Table 2.
Characteristics of UMBRELLA participants between October 2013 and July 2016
| Characteristics | Full cohort | Consent for future random allocation | No consent for future random allocation | Returned baseline questionnaire | Did not return baseline questionnaire |
|---|---|---|---|---|---|
| Number of participants | 1047a | 910 | 137 | 838 | 209 |
| Age at recruitment | |||||
| Mean (range) | 58 (27–83) | 57 (27–83) | 60 (28–82) | 58 (26–83) | 54 (23–82) |
| Surgery | |||||
| Breast conserving | 82% (858/1047) | 82% (742/910) | 83% (114/137) | 84% (700/838) | 76% (158/209) |
| Mastectomy | 17% (176/1047) | 17% (157/910) | 14% (19/137) | 15% (128/838) | 23% (48/209) |
| ALND only | <0.5% (3/1047) | <0.5% (3/910) | 0% | <0.5% (1/838) | 1% (2/209) |
| No surgery | 0.5% (6/1047) | <0.5% (4/910) | 1.5% (2/137) | 0.5% (6/838) | 0% |
| Unknown | <0.5% (4/1047) | <0.5% (4/910) | <0.5% (1/137) | <0.5% (3/838) | 0.5% (1/209) |
| Radiotherapyb | |||||
| Local | 83% (680/815) | 83% (584/700) | 83% (94/113) | 84% (561/666) | 80% (119/149) |
| Loco-regional | 14% (116/815) | 14% (99/700) | 15% (17/113) | 13% (88/666) | 19% (28/149) |
| Regional only | 1.5% (12/815) | 1% (10/700) | 2% (2/113) | 1.5% (11/666) | 0.5% (1/149) |
| None | <0.5% (3/815) | <0.5% (3/700) | 0% | <0.5% (2/666) | 0.5% (1/149) |
| Unknown | 0.5% (4/815) | 0.5% (4/700) | 0% | 0.5% (4/666) | 0% |
| Tumor histologyc | |||||
| Ductal | 82% (734/899) | 81% (634/781) | 85% (98/116) | 82% (599/731) | 80% (135/168) |
| Lobular | 11% (100/899) | 11% (89/781) | 10% (11/116) | 11% (78/731) | 13% (22/168) |
| Ductolobular | 3% (27/899) | 3% (24/781) | 3% (3/116) | 3% (25/731) | 1% (2/168) |
| Other | 4% (35/899) | 4% (31/781) | 3% (4/116) | 3% (24/731) | 5% (8/168) |
| Unknown | <0.5% (3/899) | <0.5% (3/781) | 0% | 0.5% (5/731) | 0.5% (1/168) |
| pT-stage | |||||
| in situ | 12% (109/902) | 12% (94/780) | 13% (15/120) | 13% (93/729) | 9% (16/173) |
| 1 | 58% (542/902) | 59% (459/780) | 55% (66/120) | 59% (427/729) | 57% (99/173) |
| 2 | 20% (180/902) | 20% (153/780) | 23% (27/120) | 20% (142/729) | 22% (38/173) |
| ≥3 | 3% (26/902) | 3% (21/780) | 4% (5/120) | 3% (21/729) | 3% (5/173) |
| X/0 | 7% (61/902) | 7% (53/780) | 6% (7/120) | 6% (46/729) | 9% (15/173) |
| Screen-detected | |||||
| Yes | 47% (302/638) | 47% (253/543) | 48% (45/93) | 48% (257/531) | 42% (45/107) |
| No | 50% (321/638) | 51% (276/543) | 51% (47/93) | 50% (264/531) | 53% (57/107) |
| Unknown | 2% (15/638) | 3% (14/543) | 1% (1/93) | 2% (10/531) | 5% (5/107) |
| EORTC global health status/quality of life (baseline) | 74 (18) | 74 (18) | 75 (17) | 74 (17) | 75 (19) |
| EORTC physical functioning (baseline) | 85 (16) | 85 (16) | 85 (15) | 84 (16) | 84 (15) |
| EORTC fatigue (baseline) | 71 (22) | 71 (22) | 72 (22) | 71 (23) | 70 (22) |
Percentages may not add up to exactly 100% as a result of rounding
ALND axillary lymph node dissection, pT pathological tumor size according to TNM classification
aThese numbers are based on data after linkage with the Dutch Cancer Registry files. Since this process happens annually, not all clinical data for the entire cohort have been obtained. The total amount of collected data may vary per variable as a result of available information at the time of linkage
bLoco-regional includes radiation on axillary and/or peri-clavicular lymph nodes
cTumor histology ‘other type’ comprises mucinous, medullary, and metaplastic carcinoma
EORTC scores: Scores range from 0 to 100 and higher scores represent a better health status