Krivorotko, P. V., Amirov, N. S., Artemyeva, A. S., Busko, E. A., Tabagua, T. T., Emelyanov , A. S., Yereschenko , S. S., Pesotsky, R. S., Mortada, V. V., Zernov, K. Y., Ziltsova, E. K., Gigolaeva, L. P., Nikolaev, K. S., Komyahov, A. V., Bondarchuk, Y. I., Enaldieva, D. A., Bekkeldiyeva, N., Ulrikh, D., Novikov, S. N., Krzhivitskiy, P. I., Bryantseva, Z. V., Akulova, I. A., Donskikh, R. V., Semiglazov, V. F., & Belyaev, A. M. (2024). Treatment Outcomes Evaluation in Breast Cancer Patients with a Pathological Complete Response after Neoadjuvant Systemic Therapy Depending on Different Types of Local Treatment. Voprosy Onkologii, 70(2), 330–339. https://doi.org/10.37469/0507-3758-2024-70-2-330-339

Abstract

Introduction. Current opinion is that surgery is diagnostic rather than curative and does not affect long-term outcomes in breast cancer (BC) patients with complete pathomorphological response (pCR) after neoadjuvant systemic therapy (NST). As a minimally invasive method for diagnosing pCR in BC, vacuum-assisted biopsy (VAB) of the tumour bed has shown promising results. This paper presents a retrospective analysis of the outcomes of patients with triple-negative and HER2-positive BC who achieved pCR after NST according to different types of invasive breast surgery, including patients who underwent VAB alone without subsequent breast surgery.

Materials and methods. From 1 January 2021 to 1 July 2023, we analysed 3247 patients who underwent surgery at the Department of Breast Tumours at the N.N. Petrov NMRC of Oncology. Patients were included in the study if they had unifocal invasive HER2+ and TNBC (cT1-2N0-1M0) with histologically confirmed pathological complete response (ypT0N0) to NST. Exclusion criteria were an intraductal component detected by trephine bone marrow core biopsy and germline mutations in BRCA1/2. According to the planned analysis, all patients were divided into three groups: the breast-conserving surgery (BCS) group, the mastectomy (ME) group and the VAB group. Primary endpoint was 2-year ipsilateral breast tumour recurrence-free survival [IBTR-FS]. Secondary endpoints included 2-year disease-free survival (DFS) and complication rates.

Results. Of the 3 247 patients analyzed, 81 patients who met the inclusion criteria were included in the final analysis. There were 39 patients in the BCS group, 19 patients in the ME group, and 23 patients in the VAB group. The median follow-up was 24 months. The median survival was not reached for any of the endpoints. 2-year IBTR-FS was 100 % in the BCS group vs. 100 % in the ME group vs. 91.3 % in the VAB group [p = 0.159]. 2-year DFS was 97.4 % in the BCS group vs 94.7 % in the ME group vs 87.0 % in the VAB group [p = 0.396]. There was no difference in the hazard ratio (HR) for recurrence between the different types of surgery. When measuring HR adjusted for lymph node status (cN) and disease stage, there was a statistically significant higher risk in the VAB group [HR adjusted for cN: 12.236, (95 % CI, 1.163-128.773), p = 0.037; HR adjusted for stage: 17.071, (95 % CI, 1.255-232.173), p = 0.033].

Conclusion. To determine the safety of VAB use, further observational studies and large randomised prospective trials are needed. There was no significant difference in the incidence of complications between the different types of invasive procedures in this cohort of patients.

https://doi.org/10.37469/0507-3758-2024-70-2-330-339

##article.numberofdownloads## 78

##article.numberofviews## 212

pdf (Русский)

References

Fisher B., Anderson S., Bryant J., et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002; 347(16): 1233-1241.-DOI: https://doi.org/10.1056/NEJMoa022152.

Halsted W.S.I. The results of radical operations for the cure of carcinoma of the breast. Ann Surg. 1907; 46(1): 1-19.-DOI: https://doi.org/10.1097/00000658-190707000-00001.

Veronesi U., Cascinelli N., Mariani L., et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002; 347(16): 1227-1232.-DOI: https://doi.org/10.1056/NEJMoa020989.

Balic M., Thomssen C., Würstlein R., et al. St. Gallen/Vienna 2019: A brief summary of the consensus discussion on the optimal primary breast cancer treatment. Breast Care (Basel). 2019; 14(2): 103-110.-DOI: https://doi.org/10.1159/000499931.

van la Parra R.F., Kuerer H.M. Selective elimination of breast cancer surgery in exceptional responders: historical perspective and current trials. Breast Cancer Res. 2016; 18(1): 28.-DOI: https://doi.org/10.1186/s13058-016-0684-6.

Pfob A., Sidey-Gibbons C., Lee H.B., et al. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021; 143: 134-146.-DOI: https://doi.org/10.1016/j.ejca.2020.11.006.

Lee H.B., Han W., Kim S.Y., et al. Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial. Breast Cancer Res Treat. 2020; 182(1): 97-105.-DOI: https://doi.org/10.1007/s10549-020-05678-3.

Ogston K.N., Miller I.D., Payne S., et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast. 2003; 12(5): 320-327.-DOI: https://doi.org/10.1016/s0960-9776(03)00106-1.

Heil J., Kummel S., Schaefgen B., et al. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015; 113: 1565-1570.

Heil J, Schaefgen B, Sinn P, et al. Can a pathological complete response of breast cancer after neoadjuvant chemotherapy be diagnosed by minimal invasive biopsy? Eur J Cancer. 2016;69: 142-150. -DOI: https://doi.org/10.1016/j.ejca.2016.09.034.

Kuerer H.M., Rauch G.M., Krishnamurthy S., et al. A Clinical feasibility trial for identification of exceptional responders in whom breast cancer surgery can be eliminated following neoadjuvant systemic therapy. Ann Surg. 2018; 267(5): 946-951.-DOI: https://doi.org/10.1097/SLA.0000000000002313.

Heil J., Pfob A., Sinn H.P., et al. Diagnosing pathologic complete response in the breast after neoadjuvant systemic treatment of breast cancer patients by minimal invasive biopsy: Oral presentation at the San Antonio Breast Cancer Symposium on Friday, December 13, 2019, program number GS5-03. Ann Surg. 2022; 275(3): 576-581.-DOI: https://doi.org/10.1097/SLA.0000000000004246.

Kettritz U., Rotter K., Schreer I., et al. Stereotactic vacuum-assisted breast biopsy in 2874 patients: a multicenter study. Cancer. 2004; 100(2): 245-251.-DOI: https://doi.org/10.1002/cncr.11887.

Kuerer H.M., Smith B.D., Krishnamurthy S., et al. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2022; 23(12): 1517-1524.-DOI: https://doi.org/10.1016/S1470-2045(22)00613-1.

Амиров Н.С., Криворотько П.В., Мортада В.В., и др. Объем хирургического вмешательства у пациентов с ранним раком молочной железы и полным клиническим ответом на неоадъювантную системную терапию. Вестник Северо-Западного государственного медицинского университета им. И.И. Мечникова. 2023; 15(1): 63-71.-DOI: https://doi.org/10.17816/mechnikov112622.

[Amirov N.S., Krivorotko P.V., Mortada V.V., et al. The amount of surgery in patients with early breast cancer and complete clinical response to neoadjuvant systemic therapy. HERALD of North-Western State Medical University named after I.I. Mechnikov. 2023; 15(1): 63-71.-DOI: https://doi.org/10.17816/mechnikov112622. (In Rus)].

van Mackelenbergh M.T., Loibl S., Untch M., et al. Pathologic complete response and individual patient prognosis after neoadjuvant chemotherapy plus anti-human epidermal growth factor receptor 2 therapy of human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol. 2023; 41(16): 2998-3008.-DOI: https://doi.org/10.1200/JCO.22.02241.

Broglio K.R., Quintana M., Foster M., et al. Association of pathologic complete response to neoadjuvant therapy in HER2-positive breast cancer with long-term outcomes: a meta-analysis. JAMA Oncol. 2016; 2: 751-60.-DOI: https://doi.org/10.1001/jamaoncol.2015.6113.

Huang M., O’Shaughnessy J., Zhao J., et al. Association of pathologic complete response with long-term survival outcomes in triple-negative breast cancer: a meta-analysis. Cancer Res. 2020; 80: 5427-34.-DOI: https://doi.org/10.1158/0008-5472.CAN-20-1792.

Masuda N., Lee S.J., Ohtani S., et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N Engl J Med. 2017; 376(22): 2147-2159.-DOI: https://doi.org/10.1056/NEJMoa1612645.

von Minckwitz G., Huang C.S., Mano M.S., et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019; 380(7): 617-628.-DOI: https://doi.org/10.1056/NEJMoa1814017.

De Lena M., Varini M., Zucali R., et al. Multimodal treatment for locally advanced breast cancer. Result of chemotherapy-radiotherapy versus chemotherapy-surgery. Cancer Clin Trials. 1981; 4(3): 229-36.

Ellis P., Smith I., Ashley S., et al. Clinical prognostic and predictive factors for primary chemotherapy in operable breast cancer. J Clin Oncol. 1998; 16(1): 107-114.-DOI: https://doi.org/10.1200/JCO.1998.16.1.107.

Touboul E., Buffat L., Lefranc J.P., et al. Possibility of conservative local treatment after combined chemotherapy and preoperative irradiation for locally advanced noninflammatory breast cancer. Int J Radiat Oncol Biol Phys. 1996; 34(5): 1019-1028.-DOI: https://doi.org/10.1016/0360-3016(95)02207-4.

Mauriac L., MacGrogan G., Avril A., et al. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonié Bordeaux Groupe Sein (IBBGS). Ann Oncol. 1999; 10(1): 47-52.-DOI: https://doi.org/10.1023/a:1008337009350.

Ring A., Webb A., Ashley S., et al. Is surgery necessary after complete clinical remission following neoadjuvant chemotherapy for early breast cancer? J Clin Oncol. 2003; 21(24): 4540-4545.-DOI: https://doi.org/10.1200/JCO.2003.05.208.

Pfob A., Cai L., Schneeweiss A., et al. ASO Visual abstract: minimally-invasive breast biopsy after neoadjuvant systemic treatment to identify breast cancer patients with residual disease for extended neoadjuvant treatment-a new concept. Ann Surg Oncol. 2023; 31(2): 1033-4.-DOI: https://doi.org/10.1245/s10434-023-14747-y.

Heil J. Pfob A., Morrow M. De-escalation of breast and axillary surgery in exceptional responders to neoadjuvant systemic treatment. Lancet Oncol. 2021; 22(4): 435-436.-DOI: https://doi.org/10.1016/S1470-2045(21)00057-7.

Schneeweiss A., Chia S., Hickish T., et al. Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer. Eur J Cancer. 2018; 89: 27-35.-DOI: https://doi.org/10.1016/j.ejca.2017.10.021.

Loibl S., Weber K.E., Timms K.M., et al. Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response-final results from GeparSixto. Ann Oncol. 2018; 29(12): 2341-2347.-DOI: https://doi.org/10.1093/annonc/mdy46.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Most read articles by the same author(s)

Tatiana Y. Semiglazova, Olga I. Ponasenko, Varvara A. Lyaschenko, Sheida R. Abdullaeva, Tatiana I. Kudriashova, Anton A. Krutov, Nadezhda A. Brish, Yuliya V. Alekseeva, Elena V. Tkachenko, Tatiana A. Karavaeva, Vladislav V. Semiglazov, Boris S. Kasparov, Петр Владимирович Krivorotko, Vladimir F. Semiglazov, Late Complications of Chemotherapy and Hormone Therapy in the Cancer: General Weakness, Cognitive Impairment, Peripheral Neuropathy, Treatment-Induced Myeloproliferative Diseases (Part 1) , Voprosy onkologii: Vol. 70 No. 3 (2024)
Sheyda R. Abdullaeva, Tatiana Yu. Semiglazova, Anna S. Artemyeva, Valentina A. Zagoruiko, Tatiana I. Kudriashova, Olga I. Ponasenko, Boris S. Kasparov, Larisa V. Filatova, Vladislav V. Semiglazov, Petr V. Krivorotko, Vladimir F. Semiglazov, Predictive and Prognostic Role of TILs In Platinum-Based Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer , Voprosy onkologii: Vol. 70 No. 3 (2024)
Vakhtang M. Merabishvili , Vladimir F. Semiglazov, Ekaterina A. Busko , Age-Related Features of the Prevalence, Early Diagnosis and Survival of Breast Cancer Patients (Clinical and Population-Based Study) , Voprosy onkologii: Vol. 70 No. 3 (2024)
Petr V. Krivorotko, Tengiz T. Tabagua, Sergeii N. Novikov, Nicolai Amirov, Valerii E. Levchenko, Roman. S. Pesotsky , Aleksandr S. Emelyanov, Victoria V. Mortada, Elena K. Zhiltsova, Vladislav V. Semiglazov, Pavel I. Krzhivitsky, Anna S. Artemyeva, Roman V. Donskih, Vladimir F. Semiglazov, The Sentiel Lymph Node Biopsy in breast cancer. , Voprosy onkologii: Vol. 70 No. 3 (2024)
Aleksey M. Belyaev , Message Editor-in-Chief of the journal «Voprosy Onkologii» , Voprosy onkologii: Vol. 69 No. 6 (2023)
Boris S. Kasparov, Denis V. Kovlen, Tatiana U. Semiglazova, Kristina O. Kondrateva, Gennady N. Ponomarenko, Valeria A. Kluge, Tatyana I. Kudryashova, Roman V. Donskikh, Vladislav V. Semiglazov, Alexander K. Nosov, Alexey M. Beliaev, Study of the effectiveness of personalized rehabilitation of patients with operable prostate cancer , Voprosy onkologii: Vol. 69 No. 3 (2023)
Tengiz T. Tabagua, Valerii Evgenievich Levchenko, Victoria V. Mortada, Roman. S. Pesotsky Roman. S., Nicolai Amirov, Aleksandr S. Emelyanov, Mahmud M. Mortada, Pavel I. Krzhivitsky, Vladimir F. Semiglazov, Petr V. Krivorotko, The The Role of Axillary Reverse Mapping during Sentinel Lymph Node Biopsy in Breast Cancer Patients , Voprosy onkologii: Vol. 70 No. 3 (2024)
Sergey N. Novikov, Nikolay D. Ilyin, Yulia S. Melnik, Olga I. Ponomareva, Roman V. Novikov, Yuriy O. Merezhko, Ekaterina E. Samartseva, Maria Yu. Gotovchikova, Andrey I. Arsenev, Filipp E. Antipov, Vasiliy K. Karandashov, Sergey M. Gozalishvili, Nikita O. Kuznetsov, Sergey V. Kanaev, Experience of Using Stereotactic Ablative Radiotherapy for Radical Treatment of Low and Intermediate Risk Prostate Cancer , Voprosy onkologii: Vol. 70 No. 2 (2024)