Table 3.
Summary of all 177Lu-J591 trials.
| Reference | Phase | Patients (n) | Dosing Schedule |
Treatment (mCi/m2) | Biologic Activity and Main Findings |
|---|---|---|---|---|---|
| Bander et al. (2005) [88] | Phase I | 35 | Single | 10–75 | 11.4% PSA declines 46% PSA stabilization 70 mCi/m2 was determined to be the single-dose MTD. Multiple doses of 30 mCi/m2 are well tolerated. |
| Tagawa et al. (2013) [89] | Phase 2 | 47 | Single | 65–70 | 59.6% PSA declines 70 mCi/m2 resulted in more 30% PSA declines and longer OS. |
| Tagawa et al. (2019) [90] | Phase 1b/2a dose-escalation | 49 | Two doses two weeksapart | 20–45; 40–45 |
55.1% PSA declines Fractionated administration allowed higher cumulative radiation dose. The frequency and depth of PSA decrease, OS, and toxicity (dose-limiting myelosuppression) increased with higher doses. |
| Niaz et al. (2020) [91] | Phase I | 6 | Every 2 weeks until onset of G2 toxicity | 25 | 33% PSA declines Hyperfractionation is feasible, but does not appear to have significant advantages over the two-dose fractionation regimen |
Key: MTD: maximum tolerated dose; PSA: prostate-specific antigen; OS: overall survival.