Date: May 26, 2004
by Gerald E. Marti, MD, PhD.
National Institues of Health
Editor's Note: As one of the authors of a paper recently reviewed in CLL Topics (Fludarabine Monotherapy No Longer the Gold Standard) Dr. Gerald Marti is involved in an important area of research in CLL. He has corresponded with us expressing his informed viewpoint on some topics of great interest to us. With his permission, we have reproduced below a recent communication. Dr. Marti is a scientist in the FDA's Center for Biologics Evaluation and Research and works in the Laboratory of Stem Cell Biology, a part of the Division of Cellular and Gene Therapies. His opinions, expressed clearly, should carry weight in your conversations with your physician or oncologist. We would like to thank Dr. Marti for providing this input in a form that is useful to patients.
I continue to hear good things about your web site. And yes I agree with your commentary about single use fludarabine, particularly in aggressive disease is probably to be avoided. And I like the idea of getting FISH up front but in my experience at least 50% of the CLL patients seen in consultation do not have it done. And it seems to almost easier to get it done in the community than in a research setting. At the last CRC meeting, a group was formed to begin the standardization of FISH in CLL.
It can be further added that given the wide availability of FISH cytogenetics, it can be ordered by either the GP or specialist. In terms of available prognostic indicators, CD38 and cytogenetics are useful and available. IgVH mutational status is still at the research level and to the best of my knowledge, there is no FDA approved IVD ZAP-70 assay. Although the large German study by Dohner and colleagues (shows both survival and time to treatment) is both definitive and useful, cytogenetics is just one piece of the clinical laboratory data that needs to be put together (integrated) for each patient at the clinical level. Rai and or Binet clinical stage is just as important. So yes I would like to see FISH cytogenetics up front on every new CLL patient. I would still advise patients to be sure that it is covered by their insurance plan health care dollar. And in addition to being sure that the test is performed in an appropriately certified laboratory, it would be good to have the testing done in a laboratory that is specialized in doing CLL cytogenetics.
I enjoyed hearing from you.
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