Table 4.
Overview of treatment results, side-effects, and quality of life – status October 2017
| Authors | Substance | Number of patients | Therapy Scheme | PSA RESPONSE | RECIST/PERCIST RESPONSE | Quality of life | Side effects | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any decrease | ≥50% decrease | CR | PR | SD | PD | PFS | OS | Nephrotoxicity | Hematotoxicity | Xerostomia/xerophthalmia | |||||
| Baum et al. [111] | PSMA-I&T | 56 25 |
3.4–8.7 GBq /cycle (> 2–5 cycles) |
45/56 80.4% |
25/56 58.9% | 14 | 2 | 9 | 13.7 months |
Not reached | VAS score: Pain reduction in 2/6 patients, improvement in KPS | None | Insignificant decreases of erythrocytes and leucocytes – but no grade 3 or 4 | Two transient mild cases after 3 and 4 cycles. (8%) | |
| Kulkarni et al. [112] | PSMA-617 PSMA-I&T |
117 | 6 (2–9.7 GBq)/cycle 1–7 cycles |
61/80 76.3% | 46/87 57.6% |
5/58 8.6% | 12/58 20.7% | 29/58 39.7% |
18/59 31% | 10.7 months | pain reduction and quality of life improved significantly in symptomatic patients | No grade 3 to 4 | No grade 3 to 4 | Five cases of mild dryness (4.2%), frequent fatigue | |
| Rahbar et al. [113] | PSMA-617 | 145 | 5.8 GBq (2–8 GBq)/cycle 1 cycle 2 cycles 3 cycles 4 cycles |
65/99;66% 44/61;57% |
40/99;4035/61;57 13/20;653/3;100 |
2% | 45% | 25% | 28% | n.a. | n.a. | 18/145 patients grade 3–4 Grade 3–4: anemia 10% thrombocytopenia (4%) leukopenia (3%) |
8% | ||
| Rahbar et al. [114] | PSMA-617 | 74 23/74 |
5.9 ± 0.5 GBq (1 cycle) |
23/74 (31%) | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | Grade 0–1 | n.a. | n.a. |
| Yadav et al. [115] | PSMA-617 | 31 | 5 ± 1.8 MBq (1–4 cycles) |
22/31 70.9% |
n.a. | 2/6 | 3/6 | 1/6 | 6/31 | 12 months | 16 months | ECOG 3➔1 VAS-Score 9 ➔ 1 KPS 40 ➔ 80 |
No grade 3 or 4 | ||
| Heck et al. [116] | PSMA-I&T | 19 10/19 |
7.4 GBq/cycle (1–4 cycles) 3–4 cycles |
10/18 56% |
8/18 44% |
1/19 5% 1/10 |
n.a. | 12 63% 6/10 |
6 32% 3/10 |
n.a. | n.a. | bone pain reduction in 85%, 74% ECOG-improvement | No grade 3–4 | Dry mouth 7/19 (37%) | |
| Fendler et al. [117] | PSMA-617 | 15 | 3.7 GBq (n = 5) 6 GBq (n = 10) 2 cycles |
12/15 (80%) | 9/15 > 50% |
4/15 27% | 6/15 40% | 5/15 33% | 9/15 QoL improvement 7/10 Pain relief |
No grade 4 | |||||
| Scarpa et al. [118] | PSMA-617 | 10 | (5.4–6.5 GBq)/cycle 3 cycles |
3/10 (33%) | n.a. | 3/10 | 1/10 | 1/10 | n.a., 3 patients showed mixed response | No grade 3 to 4 | |||||
| Kratochwil et al. [119] | PSMA-617 | 30 11 |
3.7–6.0 GBq /cycle (1–3 cycles) 3 cycles |
21/30 | 13/30 8/11 |
6 patients, 50% decreased SUVmax | No data | No acute and late effects up to 24 weeks | Leukopenia: Grade 2: 2 patients thrombocytopenia: 1 patient changed from Grade 2 to Grade 3. After 3 cycles decreased platelets (−20%) at 24 weeks |
2/30 after the third cycle | |||||
| Ahmadzadehfar et al. [120] | 22/24 | 4.1–7.1 GBq/cycle 2 cycles |
68.2% | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | No grade 3 or 4 | 2 patients: Grade 2–3 anemia | Dry mouth in 8.7% | ||
| Ahmadzadehfar et al. [121] | 52 | 6 (4.0–7.2) GBq/cycle 1 cycle 2 cycles 3 cycles |
42; 80.8% 35; 67.3% 28;53.8% |
23;44.2% 12; 3.1% 10; 19.2% |
n.a. | n.a. | n.a. | n.a. | 60 weeks | n.a. | n.a. | n.a. | n.a. | n.a. | |
| Yordanova et al. [122] | PSMA-617 | 55 | 6 GBq (4.0–7.1 GBq) > − 3 cycles |
n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | n.a. | No grade 3–4 | n.a. | n.a. | |
| Bräuer et al. [123] | PSMA-617 | 59 | 5.9–6.3 GBq/cycle 3 cycles (1–7 cycles) |
91% | 53% | n.a. | n.a. | n.a. | n.a. | 18 weeks | 32 weeks | Transient fatigue in 12 patients | No grade 3 to 4 | 2 patients grade 3 leucopenia and thrombocytopenia (3%), grade 3 anemia in 11 patients (19%) | 15 patients (25%) xerostomia, 1 patient mild dryness of the eyes |
VAS score Visual Analogue Scale, KPS Karnofsky Performance Score, ECOG toxicity and response criteria of the Eastern Cooperative Oncology Group