Table 2.
Median PFS in patients with bone-only, nonvisceral (excluding bone-only), and visceral disease
| PALOMA-2 | PALOMA-3 | |||||
|---|---|---|---|---|---|---|
| Palbociclib + letrozole | Placebo + letrozole | Interaction P value | Palbociclib + fulvestrant | Placebo + fulvestrant | Interaction P value | |
| ITT population | ||||||
| Bone-only, n | 102 | 48 | 0.240 | 86 | 38 | 0.471 |
| Median PFS (95% CI), months | 36.2 (27.6–NE) | 11.2 (8.2–22.0) | 14.3 (11.2–NE) | 9.2 (4.8–20.0) | ||
| Hazard ratio (95% CI) | 0.40 (0.26–0.62) | 0.40 (0.26–0.62) | 0.64 (0.38–1.06) | 0.64 (0.38–1.06) | ||
| Nonvisceral (excluding bone-only), n | 128 | 64 | 61 | 32 | ||
| Median PFS (95% CI), months | 33.4 (27.6–NE) | 23.5 (13.8–30.6) | 16.6 (11.1–NE) | 5.6 (3.5–9.3) | ||
| Hazard ratio (95% CI) | 0.60 (0.40–0.89) | 0.60 (0.40–0.89) | 0.40 (0.23–0.73) | 0.40 (0.23–0.73) | ||
| Visceral, n | 214 | 110 | 200 | 104 | ||
| Median PFS (95% CI), months | 19.3 (16.4–24.2) | 12.3 (8.4–16.4) | 9.2 (7.5–11.1) | 3.4 (1.9–5.1) | ||
| Hazard ratio (95% CI) | 0.61 (0.46–0.80) | 0.61 (0.46–0.80) | 0.47 (0.36–0.62) | 0.47 (0.36–0.62) | ||
| Biomarker population | ||||||
| Bone-only, n | 72 | 34 | 0.262 | 54 | 27 | 0.363 |
| Median PFS (95% CI), months | 31.3 (23.9–NE) | 11.2 (5.5–22.0) | 16.6 (11.2–NE) | 11.2 (4.8–20.0) | ||
| Hazard ratio (95% CI) | 0.41 (0.25–0.69) | 0.41 (0.25–0.69) | 0.79 (0.41–1.60) | 0.79 (0.41–1.60) | ||
| Nonvisceral (excluding bone-only), n | 83 | 40 | 32 | 21 | ||
| Median PFS (95% CI), months | 27.7 (21.9–NE) | 21.9 (13.8–30.6) | NE (9.1–NE) | 5.5 (1.9–NE) | ||
| Hazard ratio (95% CI) | 0.63 (0.39–1.03) | 0.63 (0.39–1.03) | 0.44 (0.20–0.96) | 0.44 (0.20–0.96) | ||
| Visceral, n | 148 | 77 | 108 | 60 | ||
| Median PFS (95% CI), months | 19.2 (14.0–24.2) | 11.3 (8.3–16.6) | 9.5 (7.5–12.1) | 2.2 (1.9–4.2) | ||
| Hazard ratio (95% CI) | 0.67 (0.49–0.93) | 0.67 (0.49–0.93) | 0.46 (0.32–0.67) | 0.46 (0.32–0.67) | ||
CI confidence interval, ITT intent-to-treat, NE not estimable, PFS progression-free survival