Specific clinical trials are needed for elderly women with breast cancer, Professor Silvio Monfardini, from the Division of Medical Oncology, Azienda Ospedaliera di Padova, Padova, Italy, told the 4th European Breast Cancer Conference in Hamburg, Germany. He said that although some women aged 70 and over were included in trials, they tended to be selected because they were particularly healthy.

"Trials are usually conceived for young adults" he said, "and therefore the results obtained from them, even with the inclusion of a few healthy elderly women, are not applicable to the majority of the older patient population."

Combination chemotherapy in advanced breast cancer can be particularly toxic to elderly patients, he said, and there was a need for special trials of single agents in older people to spare them this toxicity. Although one therapy (vinorelbine) had been shown to be really active and well tolerated in this age group, there were plenty of other current breast cancer therapies that still needed assessment in elderly people. If such treatments were seen to be effective and have low toxicity, they could be used sequentially rather than in combination in such an age group.

"Trials in older women are more difficult for a number of reasons related to their age - presence of other diseases, impaired physical status, depression, neurological impairment etc - and this means that their preparation and design requires more time. But if this is not done we will discriminate against an already vulnerable group and deny us information on a very relevant part of the breast cancer population in Europe", he said.

Although almost 50% of women diagnosed with breast cancer are over 65 years old, there are still many questions to be answered on how best to treat them. Professor Aron Goldhirsch, from the International Breast Cancer Study Group, Bern, Switzerland, told the conference that it was a mistake for doctors to use data from trials in younger postmenopausal women to inform the treatment of this older group.

Few trials have been conducted for older women, he said, but the results from those which had been undertaken specifically for this group had produced surprising results. The IBCSG trial, carried out in women aged 66 to 80 in the late 1970s, and which looked at tamoxifen-based endocrine therapy after surgery given for one year versus no adjuvant treatment, was still showing benefit in outcomes more than 20 years later. "The results of this trial, showing a significant advantage for receiving only one year of tamoxifen which is now considered suboptimal based on trials in younger women, demonstrate that older patients need a tailored adjuvant therapy, made suitable for them and their type of breast cancer", he said.

The optimal duration of endocrine therapy in older patients remains an open question, with the need to balance its advantages controlling disease against the greater risk of side effects in this group. However, an even more pressing question is the role of adjuvant chemotherapy in those older patients with tumors that did not contain hormone receptors, said Goldhirsch.

"No data are available on the use of cytotoxics in the older population, and no-one has yet tried to tailor these treatments to reduce the toxicity which is particularly difficult for this age group. With increasing life expectancy, elderly women need more than ever the opportunity to have a long-lasting benefit from a suitable adjuvant therapy."

SOURCE:
4th European Breast Cancer Conference, March 18, 2004, Hamburg, Germany