|LETTER TO EDITOR
|Year : 2020 | Volume
| Issue : 3 | Page : 664
Author's reply to Singh and Patel et al.
Manikandan Dhanushkodi1, Indhuja Muthiah Vaikundaraja1, Rama Ranganathan2
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 Submission||30-Jul-2020|
|Date of Decision||04-Aug-2020|
|Date of Acceptance||05-Aug-2020|
|Date of Web Publication||19-Sep-2020|
Department of Medical Oncology, Cancer Institute (WIA), Chennai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
|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
We thank Singh and Patel and Shivashankara for their interest, valuable comments, and suggestions on our study on fulvestrant in hormone-positive advanced breast cancer and the accompanying editorial.,
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. These could be the reasons for the inferior PFS in the CONFIRM trial.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
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:
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. [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. [Full text]
Harish P, Narayanan P. Fulvestrant: One step at a time? Cancer Res Stat Treat 2020;3:300-1. [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.