FIGURE 1.
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 |
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 | / | / | / | / |
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 |
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 |
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 |
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) | |