References
- Chumsri S, Howes T, Bao T, Sabnis G, Brodie A. Aromatase, aromatase inhibitors, and breast cancer. J Steroid Biochem Mol Biol. 2011;125(1–2):13–22. doi:https://doi.org/10.1016/j.jsbmb.2011.02.001.
- Mohd Sharial MS, Crown J, Hennessy BT. Overcoming resistance and restoring sensitivity to HER2-targeted therapies in breast cancer. Ann Oncol. 2012;23(12):3007–3016. doi:https://doi.org/10.1093/annonc/mds200.
- Lim E, Metzger-Filho O, Winer EP. The natural history of hormone receptor-positive breast cancer. Oncology. 2012;26(8):688–694.
- Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, André F, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31(12):1623–1649. doi:https://doi.org/10.1016/j.annonc.2020.09.010.
- Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and followup. Ann Oncol. 2012;23(Suppl 7):vii11–vii19. doi:https://doi.org/10.1093/annonc/mds232.
- Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, American Society of Clinical Oncology, et al. American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Clin Oncol. 2010;28(23):3784–3796. doi:https://doi.org/10.1200/JCO.2009.26.3756.
- Ring A, Dowsett M. Mechanisms of tamoxifen resistance. Endocr Relat Cancer. 2004;11(4):643–658. doi:https://doi.org/10.1677/erc.1.00776.
- Beck JT, Hortobagyi GN, Campone M, Lebrun F, Deleu I, Rugo HS, et al. Everolimus plus exemestane as first-line therapy in HR⁺, HER2⁻ advanced breast cancer in BOLERO-2. Breast Cancer Res Treat. 2014;143(3):459–467. doi:https://doi.org/10.1007/s10549-013-2814-5.
- Yardley DA, Noguchi S, Pritchard KI, Burris HA, Baselga J, Gnant M, et al. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013;30(10):870–884. doi:https://doi.org/10.1007/s12325-013-0060-1.
- Gnant M. The role of mammalian target of rapamycin (mTOR) inhibition in the treatment of advanced breast cancer. Curr Oncol Rep. 2013;15(1):14–23. doi:https://doi.org/10.1007/s11912-012-0277-1.
- Boulay A, Rudloff J, Ye J, Zumstein-Mecker S, O'Reilly T, Evans DB, et al. Dual inhibition of mTOR and estrogen receptor signaling in vitro induces cell death in models of breast cancer. Clin Cancer Res. 2005;11(14):5319–5328. doi:https://doi.org/10.1158/1078-0432.CCR-04-2402.
- Gnant M. Overcoming endocrine resistance in breast cancer: importance of mTOR inhibition. Expert Rev Anticancer Ther. 2012;12(12):1579–1589. doi:https://doi.org/10.1586/era.12.138.1
- Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20(10):1360–1369. doi:https://doi.org/10.1016/S1470-2045(19)30420-6.
- Guo Q, Lin X, Ye L, Xu R, Dai Y, Zhang Y, et al. Comparative efficacy of CDK4/6 inhibitors plus aromatase inhibitors versus fulvestrant for the first-line treatment of hormone receptor-positive advanced breast cancer: a network meta-analysis. Target Oncol. 2019;14(2):139–148. doi:https://doi.org/10.1007/s11523-019-00633-9.
- Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–524. doi:https://doi.org/10.1056/NEJMoa1911149.
- Sledge GW, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6(1):116–124. doi:https://doi.org/10.1001/jamaoncol.2019.4782.
- Rugo HS, Finn RS, Diéras V, Ettl J, Lipatov O, Joy AA, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719–729. doi:https://doi.org/10.1007/s10549-018-05125-4.
- Gao JJ, Cheng J, Bloomquist E, Sanchez J, Wedam SB, Singh H, et al. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020;21(2):250–260. doi:https://doi.org/10.1016/S1470-2045(19)30804-6.
- Afinitor (everolimus) prescribing information. Revised 2012. Novartis Pharmaceuticals Corporation: East Hanover, NJ. http://www.pharma.us.novartis.com/product/pi/pdf/afinitor.pdf.
- Baselga J, Campone M, Piccart M, Burris HA, Rugo HS, Sahmoud T, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520–529. doi:https://doi.org/10.1056/NEJMoa1109653.
- Burris HA, Lebrun F, Rugo HS, Beck JT, Piccart M, Neven P, et al. Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial. Cancer. 2013;119(10):1908–1915. doi:https://doi.org/10.1002/cncr.28010.
- Cazzaniga ME, Airoldi M, Arcangeli V, Artale S, Atzori F, Ballerio A, on behalf of EVA Study Group, et al. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: new insights beyond clinical trials. The EVA study. Breast. 2017;35:115–121. doi:https://doi.org/10.1016/j.breast.2017.06.043.
- Moscetti L, Vici P, Gamucci T, Natoli C, Cortesi E, Marchetti P, et al. Safety analysis, association with response and previous treatments of everolimus and exemestane in 181 metastatic breast cancer patients: a multicenter Italian experience. Breast. 2016;29:96–101. doi:https://doi.org/10.1016/j.breast.2016.07.005.
- Steger GG, Egle D, Bartsch R, Pfeiler G, Petru E, Greil R, et al. Efficacy and safety of everolimus plus exemestane in patients with HR+, HER2− advanced breast cancer progressing on/after prior endocrine therapy in routine clinical practice: primary results from the non-interventional study, STEPAUT. Breast. 2020;50:64–70. doi:https://doi.org/10.1016/j.breast.2020.01.035.
- Knapen LM, Geurts SME, Ibragimova KIE, Croes S, Vriens BEPJ, van den Berkmortel FWPJ, et al. A real-life study on the implementation and effectiveness of exemestane plus everolimus per hospital type in patients with advanced breast cancer. A study of the Southeast Netherlands Advanced Breast Cancer registry. Breast. 2019;44:46–51. doi:https://doi.org/10.1016/j.breast.2019.01.001.
- Jerusalem G, de Boer RH, Hurvitz S, Yardley DA, Kovalenko E, Ejlertsen B, et al. Everolimus plus exemestane vs everolimus or capecitabine monotherapy for estrogen receptor-positive, HER2-negative advanced breast cancer: the BOLERO-6 randomized clinical trial. JAMA Oncol. 2018;4(10):1367–1374. doi:https://doi.org/10.1001/jamaoncol.2018.2262.
- Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol. 2014;25(12):2357–2362. doi:https://doi.org/10.1093/annonc/mdu456.
- Tesch H, Stoetzer O, Decker T, Kurbacher CM, Marmé F, Schneeweiss A, et al. Efficacy and safety of everolimus plus exemestane in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: results of the single-arm, phase IIIB 4EVER trial. Int J Cancer. 2019;144(4):877–885. doi:https://doi.org/10.1002/ijc.31738.
- Fasching PA, Decker T, Schneeweiss A, Uleer C, Förster F, Wimberger P, et al. Breast cancer treatment with everolimus and exemestane for ER + women – results of the 2nd interim analysis of the non-interventional trial BRAWO. Ann Oncol. 2014;25(4Suppl):Abstract LBA9.
- O'Shaughnessy J, Thaddeus Beck J, Royce M. Everolimus-based combination therapies for HR+, HER2− metastatic breast cancer. Cancer Treat Rev. 2018;69:204–214. doi:https://doi.org/10.1016/j.ctrv.2018.07.013.
- Boland MR, Ryan ÉJ, Dunne E, Aherne TM, Bhatt NR, Lowery AJ, et al. Meta-analysis of the impact of progesterone receptor status on oncological outcomes in oestrogen receptor-positive breast cancer. Br J Surg. 2019;107(1):33–43. doi:https://doi.org/10.1002/bjs.11347.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: breast cancer. V6. 2020. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
- Pritchard KI, Gelmon KA, Rayson D, Provencher L, Webster M, McLeod D, et al. Endocrine therapy for postmenopausal women with hormone receptor-positive her2-negative advanced breast cancer after progression or recurrence on nonsteroidal aromatase inhibitor therapy: a Canadian consensus statement. Curr Oncol. 2013;20(1):48–61. doi:https://doi.org/10.3747/co.20.1316.
- Campone M, Bachelot T, Gnant M, Deleu I, Rugo HS, Pistilli B, et al. Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: subgroup analysis from the BOLERO-2 study. Eur J Cancer. 2013;49(12):2621–2632. doi:https://doi.org/10.1016/j.ejca.2013.04.011.
- Gnant M, Baselga J, Rugo HS, Noguchi S, Burris HA, Piccart M, et al. Effect of everolimus on bone marker levels and progressive disease in bone in BOLERO-2. J Natl Cancer Inst. 2013;105(9):654–663. doi:https://doi.org/10.1093/jnci/djt026.
- Pritchard KI, Burris HA, Ito Y, Rugo HS, Dakhil S, Hortobagyi GN, et al. Safety and efficacy of everolimus with exemestane vs. exemestane alone in elderly patients with HER2-negative, hormone receptor-positive breast cancer in BOLERO-2. Clin Breast Cancer. 2013;13(6):421–432. doi:https://doi.org/10.1016/j.clbc.2013.08.011.
- Ciccarese M, Fabi A, Moscetti L, Cazzaniga ME, Petrucelli L, Forcignanò R, et al. Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients: a multicenter Italian experience. Breast Cancer Res Treat. 2017;163(3):587–594. doi:https://doi.org/10.1007/s10549-017-4213-9.
- Jerusalem G, Mariani G, Ciruelos EM, Martin M, Tjan-Heijnen VCG, Neven P, et al. Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer progressing on prior non-steroidal aromatase inhibitors: primary results of a phase IIIb, open-label, single-arm, expanded-access multicenter trial (BALLET). Ann Oncol. 2016;27(9):1719–1725. doi:https://doi.org/10.1093/annonc/mdw249.
- Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, et al. Everolimus plus exemestane in advanced breast cancer: safety results of the BALLET study on patients previously treated without and with chemotherapy in the metastatic setting. Oncologist. 2017;22(6):648–654. doi:https://doi.org/10.1634/theoncologist.2016-0461.
- Generali D, Venturini S, Rognoni C, Ciani O, Pusztai L, Loi S, et al. A network meta-analysis of everolimus plus exemestane versus chemotherapy in the first- and second-line treatment of estrogen receptor-positive metastatic breast cancer. Breast Cancer Res Treat. 2015;152(1):95–117. doi:https://doi.org/10.1007/s10549-015-3453-9.
- Schettini F, Giuliano M, Giudici F, Conte B, De Placido P, Venturini S, et al. Endocrine-based treatments in clinically-relevant subgroups of hormone receptor-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis. Cancers (Basel). 2021;13(6):1458. doi:https://doi.org/10.3390/cancers13061458.
- Schettini F, Sobhani N, Ianza A, Triulzi T, Molteni A, Lazzari MC, et al. Immune system and angiogenesis-related potential surrogate biomarkers of response to everolimus-based treatment in hormone receptor-positive breast cancer: an exploratory study. Breast Cancer Res Treat. 2020;184(2):421–431. doi:https://doi.org/10.1007/s10549-020-05856-3.
- Prat A, Brase JC, Cheng Y, Nuciforo P, Paré L, Pascual T, et al. Everolimus plus exemestane for hormone receptor-positive advanced breast cancer: a PAM50 intrinsic subtype analysis of BOLERO-2. Oncologist. 2019;24(7):893–900. doi:https://doi.org/10.1634/theoncologist.2018-0407.
- Yi Z, Ma F. Biomarkers of everolimus sensitivity in hormone receptor-positive breast cancer. J Breast Cancer. 2017;20(4):321–326. doi:https://doi.org/10.4048/jbc.2017.20.4.321.