Table 2.
Variable | n (%) | OS (months) | Univariate analysis | Multivariable analysis | ||
---|---|---|---|---|---|---|
Median (95% CI) | HR (95% CI) | p | HR (95% CI) | p | ||
Overall | 66 (100) | 18.0 (14.6–21.4) | - | - | - | - |
TLP response | ||||||
PR | 40 (60.6) | 24.6 (15.4–33.8) | ||||
SD/PD | 26 (39.4) | 10.7 (0–21.8) | 2.78 (1.46–5.30) | 0.001 | 2.76 (1.45–5.26) | 0.002 |
PSA response | ||||||
PR | 34 (51.5) | 24.6 (15.5–33.7) | ||||
SD/PD | 32 (48.5) | 14.5 (9.6–19.4) | 2.30 (1.23–4.30) | 0.008 | 1.39 (0.52–3.69) | 0.515 |
ALPa | ||||||
< 220 U/L | 54 (81.8) | 23.4 (16.4–30.4) | ||||
≥ 220 U/L | 12 (18.2) | 7.1 (0–15.5) | 4.08 (1.90–8.76) | < 0.001 | 3.08 (1.38–6.87) | 0.006 |
Performance statusa | ||||||
ECOG < 2 | 48 (72.7) | 23.4 (17.1–29.6) | ||||
ECOG ≥ 2 | 18 (27.3) | 8.1 (0–17.0) | 2.98 (1.53–5.79) | < 0.001 | 2.21 (1.10–4.43) | 0.026 |
Visceral metastasesa | ||||||
No | 43 (65.2) | 19.3 (8.7–29.9) | ||||
Yes | 23 (34.8) | 16.2 (8.9–23.4) | 1.78 (0.96–3.32) | 0.064 | 1.61 (0.84–3.08) | 0.154 |
PSAa | ||||||
< 145 ng/mL | 33 (50.0) | 23.4 (15.6–31.1) | ||||
≥ 145 ng/mL | 33 (50.0) | 16.2 (12.2–20.1) | - | 0.105 | - | - |
Agea | ||||||
< 65 years | 17 (25.8) | 16.8 (11.1–22.6) | ||||
≥ 65 years | 49 (74.2) | 19.3 (15.1–23.5) | - | 0.473 | - | - |
Prior chemotherapya | ||||||
No | 19 (28.8) | 23.7 (12.0–35.4) | ||||
Yes | 47 (71.2) | 16.9 (11.5–22.3) | - | 0.570 | - | - |
Hemoglobina | ||||||
≥ 13 g/dL | 22 (33.3) | 18.0 (12.5–23.5) | ||||
< 13 g/dL | 44 (66.7) | 16.9 (10.8–23.0) | - | 0.566 | - | - |
TLPa | ||||||
< 5710 mL × SUV | 33 (50.0) | 19.4 (11.1–27.8) | ||||
≥ 5710 mL × SUV | 33 (50.0) | 16.9 (10.3–23.5) | - | 0.312 | - | - |
Initial 177Lu activityb | ||||||
> 14 GBq | 33 (50.0) | 16.8 (14.4–19.3) | ||||
≤ 14 GBq | 33 (50.0) | 23.7 (11.5–35.9) | - | 0.474 | - | - |
CI, confidence interval; HR, hazard ratio; TLP, total lesion PSMA; PSA, prostate-specific antigen; ALP, alkaline phosphatase; ECOG, Eastern Cooperative Oncology Group. aBaseline parameter. bCumulative activity of the first two [177Lu]Lu-PSMA-617 RLT cycles. p-values printed in bold type are statistically significant at p < 0.05