Table 3.
Primary and Secondary Endpoints.
| Arm 1 (ADT only) | Arm 2 (Palbociclib + ADT) | ||||
|---|---|---|---|---|---|
| PSA Response at 28 weeks | n = 20 | % | n = 40 | % | p value |
| PSA < or = 4ng/dL | 16 | 80 | 32 | 80 | 0.87 |
| PSA undetectable (PSA <0.2ng/mL) | 10 | 50 | 17 | 43 | 0.50 |
| PSA PFS % (95% CI) | 80 | (55-92) | 90 | (76-96) | 0.72* |
| Best PSA Response Rate | 0.25^ | ||||
| CR (PSA <0.2ng/mL) | 13 | 65 | 22 | 55 | |
| PR (PSA ≥0.2-4ng/mL) | 5 | 25 | 12 | 30 | |
| Stable Disease (not PR or PD) | 1 | 5 | 6 | 15 | |
| Progression (25% increase and an absolute increase of 2 ng/ml) | 1 | 5 | 0 | 0 | |
| Measurable Disease | 0.42^ | ||||
| # evaluable | 9 | 45 | 27 | 67.5 | |
| CR | 4 | 44.4 | 11 | 40.7 | |
| PR | 4 | 44.4 | 13 | 48.2 | |
| Stable Disease | 1 | 11.1 | 2 | 7.4 | |
| Progressive Disease | 0 | 0 | 1 | 2.7 | |
| Best Bone Response | 0.10 | ||||
| # evaluable | 14 | 70 | 30 | 75 | |
| Stable/Improved | 14 | 100 | 25 | 83.3 | |
| Progression | 0 | 0 | 5 | 16.7 | |
*
Log-Rank test
^
Mid p-value Jonckheere-Terpstra Exact Test