Article Figures & Data
Figures
- FIGURE 1.
Waterfall plots showing PSA changes relative to baseline after 2 cycles of 177Lu-PSMA (A) and any time during treatment (B).
- FIGURE 2.
Survival Kaplan–Meier curves. Kaplan–Meier curves for PSA PFS (A) and OS (B) by treatment arm. Tick marks indicate censored data. The log-rank test is given with P < 0.05 considered significant.
- FIGURE 3.
Kaplan–Meier curves for OS by PSA response after 2 cycles (A) and at any time (B). Tick marks indicate censored data. The log-rank test is given with P < 0.05 considered significant.
Tables
Characteristic Overall (n = 43) 6.0 GBq (n = 14) 7.4 GBq (n = 29) Age (y) 74 (68–78) 76 (70–79) 72 (65–78) Time since diagnosis of PCa (y) 7 (4–17) 8 (5–17) 7 (4–15) Gleason grade group at diagnosis* ≥4 25 (64%) 9 (69%) 16 (62%) PSA (ng/mL) 27.4 (9.5–115.6) 31.3 (12.6–160.2) 26.1 (9.5–124.4) PSA doubling time (mo) 1.5 (1.0–2.3) 1.3 (1.0–1.7) 1.8 (1.0–3.2) Total alkaline phosphatase (U/I) 87 (67–125) 82 (60–175) 94 (69–117) Hemoglobin (g/dL) 12.0 (10.9–13.2) 12.1 (11.2–12.9) 11.6 (10.8–13.3) Platelets (103/mL) 208 (160–245) 207 (163–356) 208 (158–238) ECOG performance status 0 13 (30%) 8 (57%) 5 (17%) 1 21 (49%) 4 (29%) 17 (59%) 2 9 (21%) 2 (14%) 7 (24%) Pain at baseline (BPI score) No pain 21 (49%) 4 (28%) 17 (58%) Mild (1–4) 11 (26%) 5 (36%) 6 (21%) Moderate to severe (5–10) 11 (26%) 5 (36%) 6 (21%) Previous mCRPC systemic treatments Chemotherapy regimen lines 0 11 (26%) 4 (29%) 7 (24%) 1 10 (23%) 4 (29%) 6 (21%) 2 12 (28%) 3 (21%) 9 (31%) ≥3 10 (23%) 3 (7%) 7 (24%) Abiraterone 41 (95%) 13 (93%) 28 (97%) Enzalutamide 37 (86%) 13 (93%) 24 (83%) Abiraterone + enzalutamide 35 (82%) 12 (86%) 23 79%) 223Ra 14 (33%) 4 (29%) 10 (35%) Prior lines of mCRPC systemic treatment 1 4 (9%) 1 (7%) 3 (10%) ≥2 39 (91%) 13 (93%) 26 (90%) ≥3 31 (72%) 10 (71%) 21 (72%) ≥4 25 (58%) 8 (57%) 17 (59%) Extent of disease on PSMA-PET ≤20 metastases 14 (33%) 4 (29%) 10 (34%) 2 metastases 29 (67%) 10 (71%) 19 (66%) Sites of disease on PSMA PET Node only (N1 or M1a) 3 (7%) 1 (7%) 2 (7%) Bone only (M1b) 9 (21%) 3 (21%) 6 (21%) Node + bone (M1b and [N1 or M1a]) 15 (35%) 7 (50%) 8 (28%) Visceral (M1c with/without any other site)† 15 (35%) 3 (21%) 12 (41%) Outcome measure Overall (n = 43) 6.0 GBq (n = 14) 7.4 GBq (n = 29) Hazard ratio (95% CI) P Primary endpoint PSA response after 2 cycles No. of evaluable patients 40 13 27 PSA decline ≥ 50% after 2 cycles 11 (28%, 95% CI 15–44) 6 (46%, 95% CI 19–75) 5 (19%, 95% CI 6–38) — 0.12* Secondary endpoint Best PSA response No. of evaluable patients 43 14 29 Best PSA response ≥ 50% 16 (37%, 95% CI 23–53) 7 (50%, 95% CI 23–77) 9 (31%, 95% CI 15–51) — 0.31* Pain response No. of evaluable patients 18 7 11 Patients with pain improvement (n) 12 (67%) 6 (86%) 6 (55%) — 0.31* Pain PFS Median (mo) 8.2 (95% CI 3.9–12.5) 5.4 (not reached) 8.2 (95% CI 2.3–14.1) 0.96 (0.35–2.66) 0.94 Post hoc analysis OS Median (mo) 14.0 (95% CI 10.1–17.9) 15.8 (95% CI 11.8–19.4) 13.5 (95% CI 10.0–17.0) 0.94 (0.46–1.92) 0.87 ↵* P values compare the 6.0- and 7.4-GBq treatment arms using exact Fisher test.
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