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Alert Number 122

The Brit. Version of FCR+M

Date: August 19, 2005

We have published two recent reviews on the subject of the FCR+M (fludarabine, cyclophosphamide, Rituxan and mitoxantrone) clinical trial at M. D. Anderson. We are concerned that patients participating in this clinical trial were not screened by echocardiogram or MUGA scan prior to start of therapy. The guidelines for use of mitoxantrone now require that patients be pre-screened for proper cardiac function. We hope this omission will soon be corrected.

Our latest article FMC plus R - Brit. Version is a brief comparison of the M. D. Anderson approach with that taken by a British clinical trial using this drug combination. Patients recruited for the British trial are relapsed CLL patients, not chemo-na´ve ones. And the British design calls for ECG, chest X-ray and even CAT scan when necessary to screen patients for cardiac function ahead of getting the drugs. The British trial design further confirms our understanding of this issue. Prudence is the better part of valor, we can see no good reason not to screening patients ahead of time for heart function.

Be well,

Chaya
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