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Unexpected benefit seen in treating HER-2 breast cancer with new preoperative drug combo

removed, they could look for evidence of an effect.

The trial they designed was the first to compare preoperative use of Herceptin and chemotherapy against use of chemotherapy alone in patients with operable breast cancer, Buzdar says.

Patients enrolled in the study were randomized to four cycles of paclitaxel followed by four cycles of fluorouracil, epirubicin and cyclophosphamide alone or the same regimen with 24 weekly, simultaneous Herceptin treatments. To reduce the substantial incidence of heart failure and cardiac dysfunction seen with traditional use of Herceptin and anthracycline-based chemotherapy, the researchers used epirubicin instead of doxorubicin, which has been shown to be less toxic to the heart.

The researchers offered the combination of therapies for a longer period of time than is usual, and the drugs also were given at the same time - another departure from traditional practice.

The goal of the study has been to see whether tailoring the chemotherapy regimen and adding Herceptin would double rates of pathologicalcompleteremission. "Instead of the 20 percent improvement we had hoped for, we saw almost twice that," Buzdar says. "We were totally surprised with these striking findings, and pleased that we may have a better treatment for women with HER-2 breast cancer."

They also found that it did not matter whether the patients' tumors were estrogen-receptor positive or negative - a distinction that usually demarcates which patients will respond to hormonal therapy. And, to date, no cases of congestive heart failure or other such serious heart problems have yet been observed in the patients, Buzdar says.

Within several months, the research team will launch additional studies, enrolling larger groups of patients, to test the effects of this approach before surgery. "The data from this trial is so convincing that we decided that in these new studies, all patients must receive Herceptin," Buzdar says
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Contact: Nancy Jensen
nwjensen@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
29-Mar-2005


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