PMID- 35131646
OWN - NLM
STAT- MEDLINE
DCOM- 20220315
LR  - 20220716
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Print)
IS  - 0960-9776 (Linking)
VI  - 62
DP  - 2022 Apr
TI  - Ribociclib plus letrozole in subgroups of special clinical interest with hormone 
      receptor-positive, human epidermal growth factor receptor 2-negative advanced 
      breast cancer: Subgroup analysis of the phase IIIb CompLEEment-1 trial.
PG  - 75-83
LID - S0960-9776(22)00023-6 [pii]
LID - 10.1016/j.breast.2022.01.016 [doi]
AB  - BACKGROUND: The phase IIIb CompLEEment-1 study evaluated ribociclib plus 
      letrozole in patients with hormone receptor-positive (HR+), human epidermal 
      growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Outcomes 
      were investigated in the following subgroups: central nervous system (CNS) 
      metastases, prior chemotherapy for advanced disease, Eastern Cooperative Oncology 
      Group (ECOG) performance status (PS) 2, and visceral metastases plus prior 
      chemotherapy for advanced disease or ECOG PS 2. PATIENTS AND METHODS: Patients 
      with HR+, HER2- ABC without prior hormonal treatment for advanced disease 
      received oral ribociclib (600 mg once daily, 3 weeks on/1 week off) plus 
      letrozole (2.5 mg once daily, continuous). Primary endpoint was 
      safety/tolerability, assessed via occurrence of adverse events (AEs); key 
      secondary endpoints included time to progression (TTP), overall response rate, 
      and clinical benefit rate. RESULTS: 51 patients had CNS metastases, 194 received 
      prior chemotherapy for advanced disease, 112 had ECOG PS 2, 146 had visceral 
      metastases plus prior chemotherapy, and 77 had visceral metastases plus ECOG PS 
      2. Safety results were consistent with those in the overall CompLEEment-1 
      population; no new safety concerns were identified. The AE profile was manageable 
      with low rates of discontinuations due to AEs. TTP in patients with CNS 
      metastases was consistent with the overall study population and shorter for other 
      patient subgroups. Each patient subgroup achieved meaningful clinical benefit 
      from treatment, consistent with the overall population. CONCLUSION: These 
      findings confirm the clinical benefit of ribociclib plus endocrine therapy in 
      high-risk patient subgroups of clinical interest commonly underrepresented in 
      clinical trials.
CI  - Copyright (c) 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Cottu, Paul
AU  - Cottu P
AD  - Department of Medical Oncology, Curie Institute, Paris, France. Electronic 
      address: paul.cottu@curie.fr.
FAU - Ring, Alistair
AU  - Ring A
AD  - Royal Marsden Hospital NHS Foundation Trust, Sutton, United Kingdom.
FAU - Abdel-Razeq, Hikmat
AU  - Abdel-Razeq H
AD  - King Hussein Cancer Center, Amman, Jordan.
FAU - Marchetti, Paolo
AU  - Marchetti P
AD  - Sapienza University of Rome, Rome, Italy.
FAU - Cardoso, Fatima
AU  - Cardoso F
AD  - Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation, Lisbon, 
      Portugal.
FAU - Salvador Bofill, Javier
AU  - Salvador Bofill J
AD  - Virgen del Rocio University Hospital, Biomedicine Institute, Seville, Spain.
FAU - Martin, Miguel
AU  - Martin M
AD  - Gregorio Maranon General University Hospital, Madrid, Spain.
FAU - Menon-Singh, Lakshmi
AU  - Menon-Singh L
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Wu, Jiwen
AU  - Wu J
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - De Laurentiis, Michelino
AU  - De Laurentiis M
AD  - Istituto Nazionale Tumori IRCCS "Fondazione Pascale", Naples, Italy.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20220131
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Aminopyridines)
RN  - 0 (Hormones)
RN  - 0 (Purines)
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - 7LKK855W8I (Letrozole)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - TK8ERE8P56 (ribociclib)
SB  - IM
MH  - Aminopyridines
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Breast Neoplasms/pathology
MH  - Female
MH  - Hormones/therapeutic use
MH  - Humans
MH  - Letrozole
MH  - Purines
MH  - Receptor, ErbB-2/metabolism
MH  - Receptors, Estrogen/metabolism
MH  - Receptors, Progesterone/metabolism
PMC - PMC9073296
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - CDK4/6 inhibitor
OT  - Endocrine therapy
OT  - Ribociclib
EDAT- 2022/02/09 06:00
MHDA- 2022/03/16 06:00
PMCR- 2022/01/31
CRDT- 2022/02/08 05:45
PHST- 2021/11/17 00:00 [received]
PHST- 2022/01/28 00:00 [revised]
PHST- 2022/01/30 00:00 [accepted]
PHST- 2022/02/09 06:00 [pubmed]
PHST- 2022/03/16 06:00 [medline]
PHST- 2022/02/08 05:45 [entrez]
PHST- 2022/01/31 00:00 [pmc-release]
AID - S0960-9776(22)00023-6 [pii]
AID - 10.1016/j.breast.2022.01.016 [doi]
PST - ppublish
SO  - Breast. 2022 Apr;62:75-83. doi: 10.1016/j.breast.2022.01.016. Epub 2022 Jan 31.