Fever and chills, especially after the initial infusion, were the most common side effects in both Cobleigh's study and the phase III trial, but these were easily manageable and not persistent Slamon said. A more serious concern is cardiac toxicity, which occurred in some patients on the randomized trial, primarily those who were also taking Adriamycin and Cytoxan. Slamon reported that the problem was manageable with medication in most cases. One of the 469 patients in the trial died of cardiac problems that were possibly related to treatment, he said. Some of the excitement surrounding Herceptin stems from the probablility that the drug, now proven in metastatic breast cancer, will have an impact in other settings.
Hope focuses particularly on other stages of breast cancer.
At least one trial to test that prediction in stage III breast cancer is now being designed, according to Memorial Sloan-Kettering's Norton. He said that a multi-center trial will combine Herceptin, doxorubicin, and cyclophosphamide with paclitaxel. All patients in this trial, as now designed, would receive all four drugs plus a drug to help prevent cardiac complications. They would then be randomized either to continue with Herceptin for a year or to have no further chemotherapy. Norton said the Cancer and Leukemia Group B, an NCI-supported group conducting clinical trials, and perhaps other cooperative trial groups will carry out the study, which could start recruiting patients by the end of year.