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| |  ASCO-DG Dispatch: Herceptin Effective Against Most Aggressive Types Of Breast Cancer By Robert H. Carlsen Special to DGNews LOS ANGELES, CA -- May 19, 1998 -- It's not a cure and it only works against the most aggressive types of breast cancer, but researchers here at the American Society of Clinical Oncology's 34th annual meeting say Genentech’s new drug herceptin will revolutionise the treatment of breast cancer. However, in another presentation here, a breast-cancer surgeon reported that many women with early-stage breast cancer who are eligible for breast-sparing techniques are still undergoing breast removal because surgeons are not offering them the alternative. Herceptin is a monoclonal antibody against the HER2/Neu gene. Breast-cancer tumours which overproduce HER2/Neu are faster growing and more resistant to chemotherapy than those which do not. About 30 percent of women with breast cancer are positive for HER2/Neu overexpression. In 1987, researchers first attempted to attach an antibody to the HER2/Neu surface protein in a breast-cancer cell and interfere with the cell's biological process, eventually causing its death. The first clones of mouse antibodies caused dangerous immunological responses in humans. Researchers at Genentech finally cloned a human/mouse antibody and human clinical trials began. Results of the first key study were presented here today, a Phase-III trial of 469 women with advanced/metastatic breast cancer. They received standard chemotherapy (adriamycin-cyclophosphamide or paclitaxel, whichever they had not previously been given) and were randomised to receive that chemotherapy with or without herceptin. "Adding herceptin increased the response rate by 50 percent and increased the duration of response by 57 percent," said principal investigator Dennis Slamon, MD, director of the women's cancer research program at the University of California at Los Angeles. The overall response rate for herceptin was 48 percent, compared to a 32-percent overall response rate for chemotherapy alone. Dr. Slamon said some of the trial's early patients are alive at five and six years. He said the herceptin New Drug Application has been granted Fast Track status by the United States Food and Drug Administration and he speculated the drug would be approved in late 1998. "This is a huge step forward, its real importance is the advance beyond poisons [chemotherapy drugs]," said I. Craig Henderson, MD, University of California at San Francisco. He said taxpayers are really getting their investment back with herceptin, the first drug developed from National Cancer Act research funds. Too many physicians still believe aggressive breast-cancer must always be treated with mastectomy, despite 20 years of experience to the contrary. If women don't ask about it, they aren't told that survival can be just as good in appropriate cases using the breast-conserving regimen of lumpectomy followed by radiation. "Seventy-five percent of women diagnosed with early-stage disease are eligible for breast-conserving therapy, but only 44 percent of these women received it," said Monica Morrow, MD, Northwestern University Medical School, referring to her study of 17,931 women treated in 1994. The study was sponsored by the American College of Radiology and the American College of Surgeons, which issued guidelines for breast-conserving therapy in 1992. This study found that many surgeons reserve breast-conserving treatment for patients with favourable histologies, even though the guidelines say prognosis and tumour type should not be used for selection criteria. Surgeons are also less likely to offer breast-conserving therapy to women over age 60, although the guidelines also indicate that age should not be a selection criteria. "Older women say they are quite willing to accept breast preservation," Dr. Morrow said.
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