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Cardiac safety

 

HER2 is part of a highly complex signalling pathway that plays a key role in the growth, repair and survival of cardiac myocytes.1-6 As Herceptin successfully inhibits HER2 signalling, it can also modify cardiac function especially when given in combination with, or proximity to, cardiotoxic chemotherapies such as anthracyclines. Careful consideration of pre-Herceptin cardiac status and appropriate cardiac monitoring during treatment is, therefore, essential.

 

 

Figure 1.3 Cardiac criteria for initiating Herceptin therapy2 (reproduced by kind permission of the author)

 

Clinical trials in both MBC and EBC have shown that by using stringent cardiac screening and monitoring procedures, cardiac dysfunction during Herceptin treatment is infrequent.3-8

Table 1.2 Low rate of cardiac dysfunction during Herceptin trials in MBC and EBC3-8

 

 

 
Evidence suggests that most Herceptin-related cardiac dysfunction occurs during treatment and very few occur after cessation of Herceptin therapy.5,6 When Herceptin-related cardiac events do occur, they are manageable and largely reversible and do not exclude patients from further treatment with Herceptin.

Guidelines for the management of cardiac dysfunction during Herceptin treatment have been established.2
   


 
 

Figure 1.4  Management of asymptomatic decrease in left ventricular ejection fraction during adjuvant Herceptin2 (reproduced by kind permission of the author)

 

 
 
 

Figure 1.5 Management of symptomatic cardiac events during adjuvant Herceptin2 (reproduced by kind permission of the author)

 
For any patient undergoing cancer therapy, the risk of cardiac dysfunction must be balanced with the expected benefit of treatment. The low risk of reversible cardiac dysfunction associated with the use of Herceptin can usually be justified, given the favourable risk:benefit ratio as well as the substantial survival benefits reported in recent randomised clinical trials in both EBC and MBC.
Full guidance on cardiac monitoring, assessments and treatment continuation are included in the European Summary of Product Characteristics for Herceptin. 

References

  1. Negro A et al. Recent Prog Horm Res 2004; 59: 1-12.
  2. Ewer MS et al. Poster 176 presented at the St Gallen Primary Therapy of Early Breast Cancer 10th International Conference, St Gallen, Switzerland, 14-17 March 2007.
  3. Kaufman B et al. Ann Oncol 2006; 17 (Suppl 9): abs LBA2.
  4. Marty M et al. J Clin Oncol 2005; 23: 4265-4274.
  5. Perez EA et al. J Clin Oncol 2008; 26: 1231-1238.
  6. Rastogi P et al. J Clin Oncol (Meeting Abstracts) 2007; 25: 6s, abs LBA513.
  7. Slamon D et al. Abstract 52 presented at the 29th SABCS, San Antonio, Texas, USA, 14-17 December 2006.
  8. Smith I et al. Lancet 2007; 369: 29-36.