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Adjuvant Herceptin delivers high cure rates in HER2-positive early breast cancer

 

Use of adjuvant Herceptin has been investigated in a global programme of four large multicentre, randomised clinical trials involving more than 13,000 women with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC).

The HERA study was the basis for obtaining approval for a label in the EU and rest of the world countries.

 
 


 
 

Figure 2.1 Designs of major Herceptin adjuvant trials6 (reproduced by kind permission of The Oncologist© AlphaMed Press)

The latest efficacy analyses were performed after a median follow-up of 2 years or longer and have consistently shown that 1 year of adjuvant Herceptin significantly extends both overall survival and disease-free survival, with risk of death reduced by about one third and risk of recurrence reduced by up to half. This consistency was achieved irrespective of differences in the trial populations, chemotherapy regimens and sequencing of treatment.
 

Table 2.1  Summary of efficacy end points in Herceptin adjuvant trials

 
 

    

 

 

Figure 2.2 Adjuvant Herceptin therapy for 1 year significantly improves overall survival and disease-free survival1,3,5

 

In the HERA trial at 2 years’ follow-up, 1 year of adjuvant Herceptin (18 infusions q3w) following chemotherapy:

 
  • reduced the risk of death by 34% (p=0.0115)1
  • reduced the risk of recurrence by 36% (p<0.0001).1
 

The appearance of an overall survival benefit so early is noteworthy. It clearly demonstrates both the aggressive nature of HER2-positive disease in the absence of treatment and the large benefit that Herceptin provides.

Adjuvant Herceptin is effective in all patient subgroups, even those at relatively low risk of relapse.3,5,7

 

The results of these major trials indicate that 1 year of adjuvant Herceptin, given either concurrently or following chemotherapy, delivers high cure rates for women with HER2-positive EBC.

 
References
  1. Smith I et al. Lancet 2007; 369: 29-36.
  2. Piccart-Gebhart MJ et al. N Engl J Med 2005; 353: 1659-1672.
  3. Perez EA et al. J Clin Oncol (Meeting Abstracts) 2007; 25: 6s, abs 512.
  4. Romond EH et al. N Engl J Med 2005; 353: 1673-1684.
  5. Slamon D et al. Abstract 52 presented at the 29th SABCS, San Antonio, Texas, USA, 13-17 December 2006.
  6. Baselga J et al. Oncologist 2006: 11 (Suppl 1): 4-12.
  7. Untch M et al. Ann Oncol 2008; 19: 1090-1096. 
 
 
 
 

Clinical Trial Register

For an overview of all Roche Herceptin trials, please visit www.roche-trials.com