Analysis of the effects of mEHT on the treatment-related toxicity and quality of life of HIV-positive cervical cancer patients

Figures & data

Table 1. Summary of local control outcomes at 6 months post-treatment in the trial by Minnaar et al. [35].

	mEHT group	Control group	p-value
Tumor response on PET/CT	49/85 (58%)	26/73 (36%)	0.005
LC censored for survival	40/88 (45% )	20/83 (24%)	0.003
LDFS	39/101 (39%)	20/101 (20%)	0.003

PET/CT: position emission tomography/computed tomography; LC: local control; LDFS: local disease free survival.

Figure 1. CONSORT diagram of the 271 patients who were screened and subsequently included or excluded in the trial, as reported by Minnaar et al. [35] and available for evaluation of early toxicity. AE: adverse events; COD: cause of death; LDFS: local disease free survival; Rx: treatment.

Table 2. Characteristics of participants and treatment.

	mEHT	Control
	105	101	p-value
HIV status
Positive	52 (50%)	53 (53%)
Negative	53 (50%)	48 (48%)
FIGO staging
IIB	40 (38%)	35 (35%)
III	65 (62%)	66 (65%)
Race
African	97 (92%)	94 (93%)
Caucasian	4 (4%)	1 (1%)
Other	4 (4%)	6 (6%)
Age (years)
Mean	48.1	49.4	0.384
SD	10.8	10.3
Range	26.5−68.9	28.4−72.7
BMI
Mean	27.8	27	0.387
SD	6.92	6.48
Range	15−49	15−42
Total RT dose
Mean	84.7Gy	85.3	0.483
SD	7.61Gy	5.69
Range	20Gy–86Gy	30−86Gy
Treatment days
Mean	41.6	42.8	0.255
SD	5.96	8.81
Range	13−65	10−97
Number of cisplatin doses
Mean	1.37	1.28	0.323
SD	0.67	0.69
0 doses	11 (11%)	14 (14%)
1 dose	44 (42%)	45 (45%)
2 doses	50 (48%)	42 (42%)
CD4 count (cells/µL)
Mean	586.1	525.1	0.242
SD	258.6	272.8
Range	148−1204	95−1524
No of mEHT doses
Mean	9.26
SD	1.65
Range	1−10
Average KJ administered during mEHT
Mean	380.18
SD	32.07
Range	237.1−454.5

BMI: body mass index; FIGO: International Federation of Gynecology and Obstetrics; KJ: kilojoules; RT: radiation therapy; SD: standard deviation.

Table 3. Reasons for missed or delayed cisplatin.

	One dose		No cisplatin
	mEHT	Control	mEHT	Control
Renal dysfunction	19	11	7	10
Delayed first dose^a	10	7
Leucopenia	0	0
Noncompliant	2	0	1	1
Anemia	1	2	2	1
Missed dose	1	1
Vomiting dehydration	1	0
Deceased	1	1
Sepsis	0	3
Technical	0	3
Too weak	0	1	0	1
Dehydration	0	1
Low CD4 count			0	1
Total	35	30	10	14

^a Reasons for delayed first dose were renal dysfunction (mEHT: n = 1; Control: n = 1), leucopenia (mEHT: n = 2; Control: n = 1), non-compliant (mEHT: n = 0; Control: n = 1), anemia (mEHT: n = 4; Control: n = 4), sepsis (mEHT: n = 2; Control: n = 1) and supply problems (mEHT: n = 1; Control: n = 0).

Table 4. Frequency of grade 3–4 toxicities in each treatment group analyzed by HIV status.

	mEHT		p-value	Control		p-value
	HIV-positive	HIV-negative		HIV-positive	HIV-negative
On treatment	n = 52	n = 53		n = 53	n = 48
Hematologic	6 (12%)	6 (11%)	0.972	8 (15%)	6 (13%)	0.706
Neurological	1 (2%)	0 (0%)	0.310	0 (0%)	0 (0%)
Lower GIT	0 (0%)	1 (2%)	0.320	0 (0%)	0 (0%)
Upper GIT	0 (0%)	1 (2%)	0.320	0 (0%)	0 (0%)
Dermatologic	3 (6%)	1 (2%)	0.299	1 (2%)	1 (2%)	0.727
Urogenital	3 (6%)	1 (2%)	0.299	1 (2%)	2 (4%)	0.500
Renal	5 (10%)	0 (0%)	0.027*	3 (6%)	3 (6%)	0.900
Multiple	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Six weeks	n = 48	n = 50		n = 48	n = 47
Hematologic	0 (0%)	2 (4%)	0.162	3 (6%)	3 (6%)	0.979
Neurological	1 (2%)	0 (0%)	0.305	0 (0%)	0 (0%)
Lower GIT	1 (2%)	0 (0%)	0.490	0 (0%)	0 (0%)
Upper GIT	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Dermatologic	0 (0%)	0 (0%)	1 (2%)	0 (0%)	0.320
Urogenital	1 (2%)	0 (0%)	0.305	0 (0%)	2 (4%)	0.149
Renal	1 (2%)	0 (0%)	0.490	0 (0%)	0 (0%)
Multiple	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Three months	n = 45	n = 48		n = 43	n = 42
Hematologic	3 (7%)	0 (0%)	0.069	1 (2%)	5 (12%)	0.085
Neurological	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Lower GIT	0 (0%)	1 (2%)	0.330	1 (2%)	2 (5%)	0.543
Upper GIT	0 (0%)	0 (0%)	1 (2%)	0 (0%)	0.320
Dermatologic	1 (2%)	0 (0%)	0.299	0 (0%)	0 (0%)
Urogenital	1 (2%)	0 (0%)	0.299	1 (2%)	3 (7%)	0.294
Renal	3 (7%)	0 (0%)	0.069	1 (2%)	2 (5%)	0.543
Multiple	0 (0%)	0 (0%)	0 (0%)	0 (0%)

GIT: gastrointestinal tract.

* Significant.

Table 5. Regression analysis for overall acute toxicity by system.

Variable	Odds ratio [OR]	p-value	95% CI
Neurological
HIV status	0.82	0.771	0.21–3.20
Cisplatin	All participants with neurological adverse events received cisplatin
mEHT	7.98	0.053	0.98–65.19
Dermatologic/subcutaneous
HIV status	2.61	0.033*	1.08–6.29
Cisplatin	3.54	0.016*	1.27–9.84
mEHT	1.35	0.485	0.58–3.11
Renal
HIV status	0.58	0.098	0.30–1.12
Cisplatin	0.13	<0.005*	0.05–0.33
mEHT	0.95	0.887	0.50–1.82

* Significant.

Table 6. Significant changes in the QoL results.

	mEHT group			Control group
	Mean change	SD	95% CI	Mean change	SD	95% CI	p-value
Six weeks
Cognitive function	13.6	33.1	6.97–20.24	3.5	30.6	2.89–9.85	0.031
Three months
Social functioning	83.9	31.6	77.4–90.4	73.3	39.4	64.8–81.8	0.049
Emotional functioning	83.9	24.3	78.9–88.9	73.5	33.3	66.3–80.6	0.017
Fatigue	−13.6	26.0	−18.86 to −8.15	3.0	39.9	11.53–5.59	0.037
Pain	−21.0	33.0	27.76 to −14.18	−6.7	36.6	−14.62 to 1.05	0.007

SD: standard deviation.

Minnaar CA, Kotzen JA, Ayeni AO, et al. The effect of modulated electro-hyperthermia on local disease control in HIV-positive and -negative cervical cancer women in South Africa: early results from a phase III randomised controlled trial. PLoS One. 2019;14(6):e0217894.

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