|Year : 2020 | Volume
| Issue : 2 | Page : 300-301
Fulvestrant: One step at a time?
P Harish, Prasad Narayanan
Department of Medical Oncology, Cytecare Cancer Hospital, Bengaluru, Karnataka, India
|Date of Submission||22-Apr-2020|
|Date of Decision||25-Apr-2020|
|Date of Acceptance||12-May-2020|
|Date of Web Publication||19-Jun-2020|
Cytecare Cancer Hospital, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Harish P, Narayanan P. Fulvestrant: One step at a time?. Cancer Res Stat Treat 2020;3:300-1
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. We are aware that the epidemiology of breast cancers in our country is different from that in the Western world., 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. 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.
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.,,,,, 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.
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.
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