PMID- 26163096
OWN - NLM
STAT- MEDLINE
DCOM- 20160428
LR  - 20220409
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 51
IP  - 13
DP  - 2015 Sep
TI  - Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised 
      phase III study.
PG  - 1660-6
LID - S0959-8049(15)00499-2 [pii]
LID - 10.1016/j.ejca.2015.05.028 [doi]
AB  - BACKGROUND: This article reports, the cardiac toxicity according to 6- versus 
      12-month durations of adjuvant trastuzumab in PHARE randomised trial 
      (NCT00381901). PATIENTS AND METHODS: Cardiac follow-up and Left Ventricular 
      Ejection Fraction (LVEF) assessment by echocardiography or multigated acquisition 
      scan were performed every 3 months while patients received trastuzumab and after 
      completion of treatment over the first 2 years and every 6 months afterwards. The 
      primary cardiac end-point was Cardiac Heart Failure (CHF) defined as New York 
      Heart Association (NYHA) class III or IV. The secondary cardiac end-points were: 
      cardiac events, cardiac dysfunctions defined by NYHA class I and II; LVEF 
      decreases, cardiac recoveries. The cardiac subcommittee reviewed cardiac events 
      and assessed if patients had favourable outcomes or not on the basis of trends 
      from LVEF measurements. RESULTS: Among 3380 patients the cardiac dysfunction 
      assessment included 14,055 and 13,218 LVEF measurements in the 12- and 6-month 
      arms. The overall incidences of CHF were 0.65% (11/1690) and 0.53% (9/1690) in 
      the 12 and 6 month arms, respectively (p>0.05). Cardiac dysfunction occurred in 
      5.9% (100/1690) and 3.4% (58/1690) of patients in the 12 and 6 month arms, 
      respectively (p=0.001). Recoveries were observed for the majority patients and 
      0.79% (27/3380) of patients experienced an unfavourable cardiac outcome. 
      CONCLUSION: PHARE confirm that the incidence of cardiac end-points remains low 
      and mostly reversible after trastuzumab. Identification at baseline of cardiac 
      risk categories of patients should be of interest to provide an optimal 
      adaptation of adjuvant modalities and a shorter duration might be an option.
CI  - Copyright (c) 2015 Elsevier Ltd. All rights reserved.
FAU - Pivot, Xavier
AU  - Pivot X
AD  - University Hospital J Minjoz, Besancon, France. Electronic address: 
      xavier.pivot@univ-fcomte.fr.
FAU - Suter, Thomas
AU  - Suter T
AD  - University Hospital, Bern, Switzerland.
FAU - Nabholtz, Jean Marc
AU  - Nabholtz JM
AD  - Centre jean Perrin, Clermont-Ferrand, France.
FAU - Pierga, Jean Yves
AU  - Pierga JY
AD  - Institut Curie, Paris, France.
FAU - Espie, Marc
AU  - Espie M
AD  - University Hospital Saint-Louis, Paris, France.
FAU - Lortholary, Alain
AU  - Lortholary A
AD  - Centre Catherine de Sienne, Nantes, France.
FAU - Khayat, David
AU  - Khayat D
AD  - University Hospital Pitie Salpetriere, Paris, France.
FAU - Pauporte, Iris
AU  - Pauporte I
AD  - French National Cancer Institut, Boulogne, France.
FAU - Romieu, Gilles
AU  - Romieu G
AD  - Centre Val d'Aurelle, Montpellier, France.
FAU - Kramar, Andrew
AU  - Kramar A
AD  - Centre Oscar Lambret, Lille, France.
FAU - Fumoleau, Pierre
AU  - Fumoleau P
AD  - Centre Georges Francois Leclerc, Dijon, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT00381901
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150707
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - Eur J Cancer. 2015 Sep;51(13):1657-9. PMID: 26185034
MH  - Antineoplastic Agents/*adverse effects
MH  - Breast Neoplasms/*drug therapy/enzymology/pathology
MH  - Chemotherapy, Adjuvant
MH  - Female
MH  - France/epidemiology
MH  - Heart Failure/*chemically induced/diagnosis/epidemiology/physiopathology
MH  - Humans
MH  - Incidence
MH  - Protein Kinase Inhibitors/*adverse effects
MH  - Receptor, ErbB-2/antagonists & inhibitors/metabolism
MH  - Risk Assessment
MH  - Risk Factors
MH  - Stroke Volume/drug effects
MH  - Time Factors
MH  - Trastuzumab/*adverse effects
MH  - Treatment Outcome
MH  - Ventricular Function, Left/drug effects
OTO - NOTNLM
OT  - Adjuvant trastuzumab
OT  - Breast cancer
OT  - Cardiac Heart Failure
OT  - Cardiotoxicity
OT  - Randomised trial
EDAT- 2015/07/15 06:00
MHDA- 2016/04/29 06:00
CRDT- 2015/07/12 06:00
PHST- 2015/01/13 00:00 [received]
PHST- 2015/03/17 00:00 [revised]
PHST- 2015/05/30 00:00 [accepted]
PHST- 2015/07/12 06:00 [entrez]
PHST- 2015/07/15 06:00 [pubmed]
PHST- 2016/04/29 06:00 [medline]
AID - S0959-8049(15)00499-2 [pii]
AID - 10.1016/j.ejca.2015.05.028 [doi]
PST - ppublish
SO  - Eur J Cancer. 2015 Sep;51(13):1660-6. doi: 10.1016/j.ejca.2015.05.028. Epub 2015 
      Jul 7.