Practical consensus recommendations regarding the use of hormonal therapy in metastatic breast cancer

Senthil Rajappa; J. Bajpai; M. Basade; M. Ganvir; C. Goswami; A. Murali; A. K. Rathi; V. Kaushal; S. Jain; Purvish M. Parikh; S. Aggarwal

doi:10.4103/sajc.sajc_121_18

South Asian Journal of Cancer, Table of Contents

CC BY-NC-ND 4.0 · South Asian J Cancer 2018; 07(02): 137-141
DOI: 10.4103/sajc.sajc_121_18

Original Article

Practical consensus recommendations regarding the use of hormonal therapy in metastatic breast cancer

Authors

Senthil Rajappa

Department of Medical Oncology, IACH, Hyderabad, Telangana
J. Bajpai

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra
M. Basade

Department of Medical Oncology, Saifee Hospital, Mumbai, Maharashtra
M. Ganvir

Department of Medical Oncology, Sir Ganga Ram Hospital, New Delhi
C. Goswami

Department of Radiation Oncology, Apollo Gleneagles Hospital, Kolkata, West Bengal
A. Murali

Department of Medical Oncology, Sarvodaya Hospital, Faridabad
A. K. Rathi

Department of Medical Oncology, Sarvodaya Hospital, Faridabad
V. Kaushal

Department of Radiation Oncology, MAMC, New Delhi
S. Jain

Department of Radiation Oncology, RCC, Rohtak, Haryana
Purvish M. Parikh

Department of Surgical Oncology, Ludhiana Medicity Hospital, Ludhinana, Punjab
S. Aggarwal

Department of Medical Oncology, Sir Ganga Ram Hospital, New Delhi

Abstract

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Abstract

Metastatic breast cancer (MBC) is cancer that has spread from the breast to another part of the body or has come back in another distant location. Treatment options for MBC depend on several factors. One of these factors is the levels of hormone receptors (HRs) in the tumor. Cancers with high levels of HRs, called HR-positive, use the hormones estrogen and progesterone to grow and spread. Hormonal therapy is a type of treatment specifically for HR-positive breast cancer. This expert group used data from published literature, practical experience and opinion of a large group of academic oncologists to arrive at these practical consensus recommendations in regards with the use of hormonal therapy and the management of HR-positive MBC for the benefit of community oncologists.

Key words

Aromatase inhibitor - combination - endocrine therapy - ESR1 testing - evorolimus - exemestane - fulvestrant - palbociclib

PDF (442 kb)

References

References
1 Agarwal G, Ramakant P. Breast cancer care in India: The current scenario and the challenges for the future. Breast Care (Basel) 2008;3:21-7.
2 Desai SB, Moonim MT, Gill AK, Punia RS, Naresh KN, Chinoy RF, et al. Hormone receptor status of breast cancer in India: A study of 798 tumours. Breast 2000;9:267-70.
3 Giordano SH, Buzdar AU, Smith TL, Kau SW, Yang Y, Hortobagyi GN, et al. Is breast cancer survival improving? Cancer 2004;100:44-52.
4 Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, et al. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer 2007;110:973-9.
5 Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: A retrospective analysis based on individual patient data from six consecutive studies. Cancer 2005;104:1742-50.
6 Dawood S, Broglio K, Gonzalez-Angulo AM, Buzdar AU, Hortobagyi GN, Giordano SH, et al. Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol 2008;26:4891-8.
7 American Cancer Society. Available from: https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html. [Last accessed on 2017 Nov 17].
8 Retsky M, Bonadonna G, Demicheli R, Folkman J, Hrushesky W, Valagussa P, et al. Hypothesis: Induced angiogenesis after surgery in premenopausal node-positive breast cancer patients is a major underlying reason why adjuvant chemotherapy works particularly well for those patients. Breast Cancer Res 2004;6:R372-4.
9 Retsky MW, Demicheli R, Hrushesky WJ, Baum M, Gukas ID. Dormancy and surgery-driven escape from dormancy help explain some clinical features of breast cancer. APMIS 2008;116:730-41.
10 Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, et al. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol 2006;13:776-82.
11 Salo M. Effects of anaesthesia and surgery on the immune response. Acta Anaesthesiol Scand 1992;36:201-20.
12 Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, et al. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: An open-label randomised controlled trial. Lancet Oncol 2015;16:1380-8.
13 King TA, Lyman J, Gonen M. A Prospective Analysis of Surgery and Survival in Stage IV Breast Cancer (TBCRC 013). 2016 ASCO Annual Meeting. Abstract 1006. Presented June 4, 2016.
14 Soran A, Ozmen V, Ozbas S. A Randomized Controlled Trial Evaluating Resection of the Primary Breast Tumor in Women Presenting With de novo Stage IV Breast Cancer: Turkish Study (Protocol MF07-01). 2016 ASCO Annual Meeting. Abstract 1005. Presented June 4, 2016.
15 Barrios C, Forbes JF, Jonat W, Conte P, Gradishar W, Buzdar A, et al. The sequential use of endocrine treatment for advanced breast cancer: Where are we? Ann Oncol 2012;23:1378-86.
16 Flaum LE, Gradishar WJ: Advances in Endocrine Therapy for Postmenopausal Metastatic Breast Cancer. Cancer Treat Res. 2018; 173: 141-54.
17 Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev 2003;D002747.
18 Rugo HS, Rumble RB, Macrae E, Barton DL, Connolly HK, Dickler MN, et al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American society of clinical oncology guideline. J Clin Oncol 2016;34:3069-103.
19 Cardoso F, Costa A, Senkus E, Aapro M, Andre F, Barrios CH, et al. 3^rd ESO–ESMO international consensus guidelines for advanced breast cancer (ABC3). Ann Oncol 2017;28:16-33.
20 Bonneterre J, Buzdar A, Nabholtz JM, Robertson JF, Thürlimann B, von Euler M, et al. Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer 2001;92:2247-58.
21 El-Saghir NS, El-Hajj II, Makarem JA, Otrock ZK. Combined ovarian ablation and aromatase inhibition as first-line therapy for hormone receptor-positive metastatic breast cancer in premenopausal women: Report of three cases. Anticancer Drugs 2006;17:999-1002.
22 Food and Drug Administration FDA Approves Ibrance for Post-Menopausal Women with Advanced Breast Cancer; 03 February, 2015. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432871.htm. [Last accessed on 2015 May 22].
23 Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): A randomised phase 2 study. Lancet Oncol 2015;16:25-35.
24 Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med 2016;375:1925-36.
25 Robertson JF, Bondarenko IM, Trishkina E, Dvorkin M, Panasci L, Manikhas A, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): An international, randomised, double-blind, phase 3 trial. Lancet 2016;388:2997-3005.
26 Ma CX, Reinert T, Chmielewska I, Ellis MJ. Mechanisms of aromatase inhibitor resistance. Nat Rev Cancer 2015;15:261-75.
27 Jeselsohn R, Buchwalter G, De Angelis C, Brown M, Schiff R. ESR1 mutations – A mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol 2015;12:573-83.
28 Jeselsohn R, Yelensky R, Buchwalter G, Frampton G, Meric-Bernstam F, Gonzalez-Angulo AM, et al. Emergence of constitutively active estrogen receptor-α mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res 2014;20:1757-67.
29 Merenbakh-Lamin K, Ben-Baruch N, Yeheskel A, Dvir A, Soussan-Gutman L, Jeselsohn R, et al. D538G mutation in estrogen receptor-α: A novel mechanism for acquired endocrine resistance in breast cancer. Cancer Res 2013;73:6856-64.
30 Toy W, Shen Y, Won H, Green B, Sakr RA, Will M, et al. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. Nat Genet 2013;45:1439-45.
31 Robinson DR, Wu YM, Vats P, Su F, Lonigro RJ, Cao X, et al. Activating ESR1 mutations in hormone-resistant metastatic breast cancer. Nat Genet 2013;45:1446-51.
32 Li S, Shen D, Shao J, Crowder R, Liu W, Prat A, et al. Endocrine-therapy-resistant ESR1 variants revealed by genomic characterization of breast-cancer-derived xenografts. Cell Rep 2013;4:1116-30.
33 Schiavon G, Hrebien S, Garcia-Murillas I, Cutts RJ, Pearson A, Tarazona N, et al. Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med 2015;7:313ra182.
34 Finn RS, Crown JP, Ettl J, Schmidt M, Bondarenko IM, Lang I, et al. Efficacy and safety of palbociclib in combination with letrozole as first-line treatment of ER-positive, HER2-negative, advanced breast cancer: Expanded analyses of subgroups from the randomized pivotal trial PALOMA-1/TRIO-18. Breast Cancer Res 2016;18:67.
35 Reinert T, Saad ED, Barrios CH, Bines J. Clinical implications of ESR1 mutations in hormone receptor-positive advanced breast cancer. Front Oncol 2017;7:26.
36 Reinert T, Barrios CH. Overall survival and progression-free survival with endocrine therapy for hormone receptor-positive, HER2-negative advanced breast cancer: Review. Ther Adv Med Oncol 2017;9:693-709.
37 Fribbens C, O'Leary B, Kilburn L, Hrebien S, Garcia-Murillas I, Beaney M, et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. J Clin Oncol 2016;34:2961-8.
38 Spoerke JM, Gendreau S, Walter K, Qiu J, Wilson TR, Savage H, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun 2016;7:11579.
39 Chandarlapaty S, Sung P, Chen D. Abstract S2-07: cfDNA analysis from BOLERO-2 plasma samples identifies a high rate of ESR1 mutations: Exploratory analysis for prognostic and predictive correlation of mutations reveals different efficacy outcomes of endocrine therapy-based regimens. Cancer Res 2016;76:S2-07.
40 U.S. Food and Drug Administration: Palbociclib (Ibrance capsules). Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm487080.htm. [Last accessed on 2016 Mar 01].
41 Ibrance (Palbociclib) Capsules, for Oral Use, Prescribing Information, Pfizer, Inc.; February, 2016. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf. [Last accessed on 2016 Mar 01].
42 Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): Final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016;17:425-39.
43 Chirila C, Mitra D, Colosia A, Ling C, Odom D, Iyer S, et al. Comparison of palbociclib in combination with letrozole or fulvestrant with endocrine therapies for advanced/metastatic breast cancer: Network meta-analysis. Curr Med Res Opin 2017;33:1457-66.
44 Beaver JA, Park BH. The BOLERO-2 trial: The addition of everolimus to exemestane in the treatment of postmenopausal hormone receptor-positive advanced breast cancer. Future Oncol 2012;8:651-7.