Table 3.
Tumor response in the ITT population and in patients with measurable disease (data cutoff date: October 23, 2015)
| Overall population | Japanese patients | |||
|---|---|---|---|---|
| PAL + FUL | PBO + FUL | PAL + FUL | PBO + FUL | |
| Intent-to-treat population, n | 347 | 174 | 27 | 8 |
| Best overall response, n (%) | ||||
| CR | 0 (0) | 4 (2.3) | 0 (0) | 0 (0) |
| PR | 73 (21.0) | 11 (6.3) | 5 (18.5) | 2 (25.0) |
| SD | 181 (52.2) | 72 (41.4) | 17 (63.0) | 6 (75.0) |
| ≥ 24 weeks | 157 (45.2) | 54 (31.0) | 15 (55.6) | 5 (62.5) |
| < 24 weeks | 24 (6.9) | 18 (10.3) | 2 (7.4) | 1 (12.5) |
| PD | 59 (17.0) | 58 (33.3) | 4 (14.8) | 0 (0) |
| Indeterminate | 34 (9.8) | 29 (16.7) | 1 (3.7) | 0 (0) |
| OR rate (CR + PR), % | 21.0 | 8.6 | 18.5 | 25.0 |
| 95% exact CI for OR ratea | 16.9‒25.7 | 4.9‒13.8 | 6.3‒38.1 | 3.2‒65.1 |
| Odds ratiob (95% CI) | 2.78 (1.56‒5.60) | 0.68 (0.082‒8.96) | ||
| One-sided P valuec | 0.0001 | 0.8204 | ||
| CBR rate (CR + PR + SD ≥ 24 weeks), % | 66.3 | 39.7 | 74.1 | 87.5 |
| 95% exact CI for CBR ratea | 61.0‒71.2 | 32.3‒47.3 | 53.7‒88.9 | 47.3‒99.7 |
| Odds ratiob (95% CI) | 3.02 (2.05‒4.57) | 0.41 (0.008‒4.34) | ||
| One-sided P valuec | < 0.0001 | 0.9057 | ||
| Patients with measurable disease, n | 267 | 138 | 21 | 8 |
| Best overall response, n (%) | ||||
| CR | 0 (0) | 4 (2.9) | 0 (0) | 0 (0) |
| PR | 73 (27.3) | 11 (8.0) | 5 (23.8) | 2 (25.0) |
| SD | 110 (41.2) | 43 (31.2) | 11 (52.4) | 6 (75.0) |
| ≥ 24 weeks | 95 (35.6) | 35 (25.4) | 10 (47.6) | 5 (62.5) |
| < 24 weeks | 15 (5.6) | 8 (5.8) | 1 (4.8) | 1 (12.5) |
| PD | 52 (19.5) | 53 (38.4) | 4 (19.0) | 0 (0) |
| Indeterminate | 32 (12.0) | 27 (19.6) | 1 (4.8) | 0 (0) |
| OR rate (CR + PR), % | 27.3 | 10.9 | 23.8 | 25.0 |
| 95% exact CI for OR ratea | 22.1‒33.1 | 6.2‒17.3 | 8.2‒47.2 | 3.2‒65.1 |
| Odds ratiob (95% CI) | 3.03 (1.64‒5.99) | 0.94 (0.11‒12.41) | ||
| One-sided P valuec | < 0.0001 | 0.7177 | ||
| CBR rate (CR + PR + SD ≥ 24 weeks), % | 62.9 | 36.2 | 71.4 | 87.5 |
| 95% exact CI for CBR ratea | 56.8‒68.7 | 28.2‒44.8 | 47.8‒88.7 | 47.3‒99.7 |
| Odds ratiob (95% CI) | 2.99 (1.92‒4.74) | 0.36 (0.007‒4.07) | ||
| One-sided P valuec | < 0.0001 | 0.9255 | ||
Stratified and unstratified odds ratio in overall population and Japanese patients, respectively
CBR clinical benefit response, CI confidence interval, CR complete response, FUL fulvestrant, ITT intent-to-treat, OR objective response, PAL palbociclib, PBO placebo, PD progressive disease, PR partial response, SD stable disease
aExact method based on Clopper–Pearson method
bOdds ratio > 1 means better response in favor of palbociclib + fulvestrant
cOne-sided exact test stratified by the presence of visceral metastases and sensitivity to prior hormonal therapy per randomization