Roche announced that the European Commission has approved the use of Herceptin (trastuzumab) in combination with Taxotere (docetaxel) in the European Union as a first-line therapy in HER2-positive metastatic breast cancer patients who have not yet received chemotherapy for their disease.

HER2-positive breast cancer patients suffer from a particularly aggressive form of breast cancer, which traditionally has a poor prognosis.

The approval is based on study results1, which showed that for women with HER2-positive breast cancer, the combination of Herceptin and Taxotere significantly improved median life expectancy by more than one-third (31 months with Herceptin plus Taxotere vs. 22 months for Taxotere alone). The study also showed that 61 per cent of patients treated with the combination responded to treatment, compared to 34 per cent of patients who received Taxotere alone.

"The early use of this new combination therapy represents a vital life-extending treatment option for patients, and highlights the critical importance of verifying HER2 status upon diagnosis of breast cancer," said William M Burns, head of Roche's Pharmaceuticals Division. "Now that this combination therapy will be made available to women across Europe, this further consolidates the position of Herceptin as the foundation of care in HER2-positive metastatic breast cancer," added Burns.

In an earlier trial, Herceptin also showed a survival benefit when used as a first-line therapy in combination with Taxol (paclitaxel). Both Taxol and Taxotere belong to the most commonly used class of chemotherapy agents for metastatic breast cancer in Europe, known as 'taxanes'. This trial with Herceptin and Taxotere firmly establishes Herceptin in combination with taxanes as the foundation of care for women with HER2-positive metastatic breast cancer.

The aggressive nature of HER2-positive breast cancer makes both the survival and response rates highly meaningful. In HER2-positive breast cancer, increased quantities of the HER2 (Human Epidermal growth factor Receptor 2) protein are present on the surface of the tumour cells. This is known as 'HER2 overexpression'. High levels of HER2 overexpression are present in a particularly aggressive form of the disease, which responds poorly to chemotherapy. Research shows that HER2 overexpression affects approximately 20-30 per cent of women with breast cancer.

From 188 patients who were recruited into the study, 94 patients randomised to receive Herceptin plus Taxotere and 94 randomised to receive Taxotere alone. Two patients in the combination arm did not receive study drug and were excluded from the final analysis. Taxotere was scheduled at a dose of 100 mg/m2 every 3 weeks for at least 6 cycles. Herceptin was administered in 2mg/kg weekly doses until disease progression (after an initial loading dose of 4mg/kg). Patients in the Taxotere arm of the study were given the option to cross over to receive Herceptin, following disease progression.

Eight to nine per cent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women. Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year.

Herceptin is a targeted humanised antibody treatment that received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein.