Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease

Figures & data

Figure 1. Patient with central recurrence in position within the MRI scanner with the HIFU device in place. T2-W image at planning study (a) and on day of treatment (b) after bowel and bladder preparation. In b, urinary and rectal catheters (black arrows) are noted in situ. The vagina is filled with degassed gel (white arrow).

Table 1. Patient characteristics of those treated.

Pt (Px)	Age	Primary	Histology	Site recurrence	Time to recur (years)	Symptom	Base KPS	Prior surgery	Prior RT	Prior chemo
1	74	Bartholin gland	Adenoid cystic	Ischiorectal fossa	19	Pain	60	Exenteration	Brachy, EBRT
2	59	Endometrial	G2 endometroid AC	Left lateral vaginal vault	13	Pain, Bleeding	70	√	EBRT, VVB	√
3	69	Vulvar	G2 SCC	R inguinal node, perineal	1	Pain, lymphedema	60	√	EBRT	√
4	64	Cervical	G3 SCC	Right ischiorectal fossa	23	Pain	80	Exenteration	EBRT, SBRT	√
2(5)	59	Endometrial	G2 endometroid AC	Left lateral vaginal vault	13	Pain, Bleeding	70	√	EBRT, VVB	√
6	42	Vulvar	G1 SCC	Left inguinal node	1	Pain	90	√	declined	√
7	54	Cervical	Mucinous AC	Left pelvic side wall	15	Pain	80	√	EBRT, VVB	√
8	49	Cervical	G3 SCC	Left popliteal fossa	1	Pain, lymphedema	70	√	EBRT	√
9	72	Endometrial	G1 endometroid AC	Left lateral vaginal vault	12	Pain, Bleeding	60	√	EBRT, VVB	√
10	54	Cervical	G3 SCC	Cervix	0.5	Pain	70	Abandoned	EBRT	√
11	54	Vulvar	G3 SCC	Left inguinal node	0.16	Pain	70	√	EBRT	√

Shaded rows are patients with extra-pelvic tumors.

Figure 2. Box and whisker plot summarizing percentage change in NRS pain scores for (a) responders (green, n = 5) and non-responders (red, n = 6) and (b) intra-pelvic (green, n = 5) versus extra-pelvic (blue, n = 6) tumors. Median (central line) and upper and lower quartiles are indicated by the upper and lower boundaries of the box. The whiskers denote maximum and minimum values.

Figure 3. Comparison of worst pain score in responders (blue) and non-responders (red).

Table 2. Relationship of thermal energy delivered and dose to change in NRS pain score at each time-point.

Patient (treatment)	Total energy applied, kJ	V240EM, ml	% change in pain score from baseline at day 7	% change in pain score from baseline at day 30	% change in pain score from baseline at day 60	% change in pain score from baseline at day 90
1	36.4	0.08	−23.1	−23.1	−53.8	−69.2
2	38.9	0	−16.7	−33.3	−100	0
3	80.3	0	16.7	0	50	–
4	61.7	0.08	0	−12.5	12.5	–
2 (5)	23.3	4.52	−100	−100	–	0
6	95.6	0	−100	−100	–	–
7	52.8	0	−23.1	−38.5	−53.8	−7.7
8	24.5	19.02	−50	25	−25	−25
9	97.1	0.63	66.7	66.7	–	–
10	86.4	0	−20	−33.3	–	–
11	31.2	0	−9.1	45.5	–	–

Shaded rows are extra-pelvic tumors. A pain spike was seen at day 30 in patient 8 with a popliteal fossa lesion because of increased mobilization.

Table 3. Percentage change in mean scores for each QoL feature.

QLQ-C15-PAL	Baseline N = 11	Day 7 N = 11	Day 30 N = 11	Day 60 N = 6	Day 90 N = 4
Physical FunctioningƗ	43.7 ± 20.1	45.5 ± 23.4	44.7 ± 22.0	51.1 ± 21.8	41.7 ± 14.8
Emotional FunctioningƗ	66.8 ± 17.8	72.0 ± 33.4	74.2 ± 22.4	82.0 ± 23.8	83.3 ± 23.6
Dyspnoea*	9.6 ± 15.8	9.1 ± 15.6	10.0 ± 16.1	16.7 ± 27.9	0.0 ± 0.0
Pain*	64.3 ± 21.8	60.6 ± 29.1	60.0 ± 33.5	58.3 ± 20.4	50.0 ± 36.0
Insomnia*	51.4 ± 34.6	42.4 ± 36.8	46.7 ± 32.2	38.9 ± 44.3	33.3 ± 38.5
Fatigue*	52.6 ± 18.0	45.5 ± 24.6	46.7 ± 21.5	51.9 ± 19.5	44.5 ± 20.3
Appetite Loss*	28.8 ± 26.5	15.2 ± 22.9	2.3 ± 22.5	33.3 ± 29.8	16.7 ± 19.3
Nausea and Vomiting*	8.2 ± 19.0	6.7 ± 16.1	3.7 ± 7.4	11.1 ± 20.2	4.2 ± 8.4

Items on the QLQ-C15-PAL were rated on a 4-point Likert scale from 1 (Not at All) to 4 (Very Much), with the exception of the overall QoL status item, which was rated from 1 (Very Poor) to 7 (Excellent). A higher score for the symptom scales (*) represents a higher level of symptomatology, and therefore a decreased QoL. In contrast, a higher score for the functional scales(Ɨ) represents a higher level of functionality, and therefore an increased QoL.

Figure 4. Axial T1W image with fat suppression pulse and after contrast enhancement with gadolinium chelate before and after treatment of an extra-pelvic tumor. The pretreatment image shows the enhancing nodule of recurrent tumor in the left ischio-rectal fat (yellow arrow). Immediately post-treatment there is complete ablation of this enhancing lesion (yellow arrow).

Table 4. Whole tumor and enhancing tumor volumes at baseline and longitudinal changes over 30 days.

	Baseline values	% change-immediate	% change day 7	% change day 30
Intra-pelvic tumors
Whole lesion volume cm^3 (median; range)	113.6 ± 162.2 (50.1; 34.7–444)	0.0 ± 10.8 (−1.4; −13.9 to 17.0)	13.6 ± 14.4 (6.9; 1.4–36.8)	26.0 ± 25.3 (16.3; 4.8–70.3)
Ratio perfused to whole lesion volume	0.78 ± 0.21 (0.8; 0.49–1.0)	−3.0 ± 5.3 (−1.7; 0 to −4.8)	−0.9 ± 4.6 (−0.8; 0–6.8)	0.3 ± 3.4 (0; 0–5.5)
Extra-pelvic tumors
Whole lesion volumecm^3 (median; range)	83.6 ± 76.2 (54.5; 1.7–192.3)	18.3 ± 5.4 (18.3; 13.2–23.2)	31.9 ± 29.5 (30.2; −1.0 to 68.1)	27.8 ± 13.9 (34.7; 13.9–73.7)
Ratio perfused to whole lesion volume	0.64 ± 0.08 (0.61; 0.47–1.0)	−18.2 ± 52.9 (−16.1; −2.0 to −100)	−23.4 ± 48.9 (−16.4; −14.3 to −100)	−22.7 ± 62.6 (−25.8; −18.4 to −100)

Figure 5. Axial T1W images with fat suppression pulse and after contrast enhancement with gadolinium chelate before and after treatment of an intra-pelvic tumor. The pretreatment image shows the non-enhancing tumor mass at the vaginal vault on the left (red arrow). There is no substantial change in tumor volume post treatment, either at Day 7 or Day 30, and no change in the relative enhancing and non-enhancing components (red arrows).

Data availability statement

Imaging data is available through the Cancer Research UK Imaging data repository (contact via study CI, N deSouza).