PMID- 35535675
OWN - NLM
STAT- MEDLINE
DCOM- 20220804
LR  - 20221007
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 38
IP  - 8
DP  - 2022 Aug
TI  - Real world incidence and management of adverse events in patients with HR+, HER2- 
      metastatic breast cancer receiving CDK4 and 6 inhibitors in a United States 
      community setting.
PG  - 1319-1331
LID - 10.1080/03007995.2022.2073122 [doi]
AB  - OBJECTIVE: To examine the real-world incidence and management of select adverse 
      events (AEs) among female patients with hormone receptor positive (HR+), human 
      epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer 
      (MBC), receiving a cyclin-dependent kinase 4 and 6 (CDK4 and 6) inhibitor 
      (palbociclib, abemaciclib, or ribociclib). METHODS: This retrospective study 
      analyzed data from the US Oncology Network iKnowMed electronic health record 
      database for 396 patients with an initial MBC diagnosis on/after 1 January 2014 
      and receipt of first CDK4 and 6 regimen between 1 January 2017 and 31 December 
      2018. In this descriptive study, the proportion of patients who experienced 
      select AEs and associated dose modifications or discontinuations were reported. 
      The occurrence of select healthcare resource utilization categories was also 
      reported. RESULTS: Median follow-up time was 451, 262, and 355 days for patients 
      in the palbociclib, abemaciclib, and ribociclib cohorts, respectively. The most 
      common AEs were neutropenia (palbociclib, 44.8%; abemaciclib, 10.6%; ribociclib, 
      36.3%), diarrhea (palbociclib, 8.0%; abemaciclib, 43.0%; ribociclib, 8.8%), and 
      fatigue (palbociclib, 12.9%; abemaciclib, 17.6%; ribociclib, 16.5%). AEs resulted 
      in a treatment hold among 91 (23.0%), a dose reduction among 86 (21.7%), and 
      permanent discontinuation among 48 (12.1%) patients overall. CONCLUSIONS: This 
      real-world study provides insight into the occurrence of AEs which varied by CDK4 
      and 6 inhibitor. Compared to clinical trials, frequencies of AEs were numerically 
      lower but dose reductions due to AEs were numerically higher. It is possible 
      these differences reflect proactive management of AEs on the part of clinicians 
      to help patients remain on therapy.
FAU - Price, Gregory L
AU  - Price GL
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Sudharshan, Lavanya
AU  - Sudharshan L
AD  - McKesson Life Sciences, The Woodlands, TX, USA.
FAU - Ryan, Paula
AU  - Ryan P
AD  - Texas Oncology - The Woodlands, The Woodlands, TX, USA.
FAU - Rajkumar, Jonathan
AU  - Rajkumar J
AD  - McKesson Life Sciences, The Woodlands, TX, USA.
FAU - Sheffield, Kristin M
AU  - Sheffield KM
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Nash Smyth, Emily
AU  - Nash Smyth E
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Morato Guimaraes, Claudia
AU  - Morato Guimaraes C
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Rybowski, Sarah
AU  - Rybowski S
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Cuyun Carter, Gebra
AU  - Cuyun Carter G
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Gathirua-Mwangi, Wambui Grace
AU  - Gathirua-Mwangi WG
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Huang, Yu-Jing
AU  - Huang YJ
AUID- ORCID: 0000-0003-1467-4113
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220513
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Aminopyridines)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.11.22 (CDK4 protein, human)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 4)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 6)
SB  - IM
MH  - Aminopyridines/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Breast Neoplasms/pathology
MH  - Cyclin-Dependent Kinase 4
MH  - Cyclin-Dependent Kinase 6
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Protein Kinase Inhibitors/adverse effects
MH  - Retrospective Studies
MH  - United States/epidemiology
OAB - Cyclin-dependent kinase 4 and 6 inhibitors (CDK4 and 6 inhibitors) have changed 
      the landscape for the treatment of metastatic breast cancer (MBC) among patients 
      who are hormone receptor positive (HR+) and human epidermal growth factor 
      receptor 2 negative (HER2-). An understanding of the real-world management of 
      adverse events (AEs) will help optimize treatment strategies. Here, data from the 
      US Oncology Network electronic health record database for 396 HR+, HER2-, MBC 
      patients receiving a CDK4 and 6 inhibitor were examined to describe the 
      proportion of patients who experienced select AEs and the associated outcomes of 
      these AEs. Compared to clinical trials, frequencies of AEs were numerically lower 
      but dose reductions due to AEs were numerically higher. It is possible that these 
      differences reflect a proactive management of AEs on the part of clinicians to 
      help patients remain on therapy.
OABL- eng
OTO - NOTNLM
OT  - CDK4/CDK6 inhibitor
OT  - adverse events
OT  - metastatic breast cancer
OT  - real-world utilization
EDAT- 2022/05/11 06:00
MHDA- 2022/08/05 06:00
CRDT- 2022/05/10 05:53
PHST- 2022/05/11 06:00 [pubmed]
PHST- 2022/08/05 06:00 [medline]
PHST- 2022/05/10 05:53 [entrez]
AID - 10.1080/03007995.2022.2073122 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2022 Aug;38(8):1319-1331. doi: 10.1080/03007995.2022.2073122. 
      Epub 2022 May 13.