Encouraging findings came from an interim report from HERA, an ongoing large, international clinical trial of Herceptin, published Oct. 19, 2005 in the New England Journal of Medicine. The analysis was led by Richard Gelber, PhD, of Harvard and Dana-Farber Cancer Institute, who led the statistical analysis for the HERA trial, which is one of the largest breast cancer trials to date. It includes more than 5,000 patients in 39 countries.
Women whose tumors were HER2-positive – that is, overexpressing a protein associated with more aggressive cancer and poorer outcomes – had approximately a 50 percent lower risk of disease recurrence. This translated into an 8 percent improvement in the number of women who were free of disease two years after beginning the treatment.
“This is probably the biggest evidence of a treatment effect I’ve ever seen in oncology,” says Gelber. “It is quite remarkable.”