SPIN-code: 5627-6696
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Konstantin Yu. Zernov
National Medical Research Center of Oncology named after N.N. Petrov
Email: konstantin_zernov@hotmail.com
ORCID iD: 0000-0002-2138-3982
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Elena K. Zhiltsova
National Medical Research Center of Oncology named after N.N. Petrov
Email: ziltsova@yandex.ru
ORCID iD: 0000-0002-2029-4582
SPIN-code: 3045-1704
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Yana I. Bondarchuk
National Medical Research Center of Oncology named after N.N. Petrov
Email: yana_bondarchuk_2015@mail.ru
ORCID iD: 0000-0002-6442-0106
SPIN-code: 9546-3222
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Diana A. Enaldieva
National Medical Research Center of Oncology named after N.N. Petrov
Email: DIANAENALDIEVA932@gmail.com
ORCID iD: 0000-0002-2773-3111
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758
Alexander A. Bessonov
Leningrad Regional Clinical Oncology Center
Email: dr.bessonov@gmail.com
ORCID iD: 0000-0002-6649-7641
SPIN-code: 3553-4670
MD, Cand. Sci. (Med.)
Russian Federation, Saint PetersburgAnna S. Artemyeva
National Medical Research Center of Oncology named after N.N. Petrov
Email: oinochoya@gmail.com
ORCID iD: 0000-0002-2948-397X
SPIN-code: 5760-5463
MD, Cand. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Sergey N. Novikov
National Medical Research Center of Oncology named after N.N. Petrov
Email: krokon@mail.ru
ORCID iD: 0000-0002-7185-1967
SPIN-code: 7346-0687
MD, Dr. Sci. (Med.), Professor
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Ekaterina A. Busko
National Medical Research Center of Oncology named after N.N. Petrov; Saint Petersburg State University
Email: Katrn@mail.ru
ORCID iD: 0000-0002-0940-6491
SPIN-code: 7323-1083
MD, Dr. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758; Saint PetersburgTatyana Yu. Semiglazova
National Medical Research Center of Oncology named after N.N. Petrov
Email: tsemiglazova@mail.ru
ORCID iD: 0000-0002-4305-6691
SPIN-code: 9773-3759
Scopus Author ID: 8562948700
MD, Dr. Sci. (Med.)
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Vladimir F. Semiglazov
National Medical Research Center of Oncology named after N.N. Petrov
Email: ssemiglazov@mail.ru
ORCID iD: 0000-0003-0077-9619
SPIN-code: 3874-9539
MD, Dr. Sci. (Med.), Professor, Corresponding Member of the Russian Academy of Sciences
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758Alexey M. Belyaev
National Medical Research Center of Oncology named after N.N. Petrov; North-Western State Medical University named after I.I. Mechnikov
Author for correspondence.
Email: bam281060@yandex.ru
ORCID iD: 0000-0001-5580-4821
SPIN-code: 9445-9473
Scopus Author ID: 54995489300
MD, Dr. Sci. (Med.), Professor
Russian Federation, 68 Leningradskaya St., Pesochny, Saint Petersburg, 197758; Saint PetersburgReferences
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СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).