Table 3.
Univariable analysis of overall survival.
| No. patients | No. events | Median OS(95%CI) | 12-month OS(95%CI) | 24-month OS (95%CI) | p-valuelog-rank test | |
|---|---|---|---|---|---|---|
| Overall no. patients | 111 | 88 | 11.9 (8.2–14.4) | 49.7 (40.0–58.7) | 24.0 (16.3–32.6) | – |
| Age, years, at first diagnosis of BM | ||||||
| <65 | 47 | 36 | 13.9 (8.0–18.6) | 56.4 (40.8–69.3) | 29.1 (16.7–42.8) | 0.235 |
| ≥65 | 64 | 52 | 10.3 (6.9–13.6) | 45.0 (32.5–56.7) | 20.4 (11.2–31.6) | |
| Gender | ||||||
| Male | 70 | 54 | 12.4 (8.0–15.4) | 50.9 (38.5–61.9) | 21.6 (12.6–32.2) | 0.842 |
| Female | 41 | 34 | 11.9 (5.8–15.8) | 47.7 (31.7–62.1) | 28.4 (15.2–43.1) | |
| ECOG at first diagnosis of BM | ||||||
| 0 | 26 | 14 | 32.9 (12.8–NE) | 76.9 (55.7–88.9) | 57.2 (36.1–73.6) | 0.002 |
| 1 | 53 | 42 | 12.6 (7.2–15.4) | 53.6 (39.1–66.0) | 20.6 (10.4–33.1) | |
| ≥2 | 6 | 6 | 5.6 (3.9–NE) | 16.7 (0.7–51.7) | 0 | |
| Treatment | ||||||
| ICI alone | 16 | 11 | 15.8 (8.2–NE) | 63.0 (38.3–84.9) | 30.8 (9.9–54.8) | <0.001 |
| ICI+Deno/Zol | 30 | 17 | 21.8 (14.5–NE) | 79.5 (59.9–90.2) | 45.7 (26.5–62.9) | |
| No ICI | 60 | 55 | 7.5 (6.1–10.9) | 33.1 (21.5–45.1) | 12.2 (5.4–21.9) | |
| Visceral metastasis | ||||||
| No | 20 | 16 | 14.9 (5.8–27.6) | 53.6 (29.6–72.6) | 37.5 (16.9–58.2) | 0.413 |
| Yes | 91 | 72 | 11.9 (8.2–13.8) | 48.9 (38.1–58.7) | 20.9 (13.0–30.2) | |
| No. BMs | ||||||
| 1 | 24 | 19 | 15.4 (7.5–19.4) | 59.9 (36.9–76.8) | 23.0 (8.4–41.8) | 0.761 |
| 2–6 | 33 | 26 | 9.8 (6.5–13.8) | 48.5 (30.8–64.0) | 25.9 (12.4–41.7) | |
| >6 | 54 | 43 | 10.9 (6.7–15.8) | 46.1 (32.4–58.7) | 23.1 (12.5–35.6) | |
| Type of bone lesion | ||||||
| Osteoblastic | 6 | 6 | 14.9 (1.6–NE) | 66.7 (19.5–90.4) | – | 0.386 |
| Lytic | 77 | 57 | 11.5 (8.2–15.8) | 49.6 (37.8–60.3) | 29.6 (19.6–40.3) | |
| Mixed | 17 | 15 | 9.8 (5.4–15.4) | 47.1 (22.9–67.9) | 17.7 (4.3–38.3) | |
| EGFR status | ||||||
| Mutated | 12 | 10 | 12.2 (5.6–NE) | 58.3 (27.0–80.1) | 25.0 (6.0–50.5) | 0.937 |
| Wild type | 84 | 65 | 12.6 (8.0–14.9) | 50.3 (39.0–60.5) | 25.4 (16.3–35.4) | |
| ALK status | ||||||
| Translocated | 4 | 2 | – | – | – | – |
| Wild type | 67 | 52 | 12.7 (8.2–14.9) | 54.3 (41.5–65.4) | 26.5 (16.3–37.9) | |
| ROS1 status | ||||||
| Rearranged | 3 | 2 | – | – | – | |
| Wild type | 48 | 32 | 13.9 (11.5–22.8) | 63.6 (48.1–75.6) | 35.8 (22.1–49.8) | |
| KRAS status | ||||||
| Mutant | 10 | 8 | 8.0 (3.1–15.8) | 23.3 (3.6–52.9) | 11.7 (0.6–40.1) | 0.005 |
| Wild type | 25 | 15 | 36.8 (13.9–NE) | 80.0 (58.4–91.2) | 52.0 (31.3–69.2) | |
| PDL1 (1) | ||||||
| <50% | 29 | 19 | 15.7 (12.6–48.6) | 78.8 (58.7–89.8) | 37.7 (19.9–55.4) | 0.995 |
| ≥50% | 9 | 4 | 13.9 (5.4–NE) | 63.5 (23.8–86.6) | 47.6 (12.3–76.9) | |
| PDL1 (2) | ||||||
| <1% | 14 | 8 | 15.8 (13.6–NE) | 100.0 | 42.8 (17.7–66.0) | 0.275 |
| ≥1% | 24 | 15 | 12.8 (8.2–NE) | 59.4 (36.3–76.5) | 38.2 (17.7–58.5) | |
| Mutational status (1) | ||||||
| EGFR mutated | 12 | 10 | 12.2 (5.6–NE) | 58.3 (27.0–80.0) | 25.0 (6.0–50.5) | 0.114 |
| ALK translocated | 4 | 2 | – | |||
| KRAS mutated | 10 | 8 | 8.0 (4.3–15.8) | 23.3 (3.6–52.9) | 11.7 (0.6–40.0) | |
| ROS1 rearranged | 3 | 2 | – | |||
| EGFR, ALK, KRAS and ROS1 wild type | 14 | 10 | 14.7 (9.6–NE) | 71.4 (40.6–88.2) | 42.9 (17.7–66.0) | |
| Mutational status (2) | ||||||
| EGFR mutated or ALK translocated or ROS1 rearranged | 19 | 14 | 17.4 (9.7–48.6) | 73.7 (47.9–88.1) | 36.8 (16.5–57.5) | 0.778 |
| None | 36 | 24 | 14.5 (9.6–27.2) | 62.5 (44.2–76.3) | 37.3 (21.1–53.4) |
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.