Table 3. Patient characteristics, response, and long-term outcomes summary from phase I/II trials.
| Author, Year | Regimen used | Carf dosing (mg/m2) | Median age (years) |
Pts analyzed, n | CR, n (%) | VGPR, n (%) | ORR, n (%) | CBR, n (%) | MedianDOR (mos) | Median PFS (mos) | Median OS (mos) | Type of cardiac events |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watanabe T et al., 2016 | Carf, Dexa | 20 (Days 1, 2 of cycle 1) f/b 27 | 67 | 50 | 0 | 2 (4) | 10 (20) | 14 (28) | 9.5 | 5.1 | 23.4 | CHF, atrioventricular block, cardiomyopathy |
| Berenson JR et al., 2016 | Carf, Dexa | 20 (Days 1 of cycle 1) f/b 45 or 56 or 70 or 88 (once weekly) | 68.5 | 104 | 11 (11) | 34 (33) | 77 (77) | 84 (84) | NA | 12.6 | NA | MI, atrial fibrillation, cardiorespiratory arrest, CHF |
| Berdeja JG et al., 2015 | Carf, Pano | 20 (Days 1, 2 of cycle 1) f/b 27 or 36 or 45 € | 66 | 42 | NA | 14 (33) | 28 (67%) | 33 (79) | 11.6 | 7.7 | NA | CHF |
| Berenson JR et al., 2014 | Carf# | 20 (cycle 1) f/b 27 (cycle 2) f/b 36 (cycle 3) f/b 45 (cycle 4)* | 67 | 37 | 3 (8.1) | 6 (16.2) | 16 (43.2) | 23 (62.2) | 9.9 | 8.3 | 15.8 | Tachyarrhythmia, CHF |
Abbreviations: See Table 1
#in various combinations with immunomodulatory drug (Thal or Len), pegylated liposomal doxorubicin, glucocorticoids, cyclophosphamide, methylprednisone, bendamustine
€4 (9.5%) out 42 patients had maximum carfilzomib dose ≤ 27 mg/m2.
*10 (27%) out 37 patients had maximum carfilzomib dose ≤ 27 mg/m2.