Xeloda/Taxotere combination chemotherapy extends survival for breast cancer patients
Roche's Xeloda (capecitabine), in combination with Aventis' Taxotere (docetaxel) is the first and only combination chemotherapy to demonstrate significantly superior survival compared to a standard treatment of Taxotere monotherapy in patients with metastatic breast cancer, according to data presented today at the 11th European Cancer Conference (ECCO) in Lisbon, Portugal. The study also showed that patients treated with the Xeloda/Taxotere combination had superior tumour shrinkage and their tumours were kept from growing for longer than in patients receiving Taxotere alone.
Earlier this month, the Committee for Proprietary Medicinal Products (CPMP) recommended the new Xeloda/Taxotere combination for European approval. In September, after priority review, this therapy was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic breast cancer for whom prior anthracycline chemotherapy had failed.
"The new Xeloda/Taxotere combination therapy represents major progress for the care of women with metastatic breast cancer," said Professor Robert Leonard, Director South Wales Cancer Institute, United Kingdom who was an investigator in the trial. "The three month survival benefit is so exciting because it is very rare to see any improvement in survival in these patients. Moreover, it is a benefit occuring over and above the benefit obtained from Taxotere alone, which is probably the most active cytotoxic agent we have at the moment. More women with metastatic breast cancer will live longer thanks to the Xeloda/Taxotere combination, making it a much needed new option available for physicians and their patients."
Clinical Trial Results
The large global study compared Xeloda/Taxotere to Taxotere monotherapy and included more than 500 patients who had failed prior therapy with anthracyclines. Patients treated with Xeloda/Taxotere had a three-month survival advantage (median 14.5 months versus 11.5 months) compared to those treated with Taxotere alone. In addition to the survival advantage, patients in the Xeloda/Taxotere group demonstrated statistically superior improvements in both time to disease progression (median of 6.1 months versus 4.2 months) and tumour response rates (41.6 percent versus 29.7 percent).2
"Based on the survival benefit, the results of the Xeloda/Taxotere combination are remarkable and have generated an overwhelming response from the oncology community," said Kevan Clemens , Business Director Oncology. "This new chemotherapy combination offers women a treatment option that allows them to live longer, this is extraordinary good news for those patients and their families. We believe Xeloda will play a major role in cancer care therapy for many years to come."
Xeloda and its Combination with Taxotere
The "smart tablet" Xeloda has a unique mechanism of activation. It is activated by an enzyme, found at higher levels in cancer cells than in healthy cells. This leads to more of the cancer-killing agent 5-FU being produced in cancer cells, where it is needed. Taxotere further increases the levels of this enzyme in cancer cells, potentially leading to even more Xeloda being converted into cancer-killing 5-FU.
Breast Cancer
Breast cancer is a primary cause of cancer-related deaths in women and the third leading cause of overall mortality. Almost 384,000 patients are newly diagnosed with breast cancer annually in Europe and in excess of 165,000 will die from the disease this year.1 About 50 percent of breast cancer patients develop metastatic disease after primary treatment and the average survival time for patients after diagnosis of metastatic disease is 18 to 30 months.
About Xeloda
Xeloda is registered in more than 50 countries worldwide for the treatment of metastatic breast cancer as monotherapy. In Europe, Xeloda monotherapy and the Xeloda/Taxotere combination in metastatic breast cancer will be available beginning of 2002, following the CPMP recommendation.
Roche received marketing authorisation in the United States and Europe for Xeloda in the treatment of metastatic colorectal cancer earlier this year. Xeloda development in other cancer indications and in combination with other cancer treatments is ongoing.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of diseases, thus enhancing well-being and quality of life.
Roche is a world leader in oncology. Its franchise includes Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea). Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).