Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population.
Advanced breast cancer
CDK4/6 inhibitor
Endocrine therapy
Ribociclib
Journal
Breast cancer research and treatment
ISSN: 1573-7217
Titre abrégé: Breast Cancer Res Treat
Pays: Netherlands
ID NLM: 8111104
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
07
12
2020
accepted:
14
07
2021
pubmed:
21
8
2021
medline:
14
10
2021
entrez:
20
8
2021
Statut:
ppublish
Résumé
CompLEEment-1 is a phase 3b trial in an expanded patient population with hormone receptor-positive (HR +), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC), the largest current trial of cyclin-dependent kinase 4 and 6 inhibitors in ABC. Patients treated with ≤ 1 line of prior chemotherapy and no prior endocrine therapy for ABC received ribociclib 600 mg/day (3-weeks-on/1-week-off) plus letrozole 2.5 mg/day and additionally monthly goserelin/leuprolide in men and pre-/perimenopausal women. Eligibility criteria allowed inclusion of patients with stable CNS metastases and an Eastern Cooperative Oncology Group performance status of 2. Primary objectives were safety and tolerability, and secondary objectives were efficacy and quality of life (QoL). Overall, 3,246 patients were evaluated (median follow-up 25.4 months). Rates of all-grade and grade ≥ 3 treatment-related adverse events (AEs) were 95.2% and 67.5%, respectively. Treatment-related discontinuations due to all grade and grade ≥ 3 AEs occurred in 12.9% and 7.3% of patients, respectively. Rates of all-grade AEs of special interest (AESI) were as follows: neutropenia (74.5%), increased alanine aminotransferase (16.2%), increased aspartate aminotransferase (14.1%), and QTcF prolongation (6.7%); corresponding values for grade ≥ 3 AESI were 57.2%, 7.7%, 5.7%, and 1.0%, respectively. Median time to progression was 27.1 months (95% confidence interval, 25.7 to not reached). Patient QoL was maintained during treatment. Safety and efficacy data in this expanded population were consistent with the MONALEESA-2 and MONALEESA-7 trials and support the use of ribociclib plus letrozole in the first-line setting for patients with HR + , HER2- ABC. linicalTrials.gov NCT02941926.
Identifiants
pubmed: 34414532
doi: 10.1007/s10549-021-06334-0
pii: 10.1007/s10549-021-06334-0
pmc: PMC8505291
doi:
Substances chimiques
Aminopyridines
0
Purines
0
Receptors, Estrogen
0
Receptors, Progesterone
0
Letrozole
7LKK855W8I
Receptor, ErbB-2
EC 2.7.10.1
ribociclib
TK8ERE8P56
Banques de données
ClinicalTrials.gov
['NCT02941926']
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
689-699Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2021. The Author(s).
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