PMID- 36476018
OWN - NLM
STAT- MEDLINE
DCOM- 20231030
LR  - 20231112
IS  - 1477-092X (Electronic)
IS  - 1078-1552 (Linking)
VI  - 29
IP  - 7
DP  - 2023 Oct
TI  - Real-world effectiveness of ribociclib in metastatic breast cancer patients: Does 
      dose affect survival?
PG  - 1619-1627
LID - 10.1177/10781552221144280 [doi]
AB  - Introduction: Real-world data are critical to demonstrate the reproducibility of 
      evidence and external generalizability of randomized clinical trials. The purpose 
      of this study was to assess real-world security profile and management of adverse 
      events (AEs) presented with ribociclib for the treatment of HR + /HER2- 
      metastatic breast cancer (MBC). Our secondary objective was to provide real-world 
      effectiveness of this treatment (measured with progression-free survival (PFS)) 
      and to confirm the hypothesis that dose reductions are not related with disease 
      progression. Material and methods: Observational retrospective study evaluating 
      all females with MBC treated with ribociclib. Study period: January 2017 to 
      September 2019. Follow-up was done until November 2021. Response was assessed 
      through the PFS according to RECIST1.1 and National Cancer Institute Common 
      Terminology Criteria for Adverse Events (CTCAE) was used to classify AEs. 
      Results: The most common AE was any grade neutropenia, documented in 37 of 53 
      patients (69.8%) during the course of treatment. By the end of the follow-up 
      period, overall median PFS with ribociclib therapy was 27.3 months (95% 
      confidence interval (CI) 20.8-71.8 months). In total, 50 patients (94.4%) 
      initiated ribociclib at 600 mg dose, 28 patients (58%) required dose reductions. 
      PFS of patients receiving ribociclib as first-line treatment was 28 (95% CI 15-41 
      months). Conclusions: Our results from patients treated in real-world clinical 
      settings indicate that ribociclib is safe and their AEs are manageable with 
      active monitoring, temporal suspension of treatment and dose reduction. 
      Furthermore, our results indicate that dose reduction of ribociclib is not 
      associated with a loss of efficacy.
FAU - Fernandez-Cuerva, Cristina
AU  - Fernandez-Cuerva C
AUID- ORCID: 0000-0002-6093-6201
AD  - Hospital Pharmacy Specialist, Hospital Regional Universitario de Malaga, , 
      Malaga, Spain.
FAU - Chinchilla-Alarcon, Teresa
AU  - Chinchilla-Alarcon T
AD  - Hospital Pharmacy Specialist, Hospital Regional Universitario de Malaga, , 
      Malaga, Spain.
FAU - Alcaraz-Sanchez, Juan Jose
AU  - Alcaraz-Sanchez JJ
AD  - Hospital Pharmacy Specialist, Hospital Alto Guadalquivir de Andujar, , Jaen, 
      Spain.
LA  - eng
PT  - Journal Article
DEP - 20221207
PL  - England
TA  - J Oncol Pharm Pract
JT  - Journal of oncology pharmacy practice : official publication of the International 
      Society of Oncology Pharmacy Practitioners
JID - 9511372
RN  - TK8ERE8P56 (ribociclib)
RN  - 0 (Aminopyridines)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Breast Neoplasms/drug therapy/pathology
MH  - Retrospective Studies
MH  - Reproducibility of Results
MH  - Aminopyridines/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Receptor, ErbB-2
OTO - NOTNLM
OT  - Ribociclib
OT  - real-world
OT  - security
COIS- Declaration of conflicting interestsThe authors declared no potential conflicts 
      of interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2022/12/09 06:00
MHDA- 2023/10/30 06:46
CRDT- 2022/12/08 09:59
PHST- 2023/10/30 06:46 [medline]
PHST- 2022/12/09 06:00 [pubmed]
PHST- 2022/12/08 09:59 [entrez]
AID - 10.1177/10781552221144280 [doi]
PST - ppublish
SO  - J Oncol Pharm Pract. 2023 Oct;29(7):1619-1627. doi: 10.1177/10781552221144280. 
      Epub 2022 Dec 7.