Modulated electro-hyperhtemia as a chemoradiosensitiser for locally advanced cervical cancer
SASCRO SASMO 2017 Abstract
Minnaar CA1, Kotzen JA1, Baeyens A1 2
1 Radiobiology, Dept Radiation Sciences, University of the Witwatersrand, Johannesburg, South Africa
2 Radiobiology, Dept Basic Medical Sciences, Ghent University, Belgium
OBJECTIVES: To report on the first 88 participants to reach 6 months post treatment in the ongoing study on modulated electro-hyperthermia (m-EHT) as a chemoradiosensitiser at the Charlotte Maxeke Johannesburg Academic Hospital
DESIGN & METHOD: The ongoing study is a phase III randomised clinical trial investigating the effects of the addition of m-EHT to standard chemoradiotherapy (CRT) protocols for locally advanced cervical cancer in HIV positive and negative women. The study aims to enrol 236 participants in FIGO stage IIB distal to IIIB of disease, with bilateral hydronephrosis and impaired renal function excluded. HIV positive participants must have been on antiretroviral treatment for at least 6 months or have a CD4 count above 200 cells/mm3. Participants are being randomised into a treatment group (m-EHT plus CRT) and a control group (CRT alone), based on HIV status, age and stage of disease. All participants are receiving 25 fractions of 2Gy external beam radiation, 3 doses of high dose rate brachytherapy (8Gy) and cisplatin. The treatment group is receiving two 55 minute local modulated electro-hyperthermia treatments per week during radiotherapy. The eligible participants with results for six months post completion of treatment have been selected to report on. The local disease control has been classified as Complete Response (no FDG uptake on PET/CT), Partial Response (more than a 50% reduction in tumour volume with residual FDG uptake on PET/CT) and No Response (less than 50% reduction in tumour volume with FDG uptake, local disease or death with proven disease progression).
RESULTS: 88 participants have results for 6 months post treatment. 52 participants are in the control group and 36 participants are from the study group. There is a 67% complete response rate in the study group and a 44% complete response rate in the control group. The disease progression in the control group is 37% versus 3% in the study group. The 6 month survival in the study group is 100% versus 90% in the control. There are no significant differences in early or late toxicity (at 6 months) between the two groups. These results are absolute and not actuarial.
CONCLUSION: The preliminary results continue to show a positive trend in local disease control and survival at 6 months in the study group without any unexpected adverse events or toxicity.