PMID- 29464389
OWN - NLM
STAT- MEDLINE
DCOM- 20190304
LR  - 20240327
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Print)
IS  - 0941-4355 (Linking)
VI  - 26
IP  - 8
DP  - 2018 Aug
TI  - Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a 
      prospective cohort study.
PG  - 2641-2650
LID - 10.1007/s00520-018-4075-7 [doi]
AB  - PURPOSE: During treatment with tyrosine kinase inhibitors, such as sunitinib, 
      patients experience treatment and/or disease-related symptoms. Although 
      application of patient-reported outcome measures (PROMs) enhances early 
      recognition of symptoms, early clinical trials are focused on symptom severity 
      objectified by the Common Terminology Criteria for Adverse Events (CTCAE) in 
      order to evaluate drug safety and to determine a personalized and/or safe dosage 
      range. To gain insight into patient-reported symptoms in addition to healthcare 
      professional-reported adverse events (AEs), a substudy was conducted in an 
      ongoing pharmacokinetic-guided sunitinib dosing study. METHODS: In patients for 
      whom sunitinib was considered standard therapy or patients with 
      advanced/metastatic tumors for whom no standard therapy was available, 
      patient-reported symptoms and well-being besides healthcare professional-reported 
      AEs were assessed. RESULTS: Twenty-nine patients were included for analysis. Over 
      50% of them experienced a decreased well-being, caused by symptoms of mild and 
      moderate intensity. Compared to healthcare professionals, all measured symptoms, 
      with the exception of fatigue and vomiting, were reported statistically 
      significantly more often by patients. CONCLUSIONS: Application of PROMs in early 
      clinical trials on personalized or individualized oral targeted anticancer agents 
      is feasible and enhances early recognition of symptom burden due to multiple 
      CTCAE grade 1-2 AEs, just as pro-active symptom management and effect evaluation 
      of interventions performed. Application of PROMs in these trials might be 
      clinically relevant in obtaining dose-limiting toxicities.
FAU - Koldenhof, J J
AU  - Koldenhof JJ
AD  - Department of Medical Oncology, HP B02.225, University Medical Center Utrecht, 
      Heidelberglaan 100, 3584 CX, Utrecht, Netherlands. j.koldenhof@umcutrecht.nl.
FAU - Lankheet, N A G
AU  - Lankheet NAG
AD  - Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands.
FAU - Steeghs, N
AU  - Steeghs N
AD  - Department of Medical Oncology and Clinical Pharmacology, The Netherlands Cancer 
      Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.
FAU - Teunissen, S C C M
AU  - Teunissen SCCM
AD  - Department of Primary Care, University Medical Center Utrecht, Utrecht, 
      Netherlands.
FAU - Witteveen, P O
AU  - Witteveen PO
AD  - Department of Medical Oncology, HP B02.225, University Medical Center Utrecht, 
      Heidelberglaan 100, 3584 CX, Utrecht, Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20180221
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cohort Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Patient Reported Outcome Measures
MH  - Precision Medicine/*methods
MH  - Prospective Studies
MH  - Sunitinib/pharmacokinetics/*therapeutic use
PMC - PMC6018583
OTO - NOTNLM
OT  - Cancer
OT  - Patient-reported outcome measures
OT  - Personalized medicine
OT  - Sunitinib
OT  - Symptom intensity
OT  - Targeted therapy
COIS- The authors declare that they have no conflict of interest.
EDAT- 2018/02/22 06:00
MHDA- 2019/03/05 06:00
PMCR- 2018/02/21
CRDT- 2018/02/22 06:00
PHST- 2017/08/24 00:00 [received]
PHST- 2018/01/29 00:00 [accepted]
PHST- 2018/02/22 06:00 [pubmed]
PHST- 2019/03/05 06:00 [medline]
PHST- 2018/02/22 06:00 [entrez]
PHST- 2018/02/21 00:00 [pmc-release]
AID - 10.1007/s00520-018-4075-7 [pii]
AID - 4075 [pii]
AID - 10.1007/s00520-018-4075-7 [doi]
PST - ppublish
SO  - Support Care Cancer. 2018 Aug;26(8):2641-2650. doi: 10.1007/s00520-018-4075-7. 
      Epub 2018 Feb 21.