PMID- 35212906
OWN - NLM
STAT- MEDLINE
DCOM- 20220412
LR  - 20220531
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 193
IP  - 1
DP  - 2022 May
TI  - Ribociclib plus letrozole in male patients with hormone receptor-positive, human 
      epidermal growth factor receptor 2-negative advanced breast cancer: subgroup 
      analysis of the phase IIIb CompLEEment-1 trial.
PG  - 95-103
LID - 10.1007/s10549-022-06543-1 [doi]
AB  - PURPOSE: CompLEEment-1 (NCT02941926) is a single-arm, open-label, multicentre 
      phase IIIb study investigating the safety and efficacy of ribociclib plus 
      letrozole (RIB + LET) in a large, diverse cohort who have not received prior 
      endocrine therapy (ET) for advanced disease. We present an exploratory analysis 
      of male patients. METHODS: Eligible patients with hormone receptor-positive 
      (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast 
      cancer (ABC), who had no prior ET and </= 1 line of prior chemotherapy for advanced 
      disease, received RIB + LET. Male patients also received goserelin or leuprolide. 
      Primary endpoint was safety and tolerability; efficacy was a secondary endpoint. 
      RESULTS: In total, 39/3246 patients were male. Baseline characteristics were 
      similar to the overall population. Male patients experienced fewer 
      treatment-related adverse events (AEs) and treatment-related serious AEs compared 
      with the overall population; fewer male patients had treatment-related AEs 
      leading to discontinuation, adjustment/interruption, or additional therapy. One 
      male patient died as a result of a serious AE that was not considered to be 
      treatment-related. The most common AE was neutropenia; the incidence of grade >/= 3 
      neutropenia in males (41.0%) was lower than in the overall population (57.2%). 
      Median follow-up was 25.4 months; median time to progression was not reached in 
      males versus 27.1 months for the overall population. CONCLUSION: The clinical 
      benefit and overall response rates in males were consistent with the overall 
      population. This analysis demonstrates the safety and efficacy of ribociclib in a 
      close-to-real-world setting, supporting the use of RIB + LET in male patients 
      with HR+, HER2- ABC. TRIAL REGISTRATION NUMBER: NCT02941926 (Registered 2016).
CI  - (c) 2022. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC, part of Springer Nature.
FAU - Campone, Mario
AU  - Campone M
AUID- ORCID: 0000-0002-5196-5908
AD  - Western Cancer Institute, Nantes, France. mario.campone@ico.unicancer.fr.
FAU - De Laurentiis, Michelino
AU  - De Laurentiis M
AD  - Istituto Nazionale Tumori IRCCS "Fondazione Pascale", Naples, Italy.
FAU - Zamagni, Claudio
AU  - Zamagni C
AD  - IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.
FAU - Kudryavcev, Igor
AU  - Kudryavcev I
AD  - Kaluga Regional Clinical Oncology Center, Kaluga, Russian Federation.
FAU - Agterof, Mariette
AU  - Agterof M
AD  - St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands.
FAU - Brown-Glaberman, Ursa
AU  - Brown-Glaberman U
AD  - University of New Mexico Cancer Center, Albuquerque, NM, USA.
FAU - Palacova, Marketa
AU  - Palacova M
AD  - Masaryk Memorial Cancer Institute, Brno, Czech Republic.
FAU - Chatterjee, Sanjoy
AU  - Chatterjee S
AD  - Tata Medical Center, Kolkata, India.
FAU - Menon-Singh, Lakshmi
AU  - Menon-Singh L
AD  - Novartis Pharmaceuticals, East Hanover, NJ, USA.
FAU - Wu, Jiwen
AU  - Wu J
AD  - Novartis Pharmaceuticals, East Hanover, NJ, USA.
FAU - Martin, Miguel
AU  - Martin M
AD  - Gregorio Maranon General University Hospital, Madrid, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT02941926
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220225
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Aminopyridines)
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/adverse effects
MH  - *Breast Neoplasms, Male/drug therapy
MH  - Humans
MH  - Letrozole/therapeutic use
MH  - Male
MH  - Neutropenia/drug therapy/etiology
MH  - Purines
MH  - Receptor, ErbB-2/genetics/metabolism
MH  - Receptors, Estrogen/metabolism
MH  - Receptors, Progesterone/metabolism
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - Male breast cancer
OT  - Men
OT  - Real-world evidence
OT  - Ribociclib
EDAT- 2022/02/26 06:00
MHDA- 2022/04/13 06:00
CRDT- 2022/02/25 12:24
PHST- 2021/10/21 00:00 [received]
PHST- 2022/02/10 00:00 [accepted]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/04/13 06:00 [medline]
PHST- 2022/02/25 12:24 [entrez]
AID - 10.1007/s10549-022-06543-1 [pii]
AID - 10.1007/s10549-022-06543-1 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. 
      Epub 2022 Feb 25.