Table 1.
Patient characteristics (n = 70) with regard to pelvic lymph node status
| Total [N = 70] | Pelvic status missing [n = 13] | Pelvic pN+ [n = 14] | Pelvic pN− [n = 43] | p-value (N+ vs. N−) | |
|---|---|---|---|---|---|
| Age, years [median (range)] | 63.0 (20.3–85.2) | 68.1 (52.0–79.2) | 71.5 (31.5–82.8) | 56.2 (20.3–85.2) | 0.026a |
| Tumor stage | |||||
| pT1b | 12 | 4 | 3 | 5 | 0.604b |
| pT2 | 35 | 4 | 6 | 25 | |
| pT3/4 | 1 | 0 | 0 | 1 | |
| Unknown | 22 | 5 | 5 | 12 | |
| Nodal status | |||||
| pN0 | 16 | 2 | 0 | 14 | 0.010b |
| pN1 | 54 | 11 | 14 | 29 | |
| No. of groin nodes affected [median (range)], n = 42 | 3 (1–30) | 2 (2–2) | 7 (1–30) | 2 (1–10) | 0.001a |
| Maximum diameter of LN metastases of the groin, mm (range), n = 9 | 27.0 (1–50) | 10 (10–10) | 42.5 (12–50) | 23.5 (1–32) | 0.187a |
| No. of pelvic nodes affected [median (range)], n = 14 | 2.5 (1–12) | NA | 2.5 (1–12) | NA | NA |
| Tumor diameter, mm [median (range)], n = 53 | 40 (2–240) | 40 (18–70) | 40 (15–240) | 39 (2–110) | 0.106a |
| Depth of invasion, mm [median (range)], n = 26 | 5.7 (1.5–70) | 3 (3–3) | 5.3 (5–6) | 9 (1.5–70) | 0.357a |
| Grading | |||||
| G1 | 3 | 0 | 0 | 3 | 0.024b |
| G2 | 34 | 3 | 4 | 27 | |
| G3 | 29 | 7 | 10 | 12 | |
| Unknown | 4 | 3 | 0 | 1 | |
| ECOG | |||||
| 0 | 23 | 1 | 0 | 22 | <0.001b |
| 1 | 9 | 0 | 4 | 5 | |
| 2 | 12 | 5 | 1 | 6 | |
| 3 | 3 | 0 | 3 | 0 | |
| 4 | 1 | 0 | 1 | 0 | |
| Unknown | 22 | 7 | 5 | 10 | |
| Surgical therapy vulva | 0.950b | ||||
| Partial vulvectomy | 19 | 2 | 3 | 14 | |
| Complete vulvectomy | 45 | 10 | 10 | 25 | |
| Exenteration/unknown | 6 | 1 | 1 | 4 | |
| Resection margin, mm [median (range)], n = 19 | 4 (0.2–11) | 4.75 (0.5–9) | 3 (2–4) | 4 (0.2–11) | 0.496a |
| Resection status | |||||
| R0 | 41 | 9 | 32 | 0.443b | |
| R1 | 12 | 3 | 9 | ||
| Rx | 4 | 2 | 2 | ||
| Type of groin surgery | |||||
| Complete (groin dissection) | 69 | 13 | 14 | 42 | 1.000b |
| Sentinel (only) | 1 | 0 | 0 | 1 | |
| Sentinel node biopsy performed | |||||
| No | 47 | 5 | 12 | 30 | 0.024b |
| Yes | 15 | 3 | 0 | 12 | |
| Unknown | 8 | 5 | 2 | 1 | |
| No. of dissected LNs (groin) per patient [median (range)], n = 57 | 17 (2–53) | 17 (5–37) | 15 (6–36) | 17 (2–53) | 0.935a |
| No. of dissected LNs (pelvis) per patient [median (range)], n = 51 | 12 (1–55) | NA | 10 (1–28) | 13 (2–55) | 0.761a |
| Radiotherapy performed | |||||
| Yes | 38 | 9 | 10 | 19 | 0.171 |
| No | 24 | 2 | 2 | 20 | |
| Unknown | 8 | 2 | 2 | 4 | |
| Type of radiotherapy | |||||
| Adjuvant therapy | 33 | 8 | 8 | 17 | 0.213b |
| Neoadjuvant therapy | 2 | 0 | 0 | 2 | |
| Palliative | 3 | 1 | 2 | 0 | |
| Unknown | 32 | 4 | 4 | 24 | |
| Radiation fields | 1.000b | ||||
| Groin ± vulva | 8 | 1 | 2 | 5 | |
| Groin and pelvis ± vulva | 21 | 5 | 6 | 10 | |
| Pelvis ± vulva | 5 | 2 | 1 | 2 | |
| Neither groin nor pelvis | 2 | 0 | 0 | 2 | |
| Unknown | 34 | 5 | 5 | 24 | |
| Median PFS (months) | 35.2 | 38.0 | 12.5 | 41.3 | 0.020c |
| Median OS (months) | NR | 72.5 | 30.8 | NR | 0.003c |
ANOVA analysis of variance, LN lymph node, ECOG Eastern Cooperative Oncology Group, PFS progression-free survival, OS overall survival, NR not reached, n. a. not applicable
aANOVA
bFisher’s exact test
cCox regression analysis
‘Missing’ and ‘unknown’ categories excluded