The findings, published in the January 6 issue of The Lancet, essentially validate previous research.
"This just confirms what we started doing at least a year ago," said Dr Lauren Cassell, a breast surgeon at Lenox Hill Hospital in New York City. "It's validating what's become the standard of care."
Dr Jay Brooks, chairman of haematology/oncology at Ochsner Health System in Baton Rouge, La., added, "This is very strong confirmation of the importance of identifying patients who would benefit from Herceptin."Radically changed prognosis
An estimated 15 percent to 25 percent of breast cancers have abnormally high levels of the HER2/neu receptor and, as a result, are usually more aggressive. Herceptin (trastuzumab) blocks activity of the receptor by binding to the part of the receptor outside the cell. The drug has radically changed the prognosis for women with this type of breast cancer, especially when used in combination with chemotherapy. The drug is now standard therapy to reduce the risk of recurrence for those patients with HER2-positive metastatic breast cancer and is even being used for earlier-stage disease.
The new trial, conducted in London, is one of several large international studies designed to test Herceptin in women with HER2-positive early breast cancer.
In the Herceptin Adjuvant (HERA) study, researchers at Royal Marsden Hospital randomly selected 1 703 women to receive Herceptin for one year after surgery and chemotherapy, while another 1 698 women received no drug after surgery and chemotherapy. All the study participants had HER2-positive breast cancer and were followed for two years.
The researchers found that more deaths occurred in the observation group than in the Herceptin group - 90 vs. 59, which corresponds to a survival benefit of 2.7 percent after three years.Timing is everything
In the case of Herceptin, timing is apparently everything.
"Many studies take many years to give an answer," Brooks said. "The thing that's so profound in these studies is that the benefit is seen so early. This is a very, very active agent. That's really important. You don't need to wait to get the information."
According to the study authors, only the drug tamoxifen has shown a similar survival benefit in such a short period of time.
There were, however, some serious side effects among women taking Herceptin, namely cardiac damage.
"That is a problem. It has to be monitored carefully, particularly in patients who have some underlying heart disease," Cassell said.
But an accompanying comment paper in the journal pointed out that "the risk of cardiac damage seems trivial compared with that of breast cancer recurrence." – (HealthDayNews)Read more:
Herceptin use expanded