Table 4.
PFS in patients from PALOMA-3 by subgroup and treatment arm.
| Patient Subgroup | ITT Population, n (%) | mPFS (95% CI), mo |
HR (95% CI) | |
|---|---|---|---|---|
| PAL + FUL | PBO + FUL | |||
| Overall (ITT) population | 521 (100) | 11.2 (9.5–12.9) | 4.6 (3.5–5.6) | 0.50 (0.40–0.62) |
| ET sensitive | 412 (79) | 12.0 (11.1–13.9) | 4.2 (3.5–5.6) | 0.46 (0.36–0.59) |
| ET resistant | 109 (21) | 7.4 (5.5–11.1) | 5.1 (1.9–7.4) | 0.69 (0.43–1.09) |
| Without prior CT in ABC | 344 (66) | 12.9 (11.0–15.0) | 5.5 (3.6–7.6) | 0.49 (0.37–0.65) |
| With prior CT in ABC | 177 (34) | 9.5 (7.3–11.3) | 3.5 (1.9–5.4) | 0.54 (0.37–0.77) |
| Without any prior therapy in ABC | 115 (22) | 11.0 (7.3–13.2) | 5.1 (2.1–9.2) | 0.59 (0.37–0.93) |
| Visceral | 313 (60) | 9.2 (7.5–11.1) | 3.5 (2.0–5.1) | 0.50 (0.38–0.65) |
| Nonvisceral | 208 (40) | 16.6 (13.2‒NE) | 5.6 (4.6–10.9) | 0.48 (0.33–0.71) |
| Bone only | 125 (24) | 14.3 (11.2‒NE) | 9.2 (4.8–20.0) | 0.63 (0.38–1.06) |
| Visceral liver involvement | 203 (39) | 7.5 (5.6–9.2) | 2.4 (1.9–3.6) | 0.49 (0.36–0.68) |
| Visceral lung involvement | 162 (31) | 11.1 (9.2–12.0) | 3.7 (2.1–7.2) | 0.45 (0.31–0.67) |
ABC = advanced breast cancer; CT = chemotherapy; ET = endocrine therapy; FUL = fulvestrant; HR = hazard ratio; ITT = intent to treat; (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-3.