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| |  DG DISPATCH - ASCO: Herceptin (Trastuzumab) Prompts Promising Response In Advanced Breast Cancer By Robert H. Carlson Special to DG News
NEW ORLEANS, LA -- May 23, 2000 -- The monoclonal antibody, Herceptin (trastuzumab), continues to enthuse researchers with its activity in breast cancer. A trial using Herceptin and the chemotoxic agent Navelbine (vinorelbine) achieved an overall response rate of 75 percent in women with advanced breast cancer, according to a report presented at 36th annual meeting of the American Society of Clinical Oncology, in New Orleans, LA. Among 40 women with metastatic breast cancer (median age 50 years), 28 had partial responses (shrinkage of the tumor by at least 50 percent) and two patients had complete disappearance of their tumors. It was just two years ago at this meeting that the first study was presented showing that Herceptin improved response rates when combined with chemotherapy. That study included Taxol (paclitaxel), a popular treatment for breast cancer. This new study, sponsored by Genentech, the makers of Herceptin, included vinorelbine, another relatively new chemotherapeutic agent. Harold J. Burstein, MD, PhD, of the Dana Farber Cancer Center, in Boston, MA, who presented the paper here, said navelbine is a fairly mild drug, as it does not cause debilitating nausea and vomiting or alopecia, and no steroids are required to support the patient during therapy. He said navelbine's good side effecti profile made it a likely drug to combine with Herceptin, which also has very few side effects, and especially no significant cardiac effects. In this Phase-II study, the only important side effect was neutropenia, Dr. Burstein said, but this was easy to manage and growth-factor support was not needed for these patients. “It was an easy regimen, the patients really appreciated that,” he said. He said three women did show signs of cardiac toxicity. These women had borderline cardiac functions and had been pretreated heavily with adriamycin in the past. However, he emphasized that there was no symptomatic cardiac toxicity seen, no heart failure, and no decreases in ejection faction after the second cycle of therapy. "What we got was a very active regimen, with an overall response rate of 75 percent," Dr. Burstein said. As a first-line regimen, for women who had not received chemotherapy since their disease had advanced, the combination produced an overall response rate of 84 percent. For women who already had treatment for advanced disease, the second-line response rate was 60 to 70 percent. That was even for the 15 women in the study who had prior cytotoxic chemotherapy with an adriamycin-taxane combination, who also had response rates of over 70 percent. "If you take a reasonably active regimen and make sure it is not very toxic, patients will like it and there will be interest in using it broadly in the population," Dr Burstein concluded.
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