Table 2.
PFS in patients from PALOMA-2 by subgroup and treatment arm.
| Patient Subgroup | ITT Population, n (%) | mPFS (95% CI), mo |
HR (95% CI) | |
|---|---|---|---|---|
| PAL + LET | PBO + LET | |||
| Overall (ITT) population | 666 (100) | 27.6 (22.4–30.3) | 14.5 (12.3–17.1) | 0.56 (0.46–0.69) |
| DFI ≤ 12 mo | 146 (22) | 16.6 (13.9–24.2) | 11.0 (5.6–12.9) | 0.48 (0.32–0.72) |
| DFI > 12 mo | 272 (41) | 30.3 (24.8‒NE) | 13.8 (8.8–18.2) | 0.55 (0.40–0.76) |
| DFI > 24 mo | 233 (35) | 38.5 (27.5‒NE) | 16.6 (13.7–23.5) | 0.52 (0.36–0.75) |
| De novo metastatic | 248 (37) | 27.9 (22.1–33.4) | 22.0 (13.9–27.4) | 0.61 (0.44–0.85) |
| Visceral | 324 (49) | 19.3 (16.4–24.2) | 12.3 (8.4–16.4) | 0.62 (0.47–0.81) |
| Nonvisceral | 340 (51) | 35.9 (27.7‒NE) | 17.0 (13.8–24.8) | 0.50 (0.37–0.67) |
| Bone only | 151 (23) | 36.2 (27.6‒NE) | 11.2 (8.2–22.0) | 0.41 (0.26–0.63) |
| Visceral liver involvement | 120 (18) | 13.7 (10.9–16.6) | 8.4 (5.5–12.9) | 0.62 (0.41–0.94) |
| Visceral lung involvement | 253 (38) | 23.2 (17.0–27.8) | 12.9 (8.1–16.6) | 0.58 (0.42–0.80) |
DFI = disease-free interval; HR = hazard ratio; ITT = intent to treat; LET = letrozole; (m)PFS=(median) progression-free survival; NE = not estimable; PAL = palbociclib; PBO = placebo. Items in bold in the Patient Subgroup column represent stratification factors from PALOMA-2.