Tumors of female reproductive systemTumors of female reproductive systemОпухоли женской репродуктивной системы1994-40981999-8627Publishing House ABV Press2310.17650/1994-4098-2014-0-2-30-36MAMMOLOGY. TREATMENTМАММОЛОГИЯ. ЛЕЧЕНИЕNeoadjuvant treatment for breast cancerНеоадъювантное лечение рака молочной железыSemiglazovV. F.СемиглазовВ. Ф.
Russian Federation
vsemiglazov@mail.ruSemiglazovV. V.СемиглазовВ. В.
Russian Federation
PaltuevR. M.ПалтуевР. М.
Russian Federation
DashyanG. A.ДашянГ. А.
Russian Federation
SemiglazovaT. Yu.СемиглазоваТ. Ю.
Russian Federation
KrivorotkoP. V.КриворотькоП. В.
Russian Federation
KomyakhovA. V.КомяховА. В.
Russian Federation
BryantsevaZh. V.БрянцеваЖ. В.
Russian Federation
NikolaevK. S.НиколаевК. С.
Russian Federation
ShchedrinD. Ye.ЩедринД. Е.
Russian Federation
YermochenkovaA. M.ЕрмоченковаА. М.
Russian Federation
N.N. Petrov Oncology Research Institute, Ministry of Health of Russia, Saint PetersburgФГБУ «НИИ онкологии им. Н.Н. Петрова» Минздрава России, Санкт-ПетербургAcad. I.P. Pavlov Saint Petersburg State Medical University, Ministry of Health of RussiaСанкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова Минздрава РоссииRailway Clinical Hospital, Russian Railways, Saint PetersburgДорожная клиническая больница ОАО «РЖД», Санкт-ПетербургI.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, Saint PetersburgГБОУ ВПО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург17072014230361807201418072014https://ojrs.abvpress.ru/ojrs/article/view/23

linical trials have shown that the status of the women achieving complete pathomorphological repression (CPR) of a tumor is characterized by significantly improved survival as compared to that of those who have not to an equal degree. The achievement of CPR as an intermediate marker for improved survival is chiefly observed in women with aggressive subtypes of breast cancer (BC): triple-negative and HER-2-positive. In patients with the latter subtype, addition of trastuzumab to neoadjuvant chemotherapy doubles the rate of CPR and correlates with higher survival rates. The performed clinical trials have established that neoadjuvant endocrine therapy is the most suitable treatment for patients with steroid hormone receptor overexpression. Whether it may be used in combination with targeted (anti-HER-2) therapy for estrogen and HER-2 coexpression is being investigated. Neoadjuvant therapy for suitable BC stages can accelerate the assessment of novel medications through identification of predictive biological markers for response (CPR in particular). Although standard neoadjuvant therapy gives an obvious benefit to patients with CPR, other patients with the so-called residual disease are at high recurrence risk.

breast cancerneoadjuvant therapyрак молочной железынеоадъювантная терапия1. Семиглазов В.Ф., Палтуев Р.М., Семиглазова Т.Ю. и др. Клинические реко- мендации по диагностике и лечению рака молочной железы. СПб.: АБС-пресс, 2013. 234 c.Семиглазов В.Ф., Палтуев Р.М., Семиглазова Т.Ю. и др. Клинические реко- мендации по диагностике и лечению рака молочной железы. СПб.: АБС-пресс, 2013. 234 c.2. Семиглазов В.Ф., Семиглазов В.В., Манихас А.Г. Рак молочной железы. Химиотерапия и таргетная терапия. М.: МЕДпресс-информ, 2012. 360 с.Семиглазов В.Ф., Семиглазов В.В., Манихас А.Г. Рак молочной железы. Химиотерапия и таргетная терапия. М.: МЕДпресс-информ, 2012. 360 с.3. Bear H.D., Anderson S., Smith R.E. et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2006;24(13):2019–27.Bear H.D., Anderson S., Smith R.E. et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2006;24(13):2019–27.4. Rastogi P., Andcrson S.J., Bear H.D. et al. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols В-18 and B-27. J Clin Oncol 2008;26(5):778–85.Rastogi P., Andcrson S.J., Bear H.D. et al. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols В-18 and B-27. J Clin Oncol 2008;26(5):778–85.5. Feldman L.D., Hortobagyi G.N., Buzdar A.U. et al. Pathological assessment of response to induction chemotherapy in breast cancer. Cancer Res 1986;46(5): 2578–81.Feldman L.D., Hortobagyi G.N., Buzdar A.U. et al. Pathological assessment of response to induction chemotherapy in breast cancer. Cancer Res 1986;46(5): 2578–81.6. Hortobagyi G.N., Ames F.C., Buzdar A.U.Hortobagyi G.N., Ames F.C., Buzdar A.U.et al. Management of stage III primary breast cancer with primary chemotherapy, surgery, and radiation therapy. Cancer 1988;62(12):2507–16. 7. Fisher В., Bryant J., Wolmark N. et al. Effect of preoperative chemotherару on the outcome of women with operable breast cancer. J Clin Oncol 1998;16(8):2672–85.8. Cortazar P., Zhang L., Untch M. et al. Meta-analysis results from the collaborative trials in neoadjuvant breast cancer (CTNeoBC). Cancer Res 2012;72–93s.Cortazar P., Zhang L., Untch M. et al. Meta-analysis results from the collaborative trials in neoadjuvant breast cancer (CTNeoBC). Cancer Res 2012;72–93s.9. Bonadonna G., Valagussa P., Brambilla C. et al. Primary chemotherapy in operable breast cancer: eight-year experience at the Milan Cancer Institute. J Clin Oncol 1998;16(1):93–100.Bonadonna G., Valagussa P., Brambilla C. et al. Primary chemotherapy in operable breast cancer: eight-year experience at the Milan Cancer Institute. J Clin Oncol 1998;16(1):93–100.10. Bear H.D., Anderson S., Brown A. et al. The effect of tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003;21(22):4165–74.Bear H.D., Anderson S., Brown A. et al. The effect of tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2003;21(22):4165–74.11. vonMinckwitzG.,UntchM.,BlohmerJ.U. et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012;30(15):1796–804.vonMinckwitzG.,UntchM.,BlohmerJ.U. et al. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 2012;30(15):1796–804.12. Esserman L.J., Berry D.A., DeMichele A. et al. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results froix the I-SPY 1 I'RIAL- CALGB 150007/150012, ACRIN 6657. J Clin Oncol 2012;30(26):3242–9.Esserman L.J., Berry D.A., DeMichele A. et al. Pathologic complete response predicts recurrence-free survival more effectively by cancer subset: results froix the I-SPY 1 I'RIAL- CALGB 150007/150012, ACRIN 6657. J Clin Oncol 2012;30(26):3242–9.13. GianniL.,EiermannW.,SemiglazovV.etal. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2+ locally advanced breast cancer (the NOAH trial): a randomized controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010;375(9712):377–84.GianniL.,EiermannW.,SemiglazovV.etal. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2+ locally advanced breast cancer (the NOAH trial): a randomized controlled superiority trial with a parallel HER2-negative cohort. Lancet 2010;375(9712):377–84.14. Mamounas E.P., Brown A., Anderson S. et al. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2005;23(12):2694–702.Mamounas E.P., Brown A., Anderson S. et al. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2005;23(12):2694–702.15. KellyA.M.,DwamenaB.,CroninP.,Carlos R.C. Breast cancer sentinel node identification and classification after neoadjuvant chemotherapysystematic review and meta analysis. Acad Radiol 2009;16(5)551–63.KellyA.M.,DwamenaB.,CroninP.,Carlos R.C. Breast cancer sentinel node identification and classification after neoadjuvant chemotherapysystematic review and meta analysis. Acad Radiol 2009;16(5)551–63.16. Xing Y., Foy M., Cox D.D. et al. Meta- analysis of sentinel lymph node biopsy following preoperative chemotherapy in patients with operable breast cancer. Br J Surg 2006;93(5):539–46.Xing Y., Foy M., Cox D.D. et al. Meta- analysis of sentinel lymph node biopsy following preoperative chemotherapy in patients with operable breast cancer. Br J Surg 2006;93(5):539–46.17. Boughey C., Suman V.J., Mittendorf E.A. et al. The role of sentinel lymph node surgery in patients presenting with node positive breast cancer (TO-T4, N1-2) who receive neoadjuvant chemotherapy – results from the ACOSOG Z1071 trial. Cancer Res 2012; 72(24 Suppl):Abstr S2–1.Boughey C., Suman V.J., Mittendorf E.A. et al. The role of sentinel lymph node surgery in patients presenting with node positive breast cancer (TO-T4, N1-2) who receive neoadjuvant chemotherapy – results from the ACOSOG Z1071 trial. Cancer Res 2012; 72(24 Suppl):Abstr S2–1.18. Kuehn T., Bauerfeind I.G.P., Fehm T. et al. Sentinel lymph node biopsy beforeKuehn T., Bauerfeind I.G.P., Fehm T. et al. Sentinel lymph node biopsy beforeor after neoadjuvant chemotherapy-final results from the Prospective German, multiinstitutional SENTINA-Trial. Cancer Res 2012;72(24 Suppl):Abstr S2–2.19. Mamounas E.P., Anderson S.J,. Dignam J.J. et al. Predictors of locoregional recurrence after neoadjuvant chemotherapy: results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18Mamounas E.P., Anderson S.J,. Dignam J.J. et al. Predictors of locoregional recurrence after neoadjuvant chemotherapy: results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18and B-27. J Clin Oncol 2012;30(32): 3960–6.20. Rastogi P., Bear H.D. Thase III clinimal trail (AO11202) complete axillary dissection plus radiotherapy versus radiotherapy alone. ASCO Educational Book. 2013. Pp. 73–9.Rastogi P., Bear H.D. Thase III clinimal trail (AO11202) complete axillary dissection plus radiotherapy versus radiotherapy alone. ASCO Educational Book. 2013. Pp. 73–9.21. Bear H.D., Tang G., Rastogi P. et al. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. N Engl J Med 2012;366(4):310–20.Bear H.D., Tang G., Rastogi P. et al. Bevacizumab added to neoadjuvant chemotherapy for breast cancer. N Engl J Med 2012;366(4):310–20.22. U.S. National Institutes of Health. I-SPY 2 Trial: neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer. http:// clinicaltrials.gov/ct2/show/study/ NCT01042379.U.S. National Institutes of Health. I-SPY 2 Trial: neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer. http:// clinicaltrials.gov/ct2/show/study/ NCT01042379.23. United States Food and Drug Administration. Guidance for Industry. Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. http://www.fda.gov/ downloads/Drugs/Guidance/ ComplianceRegulatory/Information/ Guidances/UCM305501.pdf.United States Food and Drug Administration. Guidance for Industry. Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval. http://www.fda.gov/ downloads/Drugs/Guidance/ ComplianceRegulatory/Information/ Guidances/UCM305501.pdf.24. Untch M., Fasching P.A., Konecny G.E. et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer: results from the TECHNO trial of the AGO and GBG study groups. J Clin Oncol 2011;29(25):3351–7.Untch M., Fasching P.A., Konecny G.E. et al. Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer: results from the TECHNO trial of the AGO and GBG study groups. J Clin Oncol 2011;29(25):3351–7.25. U.S. National Institutes of Health. PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-HER2-) With BRCA 1/2 Mutations. http://dinicaltrials.gov/show/NCT01074970.U.S. National Institutes of Health. PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-HER2-) With BRCA 1/2 Mutations. http://dinicaltrials.gov/show/NCT01074970.26. U.S. National Institutes of Health. Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer (ABCDE). http://clinicaltriaIs.gov/ct2/show/ NCT00925652?temi=ABCDE+Trial&rank=l.U.S. National Institutes of Health. Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer (ABCDE). http://clinicaltriaIs.gov/ct2/show/ NCT00925652?temi=ABCDE+Trial&rank=l.27. Paik S., Shak S., Tang G. et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004;351(27):2817–26.Paik S., Shak S., Tang G. et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004;351(27):2817–26.28. Paik S., Tang G., Shak S. et al. Gene expression and benefit of chemotherару in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006;24(23):3726–34.Paik S., Tang G., Shak S. et al. Gene expression and benefit of chemotherару in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006;24(23):3726–34.29. U.S. National Institutes of Health. Hormone therapy with or without combination chemotherapy in treating women who have undergone surgery for node-negative breast cancer (the TAILORx trial). http://clinicaltrials.gov/ct2/show/ NCT00310180?term=tailorx&rank= 1.U.S. National Institutes of Health. Hormone therapy with or without combination chemotherapy in treating women who have undergone surgery for node-negative breast cancer (the TAILORx trial). http://clinicaltrials.gov/ct2/show/ NCT00310180?term=tailorx&rank= 1.30. U.S. National Institutes of Health. A Phase III randomized clinical trial of standard adjuvant endocrine therapy +/– chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2- negative breast cancer with recurrence score (RS) of 25 or less. http://dinicaltrials.gov/ct2/ show/NCT01272037?term=S1007&rank==l. 31. Ellis M.J., Tao Y., Luo J. et al. Outcome prediction for estrogen receptorpositive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst 2008;100(19):1380–8.U.S. National Institutes of Health. A Phase III randomized clinical trial of standard adjuvant endocrine therapy +/– chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2- negative breast cancer with recurrence score (RS) of 25 or less. http://dinicaltrials.gov/ct2/ show/NCT01272037?term=S1007&rank==l. 31. Ellis M.J., Tao Y., Luo J. et al. Outcome prediction for estrogen receptorpositive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics. J Natl Cancer Inst 2008;100(19):1380–8.32. Smith I.E., Dowsett M., Ebbs S.R. et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen,Smith I.E., Dowsett M., Ebbs S.R. et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen,or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial. J Clin Oncol 2005;23(22):5108–16.33. Ellis M.J., Suman V.J., Hoog J. et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAMSO-based intrinsic subtype-ACOSOG Z1031. J Clin Oncol 2011;29(17):2342–9.Ellis M.J., Suman V.J., Hoog J. et al. Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAMSO-based intrinsic subtype-ACOSOG Z1031. J Clin Oncol 2011;29(17):2342–9.