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Herceptin: a well-tolerated treatment option

 

Data from pivotal clinical trials and extensive clinical experience in over 500,000 patients have demonstrated that Herceptin is generally well tolerated and has a predictable safety profile in both EBC and MBC. Herceptin can be given in combination with a wide range of chemotherapies and other agents, such as hormonal therapy, with minimal addition to the toxicity of these other treatments.1-5 Furthermore, Herceptin is not metabolised by cytochrome P450 and is not subject to pharmacokinetic drug–drug interactions,6 so it can be given irrespective of co-medications.  

 

Table 1.1 Herceptin adds little to the toxicity of chemotherapy: non-haematological adverse events reported in >20% of patients in trial M770017 (reprinted with permission from the American Society of Clinical Oncology)

 

 

Cardiac dysfunction and infusion-related reactions can occur with Herceptin treatment. However, these events arise relatively infrequently. In addition, cardiac events are generally reversible, manageable with standard therapeutic interventions and patients potentially at risk can mostly be identified prior to initiation of Herceptin.


The safety of prolonged use of Herceptin in MBC has been demonstrated8 and in four large Phase III trials of adjuvant Herceptin in EBC, 1 year of Herceptin therapy did not increase the overall severity of non-cardiac adverse events associated with the chemotherapeutic regimens.9-13
The European Summary of Product Characteristics provides comprehensive information on Herceptin’s safety profile in MBC and EBC.

 
References
  1. Kaufman B. Slide presentation LBA2 at the 31st ESMO Congress, Istanbul, Turkey, 29 September-3 October 2006.
  2. Jackisch C. Oncologist 2006; 11 (Suppl 1): 34-41.
  3. Chan A et al. Br J Cancer 2006; 95: 788-793.
  4. Wardley A. Slide presentation LBA6 at the 31st ESMO Congress, Istanbul, Turkey, 29 September-3 October 2006.
  5. Cameron DA et al. Ann Oncol 2006; 17 (Suppl 9): ix69, abs 1410.
  6. Leyland-Jones B et al. J Clin Oncol 2003; 21: 3965-3971.
  7. Marty M et al. J Clin Oncol 2005; 23: 4265-4274.
  8. Tripathy D et al. J Clin Oncol 2004; 22: 1063-1070.
  9. Slamon D et al. Oral presentation at the 29th SABCS, San Antonio, Texas, USA, 14-17 December 2006.
  10. Smith I et al. Lancet 2007; 369: 29-36.
  11. Romond EH et al. N Engl J Med 2005; 353: 1673-1684.
  12. Piccart-Gebhart MJ et al. N Engl J Med 2005; 353: 1659-1672.
  13. Tan-Chiu E et al. J Clin Oncol 2005; 23: 7811-7819.