Table 3: Estimated Radiation-Absorbed Organ Doses     
  BEXXAR
 BEXXAR
 
  mGy/MBq
 mGy/MBq
 
  Median
 Range
 
From Organ ROIs
   
 Thyroid
 2.71
 1.4 - 6.2
 
 Kidneys
 1.96
 1.5 - 2.5
 
 ULI Wall
 1.34
 0.8 - 1.7
 
 LLI Wall
 1.30
 0.8 - 1.6
 
 Heart Wall
 1.25
 0.5 - 1.8
 
 Spleen
 1.14
 0.7 - 5.4
 
 Testes
 0.83
 0.3 - 1.3
 
 Liver
 0.82
 0.6 - 1.3
 
 Lungs
 0.79
 0.5 - 1.1
 
 Red Marrow
 0.65
 0.5 - 1.1
 
 Stomach Wall
 0.40
 0.2 - 0.8
 
From Whole Body ROIs
   
 Urine Bladder Wall
 0.64
 0.6 - 0.9
 
 Bone Surfaces
 0.41
 0.4 - 0.6
 
 Pancreas
 0.31
 0.2 - 0.4
 
 Gall Bladder Wall
 0.29
 0.2 - 0.3
 
 Adrenals
 0.28
 0.2 - 0.3
 
 Ovaries
 0.25
 0.2 - 0.3
 
 Small Intestine
 0.23
 0.2 - 0.3
 
 Thymus
 0.22
 0.1 - 0.3
 
 Uterus
 0.20
 0.2 - 0.2
 
 Muscle
 0.18
 0.1 - 0.2
 
 Breasts
 0.16
 0.1 - 0.2
 
 Skin
 0.13
 0.1 - 0.2
 
 Brain
 0.13
 0.1 - 0.2
 
 Total Body
 0.24
 0.2 - 0.3
 

CLINICAL STUDIES
The efficacy of the BEXXAR therapeutic regimen was eva luated in 2 studies conducted in patients with low-grade, transformed low-grade, or follicular large-cell lymphoma. Determination of clinical benefit of the BEXXAR therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival. All patients had received prior treatment without an objective response or had progression of disease following treatment. Patients were required to have a granulocyte count >1500 cells/mm3, a platelet count ≥100,000/mm3, an average of ≤25% of the intratrabecular marrow space involved by lymphoma, and no evidence of progressive disease arising in a field irradiated with >3500 cGy within 1 year of completion of irradiation.

Study 1 was a multicenter, single-arm study of 40 patients whose disease had not responded to or had progressed after at least four doses of Rituximab therapy. The median age was 57 (range: 35−78); the median time from diagnosis to protocol entry was 50 months (range: 12−170); and the median number of prior chemotherapy regimens was 4 (range: 1−11). The efficacy outcome data from this study, as determined by an independent panel that reviewed patient records and radiologic studies, are summarized in Table 4.

Among the forty patients in the study, twenty-fo