The Italian research team reporting the findings on-line (Thursday 4 May) in Annals of Oncology[2], are sufficiently convinced of the drug's protective potential to call for a trial to test its use as a preventive in pre-menopausal healthy women at high risk of the disease. They are now seeking international partners and funding for such a trial.

The women in the long-term follow-up comprised a sub-group of 1,700 60% of the patients in a 10-centre trial lead by Professor Umberto Veronesi and co-ordinated by Milan's Istituto Nazionale Tumori when he was its director. The study, which began in 1987, randomised more than 2,800 women to receive 200 mg fenretinide daily for five years or no extra treatment after surgery for early-stage breast cancer.

The new analysis, also lead by Professor Veronesi, who is now Director of the European Institute of Oncology in Milan, followed the 1,739 patients who had been recruited by the Istituto Nazionale Tumori centre, investigating whether these patients developed a second cancer either in the treated breast or the other breast.

Co-author Dr Andrea Decensi, Director of the Department of Medical Oncology at the Galliera Hospital in Genoa, said: "We followed these patients for between 12 and 16 years and we found 168 second breast cancers in the fenretinide arm and 190 in the control arm. In post-menopausal women there were actually more cancers in the fenretinide arm than among the controls (85 as against 64). But, among pre-menopausal women there were only 83 second cancers in the fenretinide group compared with 126 in the control group.

Dr Decensi said that overall, this meant a 17% reduction in second cancers among the fenretinide group, which was of borderline statistical significance. But, there we
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Contact: Margaret Willson
m.willson@mwcommunications.org.uk
44-015-367-72181
European Society for Medical Oncology
3-May-2006