Table 2.
Univariate analysis for progression-free survival and overall survival under the Isa-PD regimen
| Univariate analysis | PFS | OS | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Factors | 1-year-PFS (%) | 95% CI | Hazard ratio | 95% CI | P-value | 1-year-OS (%) | 95% CI | Hazard ratio | 95% CI | P-value | |
| Age | < 65 years | 41.4 | 22.8–59.1 | 1 | 0.906 | 76.4 | 56.8–88.0 | 1 | 0.434 | ||
| ≥ 65 years | 43.4 | 31.6–54.7 | 0.967 | 0.556–1.682 | 65.5 | 52.9–75.4 | 1.301 | 0.671–2.523 | |||
| Gender | Male | 38.4 | 25.2–51.5 | 1 | 0.144 | 69.0 | 54.3–79.8 | 1 | 0.607 | ||
| Female | 50.2 | 35.2–63.6 | 0.685 | 0.411–1.143 | 69.4 | 54.4–80.4 | 0.859 | 0.481–1.535 | |||
| High risk cytogenic abnormalities | None | 51.7 | 35.4–65.8 | 1 | 0.280 | 76.2 | 60.1–86.5 | 1 | 0.674 | ||
| At least one | 42.5 | 25.6–58.4 | 1.240 | 0.685–2.244 | 67.1 | 49.2–79.9 | 1.338 | 0.695–2.579 | |||
| NA | 33.3 | 15.9–51.9 | 1.667 | 0.884–3.144 | 60.0 | 36.8–77.0 | 1.232 | 0.564–2.693 | |||
| White blood cell counts | ≥ 3000/μl | 49.4 | 37.5–60.3 | 1 | 0.048 | 76.3 | 65.0–84.4 | 1 | < 0.001 | ||
| < 3000/μl | 27.9 | 12.1–46.2 | 1.732 | 0.999–3.011 | 47.7 | 27.3–65.6 | 2.824 | 1.551–5.143 | |||
| Lymphocyte/monocyte ratio | ≥ 4 | 63.9 | 42.0–79.3 | 1 | 0.002 | 88.3 | 67.9–96.1 | 1 | < 0.001 | ||
| < 4 | 37.1 | 26.1–48.2 | 2.960 | 1.455–6.023 | 62.3 | 50.1–72.3 | 5.523 | 1.975–15.440 | |||
| Neutrophile/lymphocyte ratio | < 2.3 | 54.6 | 39.9–67.1 | 1 | 0.020 | 78.7 | 64.8–87.6 | 1 | 0.011 | ||
| ≥ 2.3 | 32.6 | 19.6–46.3 | 1.822 | 1.089–3.048 | 59.3 | 44.1–71.7 | 2.152 | 1.177–3.936 | |||
| ISS stage | I | 42.8 | 25.9–58.7 | 1 | 0.935 | 69.3 | 50.2–82.2 | 1 | 0.832 | ||
| II | 44.2 | 25.3–61.6 | 1.764 | 0.720–4.318 | 62.9 | 42.8–77.6 | 2.864 | 0.880–9.315 | |||
| III | 47.9 | 29.3–64.3 | 3.402 | 1.364–8.484 | 67.0 | 47.1–80.8 | 7.153 | 2.297–22.270 | |||
| κ/λ ratio | 0.1–10 | 58.6 | 36.4–75.4 | 1 | 0.074 | 81.2 | 60.4–91.7 | 1 | 0.072 | ||
| ≤ 0.1, ≥ 10 | 38.3 | 26.1–50.4 | 1.783 | 0.937–3.396 | 64.3 | 50.9–75.0 | 1.993 | 0.920–4.317 | |||
| B2MG | < 3.5 mg/L | 59.4 | 38.7–75.2 | 1 | 0.009 | 82.1 | 62.3–92.1 | 1 | 0.007 | ||
| ≥ 3.5 mg/L | 39.4 | 22.1–56.4 | 2.636 | 1.270–5.471 | 60.4 | 40.8–75.3 | 3.113 | 1.347–7.190 | |||
| Prior regimen numbers | < 6 | 62.6 | 44.1–76.5 | 1 | 0.003 | 82.6 | 65.2–91.9 | 1 | 0.006 | ||
| ≥ 6 | 33.9 | 22.5–45.6 | 2.326 | 1.310–4.129 | 60.5 | 47.3–71.4 | 2.581 | 1.280–5.203 | |||
| Prior use of daratumumab | No | 62.2 | 44.5–75.7 | 1 | 0.003 | 78.7 | 61.8–88.8 | 1 | 0.026 | ||
| Yes | 33.9 | 22.2–45.9 | 2.378 | 1.322–4.278 | 63.1 | 49.7–73.8 | 2.089 | 1.078–4.046 | |||
Progression-free survival (PFS) was calculated from the time of isatuximab treatment to the progression of the disease. Overall survival (OS) was calculated from the time of isatuximab treatment to the time of death by any cause. Univariate analyses against PFS and OS under the Isa-PD regimen were performed for each factor. The log-rank test was used for comparisons among groups. One-year-PFS (%) with the 95% confidence interval (CI), hazard ratio with the 95% CI and P-value are shown
PFS progression-free survival, OS overall survival, CI confidence interval, ISS International Staging System, B2MG β2 microglobulin, NA not available