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%)

(b)  

	Number of patients	Grade			Grade
		0-1	≥2	𝑃 =	0–2	≥3	𝑃 =
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%)

ENI: elective nodal irradiation; AHT: adjuvant hormonal therapy.

(c)  

	Number of patients	Grade			Grade
		0-1	≥2	𝑃 =	0–2	≥3	𝑃 =
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%)

ENI: elective nodal irradiation; AHT: adjuvant hormonal therapy.