Table 3 Lenalidomide discontinuations and dose modifications (safety population)a.
Non-frailb | Frail | |||||||
---|---|---|---|---|---|---|---|---|
Fit (19.9%c; n = 145/729) | Intermediate (34.3%c; n = 250/729) | Total–non-frailb (54.2%c; n = 395/729) | Frail (45.8%c; n = 334/729) | |||||
D-Rd (18.7%d; n = 68/364) | Rd (21.1%e; n = 77/365) | D-Rd (35.2%d; n = 128/364) | Rd (33.4%e; n = 122/365) | D-Rd (53.8%d; n = 196/364) | Rd (54.5%e; n = 199/365) | D-Rd (46.2%d; n = 168/364) | Rd (45.5%e; n = 166/365) | |
Lenalidomide permanent discontinuation, n (%) | 13 (19.1) | 8 (10.4) | 24 (18.8) | 17 (13.9) | 37 (18.9) | 25 (12.6) | 45 (26.8) | 23 (13.9) |
Reason for discontinuation, n (%) | ||||||||
AE | 12 (17.6) | 5 (6.5) | 18 (14.1) | 6 (4.9) | 30 (15.3) | 11 (5.5) | 37 (22.0) | 14 (8.4) |
Other | 1 (1.5) | 3 (3.9) | 6 (4.7) | 11 (9.0) | 7 (3.6) | 14 (7.0) | 8 (4.8) | 9 (5.4) |
Lenalidomide dose delay, n (%) | 13 (19.1) | 7 (9.1) | 15 (11.7) | 11 (9.0) | 28 (14.3) | 18 (9.0) | 31 (18.5) | 13 (7.8) |
Reason for delay, n (%) | ||||||||
AE | 7 (10.3) | 3 (3.9) | 8 (6.3) | 5 (4.1) | 15 (7.7) | 8 (4.0) | 14 (8.3) | 8 (4.8) |
Other | 7 (10.3) | 4 (5.2) | 7 (5.5) | 8 (6.6) | 14 (7.1) | 12 (6.0) | 21 (12.5) | 7 (4.2) |
Lenalidomide dose skipped, n (%) | 50 (73.5) | 47 (61.0) | 101 (78.9) | 78 (63.9) | 151 (77.0) | 125 (62.8) | 140 (83.3) | 109 (65.7) |
Reason for skipping, n (%) | ||||||||
AE | 39 (57.4) | 32 (41.6) | 85 (66.4) | 66 (54.1) | 124 (63.3) | 98 (49.2) | 117 (69.6) | 77 (46.4) |
Other | 30 (44.1) | 31 (40.3) | 54 (42.2) | 41 (33.6) | 84 (42.9) | 72 (36.2) | 81 (48.2) | 66 (39.8) |
Lenalidomide dose reduced, n (%) | 53 (77.9) | 40 (51.9) | 83 (64.8) | 70 (57.4) | 136 (69.4) | 110 (55.3) | 118 (70.2) | 88 (53.0) |
Reason for reduction, n (%) | ||||||||
AE | 51 (75.0) | 38 (49.4) | 74 (57.8) | 63 (51.6) | 125 (63.8) | 101 (50.8) | 108 (64.3) | 73 (44.0) |
Other | 3 (4.4) | 4 (5.2) | 13 (10.2) | 11 (9.0) | 16 (8.2) | 15 (7.5) | 22 (13.1) | 24 (14.5) |