Table 1.
Characteristic | Total (n = 1249) | N- (n = 802) | N+ (n = 447) | P* (N- vs N+) | N+ without adjuvant treatment (n = 169)† | N+ with adjuvant treatment (n = 244)† | P* (N+ with vs without adjuvant treatment) | N+ with neoadjuvant treatment (n = 3)† |
---|---|---|---|---|---|---|---|---|
Median age, y (range) | 67 (20 – 94) | 66 (21–94) | 69 (20 – 94) | <.001 | 72 (20 – 94) | 67 (30 – 87) | .002 | 68 (66 – 80) |
Tumor stage | <.001 | .38 | ||||||
pT1b | 474 (38.0%) | 399 (49.8%) | 75 (16.8%) | 30 (17.8%) | 40 (16.4%) | 0 | ||
pT2 | 650 (52.0%) | 365 (45.5%) | 285 (63.8%) | 111 (65.7%) | 154 (63.1%) | 2 (66.6%) | ||
pT3 | 115 (9.2%) | 36 (4.5%) | 79 (16.7%) | 24 (14.2%) | 46 (18.9%) | 1 (33.3%) | ||
pT4 | 7 (0.6%) | 1 (0.1%) | 6 (1.3%) | 4 (2.4%) | 2 (0.8%) | 0 | ||
Unknown | 3 (0.2%) | 1 (0.1%) | 2 (0.5%) | 0 | 2 (0.8%) | 0 | ||
Median tumor diameter, mm (range) | 25 (1 – 345) | 20 (1–345) | 35 (2 – 240) | <.001 | 35 (2 – 240) | 35 (2.8 – 200) | .51 | 82.5 (25 – 140) |
Median depth of invasion, mm (range) | 5 (0.25 – 110) | 4 (0.75–60) | 8 (0.25 - 110) | <.001 | 7 (1 – 70) | 8 (0.25 – 110) | .83 | 27 (4 – 50) |
Median resection margin, mm (range) | 5 (0.2 – 33) | 5 (0.2–33) | 4 (0.25 – 25) | .03 | 3 (1 – 16) | 4 (0.25 – 25) | .18 | 2 (2 – 2) |
Resection status of vulvar primary | <.001 | .18 | ||||||
R0 | 1022 (81.8%) | 703 (87.7%) | 319 (71.4%) | 126 (74.6%) | 173 (70.9%) | 2 (66.7%) | ||
R1 | 123 (9.9%) | 46 (5.7%) | 77 (17.2%) | 21 (12.4%) | 46 (18.9%) | 1 (33.3%) | ||
Unknown | 104 (8.3%) | 53 (6.6%) | 51 (11.4%) | 22 (13.0%) | 25 (10.3%) | 0 | ||
Grading | <.001 | .83 | ||||||
G1 | 139 (11.1%) | 120 (15.0%) | 19 (4.3%) | 8 (4.7%) | 11 (4.5%) | 0 | ||
G2 | 768 (61.5%) | 502 (62.6%) | 266 (59.5%) | 100 (59.2%) | 144 (59.0%) | 2 (66.7%) | ||
G3 | 309 (24.7%) | 158 (19.7%) | 151 (33.8%) | 58 (34.3%) | 81 (33.2%) | 1 (33.3%) | ||
Unknown | 33 (2.6%) | 22 (2.7%) | 11 (2.5%) | 3 (1.8%) | 8 (3.3%) | 0 | ||
Positive LN | n/a | .002 | ||||||
1 | n/a | n/a | 172 (38.5%) | 86 (50.9%) | 77 (31.6%) | 1 (33.3%) | ||
2 | n/a | n/a | 102 (22.8%) | 34 (20.1%) | 57 (23.4%) | 1 (33.3%) | ||
3 | n/a | n/a | 62 (13.9%) | 18 (10.7%) | 38 (15.6%) | 1 (33.3%) | ||
>3 | n/a | n/a | 87 (19.5%) | 25 (14.8%) | 57 (23.4%) | 0 | ||
Unknown | n/a | n/a | 24 (5.4%) | 6 (3.6%) | (6.2%) | 0 | ||
ECOG | <.001 | .001 | ||||||
0 | 443 (35.5%) | 332 (41.4%) | 111 (24.8%) | 33 (19.5%) | 74 (30.3%) | 0 | ||
1 | 199 (15.9%) | 114 (14.2%) | 85 (19.0%) | 24 (14.2%) | 56 (23.0%) | 0 | ||
2 | 148 (11.9%) | 86 (10.7%) | 62 (13.9%) | 22 (13.0%) | 33 (13.5%) | 1 (33.3%) | ||
3 | 47 (3.8%) | 25 (3.1%) | 22 (4.9%) | 14 (8.3%) | 6 (2.5%) | 0 | ||
4 | 5 (0.4%) | 2 (0.3%) | 3 (0.7%) | 1 (0.6%) | 0 | 0 | ||
Unknown | 407 (32.6%) | 243 (30.3%) | 164 (36.7%) | 75 (44.4%) | 75 (30.7%) | 2 (66.7%) | ||
Vulva surgery | <.001 | .04 | ||||||
Wide excision | 128 (10.3%) | 97 (12.1%) | 31 (6.9%) | 20 (11.8%) | 11 (4.5%) | 0 | ||
Partial vulvectomy | 443 (35.5%) | 323 (40.3%) | 120 (26.9%) | 42 (24.9%) | 70 (28.7%) | 0 | ||
Complete vulvectomy | 662 (53.0%) | 373 (46.5%) | 289 (64.7%) | 105 (62.1%) | 160 (65.6%) | 3 (100%) | ||
Exenteration | 14 (1.1%) | 7 (0.9%) | 7 (1.6%) | 2 (1.2%) | 3 (1.2%) | 0 | ||
Surgery type unknown | 2 (0.2%) | 2 (0.3%) | 0 | 0 | 0 | 0 | ||
No surgery | 0 | 0 | 0 | 0 | 0 | 0 | ||
Surgery status unknown | 0 | 0 | 0 | 0 | 0 | 0 | ||
Groin surgery | ||||||||
Groin dissection | ||||||||
Unilateral | 245 (19.6%) | 147 (18.3%) | 98 (21.9%) | .56 | 49 (29.0%) | 39 (16.0%) | .002 | 2 (66.7%) |
Bilateral | 919 (73.6%) | 570 (71.1%) | 349 (78.1%) | 120 (71.0%) | 205 (84.0%) | 1 (33.3%) | ||
After initial sentinel node dissection | 280 (22.4%) | 178 (22.2%) | 102 (22.8%) | .01 | 52 (30.8%) | 46 (18.9%) | .01 | 0 |
Primary complete groin dissection | 825 (66.1%) | 514 (64.1%) | 311 (69.6%) | 107 (63.3%) | 175 (71.7%) | 3 (100.0%) | ||
Unknown if primary or secondary | 59 (4.7%) | 25 (3.1%) | 34 (7.6%) | 10 (5.9%) | 23 (9.4%) | 0 | ||
Sentinel procedure only | 85 (6.8%) | 85 (10.6%) | 0 | <.001‡ | 0 | 0 | 0 | |
Pelvic node dissection | 70 (5.6%) | 16 (2.0%) | 54 (12.1%) | <.001 | 16 (9.5%) | 30 (12.3%) | .37 | 1 (33.3%) |
Median number of dissected groin LNs per patient (range) [IQR] | 15 (1 – 81) [10 – 19] | 14 (1 – 49) [10 – 18] | 15 (1 – 81) [10 – 21] | .01 | 15 (1 – 62) [11 – 20] | 15 (1 – 81) [10 – 21] | .88 | 3 (2 – 7) [2 – 7] |
Median LN metastasis diameter, mm (range) | n/a | n/a | 20 (0.3 – 100) | n/a | 15 (0.3 – 50) | 20 (1 – 100) | .01 | 15 (15 – 15) |
* All percentages refer to columns. P values were calculated using the Student’s t test for continuous variables and the chi-square test or Fisher’s exact test for categorical variables. The latter was applied if any table cell had expected counts less than 5. All tests were two-sided. N+ = node-positive patients, N- = node-negative patients, LN = lymph node.
† 31 missing up to 447 are N+ patients with no information on adjuvant treatment.
‡ P value for groin dissection vs sentinel procedure only.