TABLE 1.
Baseline characteristics of patients treated with electrochemotherapy and surgery
| Characteristics | ECT (N = 11) | Surgery (N = 15) | p-value |
|---|---|---|---|
| Age at treatment (years; mean ± SD) | 78.4 ± 9.0 | 67.8 ± 8.9 | 0.006 |
| BMI (mean ± SD) | 26.1 ± 3.9 | 26.8 ± 5.9 | 0.758 |
| Duration of procedure (minutes, mean ± SD) | 17.6 ± 3.0 | 56.1 ± 20.5 | < 0.001 |
| Days of hospital stay (mean ± SD) | 2.7 ± 1.1 | 7.5 ± 3.7 | < 0.001 |
| Longest diameter of tumor (mm, mean ± SD) | 19.5 ± 13.9 | 26.7 ± 13.3 | 0.192 |
| Number of patients with associated diseases, N (%) | 9 (81.8) | 15 (100) | 0.169 |
| Previous treatment, N (%) | |||
| Surgery | 6 (54.5) | 9 (60.0) | 0.548 |
| Surgery + radiotherapy | 5 (45.5) | 6 (40.0) | |
| Number of patients with lichen sclerosus, N (%) | 5 (45.5) | 11 (73.3) | 0.228 |
| Gradus, N (%) | |||
| 1 | 1 (9.1) | 5 (33.3) | 0.305 |
| 2 | 8 (72.7) | 7 (46.7) | |
| 3 | 2 (18.2) | 3 (20.0) | |
| Anatomical site of tumor, N (%) | |||
| Clitoris | 1 (9.1) | 2 (13.3) | 0.506 |
| Paraurethral | 3 (27.3) | 3 (20.0) | |
| Labia minora | 3 (27.3) | 4 (26.7) | |
| Labia majora | 2 (18.2) | 5 (33.3) | |
| Perineum | 2 (18.2) | 1 (8.3) | |
| Anesthesia, N (%) | |||
| Local | 4 (36.4) | 8 (53.3) | 0.453 |
| General | 7 (63.6) | 7 (46.7) | |
| p16 status, N (%) | |||
| Positive | 3 (27.3) | 3 (20.0) | 0.509 |
| Negative | 8 (72.7) | 12 (80.0) | |
TABLE 2.
Mean values before and 1, 3 and 6 months after electrochemotherapy using the EuroQol - 5 Dimension (EQ-5D) questionnaire and comparison of the mean values
| Electrochemotherapy group | ||||||||
|---|---|---|---|---|---|---|---|---|
| Mean (SD) | P | |||||||
| Before ECT | 1 month after ECT | 3 months after ECT | 6 months after ECT | Before - 6 months | Before - 1 month | 1 month - 3 months | 3 months - 6 months | |
| EQ 5-D | 0.75 ± 0.21 | 0.62 ± 0.23 | 0.82 ± 0.23 | 0.78 ± 0.20 | 0.637 | 0.126 | 0.079 | 0.652 |
TABLE 3.
Functional and symptom scales and global health status data from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) for the electrochemotherapy and surgery groups
| Electrochemotherapy group | Surgery group | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before | 3 months after | 6 months after | Before vs. 6 | Before vs. 3 | 3 vs. 6 | Before | 3 months after | 6 months after | Before vs. 6 | Before vs. 3 | 3 vs. 6 | |
| Mean (SD) | p | Mean (SD) | p | |||||||||
| Functional scales | ||||||||||||
| Physical functioning | 60.60 ± 14.13 | 75.16 ± 19.34 | 77.57 ± 21.14 | 0.148 | 0.116 | 0.748 | 52,89 ± 13.68 | 56,89 ± 15.91 | 58,22 ± 20.39 | 0.894 | 0.744 | 0.935 |
| Role functioning | 60.61 ± 13.49 | 78.79 ± 18.39 | 83.33 ± 22.36 | 0.017 | 0.056 | 0.519 | 57.78 ± 15.26 | 63.33 ± 15.69 | 57.78 ± 19.79 | 0.681 | 0.653 | 0.436 |
| Emotional functioning | 75.00 ± 8.33 | 95.46 ± 10.11 | 93.94 ± 11.84 | <0.001 | < 0.001 | 0.949 | 83.89 ± 10.67 | 90.00 ± 10.54 | 87.22 ±14.39 0.279 | 0.116 | 0.806 | |
| Cognitive functioning | 63,64 ± 14.56 | 77,27 ± 13.48 | 81,82 ± 13.85 | 0.011 | 0.034 | 0,478 | 70,00 ± 12.91 | 68.89 ± 19.79 | 61.11 ± 25.71 | 0.390 | 0.775 | 0.345 |
| Social functioning | 60.61 ± 11.24 | 81.81 ± 11.68 | 84.85 ± 13.85 | < 0.001 | < 0.001 | 0.606 | 60.00 ± 12.28 | 71.11 ± 13.31 | 65.56 ± 17.21 | 0.094 | 0.037 | 0.436 |
| Symptom scales | ||||||||||||
| Dyspnea | 21.21 ± 12.47 | 9.09 ± 5.57 | 6.06 ± 3.48 | 0.09 | 0.133 | 1.000 | 15.55 ± 5.36 | 17.78 ± 7.21 | 17.78 ± 7.21 | 0.775 | 0.775 | 1.000 |
| Pain | 45.45 ± 19.85 | 15.15 ± 5.73 | 22.73 ± 10.07 | 0.005 | 0.002 | 0.797 | 46.67 ± 16.91 | 28.89 ± 7.21 | 38.89 ± 12.42 | 0.064 | 0.023 | 0.233 |
| Fatigue | 39.42 ± 16.72 | 20.18 ± 5.58 | 15.12 ± 5.14 | 0.014 | 0.047 | 0.519 | 36.31 ± 11.46 | 34.82 ± 13.90 | 41.49 ± 16.53 | 0.421 | 0.935 | 0.285 |
| Insomnia | 39.39 ± 13.49 | 9.09 ± 5.57 | 6.06 ± 3.48 | < 0.001 | < 0.001 | 0.748 | 33.33 ± 17.82 | 33.33 ± 17.81 | 35.55 ± 19.79 | 0.926 | 1.000 | 0.806 |
| Appetite loss | 18.18 ± 7.41 | 6.06 ± 3.05 | 6.06 ± 3.05 | < 0.001 | < 0.001 | 1.000 | 15.55 ± 7.21 | 13.33 ± 6.90 | 20.00 ± 6.90 | 0.544 | 0.775 | 0.367 |
| Globa health status | 49.24 ± 10.17 | 71.97 ± 15.49 | 71.21 ± 18.01 | 0.002 | < 0.001 | 1.000 | 47.78 ± 11.56 | 51.11 ± 13.31 | 46.67 ± 18.85 | 0.695 | 0.539 | 0.461 |
TABLE 4.
Comparison of the mean values of the functional and symptom scales and global health status between the electrochemotherapy and surgery groups before and 3 and 6 months after the procedure using the EORTC QLQ-C30
| Before | 3 months after | 6 months after | |||||||
|---|---|---|---|---|---|---|---|---|---|
| ECT group | Surgery group | p | ECT group | Surgery group | p | ECT group | Surgery group | p | |
| Mean (SD) | Mean (SD) | Mean (SD | |||||||
| Functional scales | |||||||||
| Physical functioning | 60.60 ± 14.13 | 52,89 ± 13.68 | 0.164 | 75.16 ± 19.34 | 56,89 ± 15.91 | 0.020 | 77.57 ± 21.14 | 58,22 ± 20.39 | 0.027 |
| Role functioning | 60.61 ± 13.49 | 57.78 ± 15.26 | 0.721 | 78.79 ± 18.39 | 63.33 ± 15.69 | 0.054 | 83.33 ± 22.36 | 57.78 ± 19.79 | 0.008 |
| Emotional functioning | 75.00 ± 8.33 | 83.89 ± 10.67 | 0.041 | 95.46 ± 10.11 | 90.00 ± 10.54 | 0.097 | 93.94 ± 11.84 | 87.22 ± 14.39 | 0.180 |
| Cognitive functioning | 63,64 ± 14.56 | 70,00 ± 12.91 | 0.217 | 77,27 ± 13.48 | 68.89 ± 19.79 | 0.180 | 81,82 ± 13.85 | 61.11 ± 25.71 | 0.036 |
| Social functioning | 60.61 ± 11.24 | 60.00 ± 12.28 | 0.646 | 81.81 ± 11.68 | 71.11 ± 13.31 | 0.087 | 84.85 ± 13.85 | 65.56 ± 17.21 | 0.011 |
| Symptom scales | |||||||||
| Dyspnea | 21.21 ± 12.47 | 15.55 ± 5.36 | 0.610 | 9.09 ± 5.57 | 17.78 ± 7.21 | 0.258 | 6.06 ± 3.48 | 17.78 ± 7.21 | 0,134 |
| Pain | 45.45 ± 19.85 | 46.67 ± 16.91 | 0.799 | 15.15 ± 5.73 | 28.89 ± 7.21 | 0.061 | 22.73 ± 10.07 | 38.89 ± 12.42 | 0.054 |
| Fatigue | 39.42 ± 16.72 | 36.31 ± 11.46 | 0.878 | 20.18 ± 5.58 | 34.82 ± 13.90 | 0.047 | 15.12 ± 5.14 | 41.49 ± 16.53 | 0.001 |
| Insomnia | 39.39 ± 13.49 | 33.33 ± 17.82 | 0.507 | 9.09 ± 5.57 | 33.33 ± 17.81 | 0.005 | 6.06 ± 3.48 | 35.55 ± 19.79 | 0.001 |
| Appetite loss | 18.18 ± 7.41 | 15.55 ± 7.21 | 0.760 | 6.06 ± 3.05 | 13.33 ± 6.90 | 0.087 | 6.06 ± 3.05 | 20.00 ± 6.90 | 0.009 |
| Globa health status | 49.24 ± 10.17 | 47.78 ± 11.56 | 0.683 | 71.97 ± 15.49 | 51.11 ± 13.31 | 0.009 | 71.21 ± 18.01 | 46.67 ± 18.85 | 0.004 |
TABLE 5.
Comparison of mean values and p values for scarring and mutilation of the external genitalia, physical attractiveness, urination and defecation symptoms before and 1, 3 and 6 months after electrochemotherapy using the EORTC QLQ-VU34
| Electrochemotherapy group | ||||||||
|---|---|---|---|---|---|---|---|---|
| Mean (SD) | p | |||||||
| Before ECT | 1 month after ECT | 3 months after ECT | 6 months after ECT | Before – 6 months | Before - 1 month | 1 month – 3 months | 3 months – 6 months | |
| Scaring | 6.91 ± 1.58 | 6.45 ± 1.92) | 3.27 ± 0.90 | 3.27 ± 0.90 | <0.001 | 0.797 | <0.001 | 1.00 |
| Physical attractiveness | 3.00 ±0.00 | 3.00 ± 0.00 | 3.00 ± 0.00 | 3.00 ± 0.00 | / | / | / | / |
| Urination | 7.27 ± 2.05 | 6.09 ± 1.81 | 4.63 ± 1.50 | 4.45 ± 1.21 | 0.002 | 0.171 | 0.04 | 0.748 |
| Defecation | 2.00 ± 0.00 | 2.00 ± 0.00 | 2.00 ± 0.00 | 2.00 ± 0.00 | / | / | / | / |

FIGURE 1.
Vulvar cancer recurrence at the vaginal entrance near the urethra (A). Presence of necrosis one month after treatment with electrochemotherapy (B). The wound completely healed three months after treatment with electrochemotherapy (C). The woman had no problems with urination, defecation and sitting six months after treatment with electrochemotherapy (D).
TABLE 6.
Comparison of the mean values with standard deviations and p values of the VAS score between the electrochemotherapy and surgery groups before and 3 and 6 months after the procedure
| Mean (SD) | p | ||
|---|---|---|---|
| VAS | ECT | Surgery | ECT vs. Surgery |
| Before | 2.36 ± 1.12 | 2.21 ± 1.48 | 0.776 |
| 1 month after procedure | 3.64 ± 2.19 | / | / |
| 3 months after procedure | 1.64 ± 1.57 | 2.07 ± 1.07 | 0.442 |
| 6 months after procedure | 1.82 ± 1.83 | 2.14 ± 1.23 | 0.620 |