Table 3. Multivariate analyses of total OS, post-first-line OS, and survival time from the start of second-line therapy to death (OS2).
| Covariatea | HR (95% CI) | P-value |
|---|---|---|
|
Total OS (includes treated patients with or without a 2L therapy;
n=741) | ||
| Treatment group (nab-P+Gem vs Gem alone) | 0.63 (0.54–0.74) | <0.001 |
| 2L therapy (with vs without) | 0.50 (0.43–0.59) | <0.001 |
| NLR at baseline (⩽5 vs >5) | 0.59 (0.50–0.69) | <0.001 |
| KPS at baseline (70–80 vs 90–100) | 1.33 (1.13–1.55) | <0.001 |
| Presence of liver metastasis (yes vs no) | 1.50 (1.22–1.85) | <0.001 |
| CA19-9 level at baseline (continuous) | 1.16 (1.05–1.29) | 0.005 |
| Age at baseline (<65 vs ⩾65 years) | 0.88 (0.75–1.02) | 0.089 |
|
Post-1L OS (includes treated patients with or without a 2L therapy;
n=793) | ||
| Treatment group (nab-P+Gem vs Gem alone) | 0.73 (0.63–0.85) | <0.001 |
| 2L therapy (with vs without) | 0.47 (0.40–0.54) | <0.001 |
| NLR at end of 1L (⩽5 vs >5) | 0.60 (0.52–0.70) | <0.001 |
| KPS at end of 1L | ||
| 90–100 vs ⩽60 | 0.46 (0.37–0.57) | <0.001 |
| 70–80 vs ⩽60 | 0.57 (0.47–0.70) | <0.001 |
| PFS, months (⩾4.4 vs <4.4)b | 0.78 (0.67–0.91) | 0.002 |
| Geographic region (North America vs others) | 0.86 (0.74–1.00) | 0.051 |
|
OS2 (only patients who received 2L therapy;
n=346) | ||
| Number of metastatic sites | 1.15 (1.02–1.29) | 0.018 |
| NLR at end of 1L (⩽5 vs >5) | 0.76 (0.60–0.97) | 0.027 |
| KPS at end of 1L | ||
| 90–100 vs ⩽60 | 0.53 (0.35–0.81) | 0.003 |
| 70–80 vs ⩽60 | 0.66 (0.44–1.00) | 0.052 |
Abbreviations: CA19-9=carbohydrate antigen 19-9; Gem=gemcitabine; HR=hazard ratio; KPS=Karnofsky performance status; nab-P=nab-paclitaxel; NLR=neutrophil-to-lymphocyte ratio; PFS=progression-free survival; CI=confidence interval; OS=overall survival; 2L=second-line; 1L=first-line.
Covariates tested for each multivariate analysis are listed in the Materials and Methods section.
In this study, the median PFS for the entire intention-to-treat population was 4.4 months.