PMID- 35904979
OWN - NLM
STAT- MEDLINE
DCOM- 20220913
LR  - 20220921
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 198
IP  - 6
DP  - 2022 Sep
TI  - Management of chronic myeloid leukaemia patients treated with ponatinib in a 
      real-life setting: A retrospective analysis from the monitoring registries of the 
      Italian Medicines Agency (AIFA).
PG  - 965-973
LID - 10.1111/bjh.18359 [doi]
AB  - Real-world data on daily practice management, treatment modifications and outcome 
      of a large cohort of chronic myeloid leukaemia (CML) patients treated with 
      ponatinib was performed through monitoring Registries of the Italian Medicines 
      Agency (AIFA). Overall, 666 CML subjects were included in the ponatinib registry 
      from February 2015 to December 2020 and were eligible for analysis: 515 in 
      chronic phase (CP), 50 in accelerated phase (AP) and 101 in blast crisis (BC). 
      Median age at baseline was 58.7 years with a predominance of male subjects 
      (57.1%). The median time from diagnosis to start of ponatinib was 2.35 years: 259 
      (38.9%) subjects had received two previous lines of treatment, 260 (39.0%) three 
      lines and 147 (22.1%) four or more lines. A molecular response [from major 
      molecular response (MMR) to a score of </=0.01% on the international reporting 
      scale (IS)] was reported for 59% of patients out of 593 patients analysed. With a 
      median follow-up of 14.4 months, 136 subjects (20.4%) required at least one dose 
      reduction due to adverse events (AEs), whereas 309 patients (46.4%) required dose 
      reduction in the absence of any evidence of side effects. Treatment 
      discontinuation occurred in 261 patients (39%). This real-life analysis shows 
      that dose reductions were made primarily as a precaution rather than due to the 
      occurrence of adverse reactions.
CI  - (c) 2022 British Society for Haematology and John Wiley & Sons Ltd.
FAU - Breccia, Massimo
AU  - Breccia M
AUID- ORCID: 0000-0003-1163-6162
AD  - Department of Translational and Precision Medicine, Az. Policlinico Umberto 
      I-Sapienza University, Rome, Italy.
FAU - Olimpieri, Pier Paolo
AU  - Olimpieri PP
AUID- ORCID: 0000-0001-7934-9034
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Celant, Simone
AU  - Celant S
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Olimpieri, Odoardo
AU  - Olimpieri O
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Pane, Fabrizio
AU  - Pane F
AD  - Universita degli Studi di Napoli Federico II, Naples, Italy.
FAU - Iurlo, Alessandra
AU  - Iurlo A
AD  - Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
FAU - Summa, Valentina
AU  - Summa V
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Corradini, Paolo
AU  - Corradini P
AUID- ORCID: 0000-0002-9186-1353
AD  - Universita degli Studi di Milano & Divisione Ematologia, Fondazione IRCCS 
      Istituto Nazionale dei Tumori di Milano, Milan, Italy.
FAU - Russo, Pierluigi
AU  - Russo P
AD  - Italian Medicines Agency, Rome, Italy.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220729
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Imidazoles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyridazines)
RN  - 4340891KFS (ponatinib)
SB  - IM
MH  - *Antineoplastic Agents/adverse effects
MH  - Female
MH  - Humans
MH  - Imidazoles
MH  - *Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy
MH  - Male
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Pyridazines
MH  - Registries
MH  - Retrospective Studies
OTO - NOTNLM
OT  - chronic myeloid leukaemia
OT  - discontinuation
OT  - effectiveness
OT  - ponatinib
EDAT- 2022/07/30 06:00
MHDA- 2022/09/14 06:00
CRDT- 2022/07/29 12:52
PHST- 2022/06/29 00:00 [revised]
PHST- 2022/04/02 00:00 [received]
PHST- 2022/07/04 00:00 [accepted]
PHST- 2022/07/30 06:00 [pubmed]
PHST- 2022/09/14 06:00 [medline]
PHST- 2022/07/29 12:52 [entrez]
AID - 10.1111/bjh.18359 [doi]
PST - ppublish
SO  - Br J Haematol. 2022 Sep;198(6):965-973. doi: 10.1111/bjh.18359. Epub 2022 Jul 29.