Disease progression incidence rate | Kaplan-Meir estimated progression-free survival | Kaplan-Meier-estimated overall survival | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Patients with disease progression assessment | Total follow up time in first line treatment (years) | Incidence Rate (95% CI) (person-years) | N | 12-month PFS | Median PFS (95% CI) (months) | Hazard Ratio (95% CI); p-value, univariate analysis | N | 12-month survival rate | Median OS(95% CI) (months) | Hazard Ratio (95% CI); p-value; univariate analysis | |
Overall patient population | ||||||||||||
357 | 147 | 256.7 | 0.57 (0.48–0.67) | 373 | 76.0 (71.2–80.1) | 22.4 (20.4–24.7) | n/a | 379 | 88.8 (85.1–91.6) | 45.0 (40.9–55.0) | n/a | |
Patient subpopulations per MBC diagnosis state | ||||||||||||
First diagnosed at an earlier stage | 208 | 110 | 129.1 | 0.85 (0.69–1.01) | 221 | 68.1 (59.7–75.1) | 20.4 (17.8–22.8) | 1.42 (1.12–1.81); p = 0.004 | 227 | 87.9 (82.9–91.6) | 41.0 (36.9–48.4) | 1.37 (0.97–1.93); p = 0.073 |
de novo Diagnosis | 149 | 37 | 127.6 | 0.29 (0.20–0.38) | 152 | 82.7 (75.5–88.0) | 26.8 (21.8–30.3) | 152 | 90.1 (84.1–93.9) | not reached | ||
Patient subpopulations per HR/HER2 status | ||||||||||||
HR+/HER2− | 182 | 76 | 161.0 | 0.47 (0.37–0.58) | 187 | 79.2 (72.5–84.5) | 24.6 (21.3–27.9) | HR+/HER2+ vs. HR+/HER2− 1.48 (1.05–2.09); p = 0.027 HR−/HER2+ vs. HR+/HER2− 1.21 (0.82–1.77); p = 0.337 HR−/HER− vs. HR+/HER2− 1.52 (1.06–2.16); p = 0.023 | 189 | 94.1 (89.6–96.7) | 48.4 (36.3–61.0) | HR+/HER2+ vs. HR+/HER2−1.00 (0.60–1.68); p = 0.992 HR−/HER2+ vs. HR+/HER2−1.71 (1.05–2.78); p = 0.032 HR−/HER− vs. HR+/HER2−1.79 (1.12–2.87); p = 0.015 |
HR+/HER2+ | 51 | 21 | 29.7 | 0.71 (0.40–1.01) | 55 | 67.5 (53.0–78.4) | 19.7 (12.9–25.9) | 56 | 89.3 (77.7–95.0) | 45.6 (21.5–65.3) | ||
HR−/HER2+ | 43 | 22 | 25.5 | 0.86 (0.50–1.22) | 42 | 85.6 (70.8–93.3) | 23.0 (16.6–29.7) | 43 | 92.9 (79.5–97.6) | 34.0 (25.5–45.6) | ||
HR−/HER2− | 45 | 16 | 19.9 | 0.80 (0.41–1.20) | 47 | 62.2 (46.3–74.6) | 18.3 (10.0–24.7) | 49 | 72.9 (58.1–83.3) | 40.4 (18.4–55.0) |