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

March 20, 2002

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 women's quality of life between the two arms of the trial. Epirubicin proved to be more effective as the women's tumours responded better to it and their cancer did not start to progress again so quickly. The most common side effect for both drugs was haematologic toxicity; this includes symptoms such as a low red blood cell count which can lead to tiredness, a low white blood cell count which can lead to a risk of infection, and a risk of haemorrhages. However no patients in the trial suffered from infection or haemorrhages.

Some women on epirubicin suffered from hair loss and mucositis (which produces symptoms such as soreness in the mouth area so that patients have difficulty swallowing). Low white blood cell counts were found in 18% of women on epirubicin and 20% of women on gemcitabine, but this did not lead to infection.

Dr. Feher said: "The results of this large multicentre phase lll study demonstrate the effectiveness and safety of chemotherapy in elderly women with metastatic breast cancer. Epirubicin was more effective than gemcitabine in terms of time to progressive disease and tumour response.

"This study shows how important it is to perform clinical trials targeting the elderly, so that we can learn more precisely about the efficacy and tolerability of potential toxic treatments in this population. For instance, the excellent tolerance observed in both arms of our trial was surprising. Oncologists should be encouraged to enrol the elderly in clinical trials."
* The 18 countries were Australia, Brazil, Canada, France, Germany, India, Ireland, UK, Italy, South Africa, Singapore, Spain, Sweden, Venezuela, Czech Republic, Hungary and Poland.

For further information, contact Emma Mason, Margaret Willson, or Maria Maneiro at the EBCC3 press office in Barcelona, tel: +34-93-364 4487, or Emma Mason's mobile
+44-0-7711-296-986, or Margaret Willson's mobile +44-0-7973-853-347.

ECCO-the European CanCer Organisation

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