PMID- 30675102
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 1178-2234 (Print)
IS  - 1178-2234 (Electronic)
IS  - 1178-2234 (Linking)
VI  - 13
DP  - 2019
TI  - Real-World Effectiveness of Palbociclib Versus Clinical Trial Results in Patients 
      With Advanced/Metastatic Breast Cancer That Progressed on Previous Endocrine 
      Therapy.
PG  - 1178223418823238
LID - 10.1177/1178223418823238 [doi]
LID - 1178223418823238
AB  - OBJECTIVE: The aim of this study was to assess the real-world effectiveness and 
      tolerability of palbociclib combined with endocrine therapy for the treatment of 
      hormone receptor positive (HR-positive), human epidermal growth factor receptor 2 
      negative (HER2-negative), advanced/metastatic breast cancer that progressed on 
      previous endocrine therapy, and to compare these results with the outcomes of the 
      PALOMA-3 clinical trial. METHODS: This study was a retrospective observational 
      cohort study including all patients who started with palbociclib in the St. 
      Antonius Hospital between September 1, 2016 and April 1, 2018 for the treatment 
      of HR-positive, HER2-negative advanced/metastatic breast cancer that progressed 
      on previous endocrine therapy. Individual patient data were collected from 
      electronic medical records. Primary study outcomes were progression-free survival 
      (PFS) and the number of permanent treatment discontinuations before disease 
      progression due to adverse events (AEs). Secondary outcomes were the frequency of 
      all (serious) AEs and the frequency of and reasons for dose reductions, 
      -interruptions and cycle delays. RESULTS: A total of 46 patients were studied 
      with a median follow-up of 13.0 months. Overall, the median PFS in real-world 
      clinical practice was 10.0 months (95% confidence interval (CI) 4.9-15.1), 
      compared with 9.5 months in PALOMA-3 (95% CI 9.2-11.0). Two patients discontinued 
      treatment because of AEs. Neutropenia was the most frequent grade 3-4 AE, but 
      with no febrile neutropenia events. Most AEs were managed with palbociclib dose 
      modifications. Regarding these modifications, more cycle delays, less dose 
      reductions, and less dose interruptions occurred in clinical practice compared 
      with PALOMA-3 (59 vs 36%, 22 vs 34%, and 9 vs 54%, respectively). Patients who 
      did not meet the PALOMA-3 study eligibility criteria (n = 16) showed a lower 
      median PFS of 5.5 months (95% CI 4.7-6.4). CONCLUSIONS: The effectiveness and 
      tolerability of palbociclib in real-world clinical practice corresponded well 
      with the results obtained in the PALOMA-3 clinical trial. Despite the differences 
      in dose modifications, this study suggests that there is no 
      efficacy-effectiveness gap in this patient population.
FAU - Bui, Tam Binh V
AU  - Bui TBV
AD  - Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The 
      Netherlands.
FAU - Burgers, Desiree Mt
AU  - Burgers DM
AD  - Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The 
      Netherlands.
FAU - Agterof, Mariette J
AU  - Agterof MJ
AD  - Department of Internal Medicine, St. Antonius Hospital, Utrecht/Nieuwegein, The 
      Netherlands.
FAU - van de Garde, Ewoudt Mw
AU  - van de Garde EM
AD  - Department of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The 
      Netherlands.
AD  - Division of Pharmacoepidemiology and Clinical Pharmacology, Department of 
      Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20190110
PL  - United States
TA  - Breast Cancer (Auckl)
JT  - Breast cancer : basic and clinical research
JID - 101474356
PMC - PMC6330732
OTO - NOTNLM
OT  - clinical practice
OT  - efficacy-effectiveness gap
OT  - metastatic breast cancer
OT  - palbociclib
OT  - real-world
OT  - tolerability
COIS- Declaration of conflicting interests:The author(s) declared no potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article.
EDAT- 2019/01/25 06:00
MHDA- 2019/01/25 06:01
PMCR- 2019/01/10
CRDT- 2019/01/25 06:00
PHST- 2018/09/17 00:00 [received]
PHST- 2018/12/09 00:00 [accepted]
PHST- 2019/01/25 06:00 [entrez]
PHST- 2019/01/25 06:00 [pubmed]
PHST- 2019/01/25 06:01 [medline]
PHST- 2019/01/10 00:00 [pmc-release]
AID - 10.1177_1178223418823238 [pii]
AID - 10.1177/1178223418823238 [doi]
PST - epublish
SO  - Breast Cancer (Auckl). 2019 Jan 10;13:1178223418823238. doi: 
      10.1177/1178223418823238. eCollection 2019.