Systematic review and meta-analysis of post-progression outcomes in ER+/HER2- metastatic breast cancer after CDK4/6 inhibitors within randomized clinical trials.


Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
12 2021
Historique:
received: 25 10 2021
revised: 05 11 2021
accepted: 08 11 2021
pubmed: 6 12 2021
medline: 25 3 2022
entrez: 5 12 2021
Statut: ppublish

Résumé

Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors and endocrine therapy (ET) deeply transformed the treatment landscape of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. Randomized clinical trials suggest that second progression-free survival (PFS2) was not compromised and time to subsequent chemotherapy (TTC) may be delayed. We carried out a meta-analysis to assess the benefit on PFS2 and on delaying the TTC. We conducted a systematic literature search of randomized clinical trials with CDK4/6 inhibitors and ET reporting PFS2 or TTC of HR+/HER2- pre- or postmenopausal metastatic breast cancer. We also reviewed abstracts and presentations from all major conference proceedings. We calculated the pooled hazard ratios (HR) for PFS2 and TTC using random-effects models with 95% confidence intervals (CI). I Eight studies (MONALEESA-2/3/7, MONARCH-2/3, PALOMA-1/2/3) were included in this analysis (N = 4580 patients). PFS2 benefit was observed in patients who received CDK4/6 inhibitors plus ET (pooled HR = 0.68, 95% CI = 0.62-0.74, I CDK4/6 inhibitors plus ET compared with ET alone improve PFS2 and TTC. The delay of chemotherapy may postpone the start of a more toxic treatment option, delaying related toxicities and potentially maintaining a better quality of life for patients, for a longer time. The benefit in PFS2 may postpone the onset of endocrine resistance and help further validate this treatment approach.

Sections du résumé

BACKGROUND
Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors and endocrine therapy (ET) deeply transformed the treatment landscape of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer. Randomized clinical trials suggest that second progression-free survival (PFS2) was not compromised and time to subsequent chemotherapy (TTC) may be delayed. We carried out a meta-analysis to assess the benefit on PFS2 and on delaying the TTC.
METHODS
We conducted a systematic literature search of randomized clinical trials with CDK4/6 inhibitors and ET reporting PFS2 or TTC of HR+/HER2- pre- or postmenopausal metastatic breast cancer. We also reviewed abstracts and presentations from all major conference proceedings. We calculated the pooled hazard ratios (HR) for PFS2 and TTC using random-effects models with 95% confidence intervals (CI). I
RESULTS
Eight studies (MONALEESA-2/3/7, MONARCH-2/3, PALOMA-1/2/3) were included in this analysis (N = 4580 patients). PFS2 benefit was observed in patients who received CDK4/6 inhibitors plus ET (pooled HR = 0.68, 95% CI = 0.62-0.74, I
CONCLUSIONS
CDK4/6 inhibitors plus ET compared with ET alone improve PFS2 and TTC. The delay of chemotherapy may postpone the start of a more toxic treatment option, delaying related toxicities and potentially maintaining a better quality of life for patients, for a longer time. The benefit in PFS2 may postpone the onset of endocrine resistance and help further validate this treatment approach.

Identifiants

pubmed: 34864350
pii: S2059-7029(21)00294-5
doi: 10.1016/j.esmoop.2021.100332
pmc: PMC8645913
pii:
doi:

Substances chimiques

Antineoplastic Agents, Hormonal 0
Protein Kinase Inhibitors 0
Receptors, Estrogen 0
ERBB2 protein, human EC 2.7.10.1
Receptor, ErbB-2 EC 2.7.10.1
CDK4 protein, human EC 2.7.11.22
CDK6 protein, human EC 2.7.11.22
Cyclin-Dependent Kinase 4 EC 2.7.11.22
Cyclin-Dependent Kinase 6 EC 2.7.11.22

Types de publication

Journal Article Meta-Analysis Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

100332

Informations de copyright

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure EMu has acted as a consultant to Pierre Fabre, Genomic Health and Eisai; EMo had consulting or advisory role from Pierre Fabre; MC has received a research grant from Roche. All other authors have declared no conflicts of interest.

Auteurs

E Munzone (E)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy. Electronic address: elisabetta.munzone@ieo.it.

E Pagan (E)

Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.

V Bagnardi (V)

Department of Statistics and Quantitative Methods, University of Milan-Bicocca, Milan, Italy.

E Montagna (E)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.

G Cancello (G)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.

S Dellapasqua (S)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.

M Iorfida (M)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.

M Mazza (M)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy.

M Colleoni (M)

Division of Medical Senology, European Institute of Oncology, IRCCS, Milan, Italy; Program of Breast Health European Institute of Oncology, IRCCS, Milan, Italy.

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Classifications MeSH