Table 3.
Univariate regression analysis | Multivariate regression analysis | |||
---|---|---|---|---|
Overall survival (all patients, n = 4436) | Overall survival (all patients, n = 4436) | |||
HR (95% CI) | P value | HR (95%CI) | P value | |
LOT post-mCRPC diagnosis (time-dependent covariate) | ||||
LOT post-mCRPC diagnosis (ref: 1L) | ||||
Patient had not yet initiated treatment | 0.78 (0.69, 0.88) | < 0.001* | 0.86 (0.76, 0.97) | 0.013* |
2L | 1.31 (1.17, 1.47) | < 0.001* | 1.31 (1.17, 1.47) | < 0.001* |
3L | 1.92 (1.66, 2.22) | < 0.001* | 1.92 (1.66, 2.23) | < 0.001* |
4L+ | 3.07 (2.62, 3.60) | < 0.001* | 3.19 (2.71, 3.76) | < 0.001* |
Baseline characteristics (fixed covariates) | ||||
Age (per year increase) | 1.03 (1.02, 1.03) | < 0.001* | 1.03 (1.03, 1.04) | < 0.001* |
Time from initial PC diagnosis to mCRPC (per year increase) | 0.99 (0.98, 0.99) | < 0.001* | 0.98 (0.97, 0.99) | 0.003* |
Pre- mCRPC clinical states (ref: first mPC, then mCRPC) | ||||
First nmCRPC, then mCRPC | 0.88 (0.80, 0.97) | 0.009* | 0.99 (0.89, 1.11) | 0.923 |
Metastatic and CR diagnosed at the same time pre-mCRPC | 0.70 (0.48, 1.04) | 0.075 | 0.84 (0.57, 1.25) | 0.401 |
Stage IV vs. stages I–III at initial PC diagnosis | 1.31 (1.14, 1.51) | < 0.001* | 0.98 (0.82, 1.16) | 0.784 |
High-risk Gleason at initial PC diagnosis (score 9–10) vs. lower risk Gleason (score ≤ 8) | 1.28 (1.16, 1.40) | < 0.001* | 1.20 (1.09, 1.33) | < 0.001* |
ECOG performance statusa at mCRPC diagnosis ≥ 2 vs. 0–1 | 2.12 (1.80, 2.49) | < 0.001* | 1.68 (1.42, 1.99) | < 0.001* |
PSA laboratory test at mCRPC diagnosis (ref: < 4 ng/mL) | ||||
4–9 | 1.03 (0.87, 1.22) | 0.726 | 1.00 (0.84, 1.18) | 0.956 |
10–49 | 1.42 (1.23, 1.64) | < 0.001* | 1.28 (1.10, 1.48) | 0.001* |
≥ 50 | 2.20 (1.91, 2.54) | < 0.001* | 1.71 (1.47, 1.98) | < 0.001* |
Other laboratory tests at mCRPC diagnosis | ||||
Hemoglobin level (ref: ≥ 14 g/dL) | ||||
< 10 | 3.90 (3.14, 4.84) | < 0.001* | 1.92 (1.53, 2.40) | < 0.001* |
10–13 | 1.57 (1.31, 1.87) | < 0.001* | 1.20 (1.01, 1.44) | 0.043* |
Serum alkaline phosphatase (ref: 44–146 U/L) | ||||
< 44 | 0.78 (0.55, 1.12) | 0.182 | 0.87 (0.61, 1.25) | 0.451 |
≥ 147 | 2.72 (2.42, 3.06) | < 0.001* | 1.98 (1.75, 2.24) | < 0.001* |
Serum albumin < 34 vs. ≥ 34 g/L | 2.76 (2.27, 3.36) | < 0.001* | 1.77 (1.44, 2.17) | < 0.001* |
Lactose dehydrogenase (ref: 105–332 U/L) | ||||
< 105 | 0.29 (0.04, 2.06) | 0.216 | 0.60 (0.08, 4.32) | 0.615 |
≥ 333 | 2.23 (1.68, 2.96) | < 0.001* | 1.42 (1.06, 1.89) | 0.018* |
Opioid use pre-mCRPC diagnosis | 1.43 (1.28, 1.61) | < 0.001* | 1.36 (1.20, 1.54) | < 0.001* |
Type of primary treatment at initial PC diagnosis | ||||
Prostatectomy/surgery | 0.71 (0.64, 0.79) | < 0.001* | 0.91 (0.79, 1.05) | 0.197 |
Radiation | 0.94 (0.85, 1.04) | 0.213 | 0.97 (0.85, 1.11) | 0.644 |
CI confidence interval, CR castration resistance, ECOG Eastern Cooperative Oncology Group, HR hazard ratio, mCRPC metastatic castration-resistant prostate cancer, nmCRPC non-metastatic castration-resistant prostate cancer, PC prostate cancer, PSA prostate-specific antigen, ADT androgen-deprivation therapy
aECOG performance status: (0) fully active, able to carry on all pre-disease performance without restriction; (1) restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; (2) ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours; (3) capable of only limited self-care; confined to bed or chair more than 50% of waking hours; (4) completely disabled; cannot carry on any self-care; totally confined to bed or chair; not documented (ECOG values of 5 are dropped)
*P value < 0.05