ESTRO 2020 Abstract book

S340 ESTRO 2020

OC-0565 Modulated electro-hyperthermia improves two year survival in HIV+/- cervical cancer patients C. Minnaar 1 , J.A. Kotzen 2 , M. Vangu 1 , A. Baeyens 3 1 University of the Witwatersrand, Radiation Sciences, Johannesburg, South Africa ; 2 Wits Donald Gordon Medical Institute, Radiation Oncology, Johannesburg, South Africa ; 3 Gent University, Human Structure and Repair, Gent, Belgium Purpose or Objective PURPOSE: Hyperthermia (HT) is an effective radiosensitiser for cervical tumors but the cost and complexity has limited the inclusion of HT into clinical practice and blocked the use of HT in resource-constrained settings. Modulated electro-hyperthermia (mEHT) proposes an alternative dosing concept, allowing for a more accessible heating solution. We report on two year survival data from the first phase III randomized controlled trial on mEHT as a radiosensitiser and the first trial on HT to include HIV-positive patients who are at a higher risk of treatment-related toxicity and poorer outcomes. Material and Methods MATERIALS AND METHODS: Participants with FIGO stages IIB to IIIB carcinoma of the cervix were randomized (stratum: HIV status, accounting for age and stage) to receive chemoradiotherapy (50Gy/25fractions external beam radiation (EBRT); 3 fractions of 8Gy HDR Brachytherapy; 2 doses of cisplatin 80mg/m2) with/without mEHT (twice a week, 55 minutes at 130W, immediately before EBRT). HIV-positive participants with a CD4 count >200cells/µL / on antiretroviral therapy for >6 months were included. Pre- and six months post- treatment 18 F-FDG PET/CT scans were conducted to assess disease response. All participants were required to sign an informed consent. Approval was obtained from the local ethics committee (M190295) and the trial was registered on the National Clinical Trials Register (ID:3012) before recruitment began (ClincialTrials.gov ID: NCT03332069). Results RESULTS: 210 women were randomized between January 2014 to November 2017 and 101 participants in each group were available for 6 month analysis. Pre-treatment PET/CT studies showed extra-pelvic nodal disease in 54 participants in each group. mEHT did not increase the toxicity profile in HIV-positive or –negative participants. Local disease control (LDC) was significantly higher in the mEHT Group (n=40[45.5%] versus n=20[24.1%]; p=0.003 ), as was 6 month local Disease Free (DF) survival (n=39[38.6%] versus n=20[19.8%]; p=0.003 ). In participants with extra-pelvic disease on pre-treatment scans, complete metabolic resolution of all disease, including nodes outside the treatment field, was significantly higher in the mEHT group (13[24.1%]) than in the control group (3[5.6%]), ( p=0.013 ). Two year all mortality survival was 57% (55/96) in the mEHT and 42% (43/102) in the control group (HR: 0.64, 95%CI: 0.43- 0.96, p =0.030) and LDC perfectly predicted two year survival. Two year survival and DF at last follow up was significantly more likely in the mEHT group (OR: 1.84, 95%CI: 1.05-3.24, p =0.034 and OR: 2.93, 95%CI: 1.5- 5.7, p =0.002 respectively).

Conclusion CONCLUSION: The use of mEHT improves LDC, 2 year survival and DF status in high risk cervical cancer patients, even in a resource-constrained setting. The results provide first evidence of a heating solution that can be incorporated in resource-constrained settings and in general clinical practice as a radiosensitiser to improve outcomes for cervical cancer patients. OC-0566 Risk factors for nodal failure in the EMBRACE study cohort M. Peters 1 , A.A.C. De Leeuw 1 , R. Pötter 2 , C.N. Nomden 1 , K. Tanderup 3 , K. Kirchheiner 2 , M.P. Schmid 2 , I. Fortin 2 , C. Haie-Meder 4 , J.C. Lindegaard 3 , A. Sturdza 2 , U. Mahantshetty 5 , P. Hoskin 6 , B. Segedin 7 , K. Bruheim 8 , B. Rai 9 , F. Huang 10 , R. Cooper 11 , E. Van der Steen-Banasik 12 , E. Van Limbergen 13 , R. Nout 14 , I. Jürgenliemk-Schulz 1 1 UMC Utrecht, Department of Radiation Oncology, Utrecht, The Netherlands ; 2 AKH Medical University/General Hospital of Vienna, Department of Radiation Oncology-Comprehensive Cancer Center, Vienna, Austria ; 3 Aarhus University Hospital, Department of Oncology, Aarhus, Denmark ; 4 Gustave- Roussy, Department of Radiotherapy, Villejuif, France ; 5 Tata Memorial Hospital, Department of Radiation Oncology, Mumbai, India ; 6 Mount Vernon Hospital, Mount Vernon Cancer Centre, Northwood, United Kingdom ; 7 Institute of Oncology Ljubljana, Department of Radiotherapy, Ljubljana, Slovenia ; 8 The Norwegian Radium Hospital-Oslo University Hospital, Department of Oncology, Oslo, Norway ; 9 Postgraduate Institute of Medical Education and Research, Department of Radiotherapy and Oncology, Chandigarh, India ; 10 Cross Cancer Institute and University of Alberta, Department of Oncology, Edmonton, Canada ; 11 St James's University Hospital, Leeds Cancer Centre, Leeds, United Kingdom ; 12 Radiotherapiegroep Arnhem, Department of Radiotherapy, Arnhem, The Netherlands ; 13 UZ Leuven, Department of Radiation Oncology, Leuven, Belgium ; 14 Leiden University Medical Center, Department of Radiation Oncology, Leiden, The Netherlands Purpose or Objective After definitive chemoradiotherapy (CRT) and image guided brachytherapy (IGBT) for locally advanced cervical cancer (LACC), nodal failure (NF) negatively impacts survival and salvage options are limited. Data are scarce on risk factors for NF, which could help identify patients at risk and might allow for optimising primary treatment strategies. Material and Methods