May 29 2006
Drug giant Roche believes it has proof that its cancer drug Herceptin when used in combination with hormonal therapy increases the time that some breast-cancer patients live without the cancer progressing.
The pharmaceutical company says that the late-stage, or Phase III, trial results are applicable to patients whose advanced breast cancer was hormone receptor-positive, as well as HER2-positive, which is a particularly aggressive form of the disease.
The company says that hormone receptor-positive breast cancer which affects two-thirds of patients with breast cancer is typically considered lower-risk due to successful treatment with hormonal therapies; but as many as a quarter of such breast cancers are also HER2-positive, an aggressive form of the disease that requires immediate attention because the tumors are fast-growing and there is a higher likelihood of relapse.
In the study the high profile, blockbuster drug Herceptin plus the hormone therapy Arimidex was compared with Arimidex alone as a first-line therapy or second line hormonal therapy in postmenopausal women with advanced, HER2-positive and hormone receptor-positive breast cancer.
Roche says patients who received Herceptin had a statistically significant improvement in progression-free survival.
At present Herceptin is only licensed in the European Union as a treatment for metastatic cancer a late-stage condition where tumors have spread around the body. European experts have backed the early use of the drug and the new approval would extend its use to a large number of, in the main, younger patients.
The injectable medicine is appropriate for 20 to 30 percent of women with a form of breast cancer whose tumors generate a protein called HER2, making them particularly fast-growing.
The study is the first randomised study in this specific subset of 'co-positive' patients, whose prognosis has been uncertain thus far.