When combined with chemotherapy and used before surgery in early stage breast cancer the drug proved so beneficial - eliminating 42 percent more tumors than chemotherapy alone - that the clinical trial testing of this new treatment plan was halted early, the researchers report in the Journal of Clinical Oncology.
"This is a far better result than we had anticipated and seems to suggest that simultaneous use of chemotherapy and Herceptin offers a much more potent treatment than use of these drugs sequentially, or alone," says lead investigator Aman Buzdar, M.D., professor in the Department of Breast Medical Oncology at M. D. Anderson.
"This is the best treatment result we have seen in this patient population," Buzdar says. "It shows that we can potentially change the natural history of a disease that is associated with a high risk of recurrence and death."
He cautions, however, that although this combination of therapies seems to show better efficacy, as well as less risk of heart damage than has been seen before with Herceptin treatment, "the jury is still out on the long-term safety and outcome. As in all such studies, we will need to wait years to follow the progress of our patient participants," Buzdar says.
Details of the trial result, slated for the June issue of the journal, were posted online Feb. 28 because of interest in the study. Preliminary results of the trial were presented in June, 2004 at the annual meeting of the American Society of Clinical Oncology.
After only 34 of a planned 164 patients had completed therapy, the trial's Data Monitoring Committee stopped the clinical trial because of the obvious benefit seen in patients who received Herceptin and chemotherap
Contact: Nancy Jensen
University of Texas M. D. Anderson Cancer Center