Effects of Modulated Electro-Hyperthermia (mEHT) on Two and Three Year Survival of Locally Advanced Cervical Cancer Patients

Survival Months

Survival Months

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Summary

The aim of this study was to determine the effects of the addition of a mild heating technology, modulated electro-hyperthermia, to chemoradiotherapy protocols for the management of locally advanced cervical cancer patients. The results showed a significant improvement in two and three year disease free survival, without any significant changes to the toxicity profile, and with an improvement in quality of life.

Patients characteristics

210 patients with treatment-naïve, histologically confirmed FIGO stage IIB (with invasion of the distal half of the parametrium) IIIB squamous cell carcinoma of uterine cervix), Eastern cooperative oncology group (ECOG) performance status <2, estimated life expectancy of at least 12 months, adequate haematological function.

Methodology

210 patients were enrolled in this trial. Patients are divided into 2 cohorts, 106 patients in mEHT group and 104 patients in control group.

Treatment

All patients received 50 Gy of external beam radiotherapy (EBRT) in 25 fractions, administered to the whole pelvis, using 2D planning with virtual simulation. High Dose Rate (HDR) brachytherapy (BT) (Iridium-192) was administered in three fraction of 8 Gy for a total equivalent dose of 2 Gy fractions of 86 Gy.All patients were prescribed two doses of 80 mg/m2 cisplatin, administered 21 days apart, during EBRT (not administered on BT days or mEHT days).
Patients in the study group received two mEHT treatments per week (EHY2000+) with a minimum of 48 hours in between mEHT treatments, at a target power of 130 W for a minimum of 55 minutes. The EBRT started within thirty minutes of completing mEHT treatments.

Results

Two Year Survival
Data were available for 202 patients at two years pot-treatment, mEHT=100 and control group n=102. 53 (53%) of mEHT group and 43 (42%) in control group were alive at the last follow-up.
When considering patients with Stage II and Stage III disease separately, the risk of death within two years post-treatment, adjusted for age, disease stage, and HIV status, was significantly lower in the mEHT group with Stage III disease compared to the Control group with Stage III disease (mEHT Group: 34/61 [56%]; Control Group: 27/67 [40%]).
Two-year DFS was seen significantly more frequently in the mEHT Group (36/99 [36.4%]) than in the Control Group (14/102 [13.7%]), with patients treated with mEHT having 33% less risk of developing a recurrence during the first two years than the Control Group participants (adjusted for age, stage, and HIV status).
Three-Year Survival
Three-year OS was achieved by 33.7% (34/101) from the control group and 44% (44/100) from mEHT Group. The risk of death in the first three years was 28% lower for the patients who received mEHT (adjusted for age, disease stage and HIV status) and when considering only the patients with Stage III disease, the risk was significantly lower (38%) in the mEHT group (adjusted for age, and HIV status).
Toxicity
There was no significant difference in frequencies of reported late toxicity (grouped according to grades I/II and grades III/IV), between the two treatment groups or between the HIV-positive and HIV–negative patients at 9 months, 12 months, 18 months, and 24 months post-treatment. Multivariate Cox proportionate hazards models, including arm, HIV status and cisplatin doses, did not show any significant predictors of grades I/II or grades III/IV late toxicity.
Quality of Life
There were no statistically significant differences in QLQ scores between the two groups at baseline assessment. When comparing the changes in scores from baseline to 24 months between groups, the reduction in pain was significantly higher in the mEHT Group, cognitive function was significantly improved in the mEHT group, and patients in the Control Group reported a reduction in role functioning while the mEHT Group patients reported an improvement in role functioning with a significant difference between the two groups. When assessing the change from baseline to 12 months within each group, there was an improvement in all scales except for role functioning in the mEHT Group, with significant improvements in Global Health Scale, Pain, Fatigue, and Emotional functioning.
In the Control Group, there were significant improvements in the Visual Analogue Scale, Global Health Scale, Nausea and Vomiting, and Emotional Functioning, while Physical Functioning, Role Functioning and Cognitive Functioning decreased in the Control Group. When assessing the change from baseline to 24 months within each group, the mEHT group reported a significant improved of all scales except for role function (which improved by a score of 9.4), while the Control Group only reported a significant change in five out of 11 scales, with a negative change in cognitive function.

Conclusion

Modulated electro-hyperthermia enhances outcomes of LACC patients when added to CRT, without increasing the toxicity profile of treatments. The associated improvement in quality of life along with the reduction in healthcare costs makes this intervention a feasible and effective adjunct to CRT for the management of LACC. The addition of mEHT improved LDC and DFS in our sample, without additional toxicity, and with improved role functioning of the patients, benefiting both the patients, the community, and the already-strained healthcare system.

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Scientific article publishing date: 1/27/2022

Immucura identifier BSC22_373EN

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