Clinical and Health Economic Outcomes of Alternative HER2 Test Strategies for Guiding Adjuvant Trastuzumab Therapy

James A Lee; Megan Shaheen; Thomas Walke; Matt Daly

Disclosures

Expert Rev Pharmacoeconomics Outcomes Res. 2011;11(3):325-341. 

In This Article

Five-year View

While there are clinical trials to evaluate alternative biomarkers and diagnostics to target anti-HER2 therapy, it is not clear to what degree these trials will result in improved diagnostics and, ultimately, clinical outcomes. To get a sense of the breadth of studies, a search of clinicaltrials.gov listed 314 distinct open studies regarding breast cancer and HER2 status throughout the world.[102]

Regarding anti-HER2 therapy, there are numerous investigations and several promising regimens. Recent studies and clinical trials have provided insight into reasons for resistance to trastuzumab therapy and suggest that combinations of two or more anti-HER2 agents (e.g., bevacizumab, pertuzumab and TDM1) will improve patient outcomes. There are also ongoing Phase II clinical trials for anti-HER2 vaccines targeting patients with HER2-positive breast cancer. Clinically appropriate and cost-effective application of these new regimens is highly dependent on accurate HER2 testing.

Of equal importance are the subset of these trials regarding therapies directed towards the approximately 80% of breast cancer patients who are HER2-negative and unlikely to benefit from anti-HER2 therapies. As these therapies advance, the clinical and economic consequences of a false-negative test increase. Thus, in the next 5 years, the therapy options and concomitant benefits and costs are likely to increase dramatically and demand even greater accuracy in HER2 testing and related breast cancer biomarkers.

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