Urinary functional outcomes and toxicity five years after proton therapy for low- and intermediate-risk prostate cancer: Results of two prospective trials

Figures & data

Table I. Median IPSS at six-month intervals.

Pretreatment IPSS	N	Median Pretreatment IPSS (range)	Median post-treatment IPSS (range)
			6M	12M	24M	36M	48M	60M
< 15	137	6 (0–14)	5 (0–35)	7 (0–25)	6 (0–25)	6 (0–23)	6 (0–20)	6 (0–23)
			130 pts.	117 pts.	112 pts.	95 pts.	92 pts.	50 pts.
≥ 15	34	18 (15–25)	11 (1–21)	14.5 (2–27)	13.5 (3–28)	12 (3–30)	12 (3–27)	10 (3–21)
			30 pts.	30 pts.	26 pts.	20 pts.	19 pts.	12 pts.
Total	171*	8 (0–25)	7 (0–35)	7 (0–27)	7 (0–28)	6 (0–30)	7 (0–27)	7 (0–23)
			160 pts.	147 pts.	138 pts.	115 pts.	111 pts.	62 pts.

IPSS, International Prostate Symptom Score; M, month; N, number of patients.

*171 patients available for analysis of pretreatment data.

Table II. Post-treatment changes in International Prostate Symptom Score (IPSS; up to 60 months of follow-up).

Increase in post-treatment IPSS
Baseline IPSS	N*	No. of patients with > 5-point increase at any point after treatment (%)	No. of patients with > 5-point increase at last follow-up (%)	No. of patients with ≥ 5-point increase resolved at last follow-up (%)
< 15	137	62 (45.2%)	29 (21.2%)	33 (24.1%)
15–25	33	4 (12.1%)	1 (3.0%)	3 (9.1%)
Total	170	66 (38.8%)	30 (17.6%)	36 (21.2%)
Decrease in post-treatment IPSS
Baseline IPSS	N	No. of patients with > 5-point decrease at any point after treatment (%)	No. of patients with > 5-point decrease at last follow-up (%)	No. of patients with ≥ 5-point decrease in IPSS no longer present at last follow-up (%)
< 15	89**	35 (39.3%)	20 (22.5%)	15 (16.9%)
15–25	33	29 (87.9%)	18 (54.5%)	11 (33.3%)
Total	122	64 (52.5%)	38 (31.1%)	26 (21.3%)

*One patient died during treatment, leaving 170 available for follow-up analysis. **48 patients of the 137 with IPSS < 15 had baseline. IPSS < 5 and thus could not be assessed for a decrease in IPSS of ≥ 5.

Table III. Prevalence and cumulative incidence of grade (Gr) 2 + genitourinary (GU) toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v3.0*.

GU intervention required prior to PT	No. of patients developing Gr2 + toxicity during PT/no. of patients	No. of patients developing Gr2 + toxicity at a given point in time (months) after PT/no. of patients treated						Cumulative incidence of Gr 2 + GU toxicity at 5 years
		6M	12M	24M	36M	48M	60M
All patients (N = 171)	17 (9.9%)	5 (2.9%)	6 (3.6%)	13 (8.1%)	17 (10.7%)	5 (3.3%)	5 (3.6%)	39 (22.9%)
None (N = 100)	10 (10.0%)	2 (2.0%)	0 (0.0%)	3 (3.1%)	6 (6.3%)	2 (2.2%)	2 (2.4%)	15 (15.2%)
Any GU Symptom management** (N = 71)	7 (9.9%)	3 (4.2%)	6 (8.5%)	10 (15.4%)	11 (17.2%)	3 (5.0%)	3 (5.5%)	24 (33.8%)
Alpha blockers (N = 58)	4 (6.9%)	1 (1.7%)	5 (8.6%)	6 (11.3%)	10 (18.9%)	3 (6.1%)	3 (6.8%)	20 (34.5%)
Antibiotics (N = 21)	3 (14.3%)	2 (9.5%)	2 (9.5%)	3 (15.8%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	5 (23.8%)
TURP*** (N = 10)	1 (10.0%)	1 (10.0%)	1 (10.0%)	2 (22.2%)	1 (11.1%)	0 (0.0%)	0 (0.0%)	3 (30.0%)
Hormones (N = 26)	1 (3.8%)	0 (0.0%)	1 (3.8%)	4 (18.2%)	3 (13.6%)	1 (4.8%)	1 (5.3%)	7 (26.9%)

PT, proton therapy; TURP, transurethral resection of the prostate.

*Each patient coded once only at each time interval for highest grade symptom present. **Includes alpha blockers, antibiotics, TURP, or hormones. ***Transurethral resection of prostate tissue or other ablative procedure such as suprapubic prostate resection, green light laser, prostiva, etc.

Table IV. Cumulative incidence of Gr2 + acute and late events (CTCAE v.3.0).

Acute GU 2 +
International Prostate Symptom Score	None	Events	p-Value
0–14	124 (90.5%)	13 (9.5%)	0.7491
15–25	30 (88.2%)	4 (11.8%)
Late GU 2 +
International Prostate Symptom Score	None	Events	p-Value
0–14	111 (81.0%)	26 (19.0%)	0.014
15–25	20 (60.6%)	13 (39.4%)