PMID- 35575587
OWN - NLM
STAT- MEDLINE
DCOM- 20220519
LR  - 20230314
IS  - 1581-3207 (Electronic)
IS  - 1318-2099 (Print)
IS  - 1318-2099 (Linking)
VI  - 56
IP  - 2
DP  - 2022 May 17
TI  - Ribociclib plus letrozole in patients with hormone receptor-positive, 
      HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup 
      safety analysis from the phase 3b CompLEEment-1 trial.
PG  - 238-247
LID - 10.2478/raon-2022-0020 [doi]
AB  - BACKGROUND: The CDK4/6 inhibitor, ribociclib in combination with endocrine 
      therapy significantly improved progression-free survival in the first line 
      setting in post-menopausal patients with HR+/HER2- advanced breast cancer (ABC) 
      in a pivotal phase 3, placebo-controlled trial (MONALEESA-2) and demonstrated 
      superior overall survival in premenopausal patients with HR+/HER2- ABC 
      (MONALEESA-7). The multinational, phase 3b, CompLEEment-1 trial, which assessed 
      the safety and efficacy of ribociclib plus letrozole in a broader population of 
      patients who have not received prior endocrine therapy for advanced disease, is 
      the largest phase 3 clinical trial to date to evaluate the safety and efficacy of 
      a CDK4/6 inhibitor. We report a subanalysis of data from patients (N = 339) 
      enrolled in the central and south European countries of the SERCE (Southern 
      Europe, RUC, Central Europe) cluster of CompLEEment-1. PATIENTS AND METHODS: Men 
      and women of any menopausal status with HR+/HER2- ABC received once-daily oral 
      ribociclib 600 mg (3-weeks on/1-week-off), plus letrozole 2.5 mg continuously. 
      Men/premenopausal women also received a GnRH-agonist. The primary outcome was the 
      number of patients with adverse events (AEs) over a timeframe of approximately 36 
      months. Time-to-progression, overall response rate, and clinical benefit rate 
      were also measured. RESULTS: Safety results in the SERCE subgroup were consistent 
      with those in the pivotal clinical trials of ribociclib in combination with 
      endocrine therapy. Treatment-related AEs leading to dose adjustments/interruption 
      occurred in 63.1% of patients but led to treatment discontinuation in only 10.6%. 
      The most common treatment-related AEs of grade >/= 3 were neutropenia and 
      transaminase elevations. There were no fatal treatment-related events. 
      CONCLUSIONS: These findings from the SERCE subgroup support the safety and 
      manageable tolerability of ribociclib in a broad range of patients with HR+/HER2- 
      ABC more representative of patients in real-world clinical practice.
CI  - (c) 2022 Simona Borstnar, Marketa Palacova, Aleksandra Lacko, Constanta Timcheva, 
      Einav Nili Gal-Yam, Konstantinos Papazisis, Juraj Beniak, Pavol Kudela, Gabor 
      Rubovszky, published by Sciendo.
FAU - Borstnar, Simona
AU  - Borstnar S
AD  - Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, 
      Slovenia.
FAU - Palacova, Marketa
AU  - Palacova M
AD  - Clinic of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute, Brno, 
      Czech Republic.
FAU - Lacko, Aleksandra
AU  - Lacko A
AD  - Department of Clinical Oncology, Wroclaw University of Medicine, Wroclaw, Poland, 
      and Breast Unit, Lower Silesian Oncology Centre, Wroclaw, Poland.
FAU - Timcheva, Constanta
AU  - Timcheva C
AD  - Medical Oncology Clinic, Multiprofile Hospital for Active Treatment "Nadezhda" 
      Sofia, Sofia, Bulgaria.
FAU - Gal-Yam, Einav Nili
AU  - Gal-Yam EN
AD  - Talpiot medical leadership program, Institute of Oncology, Chaim Sheba Medical 
      Center, Tel-Hashomer; affiliated to the Sackler School of Medicine, Tel-Aviv 
      University, Tel-Aviv, Israel.
FAU - Papazisis, Konstantinos
AU  - Papazisis K
AD  - Euromedica General Clinic of Thessaloniki, Thessaloniki, Greece.
FAU - Beniak, Juraj
AU  - Beniak J
AD  - Regional Cancer Center, Poprad, Slovakia.
FAU - Kudela, Pavol
AU  - Kudela P
AD  - Novartis Slovakia s.r.o., Bratislava, Slovakia.
FAU - Rubovszky, Gabor
AU  - Rubovszky G
AD  - Department of Oncological Internal Medicine and Clinical Pharmacology, National 
      Institute of Oncology, Budapest, Hungary.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220517
PL  - Poland
TA  - Radiol Oncol
JT  - Radiology and oncology
JID - 9317213
RN  - 0 (Aminopyridines)
RN  - 0 (Purines)
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - 7LKK855W8I (Letrozole)
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/drug therapy
MH  - Female
MH  - Humans
MH  - Letrozole/therapeutic use
MH  - Male
MH  - Purines
MH  - Receptor, ErbB-2/therapeutic use
MH  - Receptors, Estrogen/therapeutic use
MH  - Receptors, Progesterone/therapeutic use
PMC - PMC9122294
OTO - NOTNLM
OT  - CDK4/6 inhibitor
OT  - CompLEEment-1 trial
OT  - HER2-
OT  - HR+
OT  - advanced breast cancer
OT  - ribociclib
EDAT- 2022/05/17 06:00
MHDA- 2022/05/20 06:00
PMCR- 2022/06/01
CRDT- 2022/05/16 09:14
PHST- 2022/02/25 00:00 [received]
PHST- 2022/04/08 00:00 [accepted]
PHST- 2022/05/16 09:14 [entrez]
PHST- 2022/05/17 06:00 [pubmed]
PHST- 2022/05/20 06:00 [medline]
PHST- 2022/06/01 00:00 [pmc-release]
AID - raon-2022-0020 [pii]
AID - 10.2478/raon-2022-0020 [doi]
PST - epublish
SO  - Radiol Oncol. 2022 May 17;56(2):238-247. doi: 10.2478/raon-2022-0020.