Table 4.
Summary of clinical trials for evaluation of efficacy of rhenium-186 in patients with bone metastases.
| Study | Treatment description (# patients) | Primary endpoint | Results | Other outcomes | Hematological adverse effects | Comments |
|---|---|---|---|---|---|---|
| Maxon et al. [83] Phase I/II | Re-186 (20) | Pain response | Complete pain relief in 25% and partial in 55% | – | Minimal | – |
| Tennvall et al. [81] Phase I/II | Re-186 (14) | Pain intensity response | Pain relief in 79% patients, 29% pain-free | Median survival was 6 mos in responders | Thrombocytopenia grade-2 and/or leukopenia grade-2 in 21.42% of patients | – |
| Kolesnikov-Gauthier et al. [82] Phase II | Re-186 (12) | Objective response using Pain index, analgesic index and performance index | Positive response (partial or complete) in 67% of prostate cancer patients | 50% of patients had decrease in pain index, 58.8% in analgesic index, 16.6% had improvement in performance index | Thrombocytopenia grade-2 in 23% and leukopenia grade-2 in 17.5% | – |
| Sciuto et al. [84] Phase II | Re-186 (60) | Pain response using Modified Wisconsin scale | 31% patients had complete and 80% overall some pain response | Pain relief correlated positively with degree of response (p = 0.02) and negatively with ALP (p = 0.006) and scintigraphic score (p = 0.02) | Thrombocytopenia (mean decline 32%) at 3 wks, leukopenia (mean decline 18%) at 4 wks | At 3 wks, significant improvement in Wisconsin score (p < 0.001), Karnofsky score (p < 0.001) and ALP levels (p = 0.01). Tumor markers decrease in 45% of patients at 4 wks |
| Han et al. [85] Phase III (PLACORHEN study) | Re-186 (59) vs. Placebo (52) | Number of positive pain response days | Mean percentage of pain response days 27% (Re-186) vs. 13% (placebo), p < 0.05 | Median survival 37.2 wks (placebo) vs. 30.4 wks (Re-186), p > 0.05 | – | Radiotherapy for pain required in 44% (Re-186) vs. 67% (placebo) |
| Maxon et al. [86] Phase III crossover | Re-186 (6) vs. Placebo (7) | Pain index | Significantly greater relief in pain with Re-186 (p < 0.05) | – | Significant leukopenia with Re-186 (p < 0.01) | – |
Abbreviations: ALP: alkaline phosphatase; WBC: White blood cells; mos: months; wks: weeks.