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3. Dummy run for planning of isotoxic dose-escalated radiation therapy for glioblastoma used in the PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06)

Author

Maier, Sebastian H., Schönecker, Stephan, Anagnostatou, Vasiliki, Garny, Sylvia, Nitschmann, Alexander, Fleischmann, Daniel F., Büttner, Marcel, Kaul, David, Imhoff, Detlef, Fokas, Emmanouil, Seidel, Clemens, Hau, Peter, Kölbl, Oliver, Popp, Ilinca, Grosu, Anca-Ligia, Haussmann, Jan, Budach, Wilfried, Celik, Eren, Kahl, Klaus-Henning, Hoffmann, Elgin, Tabatabai, Ghazaleh, Paulsen, Frank, Holzgreve, Adrien, Albert, Nathalie L., Mansmann, Ulrich, Corradini, Stefanie, Belka, Claus, Niyazi, Maximilian, and Bodensohn, Raphael

Published
2024
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4. Brachytherapy for rhabdomyosarcoma: Survey of international clinical practice and development of guidelines

Author

Dávila Fajardo, Raquel, Scarzello, Giovanni, Gaze, Mark N, Boterberg, Tom, Cameron, Alison, Fuchs, Joerg, Guérin, Florent, Hoskin, Peter, Krasin, Matthew J, Kroon, Petra, Magelssen, Henriette, Mercke, Claes, Merks, Johannes H.M., Paulsen, Frank, Pommier, Pascal, Ramos, Monica, Rees, Helen, Rogers, Tim, Schmid, Maximilian, Seitz, Guido, Slater, Olga, Smeulders, Naima, Stenman, Jakob, Terwisscha, Sheila, Chargari, Cyrus, and Mandeville, Henry C

Published
2024
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5. Targeted therapies in retinoblastoma: GD2-directed immunotherapy following autologous stem cell transplantation and evaluation of alternative target B7-H3

Author

Eichholz, Thomas, Heubach, Florian, Arendt, Anne-Marie, Seitz, Christian, Brecht, Ines B., Ebinger, Martin, Flaadt, Tim, Süsskind, Daniela, Richter, Lisa, Hülsenbeck, Isabel, Zerweck, Leonie, Göricke, Sophia, Paulsen, Frank, Dombrowski, Frank, Flotho, Christian, Schönberger, Stefan, Ketteler, Petra, Schulte, Johannes, and Lang, Peter

Published
2024
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9. Dosimetric feasibility analysis and presentation of an isotoxic dose-escalated radiation therapy concept for glioblastoma used in the PRIDE trial (NOA-28; ARO-2022-12)

Author

Bodensohn, Raphael, Fleischmann, Daniel F., Maier, Sebastian H., Anagnostatou, Vasiliki, Garny, Sylvia, Nitschmann, Alexander, Büttner, Marcel, Mücke, Johannes, Schönecker, Stephan, Unger, Kristian, Hoffmann, Elgin, Paulsen, Frank, Thorwarth, Daniela, Holzgreve, Adrien, Albert, Nathalie L., Corradini, Stefanie, Tabatabai, Ghazaleh, Belka, Claus, and Niyazi, Maximilian

Published
2024
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11. Dose-escalated radiotherapy with simultaneous integrated boost for bone metastases in selected patients with assumed favourable prognosis

Author

Potkrajcic Vlatko, Mueller Arndt-Christian, Frey Bettina, Gani Cihan, Zips Daniel, Hoffmann Ruediger, Frantz Sandra, Warm Verena, Paulsen Frank, and Eckert Franziska

Subjects
radiotherapy, oligometastatic disease, oligoprogressive disease, bone metastases, hypofractionated radiotherapy, simultaneous integrated boost, Medical physics. Medical radiology. Nuclear medicine, R895-920
Abstract

Stereotactic body radiotherapy (SBRT) concepts for dose escalation are increasingly used for bone metastases in patients with oligometastatic or oligoprogressive disease. For metastases that are not suitable for SBRT-regimens, a treatment with 30/40 Gy with simultaneous integrated boost (SIB) in 10 fractions represents a possible regimen. The aim of this study was to investigate the feasibility of this concept and the acute and subacute toxicities.

Published
2022
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16. The European Particle Therapy Network (EPTN) consensus on the follow-up of adult patients with brain and skull base tumours treated with photon or proton irradiation

Author

De Roeck, Laurien, van der Weide, Hiska L., Eekers, Daniëlle B.P., Kramer, Miranda C., Alapetite, Claire, Blomstrand, Malin, Burnet, Neil G., Calugaru, Valentin, Coremans, Ida E.M., Di Perri, Dario, Harrabi, Semi, Iannalfi, Alberto, Klaver, Yvonne L.B., Langendijk, Johannes A., Méndez Romero, Alejandra, Paulsen, Frank, Roelofs, Erik, de Ruysscher, Dirk, Timmermann, Beate, Vitek, Pavel, Weber, Damien C., Whitfield, Gillian A., Nyström, Petra Witt, Zindler, Jaap, Troost, Esther G.C., and Lambrecht, Maarten

Published
2022
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17. Toxicity and Efficacy of Local Ablative, Image-guided Radiotherapy in Gallium-68 Prostate-specific Membrane Antigen Targeted Positron Emission Tomography–staged, Castration-sensitive Oligometastatic Prostate Cancer: The OLI-P Phase 2 Clinical Trial

Author

Hölscher, Tobias, Baumann, Michael, Kotzerke, Jörg, Zöphel, Klaus, Paulsen, Frank, Müller, Arndt-Christian, Zips, Daniel, Koi, Lydia, Thomas, Christian, Löck, Steffen, Krause, Mechthild, Wirth, Manfred, and Lohaus, Fabian

Published
2022
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18. Hypofractionated preoperative radiotherapy for high risk soft tissue sarcomas in a geriatric patient population

Author

Potkrajcic Vlatko, Traub Frank, Hermes Barbara, Scharpf Marcus, Kolbenschlag Jonas, Zips Daniel, Paulsen Frank, and Eckert Franziska

Subjects
sarcoma, radiotherapy, preoperative, geriatric patients, wound healing, hypofractionation, Medical physics. Medical radiology. Nuclear medicine, R895-920
Abstract

Standard therapy for localised, resectable high risk soft tissue sarcomas consists of wide excision and radiotherapy over several weeks. This treatment schedule is hardly feasible in geriatric and frail patients. In order not to withhold radiotherapy from these patients, hypofractionated radiotherapy with 25 Gy in 5 fractions was evaluated in a geriatric patient population.

Published
2021
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19. Update of the EPTN atlas for CT- and MR-based contouring in Neuro-Oncology

Author

Eekers, Daniëlle B.P., Di Perri, Dario, Roelofs, Erik, Postma, Alida, Dijkstra, Jeanette, Ajithkumar, Thankamma, Alapetite, Claire, Blomstrand, Malin, Burnet, Neil G, Calugaru, Valentin, Compter, Inge, Coremans, Ida E.M., Harrabi, Semi, Iannalfi, Alberto, Klaver, Yvonne L.B., Lambrecht, Maarten, Romero, Alejandra Méndez, Paulsen, Frank, Timmermann, Beate, Vitek, Pavel, van der Weide, Hiske L, Whitfield, Gillian A, Nyström, Petra Witt, Zindler, Jaap, de Ruysscher, Dirk, Langendijk, Johannes, Weber, Damien C, and Troost, Esther G.C.

Published
2021
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21. App-based assessment of patient-reported outcomes in the Molecular Tumor Board in the Center for Personalized Medicine—(TRACE).

Author

Dörner, Lorenz, Grosse, Lucia, Stange, Felix, Hille, Hanni, Kurz, Sylvia, Becker, Hannes, Volkmer, Sebastian, Hippler, Melina, Rieger, David, Bombach, Paula, Rieger, Johannes, Weinert, Lina, Svensson, Laura, Anders, Carolin, Cekin, Sila, Paulsen, Frank, Öner, Öznur, Ruhm, Kristina, Malek, Holly Sundberg, and Möller, Yonne

Subjects
PATIENT reported outcome measures, PATIENTS' attitudes, MEDICAL personnel, QUALITY of life, INDIVIDUALIZED medicine
Abstract

Background Biomarker-based therapies are increasingly used in cancer patients outside clinical trials. Systematic assessment of patient-reported outcomes (PRO) is warranted to take patients' perspectives during biomarker-based therapies into consideration. We assessed the feasibility of an electronic PRO assessment via a smartphone application. Methods An interdisciplinary expert panel developed a smartphone application based on symptom burden and health-related quality of life (HRQoL) metrics reported in a retrospective analysis of 292 neuro-oncological patients. The app included validated assessments of health-related quality of life (HRQoL), the burden of symptoms, and psychological stress. Feasibility and usability were tested in a pilot study. Semi-structured interviews with patients and health care professionals (HCP) were conducted, transcribed, and analyzed according to Mayring´s qualitative content analysis. Furthermore, we assessed compliance and descriptive data of ePROs. Results A total of 14 patients have been enrolled, (9 female, 5 male). A total of 4 HCPs, 9 patients, and 1 caregiver were interviewed regarding usability/feasibility. The main advantages were the possibility to complete questionnaires at home and comfortable implementation in daily life. Compliance was high, for example, 82% of the weekly distributed NCCN distress thermometer questionnaires were answered on time, however, with interindividual variability. We observed a median distress score of 5 (range 0–10, 197 results, n = 12, weekly assessed) and a median Global health score of 58.3 according to the EORTC QLQ-C30 instrument (range 16.7–100, 77 results, n = 12, monthly assessed). Conclusions This pilot study proved the feasibility and acceptance of the app. We will therefore expand its application during biomarker-guided therapies to enable systematic PRO assessments. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Prospective evaluation of probabilistic dose-escalated IMRT in prostate cancer

Author

Wegener Daniel, Berger Bernhard, Outtagarts Zhoulika, Zips Daniel, Paulsen Frank, Bleif Martin, Thorwarth Daniela, Alber Markus, Dohm Oliver, and Müller Arndt-Christian

Subjects
probabilistic planned imrt, coverage probability concept, prostate cancer, imrt, dose escalation, Medical physics. Medical radiology. Nuclear medicine, R895-920
Abstract

Cure- and toxicity rates after intensity-modulated radiotherapy (IMRT) of prostate cancer are dose-and volume dependent. We prospectively studied the potential for organ at risk (OAR) sparing and compensation of tumor movement with the coverage probability (CovP) concept.

Published
2020
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23. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma

Author

Voss, Martin, Wagner, Marlies, von Mettenheim, Nina, Harter, Patrick N., Wenger, Katharina J., Franz, Kea, Bojunga, Jörg, Vetter, Manuela, Gerlach, Ruediger, Glatzel, Michael, Paulsen, Frank, Hattingen, Elke, Baehr, Oliver, Ronellenfitsch, Michael W., Fokas, Emmanouil, Imhoff, Detlef, Steinbach, Joachim P., Rödel, Claus, and Rieger, Johannes

Published
2020
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25. Neurocognitive functioning and health-related quality of life in adult medulloblastoma patients: long-term outcomes of the NOA-07 study

Author

Dirven, Linda, Luerding, Ralf, Beier, Dagmar, Bumes, Elisabeth, Reinert, Christiane, Seidel, Clemens, Bonsanto, Matteo Mario, Bremer, Michael, Rieken, Stefan, Combs, Stephanie E., Herrlinger, Ulrich, Seliger, Corinna, Kuntze, Holger, Mayer-Steinacker, Regine, Dieing, Annette, Bartels, Claudius, Schnell, Oliver, Weyerbrock, Astrid, Seidel, Sabine, Grauer, Oliver, Nadji-Ohl, Minou, Paulsen, Frank, Weller, Michael, Wick, Wolfgang, and Hau, Peter

Published
2020
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26. Immunosuppressive Total Nodal Irradiation–Based Reconditioning Regimens After Graft Rejection or Graft Failure in Pediatric Patients Treated With Myeloablative Allogeneic Hematopoietic Cell Transplantation

Author

Wegener, Daniel, Lang, Peter, Paulsen, Frank, Weidner, Nicola, Zips, Daniel, Ebinger, Martin, Holzer, Ursula, Döring, Michaela, Basu, Oliver, Gruhn, Bernd, Wittig, Andrea, Teltschik, Heiko-Manuel, Handgretinger, Rupert, and Heinzelmann, Frank

Published
2019
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27. Online Adaptive MR-Guided Ultrahypofractionated Radiotherapy of Prostate Cancer on a 1.5 T MR-Linac: Clinical Experience and Prospective Evaluation.

Author

Potkrajcic, Vlatko, Gani, Cihan, Fischer, Stefan Georg, Boeke, Simon, Niyazi, Maximilian, Thorwarth, Daniela, Voigt, Otilia, Schneider, Moritz, Mönnich, David, Kübler, Sarah, Boldt, Jessica, Hoffmann, Elgin, Paulsen, Frank, Mueller, Arndt-Christian, and Wegener, Daniel

Subjects
CANCER radiotherapy, RADIOTHERAPY, PROSTATE cancer, PROSTATE cancer patients, TREATMENT failure, TREATMENT duration
Abstract

The use of hypofractionated radiotherapy in prostate cancer has been increasingly evaluated, whereas accumulated evidence demonstrates comparable oncologic outcomes and toxicity rates compared to normofractionated radiotherapy. In this prospective study, we evaluate all patients with intermediate-risk prostate cancer treated with ultrahypofractionated (UHF) MRI-guided radiotherapy on a 1.5 T MR-Linac within our department and report on workflow and feasibility, as well as physician-recorded and patient-reported longitudinal toxicity. A total of 23 patients with intermediate-risk prostate cancer treated on the 1.5 T MR-Linac with a dose of 42.7 Gy in seven fractions (seven MV step-and-shoot IMRT) were evaluated within the MRL-01 study (NCT04172753). The duration of each treatment step, choice of workflow (adapt to shape-ATS or adapt to position-ATP) and technical and/or patient-sided treatment failure were recorded for each fraction and patient. Acute and late toxicity were scored according to RTOG and CTC V4.0, as well as the use of patient-reported questionnaires. The median follow-up was 12.4 months. All patients completed the planned treatment. The mean duration of a treatment session was 38.2 min. In total, 165 radiotherapy fractions were delivered. ATS was performed in 150 fractions, 5 fractions were delivered using ATP, and 10 fractions were delivered using both ATS and ATP workflows. Severe acute bother (G3+) regarding IPS-score was reported in five patients (23%) at the end of radiotherapy. However, this tended to normalize and no G3+ IPS-score was observed later at any point during follow-up. Furthermore, no other severe genitourinary (GU) or gastrointestinal (GI) acute or late toxicity was observed. One-year biochemical-free recurrence survival was 100%. We report the excellent feasibility of UHF MR-guided radiotherapy for intermediate-risk prostate cancer patients and acceptable toxicity rates in our preliminary study. Randomized controlled studies with long-term follow-up are warranted to detect possible advantages over current state-of-the-art RT techniques. [ABSTRACT FROM AUTHOR]

Published
2024
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28. Radiation dose constraints for organs at risk in neuro-oncology; the European Particle Therapy Network consensus

Author

Lambrecht, Maarten, Eekers, Daniëlle B.P., Alapetite, Claire, Burnet, Neil G., Calugaru, Valentin, Coremans, Ida E.M., Fossati, Piero, Høyer, Morten, Langendijk, Johannes A., Méndez Romero, Alejandra, Paulsen, Frank, Perpar, Ana, Renard, Laurette, de Ruysscher, Dirk, Timmermann, Beate, Vitek, Pavel, Weber, Damien C., van der Weide, Hiske L., Whitfield, Gillian A., Wiggenraad, Ruud, Roelofs, Erik, Nyström, Petra Witt, and Troost, Esther G.C.

Published
2018
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29. The EPTN consensus-based atlas for CT- and MR-based contouring in neuro-oncology

Author

Eekers, Daniëlle BP, in 't Ven, Lieke, Roelofs, Erik, Postma, Alida, Alapetite, Claire, Burnet, Neil G., Calugaru, Valentin, Compter, Inge, Coremans, Ida E.M., Høyer, Morton, Lambrecht, Maarten, Nyström, Petra Witt, Méndez Romero, Alejandra, Paulsen, Frank, Perpar, Ana, de Ruysscher, Dirk, Renard, Laurette, Timmermann, Beate, Vitek, Pavel, Weber, Damien C., van der Weide, Hiske L., Whitfield, Gillian A., Wiggenraad, Ruud, and Troost, Esther G.C.

Published
2018
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30. Independent validation of a new reirradiation risk score (RRRS) for glioma patients predicting post-recurrence survival: A multicenter DKTK/ROG analysis

Author

Niyazi, Maximilian, Adeberg, Sebastian, Kaul, David, Boulesteix, Anne-Laure, Bougatf, Nina, Fleischmann, Daniel F., Grün, Arne, Krämer, Anna, Rödel, Claus, Eckert, Franziska, Paulsen, Frank, Kessel, Kerstin A., Combs, Stephanie E., Oehlke, Oliver, Grosu, Anca-Ligia, Seidlitz, Annekatrin, Lattermann, Annika, Krause, Mechthild, Baumann, Michael, Guberina, Maja, Stuschke, Martin, Budach, Volker, Belka, Claus, and Debus, Jürgen

Published
2018
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36. Evolution of a Meningothelial Meningioma: From WHO Grade 1 to Anaplastic Grade 3 with Extracranial Metastasis Including Extensive Liver Metastasis.

Author

Ruff, Christer, Bombach, Paula, Gohla, Georg, Hauser, Till-Karsten, Paulsen, Frank, Farhang, Nick, Boesmueller, Hans, Beschorner, Rudi, and Bongers, Malte

Subjects
LIVER metastasis, MENINGIOMA, METASTASIS, CANCER relapse, MTOR inhibitors, ANAPLASTIC thyroid cancer
Abstract

A 61-year-old patient was diagnosed with a left-sided falx meningioma. Histopathological analysis following extirpation showed a meningothelial meningioma ZNS WHO grade 1 with sparse mitoses. Over the course of 12 years, the patient received irradiation (54.0 Gy), peptide radio-receptor therapy (177Lu-DOMITATE) and targeted therapy (mTOR inhibitor). Follow-up imaging revealed an increased size of the residual tumor. Due to increased liver function parameters, imaging of the liver was performed, showing widespread space-occupying lesions with atypical appearance. Biopsy revealed metastasis of the meningioma, now with 2.7 mitoses/mm2, necrosis and homozygous CDKN2A/B deletion, corresponding to an anaplastic CNS meningioma WHO grade 3. A second small meningioma on the left petroclival side has been consistent in size over 12 years. Metastatic meningiomas pose a pertinent clinical challenge due to poor prognosis. The lung, bone, liver and cervical lymph nodes are the most common sites of extracranial metastasis. According to the World Health Organization criteria, the most important predictive factor for recurrence and metastasis is the tumor grade. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Multimodal Therapy with Consolidating Haploidentical Stem Cell Transplantation and Dinutuximab Beta for Patients with High-Risk Neuroblastoma and Central Nervous System Relapse.

Author

Flaadt, Tim, Ebinger, Martin, Schreiber, Malin, Ladenstein, Ruth L., Simon, Thorsten, Lode, Holger N., Hero, Barbara, Schuhmann, Martin U., Schäfer, Jürgen, Paulsen, Frank, Timmermann, Beate, Eggert, Angelika, and Lang, Peter

Subjects
NEUROBLASTOMA, STEM cell transplantation, CENTRAL nervous system, COMBINED modality therapy
Abstract

Despite highly intensive multimodality treatment regimens, the prognosis of patients with high-risk neuroblastoma (HRNB) and central nervous system (CNS) relapse remains poor. We retrospectively reviewed data from 13 patients with HRNB and CNS relapse who received multimodal therapy with consolidating haploidentical stem cell transplantation (haplo-SCT) followed by dinutuximab beta ± subcutaneous interleukin-2 (scIL-2). Following individual relapse treatment, patients aged 1−21 years underwent haplo-SCT with T/B-cell-depleted grafts followed by dinutuximab beta 20 mg/m2/day × 5 days for 5–6 cycles. If a response was demonstrated after cycle 5 or 6, patients received up to nine treatment cycles. After haplo-SCT, eight patients had a complete response, four had a partial response, and one had a stable disease. All 13 patients received ≥3 cycles of immunotherapy. At the end of the follow-up, 9/13 patients (66.7%) demonstrated complete response. As of July 2023, all nine patients remain disease-free, with a median follow-up time of 5.1 years since relapse. Estimated 5-year event-free and overall survival rates were 55.5% and 65.27%, respectively. Dinutuximab beta ± scIL-2 following haplo-SCT is a promising treatment option with a generally well-tolerated safety profile for patients with HRNB and CNS relapse. [ABSTRACT FROM AUTHOR]

Published
2023
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41. Increasing Patient Safety and Treatment Quality by Using Intraoperative MRI for Organ-Preserving Tumor Resection and High-Dose Rate Brachytherapy in Children with Bladder/Prostate and Perianal Rhabdomyosarcoma.

Author

Schmidt, Andreas, Roder, Constantin, Eckert, Franziska, Baumann, David, Niyazi, Maximilian, Fideler, Frank, Ernemann, Ulrike, Tatagiba, Marcos, Schäfer, Jürgen, Urla, Cristian, Scherer, Simon, Fuchs, Jörg, Paulsen, Frank, and Bender, Benjamin

Subjects
MEDICAL quality control, BLADDER tumors, RHABDOMYOSARCOMA, INTRAOPERATIVE care, MAGNETIC resonance imaging, PRESERVATION of organs, tissues, etc., ANAL tumors, TREATMENT effectiveness, RADIOISOTOPE brachytherapy, COMBINED modality therapy, PATIENT safety, PROSTATE tumors, CHILDREN
Abstract

Simple Summary: The combination treatment of organ-preserving tumor resection and brachytherapy in children with bladder/prostate and perianal rhabdomyosarcoma can reduce therapy-associated side effects while maintaining excellent oncological outcome. This highly individualized hybrid treatment concept poses specific challenges for all clinicians involved in the local treatment. The aim of this study was to determine whether the use of an intraoperative MRI can improve the clinical workflow. These findings may have a positive impact on the treatment quality and patient safety of children with bladder/prostate and perianal RMS. In children with bladder/prostate (BP) and perianal rhabdomyosarcoma (RMS), we use a hybrid treatment concept for those suitable, combining organ-preserving tumor resection and high-dose rate brachytherapy (HDR-BT). This treatment concept has been shown to improve outcomes. However, it is associated with specific challenges for the clinicians. The exact position of the tubes for BT is a prerequisite for precise radiotherapy. It can finally be determined only with an MRI or CT scan. We evaluated the use of an intraoperative MRI (iMRI) to control the position of the BT tubes and for radiotherapy planning in all patients with BP and perianal RMS who received the above-mentioned combination therapy in our department since January 2021. iMRI was used in 12 children. All tubes were clearly localized. No adverse events occurred. In all 12 children, radiotherapy could be started on time. In a historical cohort without iMRI, this was not possible in 3 out of 20 children. The use of iMRI in children with BP and perianal RMS improved patient safety and treatment quality. This technology has proven to be successful for the patient population we have defined and has become a standard procedure in our institution. [ABSTRACT FROM AUTHOR]

Published
2023
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46. 1915: PET vs. MRI based reirradiation in glioblastoma. A prospective randomized trial (GLIAA, NCT01252459)

Author

Grosu, Anca Ligia, Weber, Wolfgang A., Graf, Erika, Mix, Michael, Wiehle, Rolf, Nestle, Ursula, Schimek-Jasch, Tanja, Niyazi, Maximilian, Belka, Claus, Paulsen, Frank, Eckert, Franziska, Eble, Michael J., König, Liane, Giordano, Frank Anton, Sperk, Elena, Momm, Felix, Spehl, Irina, Combs, Stephanie E., Bernhardt, Denise, Engenhart-Cabillic, Rita, Schymalla, Markus Michael, Stuschke, Martin, Pöttgen, Christoph, Fietkau, Rainer, and Popp, Ilinca

Published
2024
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47. A Continuous Correlation Between Residual Tumor Volume and Survival Recommends Maximal Safe Resection in Glioblastoma Patients: A Nomogram for Clinical Decision Making and Reference for Non-Randomized Trials

Author

Skardelly, Marco, Kaltenstadler, Marlene, Behling, Felix, Mäurer, Irina, Schittenhelm, Jens, Bender, Benjamin, Paulsen, Frank, Hedderich, Jürgen, Renovanz, Mirjam, Gempt, Jens, Barz, Melanie, Meyer, Bernhard, Tabatabai, Ghazaleh, and Tatagiba, Marcos Soares

Subjects
nomogram, Oncology, glioblastoma, residual tumor volume, accelerated failure time, reference, extent of resection, Original Research, prognostic survival model
Abstract

Objective The exact role of the extent of resection or residual tumor volume on overall survival in glioblastoma patients is still controversial. Our aim was to create a statistical model showing the association between resection extent/residual tumor volume and overall survival and to provide a nomogram that can assess the survival benefit of individual patients and serve as a reference for non-randomized studies. Methods In this retrospective multicenter cohort study, we used the non-parametric Cox regression and the parametric log-logistic accelerated failure time model in patients with glioblastoma. On 303 patients (training set), we developed a model to evaluate the effect of the extent of resection/residual tumor volume on overall survival and created a score to estimate individual overall survival. The stability of the model was validated by 20-fold cross-validation and predictive accuracy by an external cohort of 253 patients (validation set). Results We found a continuous relationship between extent of resection or residual tumor volume and overall survival. Our final accelerated failure time model (pseudo R2 = 0.423; C-index = 0.749) included residual tumor volume, age, O6-methylguanine-DNA-methyltransferase methylation, therapy modality, resectability, and ventricular wall infiltration as independent predictors of overall survival. Based on these factors, we developed a nomogram for assessing the survival of individual patients that showed a median absolute predictive error of 2.78 (mean: 1.83) months, an improvement of about 40% compared with the most promising established models. Conclusions A continuous relationship between residual tumor volume and overall survival supports the concept of maximum safe resection. Due to the low absolute predictive error and the consideration of uneven distributions of covariates, this model is suitable for clinical decision making and helps to evaluate the results of non-randomized studies.

Published
2021

49. Salvage-Radiation Therapy and Regional Hyperthermia for Biochemically Recurrent Prostate Cancer after Radical Prostatectomy (Results of the Planned Interim Analysis)

Author

Beck, Marcus, Ghadjar, Pirus, Mehrhof, Felix, Zips, Daniel, Paulsen, Frank, Wegener, Daniel, Burock, Susen, Kaul, David, Stromberger, Carmen, Nadobny, Jacek, Ott, Oliver J., Fietkau, Rainer, Budach, Volker, Wust, Peter, Müller, Arndt-Christian, and Zschaeck, Sebastian

Subjects
postoperative, salvage radiation therapy, ddc:610, dose-escalation, radiosensitization, prostate cancer, hyperthermia, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, human activities, lcsh:RC254-282, Article, 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
Abstract

Simple Summary: Several efforts like dose-escalated salvage radiation therapy and the use of androgen deprivation therapy aimed to improve the postoperative treatment in patients with biochemical recurrence of prostate cancer after prostatectomy. However, the oncological outcome is still not satisfactory. Hyperthermia is well-known to improve the efficacy of radiation therapy, whereas only limited data for postoperative therapy in prostate cancer are available. Thus, we conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate) investigating the implementation of combined salvage radiation therapy and regional hyperthermia in case of biochemical recurrence after prostatectomy with the aim to evaluate the safety, feasibility, and oncological outcome of this approach. The results of our planned interim analysis (n = 50) met the criteria of safety (only one patient with acute grade 3 hyperthermia-specific toxicity), showed feasibility of planned radiation and hyperthermia therapy, no significant changes in quality of life and promising short-term prostate-specific antigen response. Late toxicity and robust oncological outcome data will be reported after completion of the trial. Abstract: Efforts to improve the outcome of prostate cancer (PC) patients after radical prostatectomy (RP) include adjuvant or salvage radiation therapy (SRT), but still up to 50% of patients develop a disease progression after radiotherapy (RT). Regional hyperthermia (HT) is well-known to improve tumor sensitivity to RT in several entities. Here we report on a planned interim analysis of tolerability and feasibility after recruitment of the first 50 patients of a trial combining SRT and HT. We conducted a prospective multicenter non-randomized Phase-II-Trial (HTProstate-NCT04159051) investigating the implementation of combined moderate-dose escalated SRT (70 Gy in 35 fractions) and locoregional deep HT (7-10 HT sessions). The primary endpoints were the rate of acute genitourinary (GU), gastrointestinal (GI), and HT-related toxicities, completed HT sessions (≥7), and SRT applications per protocol (≥95% of patients). The two-step design included a planned interim analysis for acute GU-, GI- and HT-specific toxicities to ensure patients' safety. Between November 2016 and December 2019, 52 patients entered into the trial. After 50 patients completed therapy and three months of follow-up, we performed the planned interim analysis. 10% of patients developed acute grade 2 GU and 4% grade 2 GI toxicities. No grade ≥3 GU or GI toxicities occurred. HT-specific symptoms grade 2 and 3 were observed in 4% and 2% of all patients. Thus, the pre-specified criteria for safety and continuation of recruitment were met. Moreover, ≥7 HT treatments were applicable, indicating the combination of SRT + HT to be feasible. Evaluation of early QoL showed no significant changes. With its observed low rate of GU and GI toxicities, moderate and manageable rates of HT-specific symptoms, and good feasibility, the combined SRT + HT seems to be a promising treatment approach for biochemical recurrence after RP in PC patients.

Published
2021

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