Moderate hypofractionated helical tomotherapy for older patients with localized prostate cancer: long-term outcomes of a phase I–II trial
, , , , , , , y | 28 mar 2022
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Article Category: Research Article
Publicado en línea: 28 mar 2022
Páginas: 216 - 227
Recibido: 02 ago 2021
Aceptado: 11 feb 2022
DOI: https://doi.org/10.2478/raon-2022-0011
© 2022 Di Cui, Lei Du, Wei Yu, Boning Cai, Lingling Meng, Jun Yang, Yanrong Luo, Jing Chen, Lin Ma, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
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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 | |
| 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 |
| 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 | |
| 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%) | |