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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Bob L who wrote (465)	12/11/1999 12:00:00 PM
From: biowa	Read Replies (1) \| Respond to of 666

Bob, At the very high probability of being wrong: <<One patient was not treated based on site-specific (non-MIRDOSE), image-based, bone marrow dosimetry, although the estimated marrow radiation dose was acceptable on blood-derived and sacral image—derived MIRDOSE3 dosimetry performed by the central dosimetrist>> IMO a "dosimetrist" at one of the sites decided, based on a straight-forward read of the bone marrow dosimetry to exclude the patient. When the central lab put the dosimetry results through their software, they decided he could've been. In the MOST negative light for IDPH, if I were a really skeptical FDA panel member/staffer I might say: A) You're trying to tell me that dosimetry is not needed, that I should ignore the one person out of a thousand b/c when you re-processed their dosimetry off-line with some high-powered software it was okay? Somebody eating filet-o-fish in here? B) And you're telling me that I if I believe that, that I can't rely on local dosimetry, I have to ship it to Oak Ridge if I want to be sure? This is highly cynical, and it may be a non-issue (FDA veterans chime in). Of course, if they have another patient fail dosimetry... Of course, this is all probably peripheral if the lack of Zev CRs in Rituxan-failed patients bears out. Flu+Bex will be the first-line choice of a substantial number of oncologists, and CHOP+Rit for another large chunk. For those that fail first-line CHOP+Rit, will the convenience/cost factor of no dosimetry really drive them to use Zev second-line instead of Flu+Bex or Bex alone? Thus, Zev may be relegated in a large number of patients to third-line or salvage therapy. biowa