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Table of Contents
Year : 2020  |  Volume : 3  |  Issue : 2  |  Page : 300-301

Fulvestrant: One step at a time?

Department of Medical Oncology, Cytecare Cancer Hospital, Bengaluru, Karnataka, India

Date of Submission22-Apr-2020
Date of Decision25-Apr-2020
Date of Acceptance12-May-2020
Date of Web Publication19-Jun-2020

Correspondence Address:
Prasad Narayanan
Cytecare Cancer Hospital, Bengaluru, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/CRST.CRST_163_20

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How to cite this article:
Harish P, Narayanan P. Fulvestrant: One step at a time?. Cancer Res Stat Treat 2020;3:300-1

How to cite this URL:
Harish P, Narayanan P. Fulvestrant: One step at a time?. Cancer Res Stat Treat [serial online] 2020 [cited 2020 Sep 18];3:300-1. Available from: http://www.crstonline.com/text.asp?2020/3/2/300/287213

Breast carcinoma is the most common cancers among women, both globally and in India. The projection for breast cancer incidence in India for the year 2020 suggests that the numbers can go as high as 1,797,900, with its relative percentage remaining the same, i.e., 10%, among all the cancers.[1] We are aware that the epidemiology of breast cancers in our country is different from that in the Western world.[2],[3] Fulvestrant is one of the most frequently prescribed drugs in hormone receptor-positive advanced breast carcinoma (ABC). Millions of people in our country are receiving this drug regularly. However, we do not have any published literature from India about the efficacy and safety of single-agent fulvestrant in metastatic breast cancer.

In this issue of the journal, Vaikundaraja et al.[4] have presented the retrospective analysis of the data from 37 women with ABC. The response rate to fulvestrant was 60%, including 19% patients with stable disease. The median number of lines of prior systemic therapy for advanced disease was 2 (range, 0–6), and the median number of lines of prior hormonal therapy was 1 (range, 0–3). The median progression-free survival (PFS) and overall survival (OS) were 10 months (95% confidence interval [CI], 4–15.9 months) and 21 months (95% CI, 8.9–33.1 months), respectively. The 1-year PFS and OS were 41% and 64%, respectively.[4]

This study was conducted over a period of 8 years, and during this period, there has been a paradigm shift in the management of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, with the introduction of CDK4/6 inhibitors in the first- and second-line treatment of ABC showing improved outcomes.[5],[6],[7],[8],[9],[10] Therefore, it is unlikely that the implications of this study will make dramatic changes in clinical practice. Patients with hormone receptor-positive and HER2-positive ABC are usually treated with a combination of anti-HER2 therapy with chemotherapy and hormonal therapy, and these cancers behave different from the HER2-negative ones. In this study, 33% of the cohort comprised patients with hormone receptor-positive and HER2-positive ABC; however, there is no information about the anti-HER2 therapy administered to these patients. This has implications in the interpretation of the results. Multiple studies have shown that fulvestrant 250 mg has activity equivalent to that of tamoxifen or anastrozole. In this study, 24% of the women received fulvestrant at 250 mg dose as opposed to 500 mg, which has been shown to be superior.[11]

Another interesting point to note is that more patients received systemic therapy than hormonal therapy, probably because a large number of patients had visceral disease. Very few patients received chemotherapy after progression on fulvestrant. However, standard chemotherapy such as paclitaxel is used more frequently when there is disease progression after treatment, as such patients are more likely to develop visceral metastasis. Most often, hormone receptor-positive ABCs are seen primarily with bone metastasis, with few cases of visceral disease. In this study, 60% of the patients had visceral metastasis and 13% had visceral crisis. While this may have been the real-world status, we should take a step back before comparing these numbers with those from other previous studies.

With fulvestrant in second-line hormone therapy, the current evidence is moving forward with a lot of additional molecules, such as the checkpoint inhibitors, phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit alpha inhibitors, and histone deacetylase inhibitors. This is a good opportunity for us to collaborate for prospective data collection and pooled data analysis, to understand the behavior of this disease in our subcontinent.

In summary, this retrospective analysis about the role of fulvestrant in ABC confirms its efficacy in this scenario, but does not provide a direction for changes in clinical practice.

  References Top

Anonymous. Three Year Report of Population Based Cancer Registries 2012–2014. Bangalore, India: Indian Council of Medical Research (ICMR); 2016. Available from: http://www.ncdirindia.org/NCRP/all_ncrp_reports/pbcr_report_2012_2014/all_content/pdf_printed_version/preliminary_pages_printed.pdf. [Last accessed on 2020 May 12].  Back to cited text no. 1
Doval DC, Radhakrishna S, Tripathi R, Kashinath RI, Talwar V, Batra U, et al. A multi-institutional real world data study from India of 3453 non-metastatic breast cancer patients undergoing upfront surgery. Sci Rep 2020;10:5886.  Back to cited text no. 2
Ghosh J, Gupta S, Desai S, Shet T, Radhakrishnan S, Suryavanshi P, et al. Estrogen, progesterone and HER2 receptor expression in breast tumors of patients, and their usage of HER2-targeted therapy, in a tertiary care centre in India. Indian J Cancer 2011;48:391-6.  Back to cited text no. 3
[PUBMED]  [Full text]  
Vaikundaraja IM, Dhanushkodi M, Radhakrishnan V, Kalaiarasi JP, Mehra N, Rajan AK, et al. Fulvestrant in hormone-positive advanced breast cancer: Real-world outcome. Cancer Res Stat Treat 2020;3:275-80.  Back to cited text no. 4
  [Full text]  
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.  Back to cited text no. 5
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.  Back to cited text no. 6
Sledge GW Jr., Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol 2017;35:2875-84.  Back to cited text no. 7
Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017;35:3638-46.  Back to cited text no. 8
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375:1738-48.  Back to cited text no. 9
Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol 2018;36:2465-72.  Back to cited text no. 10
Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, et al. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol 2010;28:4594-600.  Back to cited text no. 11


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