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Table of Contents
Year : 2020  |  Volume : 3  |  Issue : 3  |  Page : 663

Fulvestrant: Do not forget the history and opportunities for cost saving from real-world data

1 Department of Medical Oncology, Malignant Diseases Treatment Centre, Army Hospital Research and Referral, New Delhi, India
2 Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India

Date of Submission26-Jul-2020
Date of Decision29-Jul-2020
Date of Acceptance30-Jul-2020
Date of Web Publication19-Sep-2020

Correspondence Address:
Amol Patel
Room no 3, Department of Medical Oncology, Maligant Diseases, Treatment Centre, Army Hospital Research & Referral, New Delhi,India, 110 010
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/CRST.CRST_256_20

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How to cite this article:
Patel A, Shivashankara M S. Fulvestrant: Do not forget the history and opportunities for cost saving from real-world data. Cancer Res Stat Treat 2020;3:663

How to cite this URL:
Patel A, Shivashankara M S. Fulvestrant: Do not forget the history and opportunities for cost saving from real-world data. Cancer Res Stat Treat [serial online] 2020 [cited 2021 Jan 17];3:663. Available from: https://www.crstonline.com/text.asp?2020/3/3/663/295503

We congratulate Vaikundaraja et al. for bringing out the real-world evidence on fulvestrant from southern India.[1],[2] Despite the well-maintained data, response to fulvestrant was not known in 40% of the cases. Considering this, the median progression-free survival (PFS) of 10 months observed in this study may not be representative of the real-world figures. Even in the first-line setting, as per the CONFIRM trial, the median PFS was 6.5 months.[3] Whether this reported PFS was due to a selection bias in this retrospective study or any other reasons, the authors are requested to share their views.

Only 40 patients were available for the analysis over a period of 9 years. This could be due to the lack of affordability. We request the authors to report the total number of patients who were treated for metastatic breast cancer. This is important information, which will help us to understand how many patients in a real-world setting could afford or be eligible for fulvestrant treatment.

Fulvestrant was used in combination with exemestane in four patients. As this combination has doubtful efficacy, authors are requested to discuss the outcomes of these four patients. In addition, we would like to know whether it is still being used at the author's institute.

We appreciate another important finding that the authors brought out regarding the efficacy of the 500 mg versus 250 mg dose. On univariate analysis, there was no statistically significant difference observed. Although only nine patients received the 250 mg dose of fulvestrant, the authors did not comment on the low dose (LD) schedule. In the initial dose-finding studies, three dose schedules were assessed. The approved dose schedule was 250 mg/month; for LD, 500 mg fulvestrant was administered on day 0 and 250 mg on days 14 and 28, followed by 250 mg every 28 days. In the high-dose (HD) schedule, 500 mg was administered on days 0, 14, and 28, followed by the same dose every 28 days.[5],[6] In the FINDER 2 study, the time to progression (TTP) was similar to the LD and HD schedules, 6.1 versus 6 months, respectively.[5] In the Japanese FINDER 1 study, the TTP was 7.5 versus 6 months in the LD versus HD schedule, respectively.[6] As the cost remains a major hindrance in the care of patients in India, collaborative work should be undertaken between major institutes in India to address this research question of fulvestrant 500 mg versus 250 mg dose, wherein the accessibility to fulvestrant may improve as it has the potential to reduce the cost by half.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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. 1
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Harish P, Narayanan P. Fulvestrant: One step at a time? Cancer Res Stat Treat 2020;3:300-1.  Back to cited text no. 2
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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. 3
Mrózek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, et al. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer 2012;12:151-6.  Back to cited text no. 4
Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, et al. Results of a Phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat 2010;123:453-61.  Back to cited text no. 5
Ohno S, Rai Y, Iwata H, Yamamoto N, Yoshida M, Iwase H, et al. Three dose regimens of fulvestrant in postmenopausal Japanese women with advanced breast cancer: Results from a double-blind, phase II comparative study (FINDER1). Ann Oncol 2010;21:2342-7.  Back to cited text no. 6


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