Table 1. Clinico-pathological data in total study group and the subset of patients in whom primary tumours were sampled.
| Variable | Total study group | FFPE tumour subset |
|---|---|---|
| Total number of patients | 561 | 198 |
| Number of patients with positive SNB (%) | 286 (51.0) | 131 (66.2%) |
| Age at SNB years (mean and range)a | 51.4 (7.0–88.7) | 52.2 (14.8–88.1) |
| Sex – male (number and %) | 275 (49.0) | 103 (52.0) |
| Site of tumour, number (%) | ||
| Arm | 110 (19.6) | 44 (22.2) |
| Head–neck | 38 (6.8) | 17 (8.6) |
| Leg | 202 (36.0) | 69 (34.9) |
| Trunk | 211(37.6) | 68 (34.3) |
| Breslow thickness, mm; median (range) | 1.9 (0.75–24) | 2.00 (0.8–24.0) |
| Clark's level, number (%)b | ||
| I/II/III | 160 (33.1) | 52 (31.1) |
| IV | 290 (60.1) | 100 (59.9) |
| V | 33 (6.8) | 15 (9.0) |
| Histological subtype b | ||
| Superficial spreading | 193 (52.3) | 50 (42.4) |
| Nodular | 132 (35.8) | 54 (45.8) |
| Other | 44 (11.9) | 14 (11.8) |
| Mitotic count, number (%)b | ||
| <1 | 83 (18.8) | 22 (12.2) |
| 1–6 | 227 (51.3) | 90 (50.0) |
| >6 | 132 (29.9) | 68 (37.8) |
| Ulcerated tumours, number (%)b | 142 (25.7) | 58 (29.3) |
| Presence of vessel invasion, number (%)b | 26 (4.7) | 12 (6.1) |
| Presence of regression, number (%)b | 73 (13.4) | 18 (9.2) |
| Presence of perineural invasion, number (%)b | 6 (1.1) | 2 (1.0) |
| Presence of microsatellites, number (%)b | 23 (4.2) | |
| TILs, number (%)b | ||
| Absent | 123 (25.0) | 51 (27.9) |
| Non-brisk | 264 (53.8) | 90 (49.2) |
| Brisk | 104 (21.2) | 42 (22.9) |
| Median follow-up time months (range) | 29.5 (0.03–201) | 38.4 (0.03– 111.7) |
| Number of relapsers (%) | 126 (23.0) | 63 (32.8) |
| Number of deaths (%) | 83 (14.9) | 47 (24.0) |
Abbreviations: FFPE=formalin-fixed paraffin-embedded; SNB=sentinel node biopsy; TIL=tumour-infiltrating lymphocyte.
a
Only four patients under the age of 18 years in study.
b
Clarks level available for 483 patients, histological subtype available for 369 patients, mitotic count available for 442 patients, ulceration available for 552 patients, vessel invasion available for 548 patients, regression available for 546 patients, perineural invasion available for 551 patients, microsatellites available for 550 patients, TILs data available for 491 patients. Relapse status available in 548 patients, survival status available in 559 patients.