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Table of Contents
Year : 2020  |  Volume : 3  |  Issue : 3  |  Page : 664

Author's reply to Singh and Patel et al.

1 Department of Medical Oncology, Cancer Institute, Chennai, Tamil Nadu, India
2 Department of Epidemiology and Biostatistics, Cancer Institute, Chennai, Tamil Nadu, India

Date of Submission30-Jul-2020
Date of Decision04-Aug-2020
Date of Acceptance05-Aug-2020
Date of Web Publication19-Sep-2020

Correspondence Address:
Manikandan Dhanushkodi
Department of Medical Oncology, Cancer Institute (WIA), Chennai, Tamil Nadu
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/CRST.CRST_261_20

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How to cite this article:
Dhanushkodi M, Vaikundaraja IM, Ranganathan R. Author's reply to Singh and Patel et al. Cancer Res Stat Treat 2020;3:664

How to cite this URL:
Dhanushkodi M, Vaikundaraja IM, Ranganathan R. Author's reply to Singh and Patel et al. Cancer Res Stat Treat [serial online] 2020 [cited 2020 Oct 30];3:664. Available from: https://www.crstonline.com/text.asp?2020/3/3/664/295507

We thank Singh[1] and Patel and Shivashankara[2] for their interest, valuable comments, and suggestions on our study on fulvestrant in hormone-positive advanced breast cancer and the accompanying editorial.[3],[4]

A total of 7416 patients with breast cancer were treated in the Cancer Institute, Chennai, from January 2011 to December 2019. For the fulvestrant 250 mg schedule, the loading dose was 500 mg on day 0, followed by 250 mg on days 15 and 28, and monthly thereafter. The median number of cycles of fulvestrant was 4 (range: 2–112).

The response could not be assessed in 11 (40%) patients. The response could not be evaluated as the patients were lost to follow-up before the reassessment. Of the 11 patients, 6 received 1 cycle of fulvestrant, 4 received 4 cycles, and 1 patient received the first cycle at our institute and the remaining 11 locally, near home. All 11 patients were included in the analysis of progression-free survival (PFS) and overall survival.

The median PFS for the patients who received fulvestrant monotherapy was 10 months as opposed to 12 months in those who received combination therapy. Compared to fulvestrant monotherapy, combination therapy with fulvestrant did not show a significant correlation with the PFS in the univariate analysis (hazard ratio, 0.72; 95% confidence interval, 0.31–1.65; P = 0.43). Currently, the only fulvestrant-based combination used in the Cancer Institute, Chennai, is in combination with a CDK 4/6 inhibitor.

In the CONFIRM trial (fulvestrant 500 mg arm), 48% of the patients progressed when on adjuvant endocrine therapy and 36% progressed on first-line endocrine therapy. Moreover, the response was assessed once every 12 weeks.[5] These could be the reasons for the inferior PFS in the CONFIRM trial.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Singh A. Fulvestrant in the fight against ER-positive advanced breast cancer; lone soldier or an important partner? Cancer Res Stat Treat 2020:3;662:  Back to cited text no. 1
Patel A, Shivashankara MS. Fulvestrant: Do not forget the history and opportunities for cost saving from real-world data. Cancer Res Stat Treat 2020:3;663.  Back to cited text no. 2
  [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. 3
  [Full text]  
Harish P, Narayanan P. Fulvestrant: One step at a time? Cancer Res Stat Treat 2020;3:300-1.  Back to cited text no. 4
  [Full text]  
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. 5


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