Table 4.
Maximum Grade of Hematological Toxicity After 177Lu-satoreotide tetraxetan possibly, probably, or definitely related to treatment (CTCAE 4.03) as well as administered activities of 177Lu-S satoreotide tetraxetan and associated time gaps. N/A indicates patients did not have a second therapeutic administration. Total RMD is the estimated total radiation absorbed dose to the red marrow for all 177Lu- satoreotide tetraxetan administrations combined, based on the red marrow dose estimates from the dosimetry administration. Best response to treatment per RECIST 1.1.
| Patient | Cycles (#) | Hb toxicity | WBC toxicity | PLT toxicity | ANC toxicity | Dosimetry (GBq) | D-T1 gap (days) | Therapy 1 (GBq) | T1-T2 gap (weeks) | Therapy 2 (GBq) | Total RMD (Gy) | Best Response |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 1 | 0 | 0 | 0 | 1.81 | 58 | 7.12 | 13 | 7.29 | 1 | SD |
| 2 | 2 | 3 | 4 | 4 | 4 | 1.23 | 21 | 7.18 | 11 | 7.28 | 1.54 | SD |
| 3 | 2 | 1 | 2 | 1 | 1 | 0.81 | 7 | 7.85 | 10 | 7.15 | 0.99 | PR |
| 4 | 2 | 1 | 2 | 0 | 2 | 1.98 | 14 | 7.28 | 12 | 7.3 | 1.08 | PR |
| 5 | 2 | 2 | 3 | 4 | 3 | 1.82 | 13 | 6.6 | 13 | 7.24 | 1.5 | CR |
| 6 | 2 | 2 | 2 | 4 | 2 | 1.95 | 8 | 7.33 | 13 | 7.32 | 1.71 | SD |
| 7* | 1 | 2 | 0 | 0 | 0 | 1.91 | 15 | 6.22 | N/A | N/A | 0.58 | PD |
| 8 | 2 | 3 | 3 | 4 | 3 | 1.99 | 28 | 5.65 | 12 | 4.86 | 1.44 | PR |
| 9* | 1 | 2 | 2 | 2 | 2 | 1.92 | 28 | 7.37 | N/A | N/A | 0.69 | PD |
| 10* | 1 | 0 | 0 | 1 | 0 | 1.93 | 20 | 7.37 | N/A | N/A | 0.78 | PR |
| 11 | 2 | 2 | 2 | 1 | 0 | 2.02 | 29 | 5.06 | 70 | 2.51 | 1.41 | SD |
| 12 | 2 | 2 | 2 | 1 | 2 | 1.88 | 21 | 6.16 | 74 | 3.62 | 1.42 | SD |
| 13 | 2 | 2 | 2 | 1 | 0 | 2.02 | 21 | 7.28 | 80 | 3.98 | 1.2 | PR |
| 14* | 1 | 2 | 2 | 1 | 0 | 2.01 | 29 | 6.29 | N/A | N/A | 1 | SD |
| 15* | 1 | 0 | 2 | 1 | 0 | 1.86 | 28 | 6.98 | N/A | N/A | 0.83 | SD |
| 16 | 2 | 1 | 0 | 0 | 0 | 2 | 29 | 7.28 | 84 | 4.02 | 0.74 | SD |
| 17 | 2 | 0 | 0 | 0 | 0 | 2.01 | 42 | 6.8 | 85 | 3.63 | 1.19 | PR |
| 18* | 1 | 1 | 0 | 0 | 0 | 1.96 | 7 | 4.96 | N/A | N/A | 0.8 | PD |
| 19 | 2 | 0 | 1 | 2 | 1 | 2.01 | 20 | 6.17 | 80 | 3.16 | 1.35 | PR |
| 20 | 2 | 0 | 1 | 0 | 0 | 1.83 | 20 | 7.25 | 11 | 3.9 | 0.88 | PR |
These six patients came off study after only one dose of treatment. All patients had either clinical or radiographic disease progression except for patient 10 who sustained a partial response; the patient opted to come off study instead of receiving the 2nd dose and was treated with radioembolization upon disease progression approximately 8 months later.
Note: Patient numbers were assigned at the time of inclusion in the study and do not show the order in which patients were treated.
Abbreviations: Hb, hemoglobin; WBC, white blood cells; PLT, platelets; ANC, absolute neutrophil count;