Table 2.
Frequency, timing, and duration of dose modifications in clinical practice and in PALOMA-3.
| Real-world (N = 46) | PALOMA-3 (N = 345) | |
|---|---|---|
| Duration of treatment (days) | 222.5 (42-693) | 232 (1-481) |
| Frequency, timing, and duration of dose reductions | ||
| No. of patients who had dose-level reduction(s), n (%) | ||
| 1 | 6 (13%) | 95 (28%) |
| 2 | 4 (9%) | 22 (6%) |
| ⩾1 | 10 (22%) | 117 (34%) |
| Patients who had dose level reduced, n (%) | ||
| To 100 mg | 10 (22%) | 108 (31%) |
| To 75 mg | 4 (9%) | 31 (9%) |
| Time course for patients who had 1 dose-level reduction (days) | ||
| Time until dose reduction from 125 to 100 mg | 166.5 (28-360) | 57 (27-293) |
| Duration receiving 100 mg | 64.5 (7-303) | 105 (13-248) |
| Time until reduction from 100 to 75 mg | 36 (29-85) | |
| Duration receiving 75 mg | 120 (17-159) | |
| Time course for patients who had 2 dose-level reductions (days) | ||
| Time until dose reduction from 125 to 100 mg | 36.5 (28-102) | 34 (27-142) |
| Duration receiving 100 mg | 49 (35-104) | 44 (10-196) |
| Time until reduction from 100 to 75 mg | 118 (63-141) | 120 (56-352) |
| Duration receiving 75 mg | 25.5 (19-44) | 81 (21-168) |
| Frequency, timing, and duration of cycle delays and dose interruptions | ||
| Patients who had cycle delay or interruptions, n (%) | ||
| Any cycle delay due to an AE | 27 (59%) | 123 (36%) |
| Any dose interruption due to an AE | 4 (9%) | 187 (54%) |
| Time to first cycle delay (days) | 28 (23-504) | 64 (31-349) |
| Time to first dose interruption (days) | 105.5 (15-315) | 18 (1-482) |
| Duration of cycle delay (days)a | 7 (3-28) | 3 (2-16) |
| Duration of dose interruption (days)a | 15.5 (13-21) | 6 (1-20) |
| Frequency of permanent treatment discontinuations | ||
| Permanent discontinuation of treatment because of AEs, n (%) | 2 (4%) | 14 (4%) |
Data are the median (range), unless otherwise specified.
PALOMA-3 data were adapted from Verma et al.6
Abbreviation: AE, adverse event.
a
For real-world: data are the duration of the first cycle delay/dose interruption.