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2. Irinotecan and temozolomide in combination with dasatinib and rapamycin versus irinotecan and temozolomide for patients with relapsed or refractory neuroblastoma (RIST-rNB-2011): a multicentre, open-label, randomised, controlled, phase 2 trial

Author

Corbacioglu, Selim, Lode, Holger, Ellinger, Susanne, Zeman, Florian, Suttorp, Meinolf, Escherich, Gabriele, Bochennek, Konrad, Gruhn, Bernd, Lang, Peter, Rohde, Marius, Debatin, Klaus Michael, Steinbach, Daniel, Beilken, Andreas, Ladenstein, Ruth, Spachtholz, Rainer, Heiss, Peter, Hellwig, Dirk, Tröger, Anja, Koller, Michael, Menhart, Karin, Riemenschneider, Markus J, Zoubaa, Saida, Kietz, Silke, Jakob, Marcus, Sommer, Gunhild, Heise, Tilman, Hundsdörfer, Patrick, Kühnle, Ingrid, Dilloo, Dagmar, Schönberger, Stefan, Schwabe, Georg, von Luettichau, Irene, Graf, Norbert, Schlegel, Paul-Gerhardt, Frühwald, Michael, Jorch, Norbert, Paulussen, Michael, Schneider, Dominik T, Metzler, Markus, Leipold, Alfred, Nathrath, Michaela, Imschweiler, Thomas, Christiansen, Holger, Schmid, Irene, Crazzolara, Roman, Niktoreh, Naghmeh, Cario, Gunnar, Faber, Joerg, Demmert, Martin, Babor, Florian, Fröhlich, Birgit, Bielack, Stefan, Bernig, Toralf, Greil, Johann, Eggert, Angelika, Simon, Thorsten, and Foell, Juergen

Published
2024
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4. Clinical and biological landscape of constitutional mismatch-repair deficiency syndrome: an International Replication Repair Deficiency Consortium cohort study

Author

Ercan, Ayse Bahar, Aronson, Melyssa, Fernandez, Nicholas R, Chang, Yuan, Levine, Adrian, Liu, Zhihui Amy, Negm, Logine, Edwards, Melissa, Bianchi, Vanessa, Stengs, Lucie, Chung, Jiil, Al-Battashi, Abeer, Reschke, Agnes, Lion, Alex, Ahmad, Alia, Lassaletta, Alvaro, Reddy, Alyssa T, Al-Darraji, Amir F, Shah, Amish C, Van Damme, An, Bendel, Anne, Rashid, Aqeela, Margol, Ashley S, Kelly, Bethany L, Pencheva, Bojana, Heald, Brandie, Lemieux-Anglin, Brianna, Crooks, Bruce, Koschmann, Carl, Gilpin, Catherine, Porter, Christopher C, Gass, David, Samuel, David, Ziegler, David S, Blumenthal, Deborah T, Kuo, Dennis John, Hamideh, Dima, Basel, Donald, Khuong-Quang, Dong-Anh, Stearns, Duncan, Opocher, Enrico, Carceller, Fernando, Baris Feldman, Hagit, Toledano, Helen, Winer, Ira, Scheers, Isabelle, Fedorakova, Ivana, Su, Jack M, Vengoechea, Jaime, Sterba, Jaroslav, Knipstein, Jeffrey, Hansford, Jordan R, Gonzales-Santos, Julieta Rita, Bhatia, Kanika, Bielamowicz, Kevin J, Minhas, Khurram, Nichols, Kim E, Cole, Kristina A, Penney, Lynette, Hjort, Magnus Aasved, Sabel, Magnus, Gil-da-Costa, Maria Joao, Murray, Matthew J, Miller, Matthew, Blundell, Maude L, Massimino, Maura, Al-Hussaini, Maysa, Al-Jadiry, Mazin F, Comito, Melanie A, Osborn, Michael, Link, Michael P, Zapotocky, Michal, Ghalibafian, Mithra, Shaheen, Najma, Mushtaq, Naureen, Waespe, Nicolas, Hijiya, Nobuko, Fuentes-Bolanos, Noemi, Ahmad, Olfat, Chamdine, Omar, Roy, Paromita, Pichurin, Pavel N, Nyman, Per, Pearlman, Rachel, Auer, Rebecca C, Sukumaran, Reghu K, Kebudi, Rejin, Dvir, Rina, Raphael, Robert, Elhasid, Ronit, McGee, Rose B, Chami, Rose, Noss, Ryan, Tanaka, Ryuma, Raskin, Salmo, Sen, Santanu, Lindhorst, Scott, Perreault, Sebastien, Caspi, Shani, Riaz, Shazia, Constantini, Shlomi, Albert, Sophie, Chaleff, Stanley, Bielack, Stefan, Chiaravalli, Stefano, Cramer, Stuart Louis, Roy, Sumita, Cahn, Suzanne, Penna, Suzanne, Hamid, Syed Ahmer, Ghafoor, Tariq, Imam, Uzma, Larouche, Valerie, Magimairajan Issai, Vanan, Foulkes, William D, Lee, Yi Yen, Nathan, Paul C, Maruvka, Yosef E, Greer, Mary-Louise C, Durno, Carol, Shlien, Adam, Ertl-Wagner, Birgit, Villani, Anita, Malkin, David, Hawkins, Cynthia, Bouffet, Eric, Das, Anirban, and Tabori, Uri

Published
2024
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6. Diagnostic evaluation of paediatric autoimmune lymphoproliferative immunodeficiencies (ALPID): a prospective cohort study

Author

Abinun, Mario, Abrahamsen, Tore G., Albert, Michael H., Almalky, Mohamed, Altaf, Sadaf, Babayeva, Royala, Bakhtiar, Shahrzad, Baris, Safa, Baumann, Ulrich, Becker, Martina, Beier, Rita, Berger, Thomas, Biebl, Ariane, Bielack, Stefan S., Biskup, Saskia, Bode, Sebastian FN, Borchers, Regine, Boztug, Kaan, Brockmann, Knut, Bruwier, Annelyse, Buchholz, Bernd, Caballero-Oteyza, Andres, Cant, Andrew J., Castro, Carla N., Classen, Carl F., Claviez, Alexander, Crazzolara, Roman, Cuntz, Franziska, Dąbrowska-Leonik, Nel, Derichs, Ute, Dückers, Gregor, Eberl, Wolfgang, Ebetsberger-Dachs, Georg, Erlacher, Miriam, Fabre, Alexandre, Faletti, Laura, Farmand, Susan, Figueiredo, Antonio E., Fischer, Marco, Flaadt, Tim, Full, Hermann, Gambineri, Eleonora, Girschick, Hermann, Goldacker, Sigune, Grimbacher, Bodo, Groß, Miriam, Gruhn, Bernd, Haberfellner, Florian, Hague, Rosie, Hauch, Holger, Hauck, Fabian, Heine, Sabine, Huisman, Elise J., Jakovljevic, Gordana, James, Beki, Janda, Ales, Jones, Neil, Kaiser-Labusch, Petra, Kentouche, Karim, Knight, Julian C., Knirsch, Stephanie, Kontny, Udo, Körholz, Julia, Krenn, Thomas, Kuehnle, Ingrid, Kühne, Thomas, Lee-Dimroth, Jae-Yun, Lehmann, Hartwig, Leipold, Alfred, Meinhardt, Andrea, Minkov, Milen, Mönkemöller, Kirsten, Morbach, Henner, Mücke, Urs, Nathrath, Michaela, Naumann-Bartsch, Nora, Neth, Olaf, Niemeyer, Charlotte M., Olbrich, Peter, Ostró, Róbert, Owens, Stephen, Pac, Malgorzata, Pachlopnik Schmid, Jana, Page, Matthew J.T., Pekrun, Arnulf, Prader, Seraina, Proietti, Michele, Rajacic, Nada, Rothoeft, Tobias, Ryan, Clodagh, Salou, Sarah, Salzer, Elisabeth, Savic, Sinisa, Schilling, Freimut H., Schönberger, Stefan, Schuetz, Catharina, Schuez-Havupalo, Linnea, Schulte, Björn, Schulz, Ansgar, Schuster, Volker, Seidel, Markus G., Siepermann, Kathrin, Skomska-Pawliszak, Malgorzata, Smisek, Petr, Soomann, Maarja, Stiefel, Martina, Storck, Simone, Strahm, Brigitte, Streiter, Monika, Teltschik, Heiko-Manuel, Thalhammer, Julian, Tippelt, Stephan, Toskov, Vasil, Trück, Johannes, Vieth, Simon, von Bismarck, Philipp, Wegehaupt, Oliver, Wiesel, Thomas, Wittkowski, Helmut, Yalcin Gungoren, Ezgi, Hägele, Pauline, Staus, Paulina, Scheible, Raphael, Uhlmann, Annette, Heeg, Maximilian, Klemann, Christian, Maccari, Maria Elena, Ritterbusch, Henrike, Armstrong, Martin, Cutcutache, Ioana, Elliott, Katherine S, von Bernuth, Horst, Leahy, Timothy Ronan, Leyh, Jörg, Holzinger, Dirk, Lehmberg, Kai, Svec, Peter, Masjosthusmann, Katja, Hambleton, Sophie, Jakob, Marcus, Sparber-Sauer, Monika, Kager, Leo, Puzik, Alexander, Wolkewitz, Martin, Lorenz, Myriam Ricarda, Schwarz, Klaus, Speckmann, Carsten, Rensing-Ehl, Anne, and Ehl, Stephan

Published
2024
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7. European standard clinical practice recommendations for children and adolescents with primary and recurrent osteosarcoma

Author

van Ewijk, Roelof, Herold, Nikolas, Baecklund, Fredrik, Baumhoer, Daniel, Boye, Kjetil, Gaspar, Nathalie, Harrabi, Semi B., Haveman, Lianne M., Hecker-Nolting, Stefanie, Hiemcke-Jiwa, Laura, Martin, Valentine, Fernández, Cristina Mata, Palmerini, Emanuela, van de Sande, Michiel A.J., Strauss, Sandra J., Bielack, Stefan S., and Kager, Leo

Published
2023
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8. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials

Author

Hong, David S, DuBois, Steven G, Kummar, Shivaani, Farago, Anna F, Albert, Catherine M, Rohrberg, Kristoffer S, van Tilburg, Cornelis M, Nagasubramanian, Ramamoorthy, Berlin, Jordan D, Federman, Noah, Mascarenhas, Leo, Geoerger, Birgit, Dowlati, Afshin, Pappo, Alberto S, Bielack, Stefan, Doz, François, McDermott, Ray, Patel, Jyoti D, Schilder, Russell J, Tahara, Makoto, Pfister, Stefan M, Witt, Olaf, Ladanyi, Marc, Rudzinski, Erin R, Nanda, Shivani, Childs, Barrett H, Laetsch, Theodore W, Hyman, David M, and Drilon, Alexander

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Neoplasms, Proteins, Pyrazoles, Pyrimidines, Young Adult, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundThe selective TRK inhibitor larotrectinib was approved for paediatric and adult patients with advanced TRK fusion-positive solid tumours based on a primary analysis set of 55 patients. The aim of our analysis was to explore the efficacy and long-term safety of larotrectinib in a larger population of patients with TRK fusion-positive solid tumours.MethodsPatients were enrolled and treated in a phase 1 adult, a phase 1/2 paediatric, or a phase 2 adolescent and adult trial. Some eligibility criteria differed between these studies. For this pooled analysis, eligible patients were aged 1 month or older, with a locally advanced or metastatic non-CNS primary, TRK fusion-positive solid tumour, who had received standard therapy previously if available. This analysis set includes the 55 patients on which approval of larotrectinib was based. Larotrectinib was administered orally (capsule or liquid formulation), on a continuous 28-day schedule, to adults mostly at a dose of 100 mg twice daily, and to paediatric patients mostly at a dose of 100 mg/m2 (maximum of 100 mg) twice daily. The primary endpoint was objective response as assessed by local investigators in an intention-to-treat analysis. Contributing trials are registered with ClinicalTrials.gov, NCT02122913 (active not recruiting), NCT02637687 (recruiting), and NCT02576431 (recruiting).FindingsBetween May 1, 2014, and Feb 19, 2019, 159 patients with TRK fusion-positive cancer were enrolled and treated with larotrectinib. Ages ranged from less than 1 month to 84 years. The proportion of patients with an objective response according to investigator assessment was 121 (79%, 95% CI 72-85) of 153 evaluable patients, with 24 (16%) having complete responses. In a safety population of 260 patients treated regardless of TRK fusion status, the most common grade 3 or 4 larotrectinib-related adverse events were increased alanine aminotransferase (eight [3%] of 260 patients), anaemia (six, 2%), and decreased neutrophil count (five [2%]). The most common larotrectinib-related serious adverse events were increased alanine aminotransferase (two [

Published
2020

11. Osteosarcoma Arising as a Secondary Malignancy following Treatment for Hematologic Cancer: A Report of 33 Affected Patients from the Cooperative Osteosarcoma Study Group (COSS)

Author

Bielack, Stefan S., primary, Mettmann, Vanessa, additional, Baumhoer, Daniel, additional, Blattmann, Claudia, additional, Burkhardt, Birgit, additional, Deinzer, Christoph K. W., additional, Kager, Leo, additional, Kevric, Matthias, additional, Mauz-Körholz, Christine, additional, Müller-Abt, Peter, additional, Reinhardt, Dirk, additional, Sabo, Alexandru-Anton, additional, Schrappe, Martin, additional, Sorg, Benjamin, additional, Windhager, Reinhard, additional, and Hecker-Nolting, Stefanie, additional

Published
2024
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13. Osteosarcoma and causes of death: A report of 1520 deceased patients from the Cooperative Osteosarcoma Study Group (COSS)

Author

Bielack, Stefan S., Blattmann, Claudia, Borkhardt, Arndt, Csóka, Monika, Hassenpflug, Wolf, Kabíčková, Edita, Kager, Leo, Kessler, Thorsten, Kratz, Christian, Kühne, Thomas, Kevric, Matthias, Lehrnbecher, Thomas, Mayer-Steinacker, Regine, Mettmann, Vanessa, Metzler, Markus, Reichardt, Peter, Rossig, Claudia, Sorg, Benjamin, von Luettichau, Irene, Windhager, Reinhard, and Hecker-Nolting, Stefanie

Published
2022
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15. Author Correction: Osteosarcoma

Author

Beird, Hannah C., Bielack, Stefan S., Flanagan, Adrienne M., Gill, Jonathan, Heymann, Dominique, Janeway, Katherine A., Livingston, J. Andrew, Roberts, Ryan D., Strauss, Sandra J., and Gorlick, Richard

Published
2022
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16. Osteosarcoma

Author

Beird, Hannah C., Bielack, Stefan S., Flanagan, Adrianne M., Gill, Jonathan, Heymann, Dominique, Janeway, Katherine A., Livingston, J. Andrew, Roberts, Ryan D., Strauss, Sandra J., and Gorlick, Richard

Published
2022
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17. Osteosarcoma-Approach to Therapy

Author

Bielack, Stefan, Cable, Matthew G., Gorlick, Richard, Hecker-Nolting, Stefanie, Kager, Leo, Marina, Neyssa, Randall, R. Lor, Whelan, Jeremy, Reaman, Gregory H., Series Editor, Smith, Franklin O., Series Editor, and Arndt, Carola A. S., editor

Published
2021
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19. Supplementary Figures S1-S5 from Combined Immunotherapy Improves Outcome for Replication-Repair-Deficient (RRD) High-Grade Glioma Failing Anti–PD-1 Monotherapy: A Report from the International RRD Consortium

Author

Das, Anirban, primary, Fernandez, Nicholas R., primary, Levine, Adrian, primary, Bianchi, Vanessa, primary, Stengs, Lucie K., primary, Chung, Jiil, primary, Negm, Logine, primary, Dimayacyac, Jose Rafael, primary, Chang, Yuan, primary, Nobre, Liana, primary, Ercan, Ayse B., primary, Sanchez-Ramirez, Santiago, primary, Sudhaman, Sumedha, primary, Edwards, Melissa, primary, Larouche, Valerie, primary, Samuel, David, primary, Van Damme, An, primary, Gass, David, primary, Ziegler, David S., primary, Bielack, Stefan S., primary, Koschmann, Carl, primary, Zelcer, Shayna, primary, Yalon-Oren, Michal, primary, Campino, Gadi Abede, primary, Sarosiek, Tomasz, primary, Nichols, Kim E., primary, Loret De Mola, Rebecca, primary, Bielamowicz, Kevin, primary, Sabel, Magnus, primary, Frojd, Charlotta A., primary, Wood, Matthew D., primary, Glover, Jason M., primary, Lee, Yi-Yen, primary, Vanan, Magimairajan, primary, Adamski, Jenny K., primary, Perreault, Sebastien, primary, Chamdine, Omar, primary, Hjort, Magnus Aasved, primary, Zapotocky, Michal, primary, Carceller, Fernando, primary, Wright, Erin, primary, Fedorakova, Ivana, primary, Lossos, Alexander, primary, Tanaka, Ryuma, primary, Osborn, Michael, primary, Blumenthal, Deborah T., primary, Aronson, Melyssa, primary, Bartels, Ute, primary, Huang, Annie, primary, Ramaswamy, Vijay, primary, Malkin, David, primary, Shlien, Adam, primary, Villani, Anita, primary, Dirks, Peter B., primary, Pugh, Trevor J., primary, Getz, Gad, primary, Maruvka, Yosef E., primary, Tsang, Derek S., primary, Ertl-Wagner, Birgit, primary, Hawkins, Cynthia, primary, Bouffet, Eric, primary, Morgenstern, Daniel A., primary, and Tabori, Uri, primary

Published
2024
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20. Diagnostic evaluation of paediatric autoimmune lymphoproliferative immunodeficiencies (ALPID): a prospective cohort study

Author

Hägele, Pauline, primary, Staus, Paulina, additional, Scheible, Raphael, additional, Uhlmann, Annette, additional, Heeg, Maximilian, additional, Klemann, Christian, additional, Maccari, Maria Elena, additional, Ritterbusch, Henrike, additional, Armstrong, Martin, additional, Cutcutache, Ioana, additional, Elliott, Katherine S, additional, von Bernuth, Horst, additional, Leahy, Timothy Ronan, additional, Leyh, Jörg, additional, Holzinger, Dirk, additional, Lehmberg, Kai, additional, Svec, Peter, additional, Masjosthusmann, Katja, additional, Hambleton, Sophie, additional, Jakob, Marcus, additional, Sparber-Sauer, Monika, additional, Kager, Leo, additional, Puzik, Alexander, additional, Wolkewitz, Martin, additional, Lorenz, Myriam Ricarda, additional, Schwarz, Klaus, additional, Speckmann, Carsten, additional, Rensing-Ehl, Anne, additional, Ehl, Stephan, additional, Abinun, Mario, additional, Abrahamsen, Tore, additional, Albert, Michael, additional, Almalky, Mohamed, additional, Altaf, Sadaf, additional, Babayeva, Royala, additional, Bakhtiar, Shahrzad, additional, Baris, Safa, additional, Baumann, Ulrich, additional, Becker, Martina, additional, Berger, Thomas, additional, Biebl, Ariane, additional, Bielack, Stefan, additional, Biskup, Saskia, additional, Bismarck, Philipp, additional, Bode, Sebastian, additional, Borchers, Regine, additional, Boztug, Carl Friedrich, additional, Brockmann, Knut, additional, Bruwier, Annelyse, additional, Buchholz, Bernd, additional, Cant, Andrew, additional, Castro, Carla N, additional, Classen, Carl, additional, Claviez, Alexander, additional, Crazzolara, Roman, additional, Cuntz, Franziska, additional, Dąbrowska-Leonik, Nel, additional, Derichs, Ute, additional, Dückers, Gregor, additional, Eberl, Wolfgang, additional, Ebetsberger-Dachs, Georg, additional, Erlacher, Miriam, additional, Fabre, Alexandre, additional, Faletti, Laura, additional, Farmand, Susan, additional, Figueiredo, Antonio, additional, Fischer, Marco, additional, Flaadt, Tim, additional, Full, Hermann, additional, Gambineri, Eleonora, additional, Girschick, Hermann, additional, Goldacker, Sigune, additional, Grimbacher, Bodo, additional, Groß, Miriam, additional, Gruhn, Andrew J, additional, Gungoren, Ezgi, additional, Haberfellner, Florian, additional, Hague, Rosie, additional, Hauch, Holger, additional, Hauck, Fabian, additional, Heine, Sabine, additional, Huisman, Elise, additional, Jakovljevic, Gordana, additional, James, Beki, additional, Janda, Ales, additional, Janda, Małgorzata, additional, Jones, Neil, additional, Kaiser-Labusch, Petra, additional, Kentouche, Karim, additional, Knight, Julian, additional, Knirsch, Stephanie, additional, Kontny, Udo, additional, Körholz, Julia, additional, Krenn, Ezgi Yalcin, additional, Kuehnle, Ingrid, additional, Kühne, Thomas, additional, Lee-Dimroth, Jae-Yun, additional, Lehmann, Hartwig, additional, Leipold, Michael H., additional, Meinhardt, Andrea, additional, Mönkemöller, Kirsten, additional, Morbach, Henner, additional, Mücke, Urs, additional, Nathrath, Michaela, additional, Naumann-Bartsch, Nora, additional, Neth, Olaf, additional, Niemeyer, Charlotte, additional, Olbrich, Peter, additional, Ostró, Róbert, additional, Owens, Stephen, additional, Pac, Malgorzata, additional, Pachlopnik Schmid, Rita, additional, Page, Markus G., additional, Pekrun, Arnulf, additional, Prader, Seraina, additional, Proietti, Michele, additional, Rajacic, Nada, additional, Rothoeft, Tobias, additional, Ryan, Freimut H., additional, Salou, Sarah, additional, Salzer, Elisabeth, additional, Savic, Sinisa, additional, Schilling, Antonio E., additional, Schmid, Jana, additional, Schönberger, Stefan, additional, Schuetz, Catharina, additional, Schuez-Havupalo, Tore G., additional, Schulte, Björn, additional, Schulz, Ansgar, additional, Schuster, Volker, additional, Seidel, Markus, additional, Siepermann, Kathrin, additional, Smisek, Petr, additional, Soomann, Maarja, additional, Stiefel, Martina, additional, Storck, Simone, additional, Strahm, Brigitte, additional, Streiter, Elise J, additional, Teltschik, Charlotte M., additional, Thalhammer, Julian, additional, Tippelt, Stephan, additional, Toskov, Vasil, additional, Trück, Johannes, additional, Vieth, Simon, additional, Wegehaupt, Oliver, additional, and Wiesel, Thomas, additional

Published
2024
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21. Gutartige Knochentumoren

Author

Bielack, Stefan, von Kalle, Thekla, Wirth, Thomas, Spranger, Jürgen, Section editor, Hoffmann, Georg F., editor, Lentze, Michael J., editor, Spranger, Jürgen, editor, Zepp, Fred, editor, Berner, Reinhard, editor, Schaub, Jürgen, Founding Editor, and Schulte, Franz-Josef, Founding Editor

Published
2020
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24. The impact of the temporal sequence of cranial radiotherapy and platin-based chemotherapy on hearing impairment in pediatric and adolescent CNS and head-and-neck cancer patients:A report from the PanCareLIFE consortium

Author

Scobioala, Sergiu, Parfitt, Ross, Matulat, Peter, Byrne, Julianne, Langer, Thorsten, Troschel, Fabian M., Hesping, Amélie E., Clemens, Eva, Kaatsch, Peter, Grabow, Desiree, Kaiser, Melanie, Spix, Claudia, Kremer, Leontien C., Calaminus, Gabriele, Baust, Katja, Kuehni, Claudia E., Weiss, Annette, Strebel, Sven, Kuonen, Rahel, Elsner, Susanne, Haupt, Riccardo, Garré, Maria Luisa, Gruhn, Bernd, Kepak, Tomas, Kepakova, Katerina, Winther, Jeanette Falck, Kenborg, Line, Rechnitzer, Catherine, Hasle, Henrik, Kruseova, Jarmila, Luks, Ales, Lackner, Herwig, Bielack, Stefan, Beck, Jörn Dirk, Jürgens, Heribert, van den Heuvel-Eibrink, Marry M., Zolk, Oliver, Eich, Hans Theodor, am Zehnhoff-Dinnesen, Antoinette, Scobioala, Sergiu, Parfitt, Ross, Matulat, Peter, Byrne, Julianne, Langer, Thorsten, Troschel, Fabian M., Hesping, Amélie E., Clemens, Eva, Kaatsch, Peter, Grabow, Desiree, Kaiser, Melanie, Spix, Claudia, Kremer, Leontien C., Calaminus, Gabriele, Baust, Katja, Kuehni, Claudia E., Weiss, Annette, Strebel, Sven, Kuonen, Rahel, Elsner, Susanne, Haupt, Riccardo, Garré, Maria Luisa, Gruhn, Bernd, Kepak, Tomas, Kepakova, Katerina, Winther, Jeanette Falck, Kenborg, Line, Rechnitzer, Catherine, Hasle, Henrik, Kruseova, Jarmila, Luks, Ales, Lackner, Herwig, Bielack, Stefan, Beck, Jörn Dirk, Jürgens, Heribert, van den Heuvel-Eibrink, Marry M., Zolk, Oliver, Eich, Hans Theodor, and am Zehnhoff-Dinnesen, Antoinette

Abstract

The impact of the temporal sequence by which cranial radiotherapy (CRT) and platin-based chemotherapy (PCth) are administered on sensorineural hearing loss (SNHL) in pediatric and adolescent central nervous system (CNS) and head-and-neck (HN) cancer patients has not yet been studied in detail. We examined the ototoxic effects of sequentially applied CRT and PCth. This study included children and adolescents with CNS and HN tumors who participated in the multicountry PanCareLIFE (PCL) consortium. Audiological outcomes were compared between patients who received CRT prior to PCth and those who received it afterwards. The incidence, degree and posttreatment progression of SNHL, defined as Muenster classification grade ≥MS2b, were evaluated in 141 patients. One hundred and nineteen patients were included in a time-to-onset analysis. Eighty-eight patients received CRT prior to PCth (Group 1) and 53 patients received PCth before CRT (Group 2). Over a median follow-up time of 1.6 years, 72.7% of patients in Group 1 experienced SNHL ≥ MS2b compared to 33.9% in Group 2 (P <.01). A time-to-onset analysis was performed for 74 patients from Group 1 and 45 patients from Group 2. Median time to hearing loss (HL) ≥ MS2b was 1.2 years in Group 1 and 4.4 years in Group 2 (P <.01). Thus, audiological outcomes were better for patients who received CRT after PCth than before. This finding should be further evaluated and considered within clinical practice in order to minimize hearing loss in children and adolescents with CNS and HN tumors.

Published
2024

25. Supratentorial ependymoma in childhood: more than just RELA or YAP

Author

Zschernack, Valentina, Jünger, Stephanie T., Mynarek, Martin, Rutkowski, Stefan, Garre, Maria Luisa, Ebinger, Martin, Neu, Marie, Faber, Jörg, Erdlenbruch, Bernhard, Claviez, Alexander, Bielack, Stefan, Brozou, Triantafyllia, Frühwald, Michael C., Dörner, Evelyn, Dreschmann, Verena, Stock, Annika, Solymosi, Laszlo, Hench, Jürgen, Frank, Stephan, Vokuhl, Christian, Waha, Andreas, Andreiuolo, Felipe, and Pietsch, Torsten

Published
2021
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26. Diagnostik und Therapie von Tumoren mit NTRK-Genfusionen

Author

Stenzinger, Albrecht, van Tilburg, Cornelis M., Tabatabai, Ghazaleh, Länger, Florian, Graf, Norbert, Griesinger, Frank, Heukamp, Lukas C., Hummel, Michael, Klingebiel, Thomas, Hettmer, Simone, Vokuhl, Christian, Merkelbach-Bruse, Sabine, Overkamp, Friedrich, Reichardt, Peter, Scheer, Monika, Weichert, Wilko, Westphalen, C. Benedikt, Bokemeyer, Carsten, Ivanyi, Philipp, Loges, Sonja, Schirmacher, Peter, Wörmann, Bernhard, Bielack, Stefan, and Seufferlein, Thomas T. W.

Published
2021
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28. Combined Immunotherapy Improves Outcome for Replication-Repair-Deficient (RRD) High-Grade Glioma Failing Anti–PD-1 Monotherapy: A Report from the International RRD Consortium

Author

Das, Anirban, primary, Fernandez, Nicholas R., additional, Levine, Adrian, additional, Bianchi, Vanessa, additional, Stengs, Lucie K., additional, Chung, Jiil, additional, Negm, Logine, additional, Dimayacyac, Jose Rafael, additional, Chang, Yuan, additional, Nobre, Liana, additional, Ercan, Ayse B., additional, Sanchez-Ramirez, Santiago, additional, Sudhaman, Sumedha, additional, Edwards, Melissa, additional, Larouche, Valerie, additional, Samuel, David, additional, Van Damme, An, additional, Gass, David, additional, Ziegler, David S., additional, Bielack, Stefan S., additional, Koschmann, Carl, additional, Zelcer, Shayna, additional, Yalon-Oren, Michal, additional, Campino, Gadi Abede, additional, Sarosiek, Tomasz, additional, Nichols, Kim E., additional, Loret De Mola, Rebecca, additional, Bielamowicz, Kevin, additional, Sabel, Magnus, additional, Frojd, Charlotta A., additional, Wood, Matthew D., additional, Glover, Jason M., additional, Lee, Yi-Yen, additional, Vanan, Magimairajan, additional, Adamski, Jenny K., additional, Perreault, Sebastien, additional, Chamdine, Omar, additional, Hjort, Magnus Aasved, additional, Zapotocky, Michal, additional, Carceller, Fernando, additional, Wright, Erin, additional, Fedorakova, Ivana, additional, Lossos, Alexander, additional, Tanaka, Ryuma, additional, Osborn, Michael, additional, Blumenthal, Deborah T., additional, Aronson, Melyssa, additional, Bartels, Ute, additional, Huang, Annie, additional, Ramaswamy, Vijay, additional, Malkin, David, additional, Shlien, Adam, additional, Villani, Anita, additional, Dirks, Peter B., additional, Pugh, Trevor J., additional, Getz, Gad, additional, Maruvka, Yosef E., additional, Tsang, Derek S., additional, Ertl-Wagner, Birgit, additional, Hawkins, Cynthia, additional, Bouffet, Eric, additional, Morgenstern, Daniel A., additional, and Tabori, Uri, additional

Published
2024
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29. Primary Multi-Systemic Metastases in Osteosarcoma: Presentation, Treatment, and Survival of 83 Patients of the Cooperative Osteosarcoma Study Group

Author

Mettmann, Vanessa L., primary, Blattmann, Claudia, additional, Friedel, Godehard, additional, Harrabi, Semi, additional, von Kalle, Thekla, additional, Kager, Leo, additional, Kevric, Matthias, additional, Kühne, Thomas, additional, Nathrath, Michaela, additional, Sorg, Benjamin, additional, Werner, Mathias, additional, Bielack, Stefan S., additional, and Hecker-Nolting, Stefanie, additional

Published
2024
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31. Osteosarcoma Arising After Ewing Sarcoma orVice Versa: A Report of 20 Affected Patients from the Cooperative Osteosarcoma Study Group (COSS)

Author

BIELACK, STEFAN S., primary, BLATTMANN, CLAUDIA, additional, HASSENPFLUG, WOLF, additional, KAGER, LEO, additional, KUHNE, THOMAS, additional, KEVRIC, MATTHIAS, additional, SCHLEGEL, PAUL-GERHARDT, additional, METTMANN, VANESSA, additional, SORG, BENJAMIN, additional, and HECKER-NOLTING, STEFANIE, additional

Published
2023
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32. Genotyping circulating tumor DNA of pediatric Hodgkin lymphoma

Author

Desch, Ann-Kathrin, Hartung, Kristin, Botzen, Ante, Brobeil, Alexander, Rummel, Mathias, Kurch, Lars, Georgi, Thomas, Jox, Theresa, Bielack, Stefan, Burdach, Stefan, Classen, Carl Friedrich, Claviez, Alexander, Debatin, Klaus-Michael, Ebinger, Martin, Eggert, Angelika, Faber, Jörg, Flotho, Christian, Frühwald, Michael, Graf, Norbert, Jorch, Norbert, Kontny, Udo, Kramm, Christof, Kulozik, Andreas, Kühr, Joachim, Sykora, Karl-Walter, Metzler, Markus, Müller, Hermann L., Nathrath, Michaela, Nüßlein, Thomas, Paulussen, Michael, Pekrun, Arnulf, Reinhardt, Dirk, Reinhard, Harald, Rössig, Claudia, Sauerbrey, Axel, Schlegel, Paul-Gerhardt, Schneider, Dominik T., Scheurlen, Wolfram, Schweigerer, Lothar, Simon, Thorsten, Suttorp, Meinolf, Vorwerk, Peter, Schmitz, Roland, Kluge, Regine, Mauz-Körholz, Christine, Körholz, Dieter, Gattenlöhner, Stefan, and Bräuninger, Andreas

Published
2020
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33. Methotrexate, Doxorubicin, and Cisplatin (MAP) Plus Maintenance Pegylated Interferon Alfa-2b Versus MAP Alone in Patients With Resectable High-Grade Osteosarcoma and Good Histologic Response to Preoperative MAP: First Results of the EURAMOS-1 Good Response Randomized Controlled Trial

Author

Bielack, Stefan S, Smeland, Sigbjørn, Whelan, Jeremy S, Marina, Neyssa, Jovic, Gordana, Hook, Jane M, Krailo, Mark D, Gebhardt, Mark, Pápai, Zsuzsanna, Meyer, James, Nadel, Helen, Randall, R Lor, Deffenbaugh, Claudia, Nagarajan, Rajaram, Brennan, Bernadette, Letson, G Douglas, Teot, Lisa A, Goorin, Allen, Baumhoer, Daniel, Kager, Leo, Werner, Mathias, Lau, Ching C, Hall, Kirsten Sundby, Gelderblom, Hans, Meyers, Paul, Gorlick, Richard, Windhager, Reinhard, Helmke, Knut, Eriksson, Mikael, Hoogerbrugge, Peter M, Schomberg, Paula, Tunn, Per-Ulf, Kühne, Thomas, Jürgens, Heribert, van den Berg, Henk, Böhling, Tom, Picton, Susan, Renard, Marleen, Reichardt, Peter, Gerss, Joachim, Butterfass-Bahloul, Trude, Morris, Carol, Hogendoorn, Pancras CW, Seddon, Beatrice, Calaminus, Gabriele, Michelagnoli, Maria, Dhooge, Catharina, Sydes, Matthew R, and Bernstein, Mark

Subjects
Clinical Trials and Supportive Activities, Rare Diseases, Clinical Research, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols, Asia, Australia, Bone Neoplasms, Chemotherapy, Adjuvant, Child, Child, Preschool, Cisplatin, Disease Progression, Disease-Free Survival, Doxorubicin, Europe, Female, Humans, Interferon alpha-2, Interferon-alpha, Kaplan-Meier Estimate, Male, Methotrexate, Neoadjuvant Therapy, Neoplasm Grading, North America, Osteosarcoma, Osteotomy, Polyethylene Glycols, Proportional Hazards Models, Recombinant Proteins, Risk Factors, Time Factors, Treatment Outcome, Young Adult, EURAMOS-1 investigators, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-α-2b) in patients whose osteosarcoma showed good histologic response (good response) to induction chemotherapy.Patients and methodsAt diagnosis, patients age ≤ 40 years with resectable high-grade osteosarcoma were registered. Eligibility after surgery for good response random assignment included ≥ two cycles of preoperative MAP (methotrexate, doxorubicin, and cisplatin), macroscopically complete surgery of primary tumor, < 10% viable tumor, and no disease progression. These patients were randomly assigned to four additional cycles MAP with or without IFN-α-2b (0.5 to 1.0 μg/kg per week subcutaneously, after chemotherapy until 2 years postregistration). Outcome measures were event-free survival (EFS; primary) and overall survival and toxicity (secondary).ResultsGood response was reported in 1,041 of 2,260 registered patients; 716 consented to random assignment (MAP, n = 359; MAP plus IFN-α-2b, n = 357), with baseline characteristics balanced by arm. A total of 271 of 357 started IFN-α-2b; 105 stopped early, and 38 continued to receive treatment at data freeze. Refusal and toxicity were the main reasons for never starting IFN-α-2b and for stopping prematurely, respectively. Median IFN-α-2b duration, if started, was 67 weeks. A total of 133 of 268 patients who started IFN-α-2b and provided toxicity information reported grade ≥ 3 toxicity during IFN-α-2b treatment. With median follow-up of 44 months, 3-year EFS for all 716 randomly assigned patients was 76% (95% CI, 72% to 79%); 174 EFS events were reported (MAP, n = 93; MAP plus IFN-α-2b, n = 81). Hazard ratio was 0.83 (95% CI, 0.61 to 1.12; P = .214) from an adjusted Cox model.ConclusionAt the preplanned analysis time, MAP plus IFN-α-2b was not statistically different from MAP alone. A considerable proportion of patients never started IFN-α-2b or stopped prematurely. Long-term follow-up for events and survival continues.

Published
2015

39. Prognostic Factors in High-Grade Osteosarcoma of theExtremities or Trunk: An Analysis of 1,702 Patients Treatedon Neoadjuvant Cooperative Osteosarcoma Study GroupProtocols

Author

Bielack, Stefan S., primary, Kempf-Bielack, Beate, additional, Delling, Günter, additional, Exner, G. Ulrich, additional, Flege, Silke, additional, Helmke, Knut, additional, Kotz, Rainer, additional, Salzer-Kuntschik, Mechthild, additional, Werner, Matthias, additional, Winkelmann, Winfried, additional, Zoubek, Andreas, additional, Jürgens, Heribert, additional, and Winkler, Kurt, additional

Published
2023
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40. Solitary pulmonary metastases at first recurrence of osteosarcoma: Presentation, treatment, and survival of 219 patients of the Cooperative Osteosarcoma Study Group

Author

Mettmann, Vanessa L., primary, Baumhoer, Daniel, additional, Bielack, Stefan S., additional, Blattmann, Claudia, additional, Friedel, Godehard, additional, von Kalle, Thekla, additional, Kager, Leo, additional, Kevric, Matthias, additional, Nathrath, Michaela, additional, Sorg, Benjamin, additional, Dürken, Matthias, additional, and Hecker‐Nolting, Stefanie, additional

Published
2023
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41. Outcome of rare primary malignant bone sarcoma treated with multimodal therapy: Results from the EUROpean Bone Over 40 Sarcoma Study (EURO‐B.O.S.S.)

Author

Palmerini, Emanuela, primary, Reichardt, Peter, additional, Hall, Kirsten Sundby, additional, Bertulli, Rossella, additional, Bielack, Stefan S., additional, Comandone, Alessandro, additional, Egerer, Gerlinde, additional, Hansmeier, Anna, additional, Kevric, Matthias, additional, Carretta, Elisa, additional, Hansson, Lina, additional, Jebsen, Nina, additional, Eriksson, Mikael, additional, Bruland, Øyvind S., additional, Donati, Davide Maria, additional, Ibrahim, Toni, additional, Smeland, Sigbjørn, additional, and Ferrari, Stefano, additional

Published
2023
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42. Osteosarcoma-Approach to Therapy

Author

Bielack, Stefan, primary, Cable, Matthew G., additional, Gorlick, Richard, additional, Hecker-Nolting, Stefanie, additional, Kager, Leo, additional, Marina, Neyssa, additional, Randall, R. Lor, additional, and Whelan, Jeremy, additional

Published
2020
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43. Bone Tumours

Author

Bielack, Stefan, primary, Paulussen, Michael, additional, and Helman, Lee, additional

Published
2020
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45. ECCO Essential Requirements for Quality Cancer Care: Soft Tissue Sarcoma in Adults and Bone Sarcoma. A critical review

Author

Andritsch, Elisabeth, Beishon, Marc, Bielack, Stefan, Bonvalot, Sylvie, Casali, Paolo, Crul, Mirjam, Delgado-Bolton, Roberto, Donati, Davide Maria, Douis, Hassan, Haas, Rick, Hogendoorn, Pancras, Kozhaeva, Olga, Lavender, Verna, Lovey, Jozsef, Negrouk, Anastassia, Pereira, Philippe, Roca, Pierre, de Lempdes, Godelieve Rochette, Saarto, Tiina, van Berck, Bert, Vassal, Gilles, Wartenberg, Markus, Yared, Wendy, Costa, Alberto, and Naredi, Peter

Published
2017
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47. Beyond 5-year survival. A report from the Cooperative Osteosarcoma Study Group (COSS).

Author

Fernandes, Julia S., Blattmann, Claudia, Hecker-Nolting, Stefanie, Kager, Leo, Kevric, Matthias, Mettmann, Vanessa, Sorg, Benjamin, Fernandes, Marc, and Bielack, Stefan S.

Subjects
OSTEOSARCOMA, PROGNOSIS, SYMPTOMS, NEOADJUVANT chemotherapy, THERAPEUTICS
Abstract

Purpose: Prognostic factors have been well described for osteosarcoma, but analyses evaluating the further course of long-term survivors are lacking. We used the large database of the Cooperative Osteosarcoma Study Group (COSS) to perform such an analysis. Patients and Methods: The COSS database 1980-04/2019 was searched for 5-year survivors of primary high-grade central osteosarcoma of the extremities or trunk. Identified patients were analyzed for their further survival outcomes, assessing potentially prognostic and predictive factors already evident at initial disease presentation and treatment as well as their disease course during the first 5years of follow-up. Results: Two thousand and nine former eligible patients were identified (median age at initial diagnosis 15.1 (2.5–63.0) years; male vs. female 1149 (57.2%) vs. 860 (42.8%); extremities vs. trunk 1927 (95.9%) vs. 82 (4.1%); extremity primaries <1/3 vs. ≥1/3 of the involved bone 997 (67.8%) vs. 474 (32.2%) (456 unknown); localized vs. primary metastatic 1881 (93.6%) vs. 128 (6.4%); osteosarcoma as a secondary malignancy 41/2009 (2.0%)). Therapy starting by chemotherapy versus primary surgery 1860 (92.6%) versus 149 (7.4%); definitive tumor surgery by limb salvage versus ablative 1347 (67.0%) versus 659 (1 no surgery, 2 unknown); tumor response to preoperative chemotherapy documented for 1765 (94.9%) patients receiving neoadjuvant chemotherapy, good (<10% viable tumor) versus poor 1130 (64.0%) versus 635 (36.0%), local radiotherapy documented for 19 (0.9%) tumors. Recurrence during preceding 5years no versus yes 1681 (83.7%) versus 328 (16.3%). Median follow-up starting 5years after initial diagnosis 6.1 (0.002–32.2) years; 1815 survivors and 194 deaths. Overall survival after another 5/10/15/20years 91.7%/88.9%/85.8%/83.4% for all patients; 97.5%/95.2%/92.4%/89.9% if in remission years 1–5 versus 62.7%/57.3%/53.0%/51.2% if recurrence year 1–5 (p<0.001). Significant predictors of survival for all patients age at diagnosis (p=0.038), tumor site (p=0.030), having experienced the osteosarcoma as secondary malignancy (p<0.001), tumor response to preoperative chemotherapy (p=0.002). Multivariate Cox regression testing possible for 1759 (87.6%) patients with complete dataset: Having had a recurrence in years 1–5 (p<0.001), older age at diagnosis (p=0.009), and osteosarcoma as secondary malignancy (p=0.013) retained significance. Discussion: Highly important predictors of death such as the extent of tumor response to chemotherapy no longer remain valid after 5-year survival. The individual history of malignancies and their outcomes seems to gain pivotal importance. Conclusion: This benchmark analysis clearly defined risk factors for the further course of 5-year survivors from osteosarcoma. It argues for large disease-oriented databases as well as for very long follow-up periods. Novel findings will most likely require innovative statistical models to analyze such cohorts. [ABSTRACT FROM AUTHOR]

Published
2024
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