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

Adjuvant hormone therapy Aromatase inhibitors Breast cancer Ovarian function suppression Tamoxifen

Journal

Clinical breast cancer
ISSN: 1938-0666
Titre abrégé: Clin Breast Cancer
Pays: United States
ID NLM: 100898731

Informations de publication

Date de publication:
Oct 2023
Historique:
received: 26 04 2023
revised: 12 06 2023
accepted: 30 06 2023
pubmed: 29 7 2023
medline: 29 7 2023
entrez: 28 7 2023
Statut: ppublish

Résumé

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

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
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.

Identifiants

pubmed: 37507257
pii: S1526-8209(23)00170-2
doi: 10.1016/j.clbc.2023.06.013
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

712-720.e3

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

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

Auteurs

Raffaella D'Onofrio (R)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy.

Claudia Omarini (C)

Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy; Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC), Parma, Italy.

Angela Toss (A)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy; Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.

Isabella Sperduti (I)

Biostatistics Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Federico Piacentini (F)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy; Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC), Parma, Italy.

Monica Barbolini (M)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy.

Laura Cortesi (L)

Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.

Elena Barbieri (E)

Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.

Elisa Pettorelli (E)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy.

Chiara Chiavelli (C)

Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy; Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.

Massimo Dominici (M)

Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Modena, Italy; Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.

Luca Moscetti (L)

Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy; Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC), Parma, Italy. Electronic address: moscetti.luca@aou.mo.it.

Classifications MeSH