Table 3 Comparison of patients of cohorts G3S (R1E) and cohort 2 (R2E) eligible for the RIOP trial with patients eligible for the TARGIT A study and not eligible for RIOP (TE-RE)

n

1593/7580 (21%)

2443/7580 (32.2%)

356/4445 (8%)

1153/4445 (25.9%)

Age

p < 0.0001

< 45 years

0

0

0/356 (0%)

0/1509 (0%)

45-54 years

0

1248 (51.1%)

0/356 (0%)

459/1153 (39.8%)

≥55 years

1593 (100%)

1195 (48.9%)

356/356 (100%)

694/1153 (60.2%)

Tumor size

p < 0.0001

p < 0.0001

≤20 mm

1593/1593 (100%)

2081/2443 (85.2%)

356/356 (100%)

829/1152 (72%)

>20 mm

0/1593 (0%)

362/2443 (14.8%)

0/356 (0%)

323/1152 (28%)

Histology

p = 0.002

Ductal

1391/1593 (87.3%)

2205/2443 (90.3%)

356/356 (100%)

1153/1153 (100%)

Lobular

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

Mixed

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

Colloids, ductal medullary

202/1593 (12.7%)

238/2443 (9.7%)

0/356 (0%)

0/1509 (0%)

Grade

p < 0.0001

p < 0.0001

1

931/1593 (58.4%)

844/2395 (34.5%)

211/356 (59.3%)

393/1109 (35.4%)

2

662/1593 (41.6%)

920/2395 (37.7%)

145/356 (40.7%)

475/1109 (42.8%)

3

0/1593 (0%)

631/2395 (25.8%)

0/356 (0%)

241/1109 (21.7%)

pN

0

1593/1593 (100%)

2443/2443 (100%)

356/356 (100%)

1153/1153 (100%)

1 -3

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

>3

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

RH

p < 0.0001

p < 0.0001

+

1593/1593 (100%)

499/2443 (20.4%)

356/356 (100%)

495/1143 (43.3%)

-

0/1593 (0%)

1944/2433 (79.6%)

0/356 (0%)

648/1143 (56.7%)

EVPT

p < 0.0001

p < 0.0001

Absent

1593/1593 (100%)

333/1796 (18.5%)

356/356 (100%)

725/1035 (70%)

Present

0/1593 (0%)

1463/1796 (81.5%)

0/356 (0%)

310/1035 (30%)

Excision limits

Healthy

1593/1593 (100%)

2443/2443 (100%)

356/356 (100%)

1153/1153 (100%)

Unhealthy

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

Multifocality

No

1593/1593 (100%)

2443/2443 (100%)

356/356 (100%)

1153/1153 (100%)

Yes

0/1593 (0%)

0/2443 (0%)

0/356 (0%)

0/1153 (0%)

Chemotherapy

p < 0.0001

p < 0.0001

No

1387/1469 (94.4%)

720/2065 (20.4%)

317/356 (89%)

829/1153 (71.9%)

Yes

82/1469 (5.6%)

1645/2065 (79.6%)

39/356 (11%)

324/1153 (28.1%)

HT

p < 0.0001

p < 0.0001

Yes

1426/1589 (89.7%)

1864/2437 (76.5%)

356/356 (100%)

495/1143 (43.3%)

No

163/1589 (10.3%)

573/2437 (23.5%)

0/356 (0%)

648/1143 (56.7%)

Radiothery boost to tumor bed

NS

Yes

318/355 (89.6%)

998/1106 (90.2%)

No

37/355 (10.4%)

108/1106 (9.2%)

Boost dose

p < 0.0001

<20Gy

305/313 (97.4%)

851/985 (86.4%)

≥20Gy

8/313 (2.6%)

134/985 (13.6%)