Clinical Study
Intensified Adjuvant Treatment of Prostate Carcinoma: Feasibility Analysis of a Phase I/II Trial
Table 3
(a) Acute toxicity (RTOG). (b) Patients and treatment parameters: impact on gastrointestinal acute toxicity. (c) Patients and treatment parameters: impact on genitourinary acute toxicity.
(a) |
| | Grade | | 0 | 1 | 2 | 3 | 4 |
| Gastrointestinal | 64 (52.0%) | 43 (35.0%) | 13 (10.6%) | 3 (2.4%) | 0 (0.0%) | Genitourinary | 60 (48.8%) | 47 (38.2%) | 12 (9.8%) | 4 (3.3%) | 0 (0.0%) |
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(b) |
| | Number of patients | Grade | Grade | | 0-1 | ≥2 | = | 0–2 | ≥3 | = |
| Age | | | | | | | | 65 years | 72 | 60 (83.3%) | 12 (16.7%) | 0.152 | 70 (97.2%) | 2 (2.8%) | 0.772 | 65 years | 51 | 47 (92.2%) | 4 (7.8%) | 50 (98.0%) | 1 (2.9%) | Dose | | | | | | | | 64.8 Gy | 18 | 14 (77.8%) | 4 (22.2%) | 0.185 | 18 (100.0%) | 0 (0.0%) | 0.619 | 70.2 Gy | 105 | 93 (88.6%) | 12 (11.4%) | 102 (97.1%) | 3 (2.9%) | ENI | | | | | | | | No | 52 | 48 (92.3%) | 4 (7.7%) | 0.072 | 52 (100.0%) | 0 (0.0%) | 0.189 | Yes | 71 | 59 (83.1%) | 12 (16.9%) | 68 (95.8%) | 3 (4.2%) | AHT | | | | | | | | No | 38 | 34 (89.5%) | 4 (10.5%) | 0.758 | 37 (97.4%) | 1 (2.6%) | 0.276 | Bicalutamide | 48 | 42 (87.5%) | 6 (12.5%) | 48 (100.0%) | 0 (0.0%) | LH-RH agonist | 37 | 31 (83.8%) | 6 (16.2%) | 35 (94.6%) | 2 (5.4%) |
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ENI: elective nodal irradiation; AHT: adjuvant hormonal therapy.
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(c) |
| | Number of patients | Grade | Grade | | 0-1 | ≥2 | = | 0–2 | ≥3 | = |
| Age | | | | | | | | 65 years | 72 | 62 (86.1%) | 10 (13.9%) | 0.730 | 69 (95.8%) | 3 (4.2%) | 0.497 | 65 years | 51 | 45 (88.2%) | 6 (11.8%) | 50 (98.0%) | 1 (2.0%) | Dose | | | | | | | | 64.8 Gy | 18 | 17 (94.4%) | 1 (5.6%) | 0.278 | 18 (100.0%) | 0 (0.0%) | 0.527 | 70.2 Gy | 105 | 90 (85.7%) | 15 (14.3%) | 101 (96.2%) | 4 (3.8%) | ENI | | | | | | | | No | 52 | 48 (92.3%) | 4 (7.7%) | 0.071 | 50 (96.2%) | 2 (3.8%) | 0.566 | Yes | 71 | 59 (83.1%) | 12 (16.9%) | 69 (97.2%) | 2 (2.8%) | AHT | | | | | | | | No | 38 | 35 (92.1%) | 3 (7.9%) | 0.050 | 37 (97.4%) | 1 (2.6%) | 0.264 | Bicalutamide | 48 | 44 (91.7%) | 4 (8.3%) | 45 (93.8%) | 3 (6.3%) | LH-RH agonist | 37 | 28 (75.7%) | 9 (24.3%) | 37 (100.0%) | 0 (0.0%) |
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ENI: elective nodal irradiation; AHT: adjuvant hormonal therapy.
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