Table 5.
Covariates | Level | CTCAE Grade 2+ GI Late Toxicity (6–24 Months) | CTCAE Grade 2+ GI Persistent GI Late Toxicity | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
No (n=377) |
Yes (n=52) |
Univariable | Multivariable (n = 428) |
No (n=415) |
Yes (n=18) |
Univariable | |||||
N (%) or Median (IQR) |
N (%) or Median (IQR) |
OR (95% CI) |
p value |
OR (95% CI) |
p value |
N (%) or Median (IQR) |
N (%) or Median (IQR) |
OR (95% CI) |
p value |
||
Baseline grade 2+ GI toxicity |
No Yes Missing |
373 (99) 2 (1) 2 |
49 (98) 1 (2) 2 |
308 (99) 3 (1) 4 |
18 (100) 0 (0) 0 |
||||||
Baseline EPIC-26 bowel sub-domain score |
Median (n) |
100 (96-100) (n=339) |
100 (92-100) (n=46) |
0.99 (0.95-1.02) | 0.55 | 100 (96-100) (n=373) |
96 (92-100) (n=16) |
0.98 (0.93-1.04) | 0.55 | ||
Worst acute grade 2+ GI Toxicity |
No Yes Missing |
352 (94) 24 (6) 1 |
40 (77) 12 (23) 0 |
4.4 (2.04-9.47) | <0.0001 | 4.61 (2.11-10.06) |
<0.0001 | 379 (92) 33 (8) 3 |
15 (83) 3 (17) 0 |
2.30 (0.63-8.34) | 0.21 |
Persistent grade 2+ acute GI toxicity |
No Yes |
374 (99) 3 (1) |
48 (92) 4 (8) |
10.39 (2.26-47.82) | 0.003 | 409 (99) 6 (1) |
17 (94) 1 (6) |
4.01 (0.46-35.19) |
0.21 | ||
Worst acute EPIC-26 bowel sub-domain score |
Median (n) |
92 (75-100) (n=354) |
88 (67-96) (n=51) |
0.98 (0.97-1.00) | 0.04 | 92 (75-100) (n=390) |
87.5 (67-92) (n=17) |
0.97 (0.95-1.00) | 0.02 | ||
Worst acute bowel symptoms Grade 1+ rectal bleeding Grade 2+ diarrhoea Grade 1+ rectal pain Grade 2+ proctitis |
No Yes No Yes No Yes No Yes |
319 (85) 57 (15) 395 (100) 0 (0) 333 (89) 43 (11) 368 (98) 8 (2) |
39 (75) 13 (25) 30 (83) 6 (17) 39 (75) 13 (25) 49 (94) 3 (6) |
1.87 (0.94-3.71) 3.72 (0.66-20.83) 2.58 (1.28-5.22) 2.82 (0.72-10.97) |
0.08 0.14 0.008 0.14 |
347 (84) 65 (16) 406 (99) 6 (1) 357 (87) 55 (13) 401 (97) 11 (3) |
13 (72) 5 (28) 18 (100) 0 17 (94) 1 (6) 18 (100) 0 |
2.05 (0.71-5.96) 0.38 (0.05-2.93) |
0.19 0.35 |
||
Age | Median (n) |
69 (65-73) (n=377) |
69 (66-73.5) (n=52) |
1.01 (0.96-1.05) | 0.80 | 69 (65-73) (n=415) |
70 (67-75) (n=18) |
1.04 (0.96-1.12) | 0.37 | ||
Prostate Volume (cm3) | Median (n) |
44 (33-58) (n=367) |
43 (32-55) (n=47) |
0.99 (0.98-1.01) | 0.50 | 44 (33-58) (n=401) |
38 (30-46) (n=15) |
0.98 (0.95-1.02) | 0.32 | ||
Risk group (intermediate) |
low int |
42 (11) 335 (89) |
1 (2) 51 (98) |
6.39 (0.86-47.48) | 0.07 | 6.32 (0.83-48.2) | 0.08 | 43 (10) 372(89) |
0 18 (100) |
||
Fiducial use (Yes) | No Yes |
158 (42) 219 (58) |
27 (52) 25 (48) |
0.67 (0.37-1.19) | 0.17 | 0.74 (0.41-1.35) | 0.33 | 181 (44) 234 (56) |
6 (33) 12(67) |
1.55 (0.57-4.20) | 0.39 |
OR = odds ratio; IQR = interquartile range; GI = gastrointestinal; EPIC = Expanded Prostate Cancer Index Composite; Int = Intermediate. Multivariable analysis for CTCAE grade 2+ persistent late GI toxicity was noted performed due to low number of events.