TABLE 1.
Demographics of PLACE patients
| No sleeve (n = 74) | Sleeve (n = 69) | ||
|---|---|---|---|
| Age at randomisation | 55.5 (33.5, 89.9) | 55.8 (32.0, 86.9) | |
| Body Mass Index (BMI) (pre op) |
N = 72 27.8 (17.2, 45.3) |
N = 67 28.7 (16.9, 60.9) |
|
| BMI (at PLACE entry) | 26.9 (18.0, 47.1) | 28.3 (16.9, 50.5) | |
| Smoking history | Never | 40 | 35 |
| Ex | 20 | 25 | |
| Current | 5 | 9 | |
| Follow‐up (months from randomisation) |
N = 72 41 (27.2, 53.8) |
N = 69 43 (35, 53) |
|
| Tumour site | Upper Outer Quadrant | 34 | 37 |
| Upper Inner quadrant | 9 | 7 | |
| Lower Outer Quad | 9 | 2 | |
| Lower Inner quadrant | 6 | 2 | |
| Central areolar | 5 | 10 | |
| Other | 11 | 11 | |
| Side | Right:Left | 29:36 | 23:41 |
| Dominant hand | Right;Left | 69;5 | 64:5 |
| Grade | 1 | 4 (5) | 4 (6) |
| 2 | 32 (43) | 31 (46) | |
| 3 | 36 (49) | 29 (43) | |
| Ungraded | 2 (3) | 3 (4) | |
| Type of surgery | ANC | 13 | 15 |
| WLocal Excision +ANC | 23 | 17 | |
| Mastectomy+ANC | 36 | 34 | |
| Other | 2 | 3 | |
| Radiotherapy postop | Yes | 64 | 60 |
| Dose (cGy) |
N = 64 4005 (3960, 5605) |
N = 60 4005 (1068, 6010) |
|
| # Fractions |
N = 64 15 (15, 25) |
N = 60 15 (4, 30) |
|
| Site of radiotherapy | Breast | 29 | 25 |
| Breast+SupraclavFossa | 22 | 22 | |
| Breast+Axilla | 3 | 2 | |
| Breast+SCF + Axilla | 3 | 3 | |
| Other | 7 | 8 | |
| Adjuv chemotherapy | Yes | 61 (82) | 59 (86) |
| Number of nodes | Involved | 2 (1–6.8) | 3 (1–6) |
| Removed | 16 (13–22) | 17 (11–22) | |
| HER2 | Negative | 60 (81) | 50 (72) |
| Amplified or 3+ | 14 (18.9) | 19 (27.5) | |
| Receptor status | ER positive | 55 (75) | 58 (84) |
| PR positive | 32 (62) | 29 (59) | |
| RAVI Difference (at PLACE entry) | 5.9 (4.1, 10.3) | 5.9 (4, 8.5) | |
| Time to lymphoedema (months) | 4.5 (2.0–17.5) | 9.9 (4.7–14.8) |
Note: Median (Interquartile Range): Receptor status number (percentage).
SCF radiotherapy to supraclavicular fossa nodal area.WLE (Wide Local excision).
ANC (Axillary Node Clearance). NB not all patients underwent radiotherapy or adjuvant chemotherapy. Numbers (percentages undergoing treatment).