Table 1. Patient characteristics, response and long-term outcomes summary from phase III studies with control groups.
Author, Year | Regimen used | Carf dosing (mg/m2) |
Median age (years) | Patients analyzed, n | CR, n (%) | VGPR, n (%) | ORR, n (%) | CBR, n (%) | Median DOR (mos) | Median PFS (mos) | Median OS (mos) | Type of cardiac events |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Dimopoulos MA et al., 2016 | Carf, Dexa | 20 (Days 1, 2 of cycle 1) f/b 56 | 65 | 464 | 58 (13) | 194 (42) | 356 (77) | 380 (82) | NA | 18.7 | 47.6 | Cardiac failure, Ischemic heart disease |
(ENDEAVOR) | Bort, Dexa | 65 | 465 | 29 (6) | 104 (22) | 290 (62) | 343 (74) | NA | 9.4 | 24.3 | ||
Hajek R et al., 2017 (FOCUS) |
Carf | 20 (Days 1, 2 of cycle 1) f/b 27 | 63 | 157 | 1 (1) | 5 (3) | 30 (19) | 49 (31) | 7.2 | 3.7 | 10.2 | Cardiac failure |
Pred or Dexa | 66 | 158 | 0 (0) | 5 (3) | 18 (11) | 33 (21) | 9.5 | 3.3 | 10 | |||
Stewart AK et al., 2015 (ASPIRE) |
Carf, Len, Dexa | 20 (Days 1, 2 of cycle 1) f/b 27 | 64 | 396 | 126 (31.8) | 277 (69.9) | 344 (87.1) | 359 (91) | 28.6 | 26.3 | NA | cardiac failure, ischemic heart disease |
Len, Dexa | 65 | 396 | 37 (9.3) | 160 (40.4) | 264 (66.7) | 302 (76.3) | 21.2 | 17.6 | NA |
Abbreviations: Carf, carfilzomib; CR, complete response; VGPR, very good partial response; ORR, overall response rate; CBR, clinical benefit rate; PFS, progression free survival; OS, overall survival, Pred, prednisone; Dexa, dexamethasone; Len, lenalidomide; Bort, bortezomib; NA, not available; f/b, followed by; mos, months; MI, myocardial infarction; CHF, congestive heart failure; CAD, coronary artery disease;