Breast cancer drug hailed as 'stunning breakthrough'

It reveals "a dramatic and perhaps permanent perturbation in the natural history of the disease, maybe even a cure." The results are, it concludes, "revolutionary, not evolutionary" adding: "Our care of patients with HER II positive breast cancer must change today."

Medical journals rarely speak of a cure for cancer. Women treated with Herceptin had a 46 per cent reduced risk of their breast cancer returning. The drug works on patients sensitive to the protein HER II who number 8,000 to 10,000 in the UK, 20 to 25 per cent of those newly diagnosed with the disease.

The headline results were presented at a conference in Orlando, Florida, last May, when US specialists gave the researchers a standing ovation, and are published in full for the first time today. No drug, not even tamoxifen the gold standard in breast cancer for more than 30 years, has shown such a significant reduction in risk in so short a time (one to two-and-a-half years), the journal says.

Breast cancer charities were exultant yesterday. Jeremy Hughes, chief executive of Breakthrough Breast Cancer said: "This is one of the biggest breakthroughs in breast cancer treatment. It is vital this drug, which is set to save about 1,000 women's lives a year, is made available on the NHS without delay."

The results helped boost sales for Roche, the Swiss-based pharmaceutical company, which reported third quarter profits up 20 per cent yesterday. Roche also makes Tamiflu, the drug being stockpiled by countries around the world as a defence against the threatened pandemic of avian flu.

The research on Herceptin triggered a worldwide demand for the drug even before it was licensed for early breast cancer (it is currently licensed only for advanced breast cancer that has spread to other organs). Last month, a nurse, Barbara Clark, shamed Somerset Primary Care Trust into providing the drug, which costs around £20,000 for a year's treatment, after threatening to take her case to the European Court of Human Rights.

Following Ms Clark's victory, Patricia Hewitt, the Health Secretary, pledged Herceptin would be available to all newly diagnosed patients with breast cancer who were suitable for it. Existing patients would have to apply for funding to their health authorities on a case by case basis the health department said.

Yesterday, the South West Peninsula Health authority became the first to agree to pay for Herceptin for more than 100 existing patients in Devon and Cornwall. The charity CancerBacup called on the Government to order other health authorities to do the same.

"The Secretary of State must now make it clear to all PCT's they should fund doctors decisions to prescribe Herceptin to any woman who could benefit from it," said Joanne Rule, CancerBacup's chief executive.

The trials reported in the NEJM involved 3,000 women in the US and 5,000 women in 39 other countries who were randomly allocated treatment with Herceptin after chemotherapy. Martine Piccart, who led the non-US study and is chair of the Breast International Group, said yesterday: "I cannot stress enough how crucial it is that all patients breast tumours are tested appropriately at initial diagnosis and, if patients are HER II positive, that they have access to Herceptin.

The discovery that Herceptin only works in certain women demonstrates that breast cancer is not one but several diseases and marks a new era in cancer research and the way drugs are being designed to combat them.

Medical advances

* HERCEPTIN (treats early breast cancer):

Risk of recurrence cut by almost half in 25 per cent of patients with HER II positive disease.

* IRESSA (lung cancer):

Tumours shrink by half in 15 per cent of patients with a mutant form of the disease.

* XELODA (bowel cancer):

25% patients have a "major reduction" in tumour size.

* MABTHERA (non-Hodgkin's lymphoma):

Patients gain two years disease-free on average.

* GARDASIL (cervical cancer):

100 per cent effective in trials.