Table 2.
Patient exposure to palbociclib plus fulvestrant and placebo plus fulvestrant in the overall and Japanese population (as-treated population; data cutoff date: December 5, 2014)
| Overall population | Japanese patients | |||
|---|---|---|---|---|
| PAL + FUL (n = 345) | PBO + FUL (n = 172) | PAL + FUL (n = 27) | PBO + FUL (n = 8) | |
| Palbociclib or placebo | ||||
| Duration of treatment,a median (range), day | 144 (1‒390) | 120 (14‒402) | 142 (42‒308) | 201 (123‒301) |
| Average daily dose, median (range), mg | 125 (81‒131) | 125 (109‒129) | 115 (85‒125) | 125 (125‒125) |
| Dose reductions,bn (%) | 109 (32) | 3 (2) | 14 (52) | 0 |
| Reduction to 100 mg | 100 (29) | 3 (2) | 12 (44) | 0 |
| Reduction to 75 mg | 27 (8) | 0 | 4 (15) | 0 |
| Reduction to 75 mg 2/2c | 6 (2) | 0 | 1 (4) | 0 |
| Time to first dose reduction,d median (range), day | 37 (27‒240) | 85 (58‒143) | 34 (29‒141) | ‒ |
| Dose interruption,en (%) | 301 (87) | 110 (64) | 27 (100) | 8 (100) |
| Relative dose intensity, median (range), % | 92 (22‒105) | 100 (69‒107) | 80 (50‒100) | 98 (85‒100) |
| Fulvestrant | ||||
| Dose interruption,fn (%) | 10 (3) | 2 (1) | 1 (4) | 0 |
| Relative dose intensity, median (range), % | 100 (50‒117) | 100 (50‒108) | 98 (81‒104) | 100 (96‒101) |
FUL fulvestrant, PAL palbociclib, PBO placebo
aTotal number of days from first through last day of each study treatment
bAny dose reduction from the initial prescribed dose; does not include dose interruptions
cPalbociclib dose de-escalation to 75 mg/day 2 weeks on followed by 2 weeks off (2/2 schedule)
dTimed from start date of first occurrence minus first dose date of cycle 1 + 1
eDose interruption defined as (1) any missing dose recorded from the case report form, (2) any gaps within 21 doses in a cycle, or (3) patient did not complete 21 doses in a cycle
fDose interruption defined as (1) any missing dose recorded from case report form or (2) patient did not complete 2 doses in cycle 1