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PMID- 17687157
DCOM- 20070830
LR  - 20151119
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 25
IP  - 23
DP  - 2007 Aug 10
TI  - Trastuzumab-related cardiotoxicity: calling into question the concept of
PG  - 3525-33
AB  - PURPOSE: To assess the spectrum and reversibility of the cardiotoxicity observed 
      in the adjuvant trastuzumab trials. DESIGN: The design and efficacy of the major 
      adjuvant trastuzumab trials was assessed, including the National Surgical
      Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment
      Group N9831, Herceptin Adjuvant, Breast Cancer International Research Group 006, 
      and Finland Herceptin trials. The cardiotoxicity data were evaluated with a focus
      on the follow-up cardiac evaluations of women who were diagnosed with
      cardiotoxicity. Proposed mechanisms of trastuzumab-related cardiotoxicity were
      considered. The natural history of congestive heart failure (CHF) was reviewed
      with the goal of placing the trastuzumab experience in context. RESULTS: Up to 4%
      of patients enrolled onto the adjuvant trastuzumab trials experienced severe CHF 
      during treatment. In these trials, early stopping rules that identified an
      unacceptable level of cardiotoxicity were never reached. Despite this, a large
      number of patients on these trials experienced some form of cardiotoxicity that
      ultimately required discontinuation of trastuzumab. Approximately 14% of patients
      in the NSABP B-31 trial discontinued trastuzumab because of asymptomatic
      decreases in left ventricular ejection fraction (LVEF). Results of follow-up
      cardiac evaluations of patients diagnosed with any degree of cardiotoxicity in
      the NSABP B-31 trial document that a clinically significant proportion of
      patients have sustained decrements in their LVEF to less than 50%. CONCLUSION:
      Adjuvant trastuzumab provides substantial benefits to patients with human
      epidermal growth factor receptor 2-positive breast cancer, however, competing
      immediate and long-term cardiovascular risks are a great concern. Continued
      cardiac follow-up of these women is of critical importance.
FAU - Telli, Melinda L
AU  - Telli ML
AD  - Department of Medicine, Division of Medical Oncology, Stanford University,
      Stanford, CA, USA. [email protected]
FAU - Hunt, Sharon A
AU  - Hunt SA
FAU - Carlson, Robert W
AU  - Carlson RW
FAU - Guardino, Alice E
AU  - Guardino AE
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of
      Clinical Oncology
JID - 8309333
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
CIN - J Clin Oncol. 2007 Dec 1;25(34):5532-3; author reply 5533-4. PMID: 18048835
MH  - Aged
MH  - Antibodies, Monoclonal/*adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/*adverse effects
MH  - Breast Neoplasms/complications/*drug therapy
MH  - Clinical Trials as Topic
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Follow-Up Studies
MH  - Heart/*drug effects
MH  - Heart Diseases/*chemically induced
MH  - Heart Failure/*chemically induced/drug therapy
MH  - Humans
MH  - Middle Aged
MH  - Trastuzumab
MH  - Ventricular Dysfunction, Left/*chemically induced/drug therapy
RF  - 26
EDAT- 2007/08/10 09:00
MHDA- 2007/08/31 09:00
CRDT- 2007/08/10 09:00
PHST- 2007/08/10 09:00 [pubmed]
PHST- 2007/08/31 09:00 [medline]
PHST- 2007/08/10 09:00 [entrez]
AID - 25/23/3525 [pii]
AID - 10.1200/JCO.2007.11.0106 [doi]
PST - ppublish
SO  - J Clin Oncol. 2007 Aug 10;25(23):3525-33. doi: 10.1200/JCO.2007.11.0106.