Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7 : A Phase III Randomized Clinical Trial

©2021 The Authors; Published by the American Association for Cancer Research..

PURPOSE: Ribociclib plus endocrine therapy (ET) demonstrated a statistically significant progression-free survival and overall survival (OS) benefit in the phase III MONALEESA-7 trial of pre-/perimenopausal patients with hormone receptor (HR)-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). The median OS was not reached in the ribociclib arm in the protocol-specified final analysis; we hence performed an exploratory OS and additional outcomes analysis with an extended follow-up (median, 53.5 months).

PATIENTS AND METHODS: Patients were randomized to receive ET [goserelin plus nonsteroidal aromatase inhibitor (NSAI) or tamoxifen] with ribociclib or placebo. OS was evaluated with a stratified Cox proportional hazard model and summarized with Kaplan-Meier methods.

RESULTS: The intent-to-treat population included 672 patients. Median OS was 58.7 months with ribociclib versus 48.0 months with placebo [hazard ratio = 0.76; 95% confidence interval (CI), 0.61-0.96]. Kaplan-Meier estimated OS at 48 months was 60% and 50% with ribociclib and placebo, respectively. Subgroup analyses were generally consistent with the OS benefit, including patients who received NSAI and patients aged less than 40 years. Subsequent antineoplastic therapies following discontinuation were balanced between the ribociclib (77%) and placebo (78%) groups. Use of cyclin-dependent kinase 4/6 inhibitors after discontinuation was higher with placebo (26%) versus ribociclib (13%). Time to first chemotherapy was significantly delayed with ribociclib versus placebo. No drug-drug interactions were observed between ribociclib and either NSAI.

CONCLUSIONS: Ribociclib plus ET continued to show significantly longer OS than ET alone in pre-/perimenopausal patients, including patients aged less than 40 years, with HR+/HER2- ABC with 53.5 months of median follow-up (ClinicalTrials.gov, NCT02278120).

Medienart:

E-Artikel

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

Zur Gesamtaufnahme - volume:28

Enthalten in:

Clinical cancer research : an official journal of the American Association for Cancer Research - 28(2022), 5 vom: 01. März, Seite 851-859

Sprache:

Englisch

Beteiligte Personen:

Lu, Yen-Shen [VerfasserIn]
Im, Seock-Ah [VerfasserIn]
Colleoni, Marco [VerfasserIn]
Franke, Fabio [VerfasserIn]
Bardia, Aditya [VerfasserIn]
Cardoso, Fatima [VerfasserIn]
Harbeck, Nadia [VerfasserIn]
Hurvitz, Sara [VerfasserIn]
Chow, Louis [VerfasserIn]
Sohn, Joohyuk [VerfasserIn]
Lee, Keun Seok [VerfasserIn]
Campos-Gomez, Saul [VerfasserIn]
Villanueva Vazquez, Rafael [VerfasserIn]
Jung, Kyung Hae [VerfasserIn]
Babu, K Govind [VerfasserIn]
Wheatley-Price, Paul [VerfasserIn]
De Laurentiis, Michelino [VerfasserIn]
Im, Young-Hyuck [VerfasserIn]
Kuemmel, Sherko [VerfasserIn]
El-Saghir, Nagi [VerfasserIn]
O'Regan, Ruth [VerfasserIn]
Gasch, Claudia [VerfasserIn]
Solovieff, Nadia [VerfasserIn]
Wang, Craig [VerfasserIn]
Wang, Yongyu [VerfasserIn]
Chakravartty, Arunava [VerfasserIn]
Ji, Yan [VerfasserIn]
Tripathy, Debu [VerfasserIn]

Links:

Volltext

Themen:

Aminopyridines
Aromatase Inhibitors
Clinical Trial, Phase III
EC 2.7.10.1
Journal Article
Purines
Randomized Controlled Trial
Receptor, ErbB-2
Receptors, Estrogen
Research Support, Non-U.S. Gov't
Ribociclib
TK8ERE8P56

Anmerkungen:

Date Completed 15.04.2022

Date Revised 21.04.2023

published: Print

ClinicalTrials.gov: NCT02278120

Citation Status MEDLINE

doi:

10.1158/1078-0432.CCR-21-3032

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM335017606