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. 2023 Oct;23(7):712-720.e3.
doi: 10.1016/j.clbc.2023.06.013. Epub 2023 Jul 7.

Adjuvant Endocrine Therapy in Premenopausal Women With Hormone Receptor-Positive Early-Stage Breast Cancer: Risk Stratification in a Real-World Setting

Raffaella D'Onofrio  1 , Claudia Omarini  2 , Angela Toss  3 , Isabella Sperduti  4 , Federico Piacentini  5 , Monica Barbolini  1 , Laura Cortesi  6 , Elena Barbieri  6 , Elisa Pettorelli  1 , Chiara Chiavelli  7 , Massimo Dominici  3 , Luca Moscetti  8
Affiliations

Adjuvant Endocrine Therapy in Premenopausal Women With Hormone Receptor-Positive Early-Stage Breast Cancer: Risk Stratification in a Real-World Setting

Raffaella D'Onofrio et al. Clin Breast Cancer. 2023 Oct.

Abstract

Background: Ovarian function suppression (OFS) and hormone therapy (HT) represent an adjuvant option in premenopausal hormone receptor-positive early breast cancer (HR+EBC). The SOFT-TEXT trials showed improved outcomes upon receiving aromatase inhibitors (AIs)/OFS.

Methods: In order to estimate the magnitude of absolute improvements, we conducted a retrospective study applying composite risk (CR) to 237 premenopausal HR+EBC patients.

Results: Overall, 119 of these received tamoxifen (T)/OFS and 118 received AIs/OFS. The median age was 45 years (ys). After a median follow up of 65 months, recurrence was 6.7% in T patients and 10.2% in AI ones. CR (cutoff: 2.67) and ET duration (five-year cutoff) was found to have a significant impact on DFS. Invasive disease-free survival (IDFS) at 5 ys amounted to 82.9% for a CR>2.67 and 95% with CR</=2.67 (p 0.0046). Five-year IDFS was 98.3% in patients who had completed 5-year HT compared to 54.6% of those who had stopped before 5 years (P < .0001). Excluding patients who had discontinued therapy due to disease relapse, IDFS difference at 5 years remained statistically significant (p=0.03) between the two groups, with an iDFS rate of 86.5% at 5 years in the second group. Adverse events of different grades were reported in 116 and 112 patients in the T/OFS group and the AIs/OFS, respectively. Early discontinuation due to toxicity was 3.8%. Seven patients (19.4%) discontinued therapy due to pregnancy desire (6 in the T group, 1 in the AI one); of these, one patient relapsed.

Conclusion: In a real-world setting, treatment options for premenopausal patients who are candidates for HT and OFS should take risk status into account. Therefore, every effort should be made to maintain patient adherence to treatment in order to manage toxicities and improve outcomes.

Keywords: Adjuvant hormone therapy; Aromatase inhibitors; Breast cancer; Ovarian function suppression; Tamoxifen.

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Conflict of interest statement

Disclosure L.M. reports acting as a paid consultant for Pfizer and Eli Lilly and received honoraria from Pfizer, Eli Lilly, Roche, Gilead, Novartis, Istituto Gentili, Daiichi Sankyo; A.T. reports consulting or advisory roles for Novartis, Pfizer, Eli Lilly, Daiichi Sankyo, MSD; L.C. reports acting as a paid consultant for AstraZeneca, MSD, Pfizer, Novartis, Gilead; F.P. received honoraria from Gilead, Novartis, Eli Lilly and Istituto Gentili; C.O. received honoraria from Gilead, Novartis, Eli Lilly and Istituto Gentili. All other authors declare no financial or non-financial competing interests. L.M. A.T. L.C. F.P. C.O. declare no non-financial competing interests

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