Table 1.
Completed phase I and phase II studies of 177Lu-DOTATATE.
| Study Reference | Number of Patients | Treatment Dose | Outcomes | Adverse Events |
|---|---|---|---|---|
| [25] | 35 | 86% of patients received 600–800 mCi | 37% response rate and 41% stable disease | Mild hair loss (49%), WHO G3 leukopenia (1%) and thrombocytopenia (4%) |
| [26] | 51 (43 with GEP NETs) | 22-30 Gbq | 29.4% response rate and 59% stable disease | G1/G2 leukopenia (61%), anemia (78%) and thrombocytopenia (27%). |
| [27] | 37 | 800 mCi | 28% response rate, 41% stable disease and median PFS of 16.1 months | G2 hematologic toxicity (9.4%), G3 hematologic toxicity (12.5%) and G3 hepatic toxicity (9.4%) |
Abbreviations: GEP NETs, gastroenteropancreatic neuroendocrine tumors; Gbq, gigabecquerel; mCi, millicurie; G, grade; PFS, progression-free survival