Table 2.
Efficacy outcomes considering subgroups of patients.
| Progression-free survival | Clinical benefit rate | Overall survival | |||||||
|---|---|---|---|---|---|---|---|---|---|
| N | Median | 95% CI | p value | n (%) | p value | Median | 95% CI | p value | |
| Type of cancer (EBC) | |||||||||
| Luminal A | 61 | 16.9 | 11.5–23.6 | 0.570 | 54 (88.5) | 0.198 | 43.1 | 35.0–60.3 | 0.340 |
| Luminal B | 60 | 13.2 | 7.4–21.5 | 48 (80.0) | 40.0 | 26.9–58.6 | |||
| Type of cancer (ABC, on biopsy of the metastasis) | |||||||||
| Luminal A | 25 | 18.8 | 8.3–27.4 | 0.208 | 23 (92.0) | 0.249 | 49.6 | 25.3–83.8 | 0.733 |
| Luminal B | 26 | 16.9 | 3.4–21.5 | 20 (76.9) | 52.3 | 23.0–N.R | |||
| Hormone receptors (EBC) | |||||||||
| ER-positive / PgR-positive | 101 | 18.1 | 11.7–23.2 | 0.328 | 87 (86.1) | 0.054 | 44.4 | 35.0–55.8 | 0.260 |
| ER-positive /PgR-negative | 27 | 10.9 | 6.8–27.7 | 19 (70.4) | 34.5 | 20.3–78.0 | |||
| Hormone receptors (ABC, on biopsy of the metastasis) | |||||||||
| ER-positive / PgR-positive | 43 | 23.2 | 11.5–25.2 | 0.048 | 41 (95.4) | 0.001 | 49.6 | 35.7–68.4 | 0.224 |
| ER-positive /PgR-negative | 13 | 16.1 | 1.6–21.5 | 7 (53.8) | 29.9 | 16.9–58.6 | |||
| Ki67 proliferation index (EBC) | |||||||||
| Low (≤ 20%) | 83 | 14.6 | 10.6–19.9 | 0.748 | 72 (86.8) | 0.274 | 44.4 | 25.6–58.6 | 0.371 |
| High (> 20%) | 38 | 14.3 | 5.5–24.3 | 30 (80.0) | 43.1 | 35.0–55.8 | |||
| Ki67 proliferation index (ABC, on biopsy of the metastasis) | |||||||||
| Low (≤ 20%) | 33 | 16.1 | 8.3–24.1 | 0.888 | 20 (87.0) | 1.000 | 40.0 | 23.9–40.7 | 0.692 |
| High (> 20%) | 23 | 19.8 | 5.8–23.6 | 28 (84.9) | 52.3 | 25.4–N.R | |||
| ECOG PS at the start of treatment | |||||||||
| 0 | 66 | 14.6 | 10.9–25.0 | 0.760 | 60 (90.9) | 0.012 | 47.6 | 35.7–70.2 | 0.024 |
| 1–2 | 62 | 14.0 | 7.7–19.9 | 46 (74.2) | 36.5 | 26.9–50.1 | |||
| Metastasis location | |||||||||
| Visceral | 62 | 14.3 | 10.7–24.1 | 0.901 | 49 (79.0) | 0.272 | 38.0 | 29.9–47.6 | 0.343 |
| Non-visceral | 66 | 14.6 | 10.2–23.2 | 57 (86.4) | 49.6 | 35.0–59.1 | |||
| Previous treatments in the adjuvant setting | |||||||||
| Aromatase inhibitor | 74 | 16.1 | 10.2–19.9 | 0.758 | 59 (79.7) | 0.557 | 36.5 | 30.9–52.3 | 0.692 |
| Aromatase inhibitor + tamoxifene | 27 | 23.2 | 12.0–27.4 | 24 (88.9) | 55.8 | 29.9–70.2 | |||
| Tamoxifene | 26 | 12.1 | 6.0–31.8 | 22 (84.6) | 47.4 | 25.4–58.6 | |||
| Resistance 1 | |||||||||
| Primary endocrine resistance | 24 | 12.0 | 10.0–25.0 | 0.551 | 19 (79.2) | 31.7 | 23.9–47.6 | ||
| Secondary endocrine resistance | 90 | 14.6 | 10.0–23.2 | 75 (83.3) | 0.931 | 45.3 | 35.0–58.6 | 0.223 | |
| Hormone-sensitive patients | 14 | 19.5 | 6.8–47.9 | 12 (85.7) | 52.0 | 25.3–74.5 | |||
| Resistance 2 | |||||||||
| Primary/secondary endocrine resistance | 114 | 14.3 | 10.6–19.8 | 0.275 | 94 (82.5) | 1.000 | 40.3 | 32.9–50.1 | 0.509 |
| Hormone-sensitive patients | 14 | 19.5 | 6.8–47.9 | 12 (85.7) | 52.0 | 25.3–74.5 | |||
| Resistance 3 | |||||||||
| Primary endocrine resistance | 24 | 12.0 | 10.0–25.0 | 0.795 | 19 (79.2) | 0.561 | 31.7 | 23.9–47.6 | 0.092 |
| Secondary endocrine resistance/hormone-sensitive patients | 104 | 16.9 | 10.7–23.2 | 87 (83.7) | 47.4 | 36.5–58.6 | |||
EBC early breast cancer, ABC advanced breast cancer, ER estrogen receptor, PgR progesterone receptor, ECOG PS Eastern Cooperative Oncology Group performance status, N.R. not reached.