Figure 1
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Figure 4
Demographic characteristics of patients and baseline risk assessment
| Characteristics | Full analysis set | ||
|---|---|---|---|
| Group-1 (76.0 Gy/34 F, N = 33) | Group-2 (71.6 Gy/28 F, N = 34) | p-value | |
| Age, y (mean ± SD) | 79.7 ± 3.9 | 77.3 ± 5.1 | 0.284 |
| Median time of follow-up, y (range) | 8.9 (1.5–11.4) | 6.8 (2.6–8.4) | 0.002 |
| AJCC T stage, no. (%) | 0.121 | ||
| T1c/T1x | 1 (3.0) | 0 | |
| T2a/T2b/T2c/T2x | 29 (87.9) | 27 (79.4) | |
| T3a/T3b/T3x | 3 (9.1) | 6 (17.6) | |
| T4 | 0 | 1 (2.9) | |
| Risk stage, no. (%) | 0.204 | ||
| low risk | 3 (9.1) | 1 (2.9) | |
| intermediate risk | 11 (33.3) | 10 (29.4) | |
| high risk | 15 (45.5) | 18 (53.0) | |
| very high risk | 4 (12.1) | 5 (14.7) | |
| Gleason score, no. (%) | 0.775 | ||
| 5–6 | 12 (36.4) | 13 (38.2) | |
| 7 | 10 (30.3) | 13 (38.2) | |
| 8–9 | 8 (24.2) | 5 (14.7) | |
| unknown | 3 (9.1) | 3 (8.8) | |
| Pre-treatment PSA, no. (%) | 0.442 | ||
| < 10 ng/mL | 11 (33.3) | 7 (20.6) | |
| 10–20 ng/mL | 8(24.2) | 8 (23.5) | |
| > 20 ng/mL | 14 (42.4) | 19 (55.9) | |
| Comorbidity | |||
| Diabetes | 4 (12%) | 3 (8.8%) | 0.659 |
| Hypertension | 7 (21.2%) | 8 (23.5%) | 0.820 |
| Symptomatic haemorrhoids | 3 (9.1%) | 1 (2.9%) | 0.288 |
| Intended androgen deprivation therapy | 0.288 | ||
| LHRH plus short-term AA | 30 (90.9%) | 33 (97.1%) | |
| Other | 3 (9.1%) | 1 (2.9%) | |
| Radiotherapy (mean ± SD) treatment time, w | 6.8 ± 0.4 | 5.8 ± 0.5 | < 0.001 |
| Result by Roach formula, no. (%) | 0.791 | ||
| > 15% | 23 (69.7) | 25 (73.5) | |
| ≤ 15% | 10 (30.3) | 9 (26.5) | |
| Elective (%) lymph node irradiation, no. | 0 | 25 (73.5) | |
Univariate and multivariate analysis for OS, PFS
| Factor | Univariate analysis | Multivariate analysis | ||||
|---|---|---|---|---|---|---|
| HR | 95% CI | p-value | HR | 95% CI | p-value | |
| OS | ||||||
| HFRT regimens | 0.846 | 0.083–2.286 | 0.326 | 1.681 | 0.533–5.305 | 0.375 |
| Age > 80y | 0.631 | 0.170–2.021 | 0.398 | 0.536 | 0.161–1.786 | 0.310 |
| iPSA > 20ng/ml | 1.151 | 0.088–8.015 | 0.880 | 1.008 | 0.992–1.025 | 0.303 |
| Gleason ≥ 8 | 0.835 | 0.177–4.670 | 0.908 | 0.885 | 0.252–3.104 | 0.849 |
| T > 3b | 1.062 | 0.219–14.069 | 0.596 | 2.941 | 0.505–17.137 | 0.230 |
| High and very high risk | 1.340 | 0.072–13.742 | 0.996 | 0.875 | 0.196–3.904 | 0.861 |
| Roach > 15% | 0.787 | 0.426–9.305 | 0.381 | 5.581 | 0.623–49.969 | 0.124 |
| RT time > 42 d | 0.883 | 0.218–6.949 | 0.813 | 0.267 | - | 0.605 |
| PFS | ||||||
| HFRT regimens | 1.843 | 0.347–9.794 | 0.473 | 1.659 | - | 0.198 |
| Age > 80y | 1.224 | 0.371–4.035 | 0.740 | 0.517 | - | 0.472 |
| iPSA > 20ng/ml | 0.331 | 0.023–4.806 | 0.418 | 0.277 | - | 0.598 |
| Gleason ≥ 8 | 0.749 | 0.140–4.001 | 0.735 | 0.851 | - | 0.356 |
| T > 3b | 0.119 | 0.010–1.363 | 0.087 | 0.197 | 0.065–0.594 | 0.004 |
| High and very high risk | 2.639 | 0.135–51.718 | 0.523 | 0.169 | - | 0.681 |
| Roach > 15% | 0.660 | 0.156–2.796 | 0.837 | 1.075 | - | 0.300 |
| RT time > 42 d | 0.832 | 0.144–4.807 | 0.324 | 0.257 | - | 0.605 |
Survival analysis of PC patients according to the data obtained during the last follow-up
| Measures | Events at 7 years | |||
|---|---|---|---|---|
| Total (n = 67) | Group-1 (n = 33) | Group-2 (n = 34) | p-value | |
| Full analysis set | ||||
| BF, no. (%) | 16 (23.9) | 9 (27.3) | 7 (20.6) | 0.521 |
| BCDF, no. (%) | 26 (38.8) | 15 (45.5) | 11 (32.4) | 0.271 |
| Overall deaths, no. (%) | 18 (26.9) | 12 (36.4) | 6 (17.6) | 0.164 |
| Deaths of PC in overall death, no. (%) | 5 (27.8) | 3 (25.0) | 2 (33.3) | 0.638 |
| nPC deaths, no. (%) | 13 (72.2) | 9 (75.0) | 4 (66.7) | 0.213 |
| PFS, % | 71.6 | 68.6 | 74.8 | 0.591 |
| BFFS, % | 77.6 | 74.0 | 80.3 | 0.915 |
| PCSS, % | 91.9 | 89.9 | 93.8 | 0.605 |
| OS, % | 77.0 | 71.9 | 87.5 | 0.376 |
Late genitourinary and gastrointestinal toxicities after a median follow-up of 7_2 years
| Toxicity | Safety set | ||
|---|---|---|---|
| Group-1 (n = 32) | Group-2 (n = 32) | p-value | |
| GU | 0.127 | ||
| Grade 0 | 15 (46.9%) | 17 (53.1%) | |
| Grade 1 | 15 (46.9%) | 13 (40.6%) | |
| Grade 2 | 1 (3.1%) | 0 | |
| Grade 3 or 4 | 1 (3.1%) | 2 (6.3%) | |
| GI | 0.554 | ||
| Grade 0 | 24 (75.0%) | 24 (75.0%) | |
| Grade 1 | 5 (15.6%) | 3 (9.4%) | |
| Grade 2 | 3 (9.4%) | 2 (6.2%) | |
| Grade 3 or 4 | 0 (0%) | 3 (9.4%) | |