Table 1. Patient and disease characteristics at baseline in the ASPIRE and ENDEAVOR phase 3 studies.
|
ASPIRE |
ENDEAVOR |
|||||||
|---|---|---|---|---|---|---|---|---|
|
Prior ASCT |
No prior ASCT |
Prior ASCT |
No prior ASCT |
|||||
| KRd (n=217) | Rd (n=229) | KRd (n=179) | Rd (n=167) | Kd (n=266) | Vd (n=272) | Kd (n=198) | Vd (n=193) | |
| Age (years) | ||||||||
| Median (range) | 60.0 (38.0–78.0) | 62.0 (31.0–80.0) | 69.0 (43.0–87.0) | 70.0 (41.0–91.0) | 61.5 (35.0–79.0) | 62.0 (30.0–76.0) | 72.0 (39.0–89.0) | 71.0 (44.0–88.0) |
| ECOG PS, n (%) | ||||||||
| 0–1 | 204 (94.0) | 218 (95.2) | 152 (84.9) | 143 (85.6) | 256 (96.2) | 259 (95.2) | 176 (88.9) | 176 (91.2) |
| 2 | 13 (6.0) | 11 (4.8) | 27 (15.1) | 24 (14.4) | 10 (3.8) | 13 (4.8) | 22 (11.1) | 17 (8.8) |
| ISS stage at baseline among patients with known staging a, n (%) | ||||||||
| I | 109 (50.9) | 108 (47.8) | 58 (33.3) | 46 (28.2) | 136 (51.1) | 143 (52.6) | 76 (38.4) | 62 (32.1) |
| II–III | 105 (49.1) | 118 (52.2) | 116 (66.7) | 117 (71.8) | 130 (48.9) | 129 (47.4) | 122 (61.6) | 131 (67.9) |
| Creatinine clearance (ml/min), n (%) | ||||||||
| Mean (s.d.) | 90.6 (29.7) | 92.6 (31.3) | 78.1 (26.5) | 76.5 (25.9) | 84.8 (32.4) | 83.3 (32.7) | 65.7 (27.4) | 63.4 (28.2) |
| <30 | 0 | 1 (0.4) | 0 | 0 | 11 (4.1) | 12 (4.4) | 17 (8.6) | 16 (8.3) |
| 30–<50 | 5 (2.3) | 10 (4.4) | 20 (11.2) | 21 (12.6) | 23 (8.6) | 23 (8.5) | 34 (17.2) | 48 (24.9) |
| 50–<80 | 86 (39.6) | 73 (31.9) | 85 (47.5) | 80 (47.9) | 91 (34.2) | 95 (34.9) | 95 (48.0) | 82 (42.5) |
| ⩾80 | 126 (58.1) | 143 (62.4) | 73 (40.8) | 62 (37.1) | 141 (53.0) | 142 (52.2) | 52 (26.3) | 47 (24.4) |
| Missing | 0 | 2 (0.9) | 1 (0.6) | 4 (2.4) | 0 | 0 | 0 | 0 |
| Cytogenetic risk among patients with known status by FISH b, n (%) | ||||||||
| High | 31 (29.0) | 37 (26.6) | 17 (19.3) | 15 (18.1) | 54 (24.8) | 75 (31.6) | 43 (26.4) | 38 (22.8) |
| Standard | 76 (71.0) | 102 (73.4) | 71 (80.7) | 68 (81.9) | 164 (75.2) | 162 (68.4) | 120 (73.6) | 129 (77.2) |
| Time to enrollment since first transplant (months) | ||||||||
| Median (range) | 33.0 (3.5–203.3) | 33.2 (3.6–243.4) | NA | NA | 40.2 (2.9–217.4) | 37.9 (3.5–193.6) | NA | NA |
| Prior proteasome inhibitor and IMiD treatment, n (%) | ||||||||
| Bortezomib | 155 (71.4) | 157 (68.6) | 106 (59.2) | 103 (61.7) | 167 (62.8) | 163 (59.9) | 83 (41.9) | 89 (46.1) |
| Lenalidomide | 49 (22.6) | 40 (17.5) | 30 (16.8) | 38 (22.8) | 106 (39.8) | 90 (33.1) | 71 (35.9) | 87 (45.1) |
| Duration of prior proteasome inhibitor and IMiD treatment, median months (range) | ||||||||
| Bortezomib | 3.8 (0.0–26.2) | 3.9 (0.0–32.2) | 4.9 (0.9–49.1) | 5.6 (0.4–33.6) | 4.0 (0.1–38.0) | 4.3 (0.3–27.4) | 9.0 (1.3–46.0) | 7.8 (1.0–33.0) |
| Lenalidomide | 5.7 (0.5–40.8) | 7.7 (0.8–38.0) | 11.4 (0.4–40.2) | 10.4 (0.3–30.0) | 11.0 (0.5–75.8) | 9.0 (0.5–77.2) | 11.5 (0.8–51.7) | 10.9 (0.3–86.0) |
Abbreviations: ASCT, autologous stem cell transplantation; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; IMiD, immunomodulatory drug; ISS, International Staging System; Kd, carfilzomib+dexamethasone; KRd, carfilzomib+lenalidomide+dexamethasone; NA, not available; Rd, lenalidomide+dexamethasone; Vd, bortezomib+dexamethasone.
Percentages are calculated as a proportion of the number of patients with known ISS stage. In ASPIRE, 2% of patients had missing ISS stage; in ENDEAVOR, no patients had missing ISS stage.
Percentages are calculated as a proportion of the number of patients with known cytogenetics. In ASPIRE, 47% of patients had unknown cytogenetics; in ENDEAVOR, 16% of patients had unknown or missing cytogenetics.