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Leading cancer doctor calls for new guidelines to control early reporting from clinical trials

from one of the trials (MA17 trial on the AI, letrozole) had, in effect, "killed" a sister trial looking at another AI, exemestane, instead of letrozole for extended adjuvant therapy, and other studies were in danger too.

"I suggest that guidelines should be drawn up and agreed by the research community, whereby early disclosure is based on significant differences between the rates of distant relapse. Distant relapses mean the cancer recurring in lung, liver or bone, for which there is almost no chance of cure, in contrast to relapses in the breast and regional nodes for which curative therapy exists. I will be putting this proposal to the Breast International Group and, if deemed appropriate, it will be discussed with its closest partner, the North American Breast Intergroup."

Her remarks come hot on the heels of the announcement last week that exemestane, a steroidal aromatase inhibitor (SAI), was more effective than tamoxifen in preventing cancer returning in women whose breast cancer had been caught early. This trial, led by Professor Charles Coombes of Imperial College London, reported early, although 90 per cent of participants had completed their therapy by this time.

Dr Piccart warned that big questions still remain about the long-term effects and effectiveness of AIs, and she urged physicians to make "individualized" treatment decisions with their patients.

"Although there have been several trials now that show positive results for AIs, the long-term effects are still unclear. Questions remain about their effect on bone and cardiovascular health, cognitive and sexual function, and quality of life," she said. "The biggest question is which will be the optimal new endocrine therapy: an AI upfront instead of tamoxifen or a few years of tamoxifen followed by an AI? Also, should the AI be given for two or three years, or for five years, as is now current practice with tamoxifen? At present no-one can say what is the best tre
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Contact: Emma Mason
wordmason@aol.com
49-403-569-3625
Federation of European Cancer Societies
18-Mar-2004


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