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Risk of severe cardiotoxicity following treatment with trastuzumab: a meta-analysis of randomized and cohort studies of 29,000 women with breast cancer.

Abstract Trastuzumab prolongs survival in women with HER2-positive breast cancer, but may increase the risk of heart disease. The occurrence of severe cardiotoxicity, however, is not defined in real-life settings. We performed a meta-analysis of clinical trials and cohort studies to estimate the frequency of cardiotoxicities following trastuzumab treatment. We searched MEDLINE, EMBASE, and the Cochrane Library (1996-January 2014). The primary outcome was the frequency of severe cardiotoxicities up to 3-years after trastuzumab initiation. Among 58 studies (29,598 patients), severe cardiotoxicity occurred in 3.00% (95% CI 2.41-3.64), 2.62% (95% CI 1.97-3.35), and 3.14% (95% CI 2.12-4.37) of overall, early (EBC) and metastatic (MBC) breast cancer patients, respectively. In EBC, the proportion increased from 2.40% at the first year to a plateau of approximately 3% after the second year. In MBC, the proportion increased from 3.00 to 3.68% when trastuzumab was used as first line or further lines of therapy, respectively. In EBC, cardiotoxicity occurred in 2.90% of patients treated with taxanes and anthracyclines compared to 0.92% in patients treated with taxanes without anthracyclines. The occurrence of cardiotoxicity varied according to age, increasing from 2.31% in individuals <50 years, to 3.46% in those 50-59 years, to 4.91% in those >60 years of age. Cardiotoxicity was higher in smokers (5.3%), dyslipidemic patients (3.9%), BMI ≥25 (6.5%), diabetes (6.2%), hypertension (5.5%), or positive history of cardiac disease (19.1%). RCTs consistently report lower cardiac toxicity rates than observational studies (EBC: 1.7 versus 3.2; MBC: 2.8 versus 4.4). Following trastuzumab initiation, approximately three in 100 patients develop severe cardiotoxicity after 2 years. Patients enrolled in cohort studies, who more closely reflect women treated for breast cancer in real-life settings compared to RCTs, are at higher risk of developing cardiac events.
PMID
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Authors

Mayor MeshTerms
Keywords

Cardiotoxicity

Early breast cancer

Heart failure

Meta-analysis

Metastatic breast cancer

Trastuzumab

Journal Title internal and emergency medicine
Publication Year Start




PMID- 26712595
OWN - NLM
STAT- MEDLINE
DCOM- 20170228
LR  - 20171105
IS  - 1970-9366 (Electronic)
IS  - 1828-0447 (Linking)
VI  - 11
IP  - 1
DP  - 2016 Feb
TI  - Risk of severe cardiotoxicity following treatment with trastuzumab: a
      meta-analysis of randomized and cohort studies of 29,000 women with breast
      cancer.
PG  - 123-40
LID - 10.1007/s11739-015-1362-x [doi]
AB  - Trastuzumab prolongs survival in women with HER2-positive breast cancer, but may 
      increase the risk of heart disease. The occurrence of severe cardiotoxicity,
      however, is not defined in real-life settings. We performed a meta-analysis of
      clinical trials and cohort studies to estimate the frequency of cardiotoxicities 
      following trastuzumab treatment. We searched MEDLINE, EMBASE, and the Cochrane
      Library (1996-January 2014). The primary outcome was the frequency of severe
      cardiotoxicities up to 3-years after trastuzumab initiation. Among 58 studies
      (29,598 patients), severe cardiotoxicity occurred in 3.00% (95% CI 2.41-3.64),
      2.62% (95% CI 1.97-3.35), and 3.14% (95% CI 2.12-4.37) of overall, early (EBC)
      and metastatic (MBC) breast cancer patients, respectively. In EBC, the proportion
      increased from 2.40% at the first year to a plateau of approximately 3% after the
      second year. In MBC, the proportion increased from 3.00 to 3.68% when trastuzumab
      was used as first line or further lines of therapy, respectively. In EBC,
      cardiotoxicity occurred in 2.90% of patients treated with taxanes and
      anthracyclines compared to 0.92% in patients treated with taxanes without
      anthracyclines. The occurrence of cardiotoxicity varied according to age,
      increasing from 2.31% in individuals &lt;50 years, to 3.46% in those 50-59 years, to
      4.91% in those &gt;60 years of age. Cardiotoxicity was higher in smokers (5.3%),
      dyslipidemic patients (3.9%), BMI &gt;/=25 (6.5%), diabetes (6.2%), hypertension
      (5.5%), or positive history of cardiac disease (19.1%). RCTs consistently report 
      lower cardiac toxicity rates than observational studies (EBC: 1.7 versus 3.2;
      MBC: 2.8 versus 4.4). Following trastuzumab initiation, approximately three in
      100 patients develop severe cardiotoxicity after 2 years. Patients enrolled in
      cohort studies, who more closely reflect women treated for breast cancer in
      real-life settings compared to RCTs, are at higher risk of developing cardiac
      events.
FAU - Mantarro, Stefania
AU  - Mantarro S
AD  - Department of Clinical and Experimental Medicine, University of Pisa, Pisa,
      Italy.
FAU - Rossi, Marta
AU  - Rossi M
AD  - Department of Epidemiology, IRCSS Institute for Pharmacological Research "Mario
      Negri", Milan, Italy.
AD  - Department of Clinical Medicine and Community Health, University of Milan, Milan,
      Italy.
FAU - Bonifazi, Martina
AU  - Bonifazi M
AD  - Department of Epidemiology, IRCSS Institute for Pharmacological Research "Mario
      Negri", Milan, Italy.
FAU - D'Amico, Roberto
AU  - D'Amico R
AD  - Italian Cochrane Centre, University of Modena and Reggio Emilia, Modena, Italy.
FAU - Blandizzi, Corrado
AU  - Blandizzi C
AD  - Department of Clinical and Experimental Medicine, University of Pisa, Pisa,
      Italy.
FAU - La Vecchia, Carlo
AU  - La Vecchia C
AD  - Department of Clinical Medicine and Community Health, University of Milan, Milan,
      Italy.
FAU - Negri, Eva
AU  - Negri E
AD  - Department of Epidemiology, IRCSS Institute for Pharmacological Research "Mario
      Negri", Milan, Italy.
FAU - Moja, Lorenzo
AU  - Moja L
AD  - Department of Biomedical Sciences for Public Health, University of Milan, Via
      Carlo Pascal 36, 20133, Milan, Italy. [email protected]
AD  - Clinical Epidemiology Unit, IRCCS Orthopedic Institute Galeazzi, Milan, Italy.
      [email protected]
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20151228
PL  - Italy
TA  - Intern Emerg Med
JT  - Internal and emergency medicine
JID - 101263418
RN  - 0 (Antineoplastic Agents)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Antineoplastic Agents/*adverse effects
MH  - Breast Neoplasms/complications/*drug therapy
MH  - Cardiotoxicity
MH  - Cardiovascular Diseases/*epidemiology
MH  - Female
MH  - Humans
MH  - Trastuzumab/*adverse effects
OTO - NOTNLM
OT  - *Cardiotoxicity
OT  - *Early breast cancer
OT  - *Heart failure
OT  - *Meta-analysis
OT  - *Metastatic breast cancer
OT  - *Trastuzumab
EDAT- 2015/12/30 06:00
MHDA- 2017/03/01 06:00
CRDT- 2015/12/30 06:00
PHST- 2015/07/27 00:00 [received]
PHST- 2015/11/22 00:00 [accepted]
PHST- 2015/12/30 06:00 [entrez]
PHST- 2015/12/30 06:00 [pubmed]
PHST- 2017/03/01 06:00 [medline]
AID - 10.1007/s11739-015-1362-x [doi]
AID - 10.1007/s11739-015-1362-x [pii]
PST - ppublish
SO  - Intern Emerg Med. 2016 Feb;11(1):123-40. doi: 10.1007/s11739-015-1362-x. Epub
      2015 Dec 28.