Chemotherapy trial proves the worth of including elderly patients in clinical trials

Doctors should be encouraged to include many more elderly people in clinical trials than they do at present, Dr Olavo Feher told the 3rd European Breast Cancer Conference in Barcelona today (Wednesday 20 March).

Dr. Feher, attending physician at the Hospital do Cancer in Sao Paulo, Brazil, said that the elderly were under-represented in clinical trials for cancer treatments, yet his research showed that useful results could be obtained if they were included in trials.

He said: Age is a known major risk factor for most cancers in adults. Approximately 50% of all new breast cancers occur in women aged 65 or older. However older women tend to be under-treated. Several clinical trials have shown that older women are less likely to receive post-operative radiation and systemic adjuvant therapy as compared to younger women. This population seems to be under-represented in clinical trials.

Dr. Feher told the conference that only women aged 60 or over were included in the randomized phase lll clinical trial that he and his colleagues co-ordinated in 18 countries world-wide*. The trial was performed to assess two chemotherapy agents (epirubicin and gemcitabine) as first-line, single agent treatments in elderly women with metastatic breast cancer. Both drugs are already known to be effective and well-tolerated in metastatic breast cancer, but it was not known how they would affect elderly women and what the correct doses should be. The median age of the women was 68 in the epirubicin arm of the trial and 69 in the gemcitabine arm of the trial.

Between October 1996 and February 1999, 397 women joined the trial. The results showed that both drugs were well tolerated, and that there were no differences in the womens quality of life between the two arms of the trial. Epirubicin proved to be more effective as the womens tumours responded better to it and their cancer did not start to progress again so quickly. The most common side effe

Contact: Emma Mason
Federation of European Cancer Societies

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