Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients and Data Collection
2.2. Statistical Analysis
3. Results
3.1. Patients
3.2. Relation between Inguinal and Pelvic Nodal Involvement
3.3. Recurrences
3.4. Survival
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristics | Total n = 306 | Pelvic LAE No n = 197 (64.4%) | Pelvic LAE Yes n = 109 (35.6%) | p-Value * |
---|---|---|---|---|
Tumor stage | 0.768 b | |||
pT1b | 259 (84.6%) | 168 (85.3%) | 91 (83.5%) | |
pT2 | 33 (10.8%) | 22 (11.2%) | 11 (10.1%) | |
pT3 | 6 (1.9%) | 3 (1.5%) | 3 (2.8%) | |
T4 | 2 (0.7%) | 1 (0.5%) | 1 (0.8%) | |
unknown | 6 (2%) | 3 (1.5%) | 3 (2.8%) | |
BMI median (range) | 26 (15–45) | 25.5 (15–45) | 27.1 (18–45) | 0.195 a |
ECOG Status | 0.388 c | |||
ECOG 0 | 89 (29.1%) | 56 (28.4%) | 33 (30.3%) | |
ECOG 1 | 87 (28.4%) | 62 (31.5%) | 25 (22.9%) | |
ECOG 2 | 26 (8.5%) | 20 (10.2%) | 6 (5.5%) | |
ECOG 3+4 | 7 (2.3%) | 6 (3%) | 1 (0.9%) | |
unknown | 97 (31.7%) | 53 (26.9%) | 44 (40.4%) | |
Median tumor diameter (mm) (range) | 32 (2–110) | 32.5 (2–106) | 32 (4–110) | 0.863 a |
Median depth of invasion (mm) (range) | 7 (1–120) | 7 (1–120) | 7 (1–65) | 0.280 a |
Resection status of vulvar primary | 0.225 b | |||
R0 | 273 (89.2%) | 172 (87.3%) | 101 (92.6%) | |
R1 | 21 (6.9%) | 16 (8.1%) | 5 (4.6%) | |
unknown | 12 (3.9%) | 9 (4.6%) | 3 (2.8%) | |
Median minimal resection margin (mm) (range) | 3.0 (0–22) | 3.0 (0–22) | 3.25 (0–15) | 0.970 a |
Nodal status groin | <0.001 b | |||
pN1a | 73 (23.9%) | 66 (33.5%) | 7 (6.4%) | |
with one metastasis <5 mm | 53 (17.3%) | 49 (24.9%) | 4 (3.6%) | |
with two metastasis <5 mm | 20 (6.6%) | 17 (8.6%) | 3 (2.8%) | |
pN1b | 72 (23.5%) | 51 (25.9%) | 21 (19.3%) | |
pN2a/b | 62 (20.2%) | 34 (17.3%) | 28 (25.7%) | |
pN2c/pN3 | 97 (31.7%) | 44 (22.3%) | 53 (48.6%) | |
unknown | 2 (0.7%) | 2 (1.0%) | 0 | |
Median number of removed LN groin (range) | 7 (1–23) | 6 (1–21) | 7 (1–23) | 0.003 a |
Median number of affected LN groin (range) | 1 (1–11) | 1 (1–7) | 1 (1–11) | 0.065 a |
Median number of removed SN LN groin (range) | 2 (1–11) | 2 (1–11) | 2 (1–10) | 0.990 a |
Median number of affected SN LN groin (range) | 1 (1–6) | 1 (1–6) | 1 (1–4) | 0.141 a |
Median number of removed LN pelvis (range) | 9 (1–34) | n.a. | 9 (1–34) | n.a. |
Median number of affected LN pelvis (range) | 2 (1–5) | n.a. | 2 (1–5) | n.a. |
Distant metastasis | <0.001 b | |||
M0 | 256 (83.6%) | 178 (90.4%) | 78 (71.6%) | |
M1 | 32 (10.5%) | 8 (4%) | 24 (22%) | |
unknown | 18 (5.9%) | 11 (5.6%) | 7 (6.4%) | |
Treatment of the primary | 0.346 b | |||
surgery | 289 (94.4%) | 189 (95.9%) | 100 (91.7%) | |
no surgical treatment (radiotherapy or chemoradiation) | 14 (4.6%) | 6 (3%) | 8 (7.3%) | |
(radiotherapy or chemoradiation) | ||||
unknown | 3 (1%) | 2 (0.1%) | 1 (0.9%) | |
Surgical therapy vulva | 0.832 b | |||
complete vulvectomy | 75 (24.5%) | 48 (24.4%) | 27 (24.7%) | |
partial vulvectomy | 183 (59.8%) | 119 (60.4%) | 64 (58.7%) | |
wide excision | 35 (11.4%) | 22 (11.2%) | 13 (12%) | |
exenteration | 3 (1%) | 1 (0.5%) | 2 (1.8%) | |
unknown | 10 (3.3%) | 7 (3.5%) | 3 (2.8%) | |
SNL—LAE groin | 0.012 b | |||
unilateral | 18 (5.9%) | 14 (7.1%) | 4 (3.6%) | |
bilateral | 137 (44.8%) | 98 (49.7%) | 39 (35.8%) | |
no SNL-LAE groin | 151 (49.3%) | 85 (43.2%) | 66 (60.6%) | |
Inguino-femoral LAE | 0.001 b | |||
unilateral | 49 (16%) | 38 (19.3%) | 11 (1.1%) | |
bilateral | 237 (77.4%) | 140 (71.1%) | 97 (89%) | |
no inguino-femoral LAE | 20 (6.6%) | 19 (9.6%) | 1 (0.9%) | |
Pelvic LAE | n.a. | |||
unilateral | 43 (14.1%) | 0 | 43 (39.4%) | |
bilateral | 66 (21.5%) | 0 | 66 (60.6%) | |
no pelvic LAE | 197 (64.4%) | 197 (100%) | 0 | |
Surgical approach pelvic LAE | n.a. | |||
laparascopy | 67 (21.9%) | 0 | 67 (61.4%) | |
extraperitoneal via groin | 35 (11.4%) | 0 | 35 (32.1%) | |
open | 6 (2%) | 0 | 6 (5.6%) | |
unknown | 198 (64.7%) | 197 | 1 (0.9%) | |
Adjuvant radiotherapy | 0.001b | |||
yes | 197 (64.4%) | 115 (58.3%) | 82 (75.2%) | |
no | 103 (33.7%) | 80 (40.6%) | 23 (21.1%) | |
unknown | 6 (1.9%) | 2 (0.1%) | 4 (3.7%) | |
Adjuvant chemoradiation | ||||
yes | 47 (15.4%) | 20 (10.2%) | 27 (24.8%) | |
no | 256 (83.7%) | 176 (89.3%) | 80 (73.4%) | |
unknown | 3 (0.9%) | 1 (0.5%) | 2 (1.8%) | |
Primary chemoradiation | 0.085 b | |||
yes | 14 (4.6%) | 6 (3%) | 8 (7.3%) | |
no | 289 (94.4%) | 189 (95.9%) | 100 (91.7%) | |
unknown | 3 (1%) | 2 (0.1%) | 1 (0.9%) | |
Median total dose applied (Gy) (range) | 50.4 (2–70) | 50.4 (2–66) | 50.4 (26–70) | 0.332 a |
Recurrent disease | 0.079 d | |||
yes | 102 (33.3%) | 54 (27.4%) | 48 (44%) | |
no | 181 (59.2%) | 125 (63.4%) | 56 (51.4%) | |
unknown | 11 (3.6%) | 8 (4.1%) | 3 (2.8%) | |
death without relapse | 12 (3.9%) | 10 (5.1%) | 2 (1.8%) |
Nodal Status Groin | Total n = 108 | Nodal Status Pelvis N0 (Pelvic N−) n = 88 | Nodal Status Pelvis N+ (Pelvic N+) n = 20 | p-Value * |
---|---|---|---|---|
0.001 | ||||
pN1a | 7 (6.5%) | 7 (8.0%) | 0 | |
pN1b | 21 (19.4%) | 21 (23.9%) | 0 | |
pN2a/b | 28 (25.9%) | 26 (29.5%) | 2 (10.0%) | |
pN2c/pN3 | 52 (48.2%) | 34 (38.6%) | 18 (90.0%) |
Radiation Fields | Total n = 305 | No Pelvic LAE n = 197 | Pelvic LAE Nodal Status Pelvis N0 (Pelvic N−) n = 88 | Pelvic LAE Nodal Status Pelvis N1 (Pelvic N+) n = 20 |
---|---|---|---|---|
No groin RT (including vulva only) | 99 (32.4%) | 81 (41.1%) | 12 (13.6%) | 6 (30.0%) |
Groins+/− vulva | 125 (41.0%) | 70 (35.6%) | 51 (58.0%) | 4 (20.0%) |
Groins + pelvis +− vulva | 50 (16.4%) | 31 (15.7%) | 10 (11.3%) | 9 (45.0%) |
pelvis only | 3 (1%) | 3 (1.5%) | 0 | 0 |
Missing | 28 (9.2%) | 12 (6.1%) | 15 (17.1%) | 1 (5.0%) |
Complications | Total n = 306 | Pelvic LAE No n = 197 (64.4%) | Pelvic LAE Yes n = 109 (35.6%) | p-Value * |
---|---|---|---|---|
Woundhealing problems postoperatively | 0.930 | |||
yes | 89 (29.0%) | 57 (29.0%) | 32 (29.4%) | |
no | 192 (62.8%) | 124 (62.9%) | 68 (62.3%) | |
unknown | 25 (8.2%) | 16 (8.1%) | 9 (8.3%) | |
Infection of the groin | 0.025 | |||
yes | 77 (25.1%) | 41 (20.8%) | 36 (33%) | |
no | 204 (66.7%) | 138 (70%) | 66 (60.6%) | |
unknown | 25 (8.2%) | 18 (9.2%) | 7 (6.4%) | |
Secondary surgery needed | 0.341 | |||
yes | 80 (26.1%) | 48 (24.4%) | 32 (29.3%) | |
no | 226 (73.9%) | 149 (75.6%) | 77 (70.7%) | |
Persistent lymphocele | 0.223 | |||
yes | 61 (19.9%) | 36 (18.3%) | 25 (22.9%) | |
no | 197 (64.4%) | 133 (67.5%) | 64 (58.7%) | |
missing | 48 (15.7%) | 28 (14.2%) | 20 (18.4%) |
Site of Recurrence | Total n = 291 * | No Pelvic LAE n = 186 | Pelvic LAE Nodal Status Pelvis N0 (Pelvic N−) n = 85 | Pelvic LAE Nodal Status Pelvis N1 (Pelvic N+) n = 20 |
---|---|---|---|---|
No recurrence | 169 (58.1%) | 117 (62.9%) | 45 (52.9%) | 7 (35.0%) |
Local (Vulva only) | 34 (11.7%) | 20 (10.7%) | 12 (15.3%) | 1 (5.0%) |
Groins only | 14 (4.8%) | 10 (5.3%) | 3 (3.5%) | 1 (5.0%) |
Vulva + groins | 4 (1.4%) | 4 (2.1%) | 0 | 0 |
Pelvis only | 9 (3.1%) | 6 (3.2%) | 2 (2.4%) | 1 (5.0%) |
Including pelvis | 5 (1.7%) | 1 (0.5%) | 2 (2.4%) | 2 (10.0%) |
Including distant | 35 (12.0%) | 12 (6.5%) | 16 (18.8%) | 7 (35.0%) |
Unknown location | 10 (2.4%) | 7 (3.7%) | 3 (3.5%) | 0 |
Death without relapse | 11 (3.8%) | 10 (5.1%) | 1 (1.2%) | 1 (5.0%) |
Site of Recurrence | Total n = 265 * | No Pelvic LAE RT Including Pelvis (Yes) n = 142 | No Pelvic LAE RT Including Pelvis (No) n = 33 | Pelvic LAE (Pelvic N+) RT Including Pelvis (Yes) n = 9 | Pelvic LAE (Pelvic N+) RT Including Pelvis (No) n = 10 | Pelvic LAE (Pelvic N−) RT Including Pelvis (Yes) n = 10 | Pelvic LAE (Pelvic N−) RT Including Pelvis (No) n = 61 |
---|---|---|---|---|---|---|---|
Including pelvis | 14 (5.3%) | 5 (3.5%) | 2 (6.1%) | 0 | 3 (30.0%) | 1 (10.0%) | 3 (4.9%) |
Including distant | 33 (12.4%) | 11 (7.7%) | 1 (3.0%) | 5 (55.5%) | 2 (20.0%) | 2 (20.0%) | 12 (19.7%) |
Unknown | 7 (2.6%) | 6 (4.2%) | 0 | 0 | 0 | 0 | 1 (1.6%) |
Total | 54 (20.4%) | 22 (15.4%) | 3 (9.1%) | 5 (55.5%) | 5 (50.0%) | 3 (30.0%) | 16 (26.2%) |
Total # n = 291 | Pelvic LAE No n = 86 (64.4%) | Pelvic LAE Yes n = 105 (35.6%) | p-Value * | |
---|---|---|---|---|
1year DFS in % (95% CI) | 65.9 (59.3–71.6) | 70.1 (61.9–76.9) | 58.9 (47.7–68.5) | 0.079 |
1year OS in % (95% CI) | 86.6 (81.3–90.6) | 90.2 (83.9–94.1) | 80.7 (69.8–87.9) | 0.100 |
Total # n = 265 | No Pelvic LAE Rt Including Pelvis (Yes) n = 142 | No Pelvic LAE Rt Including Pelvis (No) n = 33 | Pelvic LAE (Pelvic N+) Rt Including Pelvis (Yes) n = 9 | Pelvic LAE (Pelvic N+) Rt Including Pelvis (No) n = 10 | Pelvic LAE (Pelvic N−) Rt Including Pelvis (Yes and No) n = 19 | Pelvic LAE (Pelvic N−) Rt Including Pelvis (Yes) n = 10 | Pelvic LAE (Pelvic n-) Rt Including Pelvis (No) n = 61 | Pelvic LAE (Pelvic N−) Rt Including Pelvis (Yes and No) n = 71 | |
---|---|---|---|---|---|---|---|---|---|
1year DFS in % (95% CI) | 67.7 (58.2–75.6) | 78.8 (58.3–90.0) | 43.8 (10.1–74.2) | 11.1 (0.6–38.8) | 19.8 (3.7–45.2) | 45.0 (13.8–72.4) | 69.2 (47.1–72.1) | 65.4 (51.8–76.0) | |
Incidence of a DFS event in 10 person-years | 2.06 | 3.04 | 8.88 | 13.19 | 9.1 | 3.81 | 3.19 | 3.29 | |
Incidence of an OS event in 10 person-years | 1.27 | 0.21 | 3.81 | 7.26 | 4.5 | 2.21 | 0.99 | 1.17 |
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Woelber, L.; Hampl, M.; Eulenburg, C.z.; Prieske, K.; Hambrecht, J.; Fuerst, S.; Klapdor, R.; Heublein, S.; Gass, P.; Rohner, A.; et al. Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study. Cancers 2022, 14, 418. https://doi.org/10.3390/cancers14020418
Woelber L, Hampl M, Eulenburg Cz, Prieske K, Hambrecht J, Fuerst S, Klapdor R, Heublein S, Gass P, Rohner A, et al. Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study. Cancers. 2022; 14(2):418. https://doi.org/10.3390/cancers14020418
Chicago/Turabian StyleWoelber, Linn, Monika Hampl, Christine zu Eulenburg, Katharina Prieske, Johanna Hambrecht, Sophie Fuerst, Ruediger Klapdor, Sabine Heublein, Paul Gass, Annika Rohner, and et al. 2022. "Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study" Cancers 14, no. 2: 418. https://doi.org/10.3390/cancers14020418
APA StyleWoelber, L., Hampl, M., Eulenburg, C. z., Prieske, K., Hambrecht, J., Fuerst, S., Klapdor, R., Heublein, S., Gass, P., Rohner, A., Canzler, U., Becker, S., Bommert, M., Bauerschlag, D., Denecke, A., Hanker, L., Runnebaumn, I., Forner, D. M., Schochter, F., ... Jaeger, A. (2022). Risk for Pelvic Metastasis and Role of Pelvic Lymphadenectomy in Node-Positive Vulvar Cancer-Results from the AGO-VOP.2 QS Vulva Study. Cancers, 14(2), 418. https://doi.org/10.3390/cancers14020418