Real-world effectiveness of ribociclib in metastatic breast cancer patients: Does dose affect survival?

被引:6
|
作者
Fernandez-Cuerva, Cristina [1 ]
Chinchilla-Alarcon, Teresa [1 ]
Jose Alcaraz-Sanchez, Juan [2 ]
机构
[1] Hosp Reg Univ Malaga, Ave Carlos Haya S-N, Malaga 29010, Spain
[2] Hosp Alto Guadalquivir Andujar, Jaen, Spain
关键词
Ribociclib; real-world; security;
D O I
10.1177/10781552221144280
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:1619 / 1627
页数:9
相关论文
共 50 条
  • [1] Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer
    Garcia-Trevijano Cabetas, M.
    Lucena Martinez, P.
    Jimenez Nacher, I.
    Diaz Almiron, M.
    Zamora Aunon, P.
    Herrero Ambrosio, A.
    INTERNATIONAL JOURNAL OF CLINICAL PHARMACY, 2021, 43 (04) : 893 - 899
  • [2] Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer
    M. García-Trevijano Cabetas
    P. Lucena Martínez
    I. Jiménez Nácher
    M. Díaz Almirón
    P. Zamora Auñón
    A. Herrero Ambrosio
    International Journal of Clinical Pharmacy, 2021, 43 : 893 - 899
  • [3] Real-world safety and effectiveness of ribociclib in Korean patients with HR+/HER2-locally advanced or metastatic breast cancer
    Kim, J. H.
    Chang, M-C.
    Kim, T-H.
    Seo, J. H.
    Kim, J-J.
    Won, H. S.
    Seong, M-K.
    Kang, Y.
    Lee, Y.
    Lee, K-H.
    ANNALS OF ONCOLOGY, 2024, 35 : S1419 - S1420
  • [4] Real-world effectiveness outcomes by race in patients with metastatic triple negative breast cancer
    Skinner, K. E.
    Dufour, R.
    Haiderali, A.
    Huang, M.
    Schwartzberg, L. S.
    CANCER RESEARCH, 2019, 79 (04)
  • [5] Initial real-world experience with ribociclib in advanced breast cancer
    Nawaz, Azhar
    Zekri, Jamal
    Rasool, Haleem
    Ibrahim, Refaei
    JOURNAL OF ONCOLOGY PHARMACY PRACTICE, 2025,
  • [6] Real-world effectiveness of fulvestrant monotherapy as first endocrine treatment in patients with metastatic breast cancer
    Skinner, Karen E.
    Olufade, Temitope
    Walker, Mark S.
    Schwartzberg, Lee S.
    BREAST JOURNAL, 2020, 26 (02): : 112 - 119
  • [7] Real-world effectiveness outcomes in patients diagnosed with metastatic triple-negative breast cancer
    Skinner, Karen E.
    Haiderali, Amin
    Huang, Min
    Schwartzberg, Lee S.
    FUTURE ONCOLOGY, 2021, 17 (08) : 931 - 942
  • [8] Real-world survival of Danish patients with HER2-positive metastatic breast cancer
    Artzi, Daniel
    Berg, Tobias
    Celik, Alan
    Kumler, Iben
    Kenholm, Julia
    Al-Rawi, Sami
    Jensen, Maj-Britt
    Andersson, Michael
    Knoop, Ann
    ACTA ONCOLOGICA, 2023, 62 (06) : 601 - 607
  • [9] THE REAL-WORLD COST AND EFFECTIVENESS OF EVEROLIMUS IN METASTATIC BREAST CANCER IN THE CZECH REPUBLIC
    Rihova, B.
    Demlova, R.
    Cerna, R.
    VALUE IN HEALTH, 2018, 21 : S19 - S19
  • [10] Palbociclib versus ribociclib in first-line therapy of patients with metastatic breast cancer: Direct comparison in real-world practice
    Tsareva, E.
    Stativko, O.
    Shangina, I.
    Khachaturian, E.
    Antonova, T.
    Pokataev, I.
    Galkin, V. N.
    ANNALS OF ONCOLOGY, 2024, 35 : S1425 - S1425