PMID- 25025755
OWN - NLM
STAT- MEDLINE
DCOM- 20150528
LR  - 20220114
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 30
IP  - 11
DP  - 2014 Nov
TI  - Impact of low-grade adverse events on health-related quality of life in adult 
      patients receiving imatinib or nilotinib for newly diagnosed Philadelphia 
      chromosome positive chronic myelogenous leukemia in chronic phase.
PG  - 2317-28
LID - 10.1185/03007995.2014.944973 [doi]
AB  - OBJECTIVE: Chronic myeloid leukemia (CML) treatment relies on tyrosine kinase 
      inhibitors (TKIs), but their use can be associated with low-grade adverse events 
      (AEs). This analysis aimed to identify the low-grade AEs which significantly 
      impact the Health Related Quality of Life (HRQoL) of CML patients in chronic 
      phase (CP) and to compare the incidence of such AEs among nilotinib- and 
      imatinib-treated patients. RESEARCH DESIGN AND METHODS: Data from the 48 month 
      ENESTnd trial were used (N = 593 patients). HRQoL was assessed using generic 
      (SF-36) and leukemia-specific (FACT-Leu) HRQoL surveys. AEs were categorized into 
      26 system organ classes. RESULTS: In the adjusted regression model, five 
      low-grade AE categories - gastrointestinal disorders, blood and lymphatic system 
      disorders, general disorders and administration site conditions, musculoskeletal 
      disorders, and psychiatric disorders - significantly impaired at least one HRQoL 
      score. The incidence rate of these five AE categories was either significantly 
      lower for nilotinib than imatinib or not different between the two drugs. The AE 
      categories with lower incidence for both nilotinib 300 mg BID and 400 mg BID 
      versus imatinib 400 mg daily were gastrointestinal, blood and lymphatic system, 
      and musculoskeletal; nilotinib 300 mg BID had lower incidence than imatinib for 
      general disorders. LIMITATIONS: Low-grade AEs were grouped and analyzed by system 
      organ class category, so the effect of some rare individual AEs on HRQoL may have 
      been missed. CONCLUSIONS: The impact of low-grade AEs on HRQoL should be taken 
      into account, along with other factors, when selecting the optimal treatment for 
      patients newly diagnosed with CML-CP.
FAU - Guerin, Annie
AU  - Guerin A
AD  - Analysis Group Inc. , Montreal, QC , Canada.
FAU - Chen, Lei
AU  - Chen L
FAU - Ionescu-Ittu, Raluca
AU  - Ionescu-Ittu R
FAU - Marynchenko, Maryna
AU  - Marynchenko M
FAU - Nitulescu, Roy
AU  - Nitulescu R
FAU - Hiscock, Robert
AU  - Hiscock R
FAU - Keir, Christopher
AU  - Keir C
FAU - Wu, Eric Qiong
AU  - Wu EQ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140805
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Benzamides)
RN  - 0 (Piperazines)
RN  - 0 (Pyrimidines)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects
MH  - Benzamides/*adverse effects
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Imatinib Mesylate
MH  - Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis/*drug therapy/genetics
MH  - Male
MH  - Middle Aged
MH  - *Philadelphia Chromosome
MH  - Piperazines/*adverse effects
MH  - Pyrimidines/*adverse effects
MH  - *Quality of Life
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse effects
OT  - Imatinib
OT  - Myelogenous leukemia, chronic
OT  - Nilotinib
OT  - Quality of life
EDAT- 2014/07/16 06:00
MHDA- 2015/05/29 06:00
CRDT- 2014/07/16 06:00
PHST- 2014/07/16 06:00 [entrez]
PHST- 2014/07/16 06:00 [pubmed]
PHST- 2015/05/29 06:00 [medline]
AID - 10.1185/03007995.2014.944973 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2014 Nov;30(11):2317-28. doi: 10.1185/03007995.2014.944973. 
      Epub 2014 Aug 5.