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Any relationship between RaloxifFrom: Jones, Terrence (Terrence.Jones@kp.org)Wed Jan 26 21:15:38 2000
Agree with Gail; Pt. needs genetics consult, and they will need histopath. diagnoses. Studies in mice and hamsters, freq a doses resulting in serum conc. quite higher than those in humans at 60 mg/D, reveal B9 and malig epithelial & granulosa-theca cell tumors (along with prostate in males). These were Rx'd DURING their reproductive life with functioning/responsive ovaries. The sig.of this findings relative to humans is unknown. Have not found ANY reported inc. in ovarian ca incid. in ANY ralox trial, (and theoretically a subgroup of these Pt's SHOULD be a higher risk (if BrCa1 carriers). OTOH, and in this Pt's favor, most (not all) will manifest the disease prior to menopasuse. If relying on models for treatment decision (rather than clinical trials involving people) there may be some solace from mutagenesis studies -- NO genotoxicity in Ames/rat hepatocyte DNA synthesis/mouse lymphoma assay/Chinese hamster ovary chromosome aberration or in-vitro sister chromatid assays, or murine micronucleus test. Encourage Your Pt. to continue Her exploration, but to weigh carefully, the *known* risks & benefits. Maybe Jeff Clemens might have a comment? tj.
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