women with HER2 positive tumors compared to 97.2 percent in women with HER2-negative tumors. Patients with HER2-positive tumors had 2.68 times higher risk of recurrence and 5.3 times higher risk of distant recurrence than those with HER2-negative tumors.
In addition, women with HER2-positive tumors had 5.09 times the risk of recurrence and 7.81 times risk of distant recurrence than women with hormone receptor-positive tumors.
The European subset confirmed the M. D. Anderson findings and showed reproducibility, said Gonzalez-Angulo.
"The risk of recurrence was much higher than we suspected. With this study, we now have concrete evidence to discuss with our HER2 positive patients with even the smallest of tumors, and Herceptin alone or combined with chemotherapy should be strongly considered as adjuvant therapy," said Gonzalez-Angulo. "This data should also encourage this subset of patients to be included in ongoing clinical trials with HER2-targeted therapies."
Gonzalez-Angulo hopes that a specific, three-arm clinical trial can be designed comparing observation, Herceptin, and Herceptin combined with chemotherapy.
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JCI online early table of contents: Dec. 1, 2008