PMID- 38242689
OWN - NLM
STAT- Publisher
LR  - 20240119
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Linking)
DP  - 2024 Jan 18
TI  - Ribociclib-Induced Cutaneous Adverse Events in Metastatic HR+/HER2- Breast 
      Cancer: Incidence, Multidisciplinary Management, and Prognostic Implication.
LID - oyae004 [pii]
LID - 10.1093/oncolo/oyae004 [doi]
AB  - BACKGROUND: Ribociclib is approved for hormone receptor positive (HR+), human 
      epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) 
      treatment, in combination with endocrine therapy. Hematological, hepatic, and 
      cardiac adverse events (AEs) emerged from pivotal trials, but little is known 
      about cutaneous adverse events (CAEs). PATIENTS AND METHODS: We report data from 
      a retrospective cohort study of all patients with HR+/HER2- ABC treated with 
      ribociclib at Humanitas Cancer Center between June 2017 and December 2022. We 
      recorded clinical-pathological data, the incidence, and treatment of 
      ribociclib-related CAEs. These were evaluated according to the NCI-CTCAE v5.0 
      classification. Progression-free survival (PFS) was estimated by Kaplan-Meier 
      method and the log-rank test was used to analyze differences between groups. 
      RESULTS: Thirteen of 91 patients (14.3%) experienced treatment-related CAEs (mean 
      time to the occurrence: 3.9 months). The most frequent CAEs were eczematous 
      dermatitis (53.8%) and maculo-papular reaction (15.4%). Itch was reported by all 
      13 patients. The grade was G3 in 8 cases, G2 in 4, and G1 in 1. An integrated 
      approach based on ribociclib dose modulation and dermatological interventions 
      (oral antihistamine, moisturized cream, topical, and/or systemic steroids) could 
      prevent ribociclib discontinuation in most patients. At a median follow-up of 20 
      months, the median PFS was 13 months (range, 1-66) with a better PFS curves for 
      patients experiencing CAEs (P = .04). CONCLUSION: We mapped frequency and types 
      of ribociclib-induced CAEs. An interdisciplinary management of CAEs incorporated 
      into routine care may reduce the rate of drug discontinuation thus potentially 
      contributing to better long-term outcomes.
CI  - (c) The Author(s) 2024. Published by Oxford University Press.
FAU - Borroni, Riccardo Giovanni
AU  - Borroni RG
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy.
FAU - Bartolini, Michela
AU  - Bartolini M
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Gaudio, Mariangela
AU  - Gaudio M
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Jacobs, Flavia
AU  - Jacobs F
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Benvenuti, Chiara
AU  - Benvenuti C
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Gerosa, Riccardo
AU  - Gerosa R
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Tiberio, Paola
AU  - Tiberio P
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Manara, Sofia Ada Assunta Maria
AU  - Manara SAAM
AD  - Pathology Unit, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy.
FAU - Solferino, Alessandra
AU  - Solferino A
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - Santoro, Armando
AU  - Santoro A
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
FAU - De Sanctis, Rita
AU  - De Sanctis R
AUID- ORCID: 0000-0003-3202-1933
AD  - Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), 
      Italy.
AD  - Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Rozzano 
      (MI), Italy.
LA  - eng
PT  - Journal Article
DEP - 20240118
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
SB  - IM
OTO - NOTNLM
OT  - eczematous dermatitis
OT  - endocrine therapy
OT  - metastatic breast cancer
OT  - progression-free survival
OT  - ribociclib
EDAT- 2024/01/20 05:42
MHDA- 2024/01/20 05:42
CRDT- 2024/01/19 21:37
PHST- 2023/08/04 00:00 [received]
PHST- 2023/12/04 00:00 [accepted]
PHST- 2024/01/20 05:42 [medline]
PHST- 2024/01/20 05:42 [pubmed]
PHST- 2024/01/19 21:37 [entrez]
AID - 7577601 [pii]
AID - 10.1093/oncolo/oyae004 [doi]
PST - aheadofprint
SO  - Oncologist. 2024 Jan 18:oyae004. doi: 10.1093/oncolo/oyae004.