Follow-up data from the HERA study of Roche’s Herceptin in women with early-stage breast cancer show a clear 34% improvement in survival after two years compared to a control observation group.

The data answers critics who have argued that Herceptin (trastuzumab) should not be made available to patients with early-stage breast cancer because, after one year’s follow-up, no improvement in overall survival benefit had been seen, accoridng to the trial's principle investigator.

Professor Ian Smith, head of the breast unit at Royal Marsden Hospital, London, UK, told the American Society of Clinical Oncology annual meeting in Atlanta, that the data should help patients with early-stage disease get funding for Herceptin from reluctant healthcare payers.

Herceptin taken for 12 months following standard chemotherapy significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer, according to Prof Smith, while reinforcing data reported last year which showed that the drug could block cancer recurrence and progression.

Roche was granted approval by the European Commission for Herceptin in early-stage breast cancer last month, but patients with have been clamouring for access to the drug ever since the HERA data first became available.

In the UK, for example, patients have been taking to the courts to force their primary care trusts to pay for the drug, prompting Health Secretary Patricia Hewitt to call for expanded access to it and place pressure on the National Institute for Health and Clinical Excellence – the government’s cost-effectiveness agency – to complete the job of assessing whether Herceptin should be available on the National Health Service. The NICE is due to publish its verdict in July.

Another arm of the HERA study is looking at the effects of two years of Herceptin treatment in this setting, although these data were not available for presentation at this year’s ASCO meeting.