Quality of life of women with recurrent vulvar cancer treated with electrochemotherapy

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)