PMID- 29265184
OWN - NLM
STAT- MEDLINE
DCOM- 20180222
LR  - 20220114
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 180
IP  - 3
DP  - 2018 Feb
TI  - Nilotinib after imatinib first-line: a real-life longitudinal cohort of patients 
      with chronic myeloid leukaemia in chronic phase.
PG  - 356-364
LID - 10.1111/bjh.15042 [doi]
AB  - This prospective, observational study enrolled 150 adult patients with chronic 
      myeloid leukaemia (CML) in chronic phase (CP) treated with nilotinib as 
      second-line after imatinib, in a real life setting in France. Two-thirds of 
      patients switched to nilotinib treatment due to lack of imatinib efficacy. Of 146 
      evaluable patients, 16 (11.0%) (95% confidence interval: 6.4-17.2%) achieved 
      uMR(4) , defined as undetectable molecular disease in cDNA with MR(4) sensitivity 
      (>/=10 000 ABL1 transcripts) at 18 months and confirmed at 24 months (primary 
      endpoint). Among patients without major molecular response (MMR) or deep 
      molecular response (DMR) at study entry, 66.3% achieved MMR and 44.2% DMR within 
      a median of 5.7 and 6.24 months, respectively. Fifty-three patients (36.3%) have 
      prematurely terminated the study before 24 months of follow-up, primarily due to 
      nilotinib treatment discontinuation (n = 43; 29.5%), mainly motivated by 
      treatment intolerance (n = 27; 18.5%) and inefficacy (n = 10; 6.8%). The most 
      frequent extra-haematological adverse events (AEs) reported as related to 
      treatment with nilotinib were pruritus (16.4%), asthenia (13.7%) and dry skin 
      (13.0%). Ischaemic cardiovascular AEs were reported in 18 patients (12.3%). This 
      French nationwide large cohort adds valuable information to the body of evidence 
      on the efficiency and safety of nilotinib in the treatment of patients with 
      CP-CML.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Cony-Makhoul, Pascale
AU  - Cony-Makhoul P
AUID- ORCID: 0000-0002-1633-6479
AD  - Centre Hospitalier Annecy Genevois, Pringy, France.
AD  - Fi LMC group, Institut Bergonie, Bordeaux, France.
FAU - Gardembas, Martine
AU  - Gardembas M
AD  - Fi LMC group, Institut Bergonie, Bordeaux, France.
AD  - Centre Hospitalier Universitaire d'Angers, Angers, France.
FAU - Coiteux, Valerie
AU  - Coiteux V
AD  - Fi LMC group, Institut Bergonie, Bordeaux, France.
AD  - Centre Hospitalier Regional Universitaire de Lille 2, Lille, France.
FAU - Carpentier, Nathalie
AU  - Carpentier N
AD  - Novartis Pharma, Rueil-Malmaison, France.
FAU - Pommier, Cecile
AU  - Pommier C
AD  - IT&M Stats, Neuilly-Sur-Seine, France.
FAU - Violet, Isabelle
AU  - Violet I
AD  - Novartis Pharma, Rueil-Malmaison, France.
FAU - Quittet, Philippe
AU  - Quittet P
AD  - Fi LMC group, Institut Bergonie, Bordeaux, France.
AD  - Centre Hospitalier Universitaire de Montpellier, Montpellier, France.
FAU - Berger, Marc G
AU  - Berger MG
AD  - Fi LMC group, Institut Bergonie, Bordeaux, France.
AD  - Service d'Hematologie Biologique, Centre Hospitalier Universitaire de 
      Clermont-Ferrand, Hopital Estaing, Clermont-Ferrand, France.
AD  - EA7453 CHELTER, Universite Clermont Auvergne, Clermont-Ferrand, France.
CN  - TARGET-RMC Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171219
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antineoplastic Agents)
RN  - 0 (BCR-ABL1 fusion protein, human)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - EC 2.7.10.2 (Fusion Proteins, bcr-abl)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Cohort Studies
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Fusion Proteins, bcr-abl/genetics
MH  - Humans
MH  - Imatinib Mesylate/administration & dosage/adverse effects/therapeutic use
MH  - Leukemia, Myeloid, Chronic-Phase/*drug therapy/genetics/mortality/*pathology
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Pyrimidines/administration & dosage/adverse effects/*therapeutic use
MH  - Retreatment
MH  - Treatment Outcome
OTO - NOTNLM
OT  - BCR-ABL1
OT  - chronic myeloid leukaemia
OT  - nilotinib
OT  - real-life practice
OT  - second line treatment
EDAT- 2017/12/22 06:00
MHDA- 2018/02/23 06:00
CRDT- 2017/12/22 06:00
PHST- 2017/07/12 00:00 [received]
PHST- 2017/09/26 00:00 [accepted]
PHST- 2017/12/22 06:00 [pubmed]
PHST- 2018/02/23 06:00 [medline]
PHST- 2017/12/22 06:00 [entrez]
AID - 10.1111/bjh.15042 [doi]
PST - ppublish
SO  - Br J Haematol. 2018 Feb;180(3):356-364. doi: 10.1111/bjh.15042. Epub 2017 Dec 19.