Table 1 Demographic and disease characteristics of the patients (N = 172)
Characteristic | IORT Group | IORT+EBRT Group | P |
|---|---|---|---|
no. (%) | N = 92 (53.5) | N = 80 (46.5) | |
Follow-up duration - median (range) - months | 25 (0.9–62.5) | 22 (0–57.7) | 0.52 |
Age | 0.67 | ||
Median (range) - yr | 65.5 (38.0–83.0) | 65 (33.0–85.0) | |
< 65 yr - no (%) | 40 (43.5) | 38 (47.5) | |
Male sex - no. (%) | 49 (53.3) | 39 (48.8) | 0.55 |
Primary Cancer Site - no. (%) | < 0.0001 | ||
Upper Third Rectum (incl. rectosigmoid) | 17 (18.5) | 5 (6.3) | |
Middle Third Rectum | 53 (57.6) | 19 (23.8) | |
Lower Third Rectum | 22 (23.9) | 56 (70.0) | |
neoadjuvant EBRT Dose [Gy] - no. (%) | |||
50,4 | 0 | 79 (98.7) | |
< 50,4 | 0 | 1 (1.3) | |
Pathologic Tumor Stage - no. (%) | |||
T | 0.047 | ||
T2 | 2 (2.2) | 2 (2.5) | |
T3 | 82 (89.1) | 59 (73.8) | |
T4a | 7 (7.6) | 14 (17.5) | |
T4b | 1 (1.1) | 5 (6.3) | |
N | 0.0001 | ||
N0 | 78 (84.8) | 41 (51.3) | |
N1 | 11 (12.0) | 25 (31.3) | |
N2 | 3 (3.3) | 14 (17.5) | |
Stage Group - no. (%) | 0.0001 | ||
II | 77 (83.7) | 41 (51.3) | |
IIA | 72 (87.3) | 32 (40.0) | |
IIB | 5 (5.4) | 8 (10.0) | |
IIC | 0 | 1 (1.3) | |
III | 15 (16.3) | 39 (48.8) | |
IIIA | 8 (8.7) | 13 (16.25) | |
IIIB | 7 (7.6) | 24 (30.6) | |
IIIC | 0 | 2 (2.5) | |
Histology - no. (%) | 0.5 | ||
Adenocarcinoma | 91 (98.9) | 78 (97.5) | |
Squamous cell carcinoma | 1 (1.1) | 1 (1.2) | |
Mucinous carcinoma with ring cell components | 0 | 1 (1.2) | |
Differentiation - no. (%) | 0.25 | ||
Well differentiated (G1) | 4 (4.3) | 0 | |
Modarately differentiated (G2) | 79 (85.9) | 72 (90.0) | |
Poorly differentiated (G3) | 8 (8.7) | 6 (7.5) | |
Grade cannot be assessed (Gx) | 1 (1.1) | 6 (7.5) | |
Tumor size | 0.02 | ||
median (range) - cm | 4.0 (1.5–9) | 5.0 (2.0–8.0) | |
< 2.5 cm - no. (%) | 5 (5.4) | 2 (2.6) | |
2.5–4.0 cm - no. (%) | 43 (46.7) | 29 (36.3) | |
> 4.0 cm - no. (%) | 44 (47.8) | 49 (61.3) | |
Resection - no. (%) | 0.0001 | ||
High anterior resection | 15 (16.3) | 4 (5.0) | |
Low anterior resection | 63 (68.5) | 15 (18.8) | |
Ultra Low anterior resection | 3 (3.3) | 1 (1.3) | |
Abdomnial perineal excision | 8 (7.9) | 63 (75.0) | |
Hartmann’s Procedure | 3 (3.3) | 1 (1.3) | |
Resection status - no. (%) | 0.2 | ||
R0 | 89 (96.7) | 73 (91.3) | |
R1 | 3 (3.3) | 5 (6.3) | |
R2 | 0 | 2 (2.5) | |
Stoma - no. (%) | 0.0001 | ||
End Colostomy | 20 (21.7) | 60 (75.0) | |
Loop Colostomy | 66 (71.7) | 19 (23.8) | |
Loop Ileostomy | 5 (5.4) | 1 (1.3) | |
none | 1 (1.1) | 0 | |
IORT - median (range) | |||
Dose on applicator surface (Gy) | 15 (15.0–17.0) | 15 (8.4–17) | 0.1 |
Treatment Time (min) | 34 (25.0–38.0) | 34 (15.0–38.0) | 0.64 |
Applicator Size (cm) | 5 (4.5–5.0) | 5 (4.5–5.0) | 0.68 |
Days to discharge after surgery - median (range) | 16 (5.0–25.0) | 16 (9.0–42.0) | 0.4 |
Chemotherapy - no. (%) | 0.0001 | ||
any | 10 (10.9) | 37 (46.3) | |
both | 0 | 17 (21.3) | |
neoadjuvant | 0 | 20 (25.0) | |
adjuvant | 10 (10.9) | 34 (42.5) | |