Gustavo R Sarria1, Elena Sperk2, Xiaodi Han3, Gustavo J Sarria4, Frederik Wenz5, Stefanie Brehmer6, Bing Fu7, Siming Min7, Hongjun Zhang7, Shusen Qin7, Xiaoguang Qiu8, Daniel Hänggi6, Yasser Abo-Madyan1, David Martinez9, Carla Cabrera10, Frank A Giordano11. 1. Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 2. Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: elena.sperk@umm.de. 3. Department of Neurosurgery Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Department of Neurosurgery, Beijing Tiantan Puhua Hospital, China; China National Clinical Research Center for Neurological Diseases, Beijing, China. 4. Department of Radiotherapy, Oncosalud - AUNA, Lima, Peru; Department of Radiotherapy, Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. 5. Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; University Medical Center Freiburg, Freiburg, Germany. 6. Department of Neurosurgery, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 7. Department of Neurosurgery, Beijing Tiantan Puhua Hospital, China. 8. Department of Radiotherapy, Beijing Tiantan Puhua Hospital, Capital Medical University, Beijing, China. 9. Department of Radiotherapy, Oncosalud - AUNA, Lima, Peru. 10. Department of Radiotherapy, Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. 11. Department of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: Frank.Giordano@umm.de.
Abstract
PURPOSE: To report the results of the first international pooled analysis of patients with glioblastoma treated with intraoperative radiotherapy (IORT) in addition to standard of care therapy. METHODS: Data from 51 patients treated at five centers in Germany, China and Peru were analyzed. All patients underwent tumor resection followed by a single application of IORT (10-40 Gy, prescribed to the applicator surface) with low-energy X-rays. Thereafter, standard adjuvant radiochemotherapy and maintenance chemotherapy were applied. Factors of interest were overall survival (OS), progression-free survival (PFS), local PFS (L-PFS; defined as appearance of new lesions ≤1 cm to the cavity border) and distant PFS (D-PFS; lesions >1 cm). The same endpoints were estimated at 1-, 2- and 3-years using the Kaplan-Meier method. Additionally, rates and severity (as per Common Terminology Criteria for Adverse Events Version 5.0) of radionecrosis (RN) were analyzed. RESULTS: The median age was 55 years (range: 16-75) and the median Karnofsky Performance Status was 80 (20-100). At a median follow-up of 18.0 months (2-42.4), the median OS, PFS, L-PFS and D-PFS were 18.0 months (95% CI: 14.7-21.3), 11.4 months (95%CI: 7.58-15.22), 16 months (95%CI: 10.21-21.8) and 30.0 months (95%CI: 18.59 - 41.41), respectively. The estimated 1-, 2- and 3-year OS, PFS, L-PFS and D-PFS were 79.5%, 38.7% and 25.6%; 46.2%, 29.4%, and 5.9%; 60.9, 37.9%, and 12.6%; and 76.7%, 65.0%, and 39.0% respectively. First progression occurred locally in only 35.3% of cases. Grade 1 RN was detected in 7.8% and grade 3 in 17.6% of the patients. No grade 4 toxicity was reported and no treatment-related deaths occurred. CONCLUSION: Compared to historical data, this pooled analysis suggests improved efficacy and safety of IORT with low-energy X-rays for newly diagnosed glioblastoma. Prospective data is warranted to confirm these findings.
PURPOSE: To report the results of the first international pooled analysis of patients with glioblastoma treated with intraoperative radiotherapy (IORT) in addition to standard of care therapy. METHODS: Data from 51 patients treated at five centers in Germany, China and Peru were analyzed. All patients underwent tumor resection followed by a single application of IORT (10-40 Gy, prescribed to the applicator surface) with low-energy X-rays. Thereafter, standard adjuvant radiochemotherapy and maintenance chemotherapy were applied. Factors of interest were overall survival (OS), progression-free survival (PFS), local PFS (L-PFS; defined as appearance of new lesions ≤1 cm to the cavity border) and distant PFS (D-PFS; lesions >1 cm). The same endpoints were estimated at 1-, 2- and 3-years using the Kaplan-Meier method. Additionally, rates and severity (as per Common Terminology Criteria for Adverse Events Version 5.0) of radionecrosis (RN) were analyzed. RESULTS: The median age was 55 years (range: 16-75) and the median Karnofsky Performance Status was 80 (20-100). At a median follow-up of 18.0 months (2-42.4), the median OS, PFS, L-PFS and D-PFS were 18.0 months (95% CI: 14.7-21.3), 11.4 months (95%CI: 7.58-15.22), 16 months (95%CI: 10.21-21.8) and 30.0 months (95%CI: 18.59 - 41.41), respectively. The estimated 1-, 2- and 3-year OS, PFS, L-PFS and D-PFS were 79.5%, 38.7% and 25.6%; 46.2%, 29.4%, and 5.9%; 60.9, 37.9%, and 12.6%; and 76.7%, 65.0%, and 39.0% respectively. First progression occurred locally in only 35.3% of cases. Grade 1 RN was detected in 7.8% and grade 3 in 17.6% of the patients. No grade 4 toxicity was reported and no treatment-related deaths occurred. CONCLUSION: Compared to historical data, this pooled analysis suggests improved efficacy and safety of IORT with low-energy X-rays for newly diagnosed glioblastoma. Prospective data is warranted to confirm these findings.
Authors: Gustavo R Sarria; Zuzanna Smalec; Thomas Muedder; Jasmin A Holz; Davide Scafa; David Koch; Stephan Garbe; Matthias Schneider; Motaz Hamed; Hartmut Vatter; Ulrich Herrlinger; Frank A Giordano; Leonard Christopher Schmeel Journal: Front Oncol Date: 2021-10-28 Impact factor: 6.244
Authors: Salah Dajani; Virginia B Hill; John A Kalapurakal; Craig M Horbinski; Eric G Nesbit; Sean Sachdev; Amulya Yalamanchili; Tarita O Thomas Journal: J Clin Med Date: 2022-10-10 Impact factor: 4.964
Authors: Motaz Hamed; Anna-Laura Potthoff; Julian P Layer; David Koch; Valeri Borger; Muriel Heimann; Davide Scafa; Gustavo R Sarria; Jasmin A Holz; Frederic Carsten Schmeel; Alexander Radbruch; Erdem Güresir; Niklas Schäfer; Patrick Schuss; Stephan Garbe; Frank A Giordano; Ulrich Herrlinger; Hartmut Vatter; Leonard Christopher Schmeel; Matthias Schneider Journal: Cancers (Basel) Date: 2022-03-16 Impact factor: 6.639