Cihan Gani1, Ulf Lamprecht2, Alexander Ziegler3, Matthias Moll4, Johanna Gellermann5, Vanessa Heinrich2, Svetlana Wenz6, Falko Fend7, Alfred Königsrainer8, Michael Bitzer9, Daniel Zips10. 1. University Hospital Tübingen, Department of Radiation Oncology, Germany; German Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany. Electronic address: cihan.gani@med.uni-tuebingen.de. 2. University Hospital Tübingen, Department of Radiation Oncology, Germany. 3. Department of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Germany. 4. Department of Radiation Oncology, Medical University of Vienna, Wien, Austria. 5. Praxis/Zentrum für Strahlentherapie und Radioonkologie, Berlin, Germany. 6. Institute of Pathology and Neuropathology, Eberhard-Karls University, Tuebingen, Germany. 7. German Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany; Institute of Pathology and Neuropathology, Eberhard-Karls University, Tuebingen, Germany. 8. University Hospital Tübingen, Department of General, Visceral and Transplant Surgery, Germany. 9. University Hospital Tübingen, Department of Internal Medicine I, Germany. 10. University Hospital Tübingen, Department of Radiation Oncology, Germany; German Cancer Research Center (DKFZ) Heidelberg and German Consortium for Translational Cancer Research (DKTK), Partner Site Tübingen, Germany.
Abstract
PURPOSE: The goal of the present study was to investigate the effect of deep regional hyperthermia on early and long-term oncological outcomes in the context of preoperative radiochemotherapy in rectal cancer. METHODS: In this prospective phase II trial, patients with locally advanced rectal cancer were treated with 5-fluorouracil based preoperative radiochemotherapy with 50.4 Gy in 28 fractions. Deep regional hyperthermia was scheduled twice weekly. Pathological tumor regression was scored according to the Dworak regression system. The primary endpoint was pathological complete response (pCR). Further endpoints were local control (LC), distant control (DC), disease-free survival (DFS) and overall survival (OS). Hyperthermia was defined as feasible if 70% of patients received at least eight treatments. Quality of life was assessed at follow-up by the EORTC-QLQ-C30 and QLQ-CR29 questionnaires. Time to event data was analyzed according to Kaplan-Meier based on first-events. The study was registered on clinicaltrials.gov (NCT02353858). RESULTS: From 2012 until 2017, 78 patients were recruited. Median follow-up was 54 months. Based on magnetic resonance imaging, the mesorectal fascia was involved or threatened in 60% of the patients. Compliance with radiotherapy was 99%, 91% received both cycles of chemotherapy and 77% had eight or more hyperthermia treatments. Median time from the end of radiotherapy to surgery was 6.7 weeks. A pathological complete response was reported in 14% of the patients, 50% had either Dworak 4 (complete regression) or Dworak 3 regression (scattered tumor cells only). Three year estimates for OS, DFS, LC and DC were 94%, 81%, 96% and 87%. Patients with higher hyperthermia related cumulative temperatures showed stronger tumor regression. Global health status based on EORTC-QLQ-C30 was comparable with data from the general population. CONCLUSION: Deep regional hyperthermia was feasible, did not compromise standard treatments and resulted in promising long-term oncological outcomes and QoL.
PURPOSE: The goal of the present study was to investigate the effect of deep regional hyperthermia on early and long-term oncological outcomes in the context of preoperative radiochemotherapy in rectal cancer. METHODS: In this prospective phase II trial, patients with locally advanced rectal cancer were treated with 5-fluorouracil based preoperative radiochemotherapy with 50.4 Gy in 28 fractions. Deep regional hyperthermia was scheduled twice weekly. Pathological tumor regression was scored according to the Dworak regression system. The primary endpoint was pathological complete response (pCR). Further endpoints were local control (LC), distant control (DC), disease-free survival (DFS) and overall survival (OS). Hyperthermia was defined as feasible if 70% of patients received at least eight treatments. Quality of life was assessed at follow-up by the EORTC-QLQ-C30 and QLQ-CR29 questionnaires. Time to event data was analyzed according to Kaplan-Meier based on first-events. The study was registered on clinicaltrials.gov (NCT02353858). RESULTS: From 2012 until 2017, 78 patients were recruited. Median follow-up was 54 months. Based on magnetic resonance imaging, the mesorectal fascia was involved or threatened in 60% of the patients. Compliance with radiotherapy was 99%, 91% received both cycles of chemotherapy and 77% had eight or more hyperthermia treatments. Median time from the end of radiotherapy to surgery was 6.7 weeks. A pathological complete response was reported in 14% of the patients, 50% had either Dworak 4 (complete regression) or Dworak 3 regression (scattered tumor cells only). Three year estimates for OS, DFS, LC and DC were 94%, 81%, 96% and 87%. Patients with higher hyperthermia related cumulative temperatures showed stronger tumor regression. Global health status based on EORTC-QLQ-C30 was comparable with data from the general population. CONCLUSION: Deep regional hyperthermia was feasible, did not compromise standard treatments and resulted in promising long-term oncological outcomes and QoL.
Authors: Baard-Christian Schem; Frank Pfeffer; Martin Anton Ott; Johan N Wiig; Nils Sletteskog; Torbjørn Frøystein; Mette Pernille Myklebust; Sabine Leh; Olav Dahl; Olav Mella Journal: Cancers (Basel) Date: 2022-01-29 Impact factor: 6.639
Authors: Adela Ademaj; Danai P Veltsista; Pirus Ghadjar; Dietmar Marder; Eva Oberacker; Oliver J Ott; Peter Wust; Emsad Puric; Roger A Hälg; Susanne Rogers; Stephan Bodis; Rainer Fietkau; Hans Crezee; Oliver Riesterer Journal: Cancers (Basel) Date: 2022-01-26 Impact factor: 6.639