По следам SABCS 2022: TOP-12 исследований по распространенному раку молочной железы, которые могут изменить нашу клиническую практику

Колядина И.В. По следам SABCS 2022: TOP-12 исследований по распространенному раку молочной железы, которые могут изменить нашу клиническую практику. Современная Онкология. 2023;25(1):46–54. DOI: 10.26442/18151434.2023.1.202102

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Kolyadina IV. Following in the footsteps of SABCS 2022: top 12 advanced breast cancer studies that could change our clinical practice: A review. Journal of Modern Oncology. 2023;25(1):46–54.
DOI: 10.26442/18151434.2023.1.202102

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Аннотация

Проведен анализ материала, представленного на конференции SABCS 2022, по лечению распространенного рака молочной железы (мРМЖ); выделены 12 наиболее ярких, креативных и важных рандомизированных и популяционных исследований, результаты которых доложены на устных или постерных сессиях. В лечении HR+HER2-негативного мРМЖ впервые представлены новые и уникальные данные рандомизированного клинического исследования II фазы RIGHT Choice (комбинированная эндокринотерапия с рибоциклибом против химиотерапии при агрессивном течении заболевания, включая висцеральный криз), исследования PACE (комбинированная эндокринотерапия с палбоциклибом после прогрессирования на ингибиторах CDK4/6, а также целый ряд исследований по выбору оптимальной лечебной стратегии при гормонорезистентном РМЖ (CAPItello-291, EMERALD, SERENA-2, TROPiCS-02). В лечении предлеченного HER2+ мРМЖ появился безусловный фаворит – трастузумаб дерукстекан; на конференции SABCS 2022 представлены новые данные рандомизированных клинических исследований III фазы (DESTINY-Breast 02 и 03) и 2 крупных популяционных анализа из рутинной практики онкологов Италии и Японии. Среди исследований по распространенному тройному негативному мРМЖ заслуживают внимания результаты двух неординарных клинических исследований II фазы – DORA и ALICE, в которых изучена эффективность и безопасность иммунотерапии с неожиданными комбинаторными партнерами (с олапарибом – в исследовании DORA, с иммуномодулирующей химиотерапией – в исследовании ALICE).

Ключевые слова: новости SABCS, распространенный (метастатический) рак молочной железы, ингибиторы CDK4/6, рибоциклиб, палбоциклиб, терапия гормонорезистентного рака молочной железы, анти-HER2 терапия, трастузумаб дерукстекан, метастазы в головной мозг, тройной негативный рак, иммунотерапия, иммуномодулирующая химиотерапия

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A review of the data presented at the SABCS 2022 conference on the treatment of advanced breast cancer (metastatic breast cancer – mBC) was conducted; 12 of the most exciting, creative, and significant randomized and population studies were identified, the results of which were reported at oral or poster sessions. For the first time, new and unique data on the treatment of HR+HER2-negative mBC from the following studies were presented: RIGHT Choice phase II randomized clinical study (combination endocrine therapy with ribociclib versus chemotherapy in aggressive disease, including visceral crisis), PACE study (combination endocrine therapy with palbociclib after disease progression on CDK4/6 inhibitors), and several studies on choosing the optimal treatment strategy for hormone-resistant breast cancer (CAPItello-291, EMERALD, SERENA-2, TROPiCS-02). A clear-cut favorite, trastuzumab deruxtecan, became available in treating pre-treated HER2+ mBC; at the SABCS 2022 conference, new data from a randomized phase III clinical trials (DESTINY-Breast 02 and 03) and two large real-world population analyses from Italy and Japan were presented. Among the studies on advanced triple-negative mBC, noteworthy are the results of two extraordinary phase II clinical studies, DORA and ALICE, which studied the effectiveness and safety of immunotherapy with unusual combinations (with olaparib in the DORA study and with immunomodulatory chemotherapy in the ALICE study).

Keywords: SABCS news, advanced (metastatic) breast cancer, CDK4/6 inhibitors, ribociclib, palbociclib, hormone-resistant breast cancer therapy, anti-HER2 therapy, trastuzumab deruxtecan, brain metastases, triple negative cancer, immunotherapy, immunomodulatory chemotherapy

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Список литературы

1. Lu Y-S. Primary Results From the Randomized Phase II RIGHT Choice Trial of Premenopausal Patients With Aggressive HR+/HER2- Advanced Breast Cancer Treated With Ribociclib + Endocrine Therapy vs Physician’s Choice Combination Chemotherapy, SABCS 2022, Oral Presentation.
2. Рак молочной железы. Клинические рекомендации Минздрава России. Современная Онкология. 2021;23(1):5-40 [Breast cancer. Clinical recommendations. Journal of Modern Oncology. 2021;23(1):5-40 (in Russian)]. DOI:10.26442/18151434.2021.1.200823
3. ESMO Metastatic breast cancer guidelines. Available at: https://www.esmo.org/living-guidelines/esmo-metastatic-breast-cancer-living-guideline/er-positive-he.... Accessed: 05.01.2023.
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 1.2023 – January 27, 2023. Available at: https://www.nccn.org/guidelines. Accessed: 05.01.2023.
5. Kalinsky K, Accordino MK, Chiuzan C, at al. A randomized, phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor–positive (HR+), HER2-negative metastatic breast cancer (MBC): MAINTAIN trial. J Clin Oncol. 2022;40(Suppl. 17):LBA1004. DOI:10.1200/JCO.2022.40.17_suppl.LBA1004
6. Mayer EL, Ren Y, Wagle N, et al. Palbociclib After CDK4/6i and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer. SABCS 2022, Oral Presentation.
7. Turner NC. Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant hormone receptor- positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the Phase III CAPItello-291 trial. SABCS 2022, Oral Presentation.
8. Bardia A. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022, Oral Presentation.
9. Oliveira M, Pominchuk D, Nowecki Z, et al. Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose Phase 2 SERENA-2 trial. SABCS 2022, Oral Presentation.
10. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC): Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients (Pts) With HR+/HER2- Metastatic Breast Cancer (mBC). SABCS 2022. Cancer Res. 2023;83(Suppl. 5):GS1-11.
11. Krop I, Park YH, Kim S-B, et al. Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized phase 3 study DESTINY-Breast02. SABCS 2022, Oral Presentation.
12. Hurvitz S. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results of the randomized, phase 3 study DESTINY-Breast03. SABCS 2022, Oral Presentation.
13. Botticelli A. (P1-11-13) DE-REAL: Italian multicenter experience of trastuzumab deruxtecan in a real world setting. SABCS 2022, Poster #534596.
14. Yamanaka T. (PD7-01) Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: A multicenter retrospective study (ROSET-BM study). SABCS 2022, Poster #534479.
15. Nakada T, Sugihara K, Jikoh T, et al. The Latest Research and Development into the Antibody-Drug Conjugate, [fam-] Trastuzumab Deruxtecan (DS-8201a), for HER2 Cancer Therapy. Chem Pharm Bull (Tokyo). 2019;67(3):173-85. DOI:10.1248/cpb.c18-00744
16. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1. Clin Cancer Res. 2016;22(20):5097-108.
17. Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020;382(7):610-21. DOI:10.1056/NEJMoa1914510
18. Cortés J, Kim SB, Chung WP, et al. DESTINY-Breast03 Trial Investigators. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143-54.
19. Sammons S. (PD11-12) DORA: A Phase II, Multicenter, International, Non-Comparator Study of Olaparib (O) +/- Durvalumab (D) as a chemotherapy-free maintenance strategy in platinum treated advanced triple-negative breast cancer (aTNBC). SABCS 2022, Poster #534538.
20. Kyte JA. (PD11-11) Results from ALICE – Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer, a Randomized Phase IIb Trial. SABCS 2022, Poster #534018.
21. Røssevold AH , Andresen NK, Bjerre CA, et al. Atezolizumab plus anthracycline-based chemotherapy in metastatic triple-negative breast cancer: the randomized, double-blind phase 2b ALICE trial. Nat Med. 2022;28(12):2573-83. DOI:10.1038/s41591-022-02126-1

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1. Lu Y-S. Primary Results From the Randomized Phase II RIGHT Choice Trial of Premenopausal Patients With Aggressive HR+/HER2- Advanced Breast Cancer Treated With Ribociclib + Endocrine Therapy vs Physician’s Choice Combination Chemotherapy, SABCS 2022, Oral Presentation.
2. Breast cancer. Clinical recommendations. Journal of Modern Oncology. 2021;23(1):5-40 (in Russian). DOI:10.26442/18151434.2021.1.200823
3. ESMO Metastatic breast cancer guidelines. Available at: https://www.esmo.org/living-guidelines/esmo-metastatic-breast-cancer-living-guideline/er-positive-he.... Accessed: 05.01.2023.
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 1.2023 – January 27, 2023. Available at: https://www.nccn.org/guidelines. Accessed: 05.01.2023.
5. Kalinsky K, Accordino MK, Chiuzan C, at al. A randomized, phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor–positive (HR+), HER2-negative metastatic breast cancer (MBC): MAINTAIN trial. J Clin Oncol. 2022;40(Suppl. 17):LBA1004. DOI:10.1200/JCO.2022.40.17_suppl.LBA1004
6. Mayer EL, Ren Y, Wagle N, et al. Palbociclib After CDK4/6i and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer. SABCS 2022, Oral Presentation.
7. Turner NC. Capivasertib and fulvestrant for patients with aromatase inhibitor-resistant hormone receptor- positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the Phase III CAPItello-291 trial. SABCS 2022, Oral Presentation.
8. Bardia A. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. SABCS 2022, Oral Presentation.
9. Oliveira M, Pominchuk D, Nowecki Z, et al. Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose Phase 2 SERENA-2 trial. SABCS 2022, Oral Presentation.
10. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC): Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients (Pts) With HR+/HER2- Metastatic Breast Cancer (mBC). SABCS 2022. Cancer Res. 2023;83(Suppl. 5):GS1-11.
11. Krop I, Park YH, Kim S-B, et al. Trastuzumab deruxtecan vs physician’s choice in patients with HER2+ unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine: primary results of the randomized phase 3 study DESTINY-Breast02. SABCS 2022, Oral Presentation.
12. Hurvitz S. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results of the randomized, phase 3 study DESTINY-Breast03. SABCS 2022, Oral Presentation.
13. Botticelli A. (P1-11-13) DE-REAL: Italian multicenter experience of trastuzumab deruxtecan in a real world setting. SABCS 2022, Poster #534596.
14. Yamanaka T. (PD7-01) Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: A multicenter retrospective study (ROSET-BM study). SABCS 2022, Poster #534479.
15. Nakada T, Sugihara K, Jikoh T, et al. The Latest Research and Development into the Antibody-Drug Conjugate, [fam-] Trastuzumab Deruxtecan (DS-8201a), for HER2 Cancer Therapy. Chem Pharm Bull (Tokyo). 2019;67(3):173-85. DOI:10.1248/cpb.c18-00744
16. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1. Clin Cancer Res. 2016;22(20):5097-108.
17. Modi S, Saura C, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020;382(7):610-21. DOI:10.1056/NEJMoa1914510
18. Cortés J, Kim SB, Chung WP, et al. DESTINY-Breast03 Trial Investigators. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med. 2022;386(12):1143-54.
19. Sammons S. (PD11-12) DORA: A Phase II, Multicenter, International, Non-Comparator Study of Olaparib (O) +/- Durvalumab (D) as a chemotherapy-free maintenance strategy in platinum treated advanced triple-negative breast cancer (aTNBC). SABCS 2022, Poster #534538.
20. Kyte JA. (PD11-11) Results from ALICE – Atezolizumab Combined with Immunogenic Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer, a Randomized Phase IIb Trial. SABCS 2022, Poster #534018.
21. Røssevold AH , Andresen NK, Bjerre CA, et al. Atezolizumab plus anthracycline-based chemotherapy in metastatic triple-negative breast cancer: the randomized, double-blind phase 2b ALICE trial. Nat Med. 2022;28(12):2573-83. DOI:10.1038/s41591-022-02126-1

Авторы

И.В. Колядина*

ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия; ФГБУ «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии им. акад. В.И. Кулакова» Минздрава России, Москва, Россия
*irinakolyadina@yandex.ru

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Irina V. Kolyadina*

Russian Medical Academy of Continuous Professional Education, Moscow, Russia; Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia
*irinakolyadina@yandex.ru

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