Hematologic Toxicity
| Group 1: No prior HDC | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient | GBq/m2 | BM* | No. of prior chemo | Time from last chemo | Prior XRT† | RM dose‡ (mGy/MBq) | ANC | Thrombocytopenia | ||||||||||||
| Nadir grade | TTR§ (d) | Nadir grade | TTR (d) | |||||||||||||||||
| 1-1‖ | 0.370 | + | 1 | >1 y | Yes | 1.59 | ND | ND | 3 | ND | ||||||||||
| 1-3 | 0.370 | + | 1 | 7 mo | No | 1.16 | 1 | 14 | 1 | 14 | ||||||||||
| 1-5 | 0.370 | + | 3 | 7 mo | No | 0.62 | 3 | 62 | 3 | 35 | ||||||||||
| 1-7 | 0.370 | − | 4 | 8 mo | No | 1.81 | 2 | 35 | 1 | 11 | ||||||||||
| 1-8 | 0.370 | − | 1 | >1 y | No | 2.41 | 1 | 8 | 0 | NA | ||||||||||
| 1-9 | 0.555 | + | 1 | >1 y | Yes | 2.68 | 3 | 34 | 3 | 21 | ||||||||||
| 1-10 | 0.555 | − | 2 | >1 y | No | 1.57 | 0 | NA | 1 | 49 | ||||||||||
| 1-11 | 0.555 | − | 1 | >1 y | Yes | 1.32 | 1 | 8 | 1 | 8 | ||||||||||
| 1-12 | 0.740 | − | 2 | 11 mo | Yes | 1.86 | 3 | 24 | 3 | 24 | ||||||||||
| 1-13 | 0.740 | − | 3 | >1 y | No | 2.24 | 2 | 20 | 3 | 10 | ||||||||||
| 1-14¶ | 0.740 | − | 2 | 5 mo | No | 2.05 | 0 | NA | 0 | NA | ||||||||||
| Group 2: High risk (prior HDC) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient | GBq/m2 | BM* | No. of prior chemo | Time from last chemo** | Prior XRT† | RM dose‡ (mGy/MBq) | ANC | Thrombocytopenia | ||||||||||||
| Nadir grade | TTR§ (d) | Nadir grade | TTR (d) | |||||||||||||||||
| 2-1 | 0.185 | − | 3 | >1 y | Yes | 1.49 | 0 | NA | 0 | NA | ||||||||||
| 2-3 | 0.185 | − | 6 | H, 11 mo | Yes | 2.35 | 4 | ND | 3 | ND | ||||||||||
| 2-4 | 0.185 | ND | 4 | 3 mo (H, >1 y) | No | 1.32 | 1 | NA | 1 | NA | ||||||||||
| 2-5 | 0.185 | − | 4 | 5 mo (H, >1 y) | Yes | 1.57 | ND | ND | 3 | ND | ||||||||||
| 2-7 | 0.185 | − | 4 | H, 10 mo | Yes | 2.30 | 0 | NA | 0 | NA | ||||||||||
| 2-8 | 0.185 | − | 3 | >1 y | Yes | 1.57 | 0 | NA | 2 | 7 | ||||||||||
| 2-9 | 0.185 | − | 4 | 6 mo (H, >1 y) | No | 2.35 | 1 | ND | 1 | ND | ||||||||||
| 2-10 | 0.370 | − | 3 | H, 11 mo | Yes | 1.30 | ND | ND | 3 | ND | ||||||||||
| 2-11 | 0.370 | − | 3 | >1 y | Yes | 1.95 | 0 | NA | 1 | NA | ||||||||||
| 2-12 | 0.370 | − | 3 | 6 mo (H, >1 y) | No | 0.35 | 0 | NA | 3 | ND | ||||||||||
↵* Indicates whether there was (+) or was not (−) tumor involvement.
↵† Refer to Table 1 for more comprehensive review of all prior XRT treatments.
↵‡ Red marrow (RM) dose for 90Y-epratuzumab based on scintigraphy of pretherapy 111In-epratuzumab. Data for patients 1-3, 1-5, and 2-4 were estimated from blood clearance rather than scintigraphy because of interference by overlying tumor in both sacral and lumbar regions. Effective residence time from blood clearance curves was based on assumption of red marrow mass of 1,500 g and marrow-to-blood ratio of 0.36.
↵§ Time to recovery (TTR): number of days from time most severe toxicity grade was first observed until recovery to ≤grade 1 was first observed with evidence for at least 2 wk of stable or continuing improvement in counts. A number of patients in group 2 required support (i.e., G-CSF and platelets), and, therefore, TTR could not be determined.
↵‖ Recovery time for WBC/ANC and platelets was not determined for patient 1-1 because of intervention with G-CSF and subsequent chemotherapy.
↵¶ Patient 1-14 only had 6-wk follow-up, during which time small drop in blood counts was observed with recovery subsequent to withdrawal from study.
↵** All patients in this group had prior history of HDC with transplant (bone marrow or stem cells). Several patients had additional chemotherapy even after receiving HDC. When “H” is shown in column, it indicates time when HDC was given before 90Y-epratuzumab treatment. When additional times are indicated, this represents additional chemotherapy given sometime after HDC treatment.
chemo = chemotherapy; ANC = absolute neutrophil count; G-CSF = granulocyte colony-stimulating factor; ND = not determined; NA = not applicable, either not gradable or only grade 1 toxicity.