Patient Characteristics, Including Relevant Clinical Trial Data
| Patient* | Age (y) | Sex | Type of NET | Grade | Ki-67 | Stage | Time gap (y) | No. of cycles | Total dose (MBq) | RECIST 1.1 response† | 68Ga PET response‡ | Duration of response (mo)§ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SAD1-01 | 75 | M | Small bowel | 2 | 4 | IV | 6.4 | 1 | 81 (2.2) | Stable disease | NA | NP |
| SAD1-02 | 76 | F | Pancreatic | 2 | NA | IV | 8.8 | 1 | 85 (2.3) | Stable disease | NA | NP |
| SAD1-03 | 77 | M | Pancreatic | 3 | 27 | IV | 4.5 | 1 | 85 (2.3) | Stable disease | NA | NP |
| SAD2-01 | 56 | M | Rectal | 2 | NA | IV | 5.2 | 1 | 122 (3.3) | Stable disease | NA | NP |
| SAD2-02 | 27 | F | Small bowel | 1 | NA | IV | 4.7 | 1 | 100 (2.7) | Stable disease | NA | NP |
| SAD2-03 | 72 | F | Small bowel | 1 | 2 | IV | 6.1 | 1 | 115 (3.2) | Stable disease | NA | NP |
| MAD3-01 | 61 | F | Small bowel | 2 | 6 | IV | 10.7 | 3 | 574 (15.5) | Stable disease | NSC | 0 |
| MAD3-02 | 62 | F | Pancreatic | 2 | 3 | IV | 7.2 | 2‖ | 329 (8.9) | Stable disease | NSC | 0 |
| MAD3-03 | 68 | F | Small bowel | NA | NA | IV | 10.7 | 3 | 266 (7.2) | Stable disease | NSC | 0 |
| MAD3-04 | 51 | M | Pancreatic | NA | NA | IV | 5.6 | 3 | 455 (12.3) | Stable disease | −40% | 0 |
| MAD4-01 | 62 | M | Small bowel | 3 | 22 | IV | 2.2 | 4 | 814 (22.0) | PR | −95% | 22 |
| MAD4-02 | 45 | M | Bronchial carcinoid | 1 | >20 | IV | 6.2 | 4 | 796 (21.5) | PR | −100% | 22 |
| MAD4-03 | 71 | F | Bronchial carcinoid | 2 | 15 | III | 4.8 | 4 | 707 (19.8) | CR | −100% | 20 |
| MAD4-04 | 39 | F | Rectal | 3 | 30 | IV | 5.1 | 4 | 807 (21.8) | Stable disease | −40% | 0 |
| MAD4-05 | 62 | M | Pancreatic | 1 | 2 | IV | 7.3 | 4 | 873 (23.6) | PR | −80% | 8 |
| MAD4-06 | 49 | F | Pancreatic | 2 | 19 | IV | 2.9 | 4 | 681 (18.4) | PR | −100% | 14 |
| MAD4-07 | 45 | M | Rectal | 2 | 12 | IV | 5.7 | 4 | 858 (23.2) | PR | −95% | 5 |
| MAD4-08 | 60 | M | Small bowel | 2 | 5 | IV | 0.3 | 4 | 692 (18.7) | Stable disease | −15% | 0 |
| MAD4-09 | 80 | M | Bronchial carcinoid | 2 | 10 | IV | 1.1 | 4 | 836 (22.6) | PR | −60% | 1 |
| MAD4–10 | 59 | F | Bronchial carcinoid | 2 | 5 | IV | 1.8 | 4 | 847 (22.9) | PR | −30% | 5 |
* MAD3 cohort started as SAD3 cohort, with single injection of 1.92 MBq/kg (52.0 μCi/kg). When quality-of-life improvements were reported after first cycle, approval was obtained from disease safety monitoring board and these subjects were transitioned to MAD cohort, with 2 additional cycles at same dose administered at 8-wk intervals.
↵†For SAD cohort, response was established 2 mo after injection, before other therapies began.
↵‡Percentage decrease in overall tumor burden on 68Ga-DOTATATE PET/CT was visually estimated.
↵§As of June 2021.
↵‖Subject dropped out of study after second cycle.
NA = not available; NP = not applicable; NSC = no significant change.
As per 2017 WHO classification: G1 = <3, G2 = 3–20, and G3 = >20 Ki-67 index. Data in parentheses are microcuries. Time gap is difference in years between original histopathologic diagnosis and first treatment cycle with 212Pb-DOTAMTATE.