Table 4.
Univariable analysis of progression-free survival.
| No. patients | No. events | Median PFS (95%CI) | 6-month PFS (95%CI) | 12-month PFS (95%CI) | p-valuelog-rank test | |
|---|---|---|---|---|---|---|
| Overall no. patients | 46 | 30 | 4.9 (2.8–10.0) | 47.4 (29.9–61.4) | 29.9 (15.5–45.6) | – |
| Age, years, at first diagnosis of BM | ||||||
| <65 | 18 | 11 | 6.4 (2.0–11.9) | 57.1 (28.4–77.9) | 11.4 (0.7–39.0) | 0.698 |
| ≥65 | 28 | 19 | 4.6 (2.2–15.9) | 40.6 (21.1–59.3) | 36.1 (17.6–55.0) | |
| Gender | ||||||
| Male | 35 | 23 | 4.9 (2.2–10.0) | 47.3 (28.3–64.2) | 25.8 (10.9–34.7) | 0.451 |
| Female | 11 | 7 | 5.1 (2.0–38.1) | 44.4 (13.6–71.9) | 44.4 (13.6–71.9) | |
| ECOG PS at first diagnosis of BM | ||||||
| 0 | 15 | 9 | 7.2 (2.1–NE) | 54.5 (22.9–77.9) | 21.8 (3.5–50.1) | 0.955 |
| 1 | 29 | 21 | 4.9 (1.9–13.3) | 43.5 (24.5–61.1) | 33.8 (16.3–52.3) | |
| ≥2 | 2 | 0 | – | – | – | |
| Treatment | ||||||
| Only ICIs | 16 | 10 | 3.9 (1.9–6.4) | 26.7 (5.1–55.6) | – | 0.068 |
| ICI+Deno | 6 | 4 | 15.9 (5.1–NE) | 83.3 (27.3–97.5) | 66.7 (19.5–90.4) | |
| ICI+Zol | 24 | 16 | 2.7 (1.8–13.3) | 45.0 (23.1–65.7) | 32.1 (12.8–53.4) | |
| Presence of visceral metastasis | ||||||
| No | 7 | 2 | – | – | – | – |
| Yes | 39 | 28 | 4.6 (2.2–9.3) | 43.6 (26.7–59.3) | 29.1 (14.4–45.5) | |
| No. BMs | ||||||
| 1 | 11 | 8 | 4.3 (1.7–16.1) | 50.0 (18.4–75.3) | 25.0 (4.1–54.9) | 0.343 |
| 2–6 | 15 | 8 | 4.9 (2.4–NE) | 45.5 (16.7–70.7) | 36.4 (11.2–62.7) | |
| >6 | 20 | 14 | 5.1 (2.2–13.3) | 45.4 (20.9–67.2) | 27.2 (7.4–52.1) | |
| Type of bone lesion | ||||||
| Osteoblastic | 1 | 0 | – | – | – | – |
| Lytic | 38 | 24 | 6.4 (3.6–11.9) | 51.9 (33.3–67.7) | 31.9 (15.8–49.4) | |
| Mixed | 6 | 5 | 1.8 (1.7–NE) | 20.0 (0.8–58.2) | 20.0 (0.8–58.2) | |
| Unknown | 1 | 1 | – | – | – | |
| EGFR status | ||||||
| Mutant | 1 | 0 | – | – | – | – |
| Wild–type | 38 | 24 | 5.1 (2.2–11.9) | 47.8 (29.5–64.0) | 31.9 (15.8–49.2) | |
| ALK status | ||||||
| Translocated | 0 | – | – | – | – | – |
| Wild type | 35 | 22 | 4.9 (2.4–9.3) | 44.7 (26.5–62.2) | 29.8 (13.1–48.6) | |
| ROS1 status | ||||||
| Rearranged | 1 | – | – | – | – | – |
| Wild–type | 30 | 20 | 5.1 (2.7–13.3) | 48.1 (27.7–65.9) | 32.1 (14.1–51.7) | |
| KRAS status | ||||||
| Mutant | 8 | 3 | 4.9 (1.7–NE) | 44.4 (6.6–78.5) | 44.4 (6.6–78.5) | 0.565 |
| Wild-type | 13 | 11 | 7.2 (2.4–11.9) | 61.5 (30.8–81.8) | 20.5 (33.3–47.8) | |
| PDL1 (1) | ||||||
| <50% | 23 | 15 | 4.4 (2.2–7.2) | 37.1 (16.3–58.2) | 14.9 (2.6–36.8) | 0.810 |
| ≥50% | 7 | 6 | 5.1 (1.7–NE) | 42.8 (9.8–73.4) | 42.8 (9.8–73.4) | |
| PDL1 (2) | ||||||
| <1% | 12 | 8 | 4.6 (1.6–9.3) | 50.0 (18.4–75.3) | 12.5 (0.7–41.8) | 0.941 |
| ≥1% | 18 | 13 | 4.3 (2.2–13.3) | 30.9 (10.5–54.3) | 30.9 (10.5–54.3) |
PFS, progression-free survival; 95%CI, 95% confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; BM, bone metastasis; ICI, immune checkpoint inhibitor; Deno, denosumab; Zol, zoledronate; NE, not estimable; EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; ROS1, c-ros oncogene 1; KRAS, Kirsten rat sarcoma viral oncogene homolog; PDL1, programmed death-ligand 1.