<2.96 GBq (<80 mCi) | 2.96 GBq (80 mCi) | 3.7 GBq (100 mCi) | |||||||
---|---|---|---|---|---|---|---|---|---|
Stratum | No. Treated | No. with DLT* | Type DLT* | No. Treated | No. with DLT* | Type DLT* | No. Treated | No. with DLT* | Type DLT* |
A (n = 19) | 2 | 2 (100) | Hematologic; MDS† | 8 | 0 | None | 9 | 3 (33) | Hematologic; MDS† |
B (n = 16) | 3 | 2 (67) | Neuromotor; aphasia | 10 | 0 | None | 3 | 2 (67) | Hematologic |
C (n = 12) | 0 | 0 | None | 6 | 0 | None | 6‡ | 3 (50) | Hematologic; aphasia |
Total | 5 | 4 (80) | Hematologic; MDS†; neuromotor | 24 | 0 | None | 18 | 7 (39) | Hematologic; MDS†; aphasia |
↵* DLT: (a) grade 3 or greater nonhematologic toxicity attributable to 131I-ch81C6; or (b) hematologic toxicity occurring within 6 wk of 131I-ch81C6 administration and consisting of >14 d of either an absolute neutrophil count of <500 cells per milliliter or a platelet count of <20,000 platelets per milliliter.
↵† MDS = myelodysplasia.
↵‡ Includes 1 patient inadvertently treated with 4.44 GBq (120 mCi) who did not experience DLT.
Values in parentheses are percentages.