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ATLANTA -- An experimental drug delays the growth of advanced breast cancer in certain women who no longer benefit from standard therapies, researchers announced Saturday.
Scientists designed the drug, Tykerb, for the 20% to 25% of breast cancer patients with aggressive tumors that make large amounts of a protein called HER2, says Charles Geyer Jr. of Allegheny General Hospital in Pittsburgh.
Many of these women already benefit from combining chemotherapy with the drug Herceptin, which blocks the growth signals that drive their cancers. Women can survive on the drugs for several years, Geyer says.
Though breast cancer that has spread to other organs is considered incurable, Tykerb appears to buy women more time. In a study of 321 patients who already had tried other drugs, combining Tykerb with an older chemotherapy delayed tumor growth by a median of 8.5 months, nearly twice as long as chemo alone, says Geyer, lead author of a study presented at the annual meeting here of the American Society of Clinical Oncology. Nearly 215,000 Americans will develop breast cancer this year.
Tykerb's results were so impressive that researchers halted the trial to give the new drug to all patients, Geyer says. The trial has not gone on long enough to determine whether Tykerb will help women live longer overall. About 14% of patients taking the combination had to stop therapy because of side effects, compared with 11% of those who got just chemo, Geyer says.
Tykerb may offer another benefit: reducing the risk of cancer spreading to the brain. Four women taking Tykerb developed brain tumors, compared with 11 who took chemo alone. Doctors say they need to perform more studies to confirm the findings. But Julie Gralow of the University of Washington says it's possible that Tykerb -- a very small molecule -- could protect the brain by passing through blood vessels that large molecules such as Herceptin can't navigate.
Jose Baselga of Vall d'Hebron University Hospital in Barcelona says Herceptin was one of the first "targeted therapies," which injure fewer healthy cells than traditional chemo. Tykerb belongs to the second generation of these therapies.
GlaxoSmithKline, which paid for the study, is working with the Food and Drug Administration to make Tykerb available free through a special program beginning June 12. The company plans to apply for FDA approval this year.
Ann-Michele Higgins, 43, of Radnor, Pa., says her cancer has been stable since adding Tykerb to her chemo regimen in March. She feels well enough to spend time with her husband and children, work as a lawyer and volunteer. Higgins sometimes stops chemo, though, because it makes her hands crack and bleed so badly that she can't even button her clothes.
"My hands look 30 years older. But I've had no hair loss. To my girls and outsiders, though, no one would ever know I'm ill."
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