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Barbara Bradfield, 55, is living proof that this can work. A teacher turned homemaker in La Canada Flintridge, Calif., Bradfield is one of the lucky cancer patients who have already benefited from the new generation of gene-based treatments. She was 47 years old when she discovered a large lump in her breast. Tests showed that the malignancy had spread to her lymph nodes. Bradfield got the works: a double mastectomy and six months of chemotherapy, followed by radiation and then more chemo. It bought her 18 months of symptom-free life. Then one hot August night, she recalls, "I went to rub my neck, and there was a tumor about the size of a marshmallow." Bradfield was already depressed--her daughter had just died in a car accident--and she never wanted to face chemo again. "I thought I was probably going to die, and I didn't want to die bald and throwing up."
As it happened, Bradfield's tumor cells had a characteristic present in about 30% of breast-cancer cells: too many copies of a gene known as HER-2/neu. This gene makes a protein that helps relay the signal telling cells to divide. Having too much of it is associated with an especially rampaging, hard-to-treat cancer. Once this form of breast cancer metastasizes, a patient typically has just six to 12 months to live.
Bradfield's doctor put her in touch with UCLA's Slamon, who was testing a brand-new antibody that targeted the HER-2/neu protein. Although Slamon was using the antibody in combination with chemotherapy--and Bradfield was loath to go back to chemo--the combined therapy proved miraculous in her case. Sixteen small tumors in her lungs melted away. By 1993 she was in remission, and still is. "I got to be at my son's wedding," she exults. "The gift is that I'm here!"
The antibody is not a panacea. It didn't work as well for Bradfield's fellow guinea pigs in the initial study. But results of a just completed trial with 470 women do show it to be a significant improvement over chemo alone for women with this awful form of breast cancer. The details of the study will be revealed by Slamon this Sunday at a meeting in Los Angeles of the American Society of Clinical Oncology. Manufactured by Genentech under the name Herceptin, the drug is on a fast track for approval by the FDA, perhaps before year's end.
Herceptin, if approved, will join the lymphoma drug Rituxan, also an antibody, as the first of the new gene-based therapies to make it to market. Rituxan, made by IDEC Pharmaceuticals, was approved late last year.