Article Figures & Data
Figures
- FIGURE 1.
Kaplan–Meier curves for OS (A) and rPFS (B) for both T-pretreated and T-naïve patients.
Tables
- TABLE 1
Baseline Characteristics at Time of First 177Lu-PRLT and Gleason Score/Disease Stage at Initial Diagnosis
Characteristic T-pretreated (n = 83) T-naïve (n = 84) P Age (y) 69.3 ± 8.7 70.8 ± 7.8 0.249 Karnofsky performance status 0.003 <70 16 (19%) 6 (7%) 70 13 (16%) 7 (8%) 80 24 (29%) 24 (29%) 90 28 (34%) 33 (39%) 100 2 (2%) 14 (17%) Metastatic disease extent Bone metastases 75 (90%) 66 (79%) 0.036 Nodal metastases 68 (82%) 68 (81%) 0.871 Visceral metastases (liver or lung) 20 (24%) 16 (19%) 0.428 Additional prior therapy Abiraterone or enzalutamide 63 (76%) 32 (38%) <0.001 Nontaxane chemotherapy 9 (11%) 0 (0%) NA 223Ra 12 (14%) 2 (2%) 0.005 External beam radiotherapy to bone 30 (36%) 25 (30%) 0.380 Time between initial diagnosis and first 177Lu-PRLT (mo) 68.8 (34.3–125.7) 72.3 (32.5–132.8) 0.813 PSA (ng/mL) 196.3 (34.1–766.1) 33.6 (4.9–106.4) <0.001 Hematologic results Hemoglobin (mmol/L) 6.9 (5.9–7.9) 8.0 (7.2–8.5) <0.001 Red blood cell count (10 ^ 6/μL) 4.0 (3.5–4.3) 4.2 (3.9–4.5) 0.002 White blood cell count (10 ^ 3/μL) 6.6 (5.0–8.1) 6.2 (5.0–7.2) 0.129 Platelet count (10 ^ 3/μL) 207 (181–265) 216 (173–259) 0.794 Renal function tests* Creatinine (μmol/L) 77.5 (67.8–92.0) 77.7 (68.2–92.6) 0.753 Urea (mmol/L) 7.0 (5.4–8.5) 6.3 (5.3–7.4) 0.048 eGFR (mL/min) 86.1 (70.5–100.6) 86.2 (70.0–97.8) 0.848 Liver function tests* Bilirubin (μmol/L) 5 (4–7) 6 (5–8) 0.016 AST (U/L) 26 (20–50) 23 (19–31) 0.044 ALT (U/L) 16 (12–24) 17 (12–24) 0.600 GGT (U/L)† 32 (22–80) 22 (17–48) 0.004 ALP (U/L) 128 (69–282) 84 (60–150) 0.007 Gleason score at initial diagnosis 0.062 ≤7 19 (23%) 33 (39%) ≥8 46 (55%) 41 (49%) Unknown 18 (22%) 10 (12%) Disease stage at initial diagnosis T stage 0.165 T1/2 11 (13%) 18 (21%) T3/4 49 (59%) 44 (52%) TX 23 (28%) 22 (26%) N stage 0.540 N0 30 (36%) 32 (38%) N1 25 (30%) 21 (25%) NX 28 (34%) 31 (37%) M stage 0.698 M0 35 (42%) 30 (36%) M1 18 (22%) 13 (15%) MX 30 (36%) 41 (49%) Treatment details T-pretreated (n = 83) T-naïve (n = 84) Median number of cycles 3 (1–3) 3 (2–4) Average administered activity per cycle (GBq) 6.3 (5.7–6.8) 6.3 (5.7–6.7) Median total administered activity (GBq) 15.5 (7.5–20.0) 16.3 (10.9–24.8) - TABLE 3
Univariate Analysis and Multivariable Analysis of OS and rPFS in T-Pretreated Patients
Univariate analysis Multivariable analysis OS rPFS OS rPFS Subgroup HR P HR P HR P HR P Age: >70 y 0.97 (0.55–1.72) 0.926 1.00 (0.62–1.61) 0.985 NA NA NA NA Karnofsky performance status: ≤80 2.94 (1.43–6.07) 0.003 1.56 (0.94–2.60) 0.088 2.71 (1.22–6.03) 0.015 1.41 (0.81–2.46) 0.221 Baseline PSA: >60 ng/mL 2.59 (1.28–5.26) 0.008 1.43 (0.86–2.39) 0.173 0.96 (0.44–2.10) 0.924 0.61 (0.32–1.15) 0.125 Time from diagnosis to first 177Lu-PRLT treatment: >5 y 0.70 (0.40–1.23) 0.217 0.54 (0.33–0.88) 0.013 NA NA 0.49 (0.30–0.82) 0.006 Cumulative administered activity: >16 GBq 0.32 (0.18–0.58) <0.001 0.81 (0.50–1.30) 0.375 0.37 (0.20–0.69) 0.002 NA NA Bone metastases: yes 11.77 (1.61–86.20) 0.015 2.29 (0.98–5.34) 0.057 3.03 (0.38–24.15) 0.295 1.13 (0.44–2.88) 0.801 Visceral metastases: yes 2.71 (1.50–4.89) 0.001 1.55 (0.91–2.64) 0.110 1.72 (0.92–3.24) 0.090 0.97 (0.53–1.76) 0.908 Baseline hemoglobin: ≤7.5 mmol/L 4.61 (2.04–10.39) <0.001 2.56 (1.45–4.50) 0.001 2.76 (1.11–6.89) 0.029 2.59 (1.26–5.33) 0.010 Baseline ALP: ≥220 U/L 1.84 (1.02–3.33) 0.043 2.21 (1.33–3.65) 0.002 1.20 (0.64–2.27) 0.570 2.00 (1.14–3.50) 0.015 HR = hazard ratio; NA = not applicable.
Data in parentheses are 95% CIs.
Univariate analysis Multivariable analysis* OS rPFS OS rPFS Subgroup HR P HR P HR P HR P Age: >70 y 1.23 (0.59–2.53) 0.584 0.68 (0.41–1.14) 0.142 NA NA 0.71 (0.42–1.21) 0.212 Karnofsky performance status: ≤80 2.05 (0.99–4.26) 0.055 0.83 (0.49–1.39) 0.477 0.60 (0.22–1.66) 0.326 NA NA Baseline PSA: >60 ng/mL 2.40 (1.16–4.98) 0.019 1.88 (1.09–3.24) 0.024 1.41 (0.50–4.00) 0.521 1.01 (0.50–2.03) 0.977 Time from diagnosis to first 177Lu-PRLT treatment: >5 y 0.42 (0.20–0.86) 0.018 0.59 (0.35–0.98) 0.040 0.72 (0.32–1.65) 0.439 0.71 (0.42–1.21) 0.205 Cumulative administered activity: >16 GBq 0.42 (0.21–0.86) 0.017 0.89 (0.53–1.49) 0.658 0.44 (0.18–1.10) 0.080 NA NA Bone metastases: yes 3.46 (1.05–11.42) 0.041 1.49 (0.77–2.86) 0.235 2.51 (0.70–8.97) 0.156 NA NA Visceral metastases: yes 1.56 (0.69–3.52) 0.285 2.08 (1.13–3.82) 0.018 NA NA 2.30 (1.23–4.33) 0.009 Baseline hemoglobin: ≤7.5 mmol/L 2.96 (1.45–6.05) 0.003 1.76 (1.03–3.02) 0.039 1.22 (0.44–3.37) 0.706 1.28 (0.70–2.32) 0.428 Baseline ALP*: ≥220 U/L 12.93 (4.98–33.60) <0.001 4.03 (2.03–7.98) <0.001 11.7 (2.92–47.15) 0.001 3.87 (1.55–9.70) 0.004 ↵* Data available for 83 patients.
HR = hazard ratio; NA = not applicable.
Data in parentheses are 95% CIs.
- TABLE 5
Baseline Toxicity Grade Before 177Lu-PRLT and Worst Toxicity Grade Achieved After 177Lu-PRLT
T-pretreated (n = 83) T-naïve (n = 84) Organ system Before 177Lu-PRLT After 177Lu-PRLT Before 177Lu-PRLT After 177Lu-PRLT Hematologic toxicity Anemia All grades 77 (93%) 80 (96%) 65 (77%) 82 (98%) Grade 3 or 4 3 (4%) 7 (8%) 0 (0%) 1 (1%) Leukocytopenia All grades 10 (12%) 25 (30%) 8 (10%) 22 (26%) Grade 3 or 4 0 (0%) 2 (2%) 0 (0%) 0 (0%) Thrombocytopenia All grades 11 (13%) 30 (36%) 10 (12%) 22 (26%) Grade 3 or 4 1 (1%) 3 (4%) 0 (0%) 1 (1%) Renal toxicity* Creatinine All grades 16 (19%) 21 (25%) 9 (11%) 20 (24%) Grade 3 or 4 0 (0%) 0 (0%) 0 (0%) 0 (0%) eGFR All grades 17 (20%) 22 (27%) 9 (11%) 20 (24%) Grade 3 or 4 2 (2%) 2 (2%) 1 (1%) 2 (2%) Hepatic toxicity* Bilirubin All grades 1 (1%) 4 (5%) 2 (2%) 3 (4%) Grade 3 or 4 0 (0%) 0 (0%) 0 (0%) 0 (0%) AST All grades 19 (23%) 33 (40%) 8 (10%) 15 (18%) Grade 3 or 4 0 (0%) 0 (0%) 0 (0%) 0 (0%) ALT All grades 2 (2%) 10 (12%) 2 (2%) 4 (5%) Grade 3 or 4 0 (0%) 0 (0%) 0 (0%) 0 (0%) GGT† All grades 24 (29%) 31 (38%) 13 (16%) 20 (24%) Grade 3 or 4 4 (5%) 10 (12%) 0 (0%) 3 (4%) ALP All grades 41 (49%) 50 (60%) 22 (27%) 30 (36%) Grade 3 or 4 5 (6%) 9 (11%) 4 (5%) 8 (10%)
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