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1. Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

Author

Kimby, Eva, Schär, Sämi, Pirosa, Maria Cristina, Vanazzi, Anna, Mey, Ulrich, Rauch, Daniel, Wahlin, Björn E., Hitz, Felicitas, Hernberg, Micaela, Johansson, Ann-Sofie, de Nully Brown, Peter, Hagberg, Hans, Ferreri, Andrés José María, Krasniqi, Fatime, Voegeli, Michèle, Novak, Urban, Zander, Thilo, Bersvendsen, Hanne, Mamot, Christoph, Mingrone, Walter, Stathis, Anastasios, Dirnhofer, Stefan, Hayoz, Stefanie, Østenstad, Bjørn, and Zucca, Emanuele

Published
2025
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2. High dose chemotherapy with autologous stem cell transplantation in diffuse large B-cell lymphoma

Author

Popp, Henning, Hoebert, Eckfried, Rabe, Christian, Gorschlueter, Marcus, Strehl, John W., Jha, Vandana, Mey, Ulrich J.M., and Schmidt-Wolf, Ingo G.H.

Subjects
diffuse large B-cell lymphoma, high-dose chemotherapy, autologous stem cell transplantation, Medicine
Abstract

Background: High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays an important role in the treatment of aggressive non-Hodgkin’s lymphoma (NHL). We report on a retrospective analysis of all patients with diffuse large B-cell lymphoma who were consecutively treated with HDT followed by ASCT at the University Hospital of Bonn, Germany, between 1996 and 2004. Methods: A total of 25 patients were transplanted for biopsy-proven diffuse large B-cell lymphoma (DLBCL). Eight patients received up-front HDT as first-line therapy, four patients received HDT due to incomplete response to conventional induction chemotherapy, and six patients were treated for primary refractory disease. Seven patients had recurrent lymphoma. Results: A complete remission (CR) was achieved in 14 of 25 patients (56%). Estimated 3-year survival for patients treated with upfront HDT, chemosensitive patients with incomplete response to first line therapy, and patients with chemosensitive relapsed disease was 87.5%, 50.0% and 60.0%, respectively. In contrast, no patient with primary refractory disease or relapsed disease lacking chemosensitivity lived longer than 8 months. Chemosensitivity was the only significant prognostic factor for overall survival (OS) in multivariate analysis. Conclusions: Our results confirm that HDT and ASCT is a highly effective therapy in patients with DLBCL leading to long-term survival in a substantial proportion of patients. Patients treated upfront for high-risk disease, incomplete response to conventional first-line therapy, or for chemosensitive relapse have a good prognosis. In contrast, patients with primary chemorefractory disease and patients with relapsed disease lacking chemosensitivity do not benefit from HDT with ASCT.

Published
2007

3. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network

Author

Dreyling, Martin, Doorduijn, Jeanette, Giné, Eva, Jerkeman, Mats, Walewski, Jan, Hutchings, Martin, Mey, Ulrich, Riise, Jon, Trneny, Marek, Vergote, Vibeke, Shpilberg, Ofer, Gomes da Silva, Maria, Leppä, Sirpa, Jiang, Linmiao, Stilgenbauer, Stephan, Kerkhoff, Andrea, Jachimowicz, Ron D, Celli, Melania, Hess, Georg, Arcaini, Luca, Visco, Carlo, van Meerten, Tom, Wirths, Stefan, Zinzani, Pier Luigi, Novak, Urban, Herhaus, Peter, Benedetti, Fabio, Sonnevi, Kristina, Hanoun, Christine, Hänel, Matthias, Dierlamm, Judith, Pott, Christiane, Klapper, Wolfram, Gözel, Döndü, Schmidt, Christian, Unterhalt, Michael, Ladetto, Marco, and Hoster, Eva

Published
2024
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4. Combined therapy with ibrutinib and bortezomib followed by ibrutinib maintenance in relapsed or refractory mantle cell lymphoma and high-risk features: a phase 1/2 trial of the European MCL network (SAKK 36/13)

Author

Novak, Urban, Fehr, Martin, Schär, Sämi, Dreyling, Martin, Schmidt, Christian, Derenzini, Enrico, Zander, Thilo, Hess, Georg, Mey, Ulrich, Ferrero, Simone, Mach, Nicolas, Boccomini, Carola, Böttcher, Sebastian, Voegeli, Michèle, Cairoli, Anne, Ivanova, Vanesa-Sindi, Menter, Thomas, Dirnhofer, Stefan, Scheibe, Bernhard, Gadient, Sandra, Eckhardt, Katrin, Zucca, Emanuele, Driessen, Christoph, and Renner, Christoph

Published
2023
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6. SAKK 35/15: a phase 1 trial of obinutuzumab in combination with venetoclax in patients with previously untreated follicular lymphoma

Author

Stathis, Anastasios, Mey, Ulrich, Schär, Sämi, Hitz, Felicitas, Pott, Christiane, Mach, Nicolas, Krasniqi, Fatime, Novak, Urban, Schmidt, Christian, Hohloch, Karin, Kienle, Dirk Lars, Hess, Dagmar, Moccia, Alden A., Unterhalt, Michael, Eckhardt, Katrin, Hayoz, Stefanie, Forestieri, Gabriela, Rossi, Davide, Dirnhofer, Stefan, Ceriani, Luca, Sartori, Giulio, Bertoni, Francesco, Buske, Christian, Zucca, Emanuele, and Hiddemann, Wolfgang

Published
2022
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7. Prospective long-term follow-up after first-line subcutaneous cladribine in hairy cell leukemia: a SAKK trial

Author

Benz, Rudolf, Arn, Kornelius, Andres, Martin, Pabst, Thomas, Baumann, Michael, Novak, Urban, Hitz, Felicitas, Hess, Urs, Zenhaeusern, Reinhard, Chalandon, Yves, Mey, Ulrich, Blum, Sabine, Rauch, Daniel, O'Meara Stern, Alix, Cantoni, Nathan, Bargetzi, Mario, Bianchi-Papina, Elena, Rossi, Davide, Passweg, Jakob, Lohri, Andreas, Berardi, Simona, Li, Qiyu, Feller, Anita, and Stussi, Georg

Published
2020
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8. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE):a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network

Author

Dreyling, Martin, Doorduijn, Jeanette, Giné, Eva, Jerkeman, Mats, Walewski, Jan, Hutchings, Martin, Mey, Ulrich, Riise, Jon, Trneny, Marek, Vergote, Vibeke, Shpilberg, Ofer, Gomes da Silva, Maria, Leppä, Sirpa, Jiang, Linmiao, Stilgenbauer, Stephan, Kerkhoff, Andrea, Jachimowicz, Ron D., Celli, Melania, Hess, Georg, Arcaini, Luca, Visco, Carlo, van Meerten, Tom, Wirths, Stefan, Zinzani, Pier Luigi, Novak, Urban, Herhaus, Peter, Benedetti, Fabio, Sonnevi, Kristina, Hanoun, Christine, Hänel, Matthias, Dierlamm, Judith, Pott, Christiane, Klapper, Wolfram, Gözel, Döndü, Schmidt, Christian, Unterhalt, Michael, Ladetto, Marco, Hoster, Eva, Dreyling, Martin, Doorduijn, Jeanette, Giné, Eva, Jerkeman, Mats, Walewski, Jan, Hutchings, Martin, Mey, Ulrich, Riise, Jon, Trneny, Marek, Vergote, Vibeke, Shpilberg, Ofer, Gomes da Silva, Maria, Leppä, Sirpa, Jiang, Linmiao, Stilgenbauer, Stephan, Kerkhoff, Andrea, Jachimowicz, Ron D., Celli, Melania, Hess, Georg, Arcaini, Luca, Visco, Carlo, van Meerten, Tom, Wirths, Stefan, Zinzani, Pier Luigi, Novak, Urban, Herhaus, Peter, Benedetti, Fabio, Sonnevi, Kristina, Hanoun, Christine, Hänel, Matthias, Dierlamm, Judith, Pott, Christiane, Klapper, Wolfram, Gözel, Döndü, Schmidt, Christian, Unterhalt, Michael, Ladetto, Marco, and Hoster, Eva

Abstract

Background: Adding ibrutinib to standard immunochemotherapy might improve outcomes and challenge autologous stem-cell transplantation (ASCT) in younger (aged 65 years or younger) mantle cell lymphoma patients. This trial aimed to investigate whether the addition of ibrutinib results in a superior clinical outcome compared with the pre-trial immunochemotherapy standard with ASCT or an ibrutinib-containing treatment without ASCT. We also investigated whether standard treatment with ASCT is superior to a treatment adding ibrutinib but without ASCT. Methods: The open-label, randomised, three-arm, parallel-group, superiority TRIANGLE trial was performed in 165 secondary or tertiary clinical centres in 13 European countries and Israel. Patients with previously untreated, stage II–IV mantle cell lymphoma, aged 18–65 years and suitable for ASCT were randomly assigned 1:1:1 to control group A or experimental groups A+I or I, stratified by study group and mantle cell lymphoma international prognostic index risk groups. Treatment in group A consisted of six alternating cycles of R-CHOP (intravenous rituximab 375 mg/m2 on day 0 or 1, intravenous cyclophosphamide 750 mg/m2 on day 1, intravenous doxorubicin 50 mg/m2 on day 1, intravenous vincristine 1·4 mg/m2 on day 1, and oral prednisone 100 mg on days 1–5) and R-DHAP (or R-DHAOx, intravenous rituximab 375 mg/m2 on day 0 or 1, intravenous or oral dexamethasone 40 mg on days 1–4, intravenous cytarabine 2 × 2 g/m2 for 3 h every 12 h on day 2, and intravenous cisplatin 100 mg/m2 over 24 h on day 1 or alternatively intravenous oxaliplatin 130 mg/m2 on day 1) followed by ASCT. In group A+I, ibrutinib (560 mg orally each day) was added on days 1–19 of R-CHOP cycles and as fixed-duration maintenance (560 mg orally each day for 2 years) after ASCT. In group I, ibrutinib was given the same way as in group A+I, but ASCT was omitted. Three pairwise o

Published
2024

9. Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

Author

Zucca, Emanuele, Rondeau, Stephanie, Vanazzi, Anna, Østenstad, Bjørn, Mey, Ulrich J.M., Rauch, Daniel, Wahlin, Björn E., Hitz, Felicitas, Hernberg, Micaela, Johansson, Ann-Sofie, de Nully Brown, Peter, Hagberg, Hans, Ferreri, Andrés J.M., Lohri, Andreas, Novak, Urban, Zander, Thilo, Bersvendsen, Hanne, Bargetzi, Mario, Mingrone, Walter, Krasniqi, Fatime, Dirnhofer, Stefan, Hayoz, Stefanie, Hawle, Hanne, Vilei, Simona Berardi, Ghielmini, Michele, and Kimby, Eva

Published
2019
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11. ESMO Consensus Conference on malignant lymphoma: general perspectives and recommendations for the clinical management of the elderly patient with malignant lymphoma

Author

Buske, Christian, Dreyling, Martin, Ferreri, Andrés J M, Fields, Paul, Gaidano, Gianluca, Goede, Valentin, Hutchings, Martin, Ladetto, Marco, Le Gouill, Steven, Luminari, Stefano, Mey, Ulrich, de Nully Brown, Peter, Pfreundschuh, Michael, Pott, Christiane, Schmitz, Norbert, Soubeyran, Pierre, Spina, Michele, Stauder, Reinhard, Balari, Anna Sureda, Trněný, Marek, van Imhoff, Gustaaf, Walewski, Jan, Wedding, Ulrich, Zamò, Alberto, Zucca, Emanuele, Buske, C., Hutchings, M., Ladetto, M., Goede, V., Mey, U., Soubeyran, P., Spina, M., Stauder, R., Trněný, M., Wedding, U., and Fields, P.

Published
2018
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12. Progression-free survival of early interim PET-positive patients with advanced stage Hodgkin's lymphoma treated with BEACOPPescalated alone or in combination with rituximab (HD18): an open-label, international, randomised phase 3 study by the German Hodgkin Study Group

Author

Borchmann, Peter, Haverkamp, Heinz, Lohri, Andreas, Mey, Ulrich, Kreissl, Stefanie, Greil, Richard, Markova, Jana, Feuring-Buske, Michaela, Meissner, Julia, Dührsen, Ulrich, Ostermann, Helmut, Keller, Ulrich, Maschmeyer, Georg, Kuhnert, Georg, Dietlein, Markus, Kobe, Carsten, Eich, Hans, Baues, Christian, Stein, Harald, Fuchs, Michael, Diehl, Volker, and Engert, Andreas

Published
2017
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15. Efficacy and Safety of Ibrutinib Combined with Standard First-Line Treatment or As Substitute for Autologous Stem Cell Transplantation in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network

Author

Dreyling, Martin, primary, Doorduijn, Jeanette K., additional, Gine, Eva, additional, Jerkeman, Mats, additional, Walewski, Jan, additional, Hutchings, Martin, additional, Mey, Ulrich, additional, Riise, Jon, additional, Trneny, Marek, additional, Vergote, Vibeke K.J., additional, Celli, Melania, additional, Shpilberg, Ofer, additional, Gomes da Silva, Maria, additional, Leppa, Sirpa, additional, Jiang, Linmiao, additional, Pott, Christiane, additional, Klapper, Wolfram, additional, Gözel, Döndü, additional, Schmidt, Christian, additional, Unterhalt, Michael, additional, Ladetto, Marco, additional, and Hoster, Eva, additional

Published
2022
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16. Decision-Making among Experts in Advanced Hodgkin Lymphoma

Author

Hitz, Felicitas, primary, Lang, Noémie, additional, Mey, Ulrich, additional, Mingrone, Walter, additional, Moccia, Alden, additional, Taverna, Christian, additional, Novak, Urban, additional, Stenner, Frank, additional, Schmidt, Adrian, additional, Mamot, Christoph, additional, Fischer, Natalie, additional, and Putora, Paul M., additional

Published
2022
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18. Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2nd‐line therapy for relapsed and refractory multiple myeloma – a phase II trial

Author

Mey, Ulrich J. M., Brugger, Wolfram, Schwarb, Heike, Pederiva, Stefanie, Schwarzer, Andreas, Dechow, Tobias, Jehner, Paul, Rauh, Jacqueline, Taverna, Christian J., Schmid, Mathias, SchmidtHieber, Martin, Doerfel, Steffen, Fischer, Natalie, Ruefer, Axel, Ziske, Carsten, Knauf, Wolfgang, Cathomas, Richard, von Moos, Roger, Hitz, Felicitas, Sauter, Rafael, Hiendlmeyer, Elke, Cantoni, Nathan, Bargetzi, Mario, and Driessen, Christoph

Published
2017
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19. Decision-Making among Experts in Advanced Hodgkin Lymphoma.

Author

Hitz, Felicitas, Lang, Noémie, Mey, Ulrich, Mingrone, Walter, Moccia, Alden, Taverna, Christian, Novak, Urban, Stenner, Frank, Schmidt, Adrian, Mamot, Christoph, Fischer, Natalie, and Putora, Paul M.

Subjects
HODGKIN'S disease treatment, CONSENSUS (Social sciences), DECISION trees, CLINICAL decision support systems, MEDICAL personnel, INFORMED consent (Medical law), EXPERTISE, FERTILITY preservation, POSITRON emission tomography, DECISION making in clinical medicine, IMMUNOTHERAPY, ALGORITHMS
Abstract

Introduction: In the treatment of advanced Hodgkin lymphoma (aHL), based on guidelines a multitude of treatment options are available. The availability of PET-guided decision-making and new therapeutic agents increase the complexity of the decision-making process. Methods: Thirteen experts of Swiss university and cantonal hospitals in Switzerland were asked to describe their institutional decision-making practice in aHL. Variables influencing the decision-making process were identified, standardized, and converted into decision trees for analysis of consent and discrepancies. The algorithms of all participating experts were analyzed with the objective consensus methodology. Results: Four decision criteria (age, fertility preservation, fitness, and interim PET) and 12 unique treatment regimens were identified. Consensus for the treatment of aHL for young and fit, as well as for older patients without comorbidity, was found. Large heterogeneity was identified with use of a variety of different regimens for unfit patients with aHL and for young female patients with a desire of fertility preservation. Conclusions: Four major decision criteria were identified allowing the representation of expert's approach to first-line treatment of aHL. Among Swiss experts, consensus for a PET-guided curative treatment of aHL was identified. The use of a multitude of treatment regimens was observed for older and comorbid (unfit) aHL patients, highlighting the need for clinical trials and recommendations for this group of patients. [ABSTRACT FROM AUTHOR]

Published
2023
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20. P-227: Alternate day dosing of pomalidomide in patients with refractory/relapsed multiple myeloma (RRMM): Results of a multicenter, single arm phase 2 trial (SAKK 39/16 OptiPOM Study)

Author

Zander, Thilo, primary, Pabst, Thomas, additional, Schär, Sämi, additional, Aebi, Stefan, additional, Pabst, Tobias, additional, Mey, Ulrich, additional, Novak, Urban, additional, Lerch, Erika, additional, Rhyner, Gaëlle, additional, Goede, Jeroen, additional, Maniecka, Zuzanna, additional, Hayoz, Stefanie, additional, Rufer, Axel, additional, Renner, Christoph, additional, and Driessen, Christoph, additional

Published
2021
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25. Leitlinie : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie h��matologischer und onkologischer Erkrankungen

Author

Cairoli, Anne, ��sterreichische Gesellschaft F��r H��matologie & Medizinische Onkologie, Schweizerische Gesellschaft F��r H��matologie, Dreyling, Martin, He��, Georg, Mey, Ulrich Jeremi Manuel, Raderer, Markus, Schweizerische Gesellschaft F��r Medizinische Onkologie, Buske, Christian, Deutsche Gesellschaft F��r H��matologie Und Medizinische Onkologie, and Pott, Christiane

Subjects
Medizin und Gesundheit
Published
2021
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26. Ibrutinib Lead-in followed by Venetoclax Plus Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia - SAKK 34/17

Author

Condoluci, Adalgisa, Romano, Ilaria, Dietrich, Daniel, Pini, Katia, Stüssi, Georg, Müller, Gisela, Cantoni, Nathan, Cathomas, Richard, Mey, Ulrich, Widmer, Anouk, Zenz, Thorsten, Gregor, Michael, Heim, Dominik, Andres, Martin, Benz, Rudolf, and Rossi, Davide

Abstract

•Longer ibrutinib lead-in phase decreases TLS risk and a minimum of 24-month IV combination enhances uMRD CR/CRi rates.•Plasma ctDNA did not provide additional insights to Ig HTS MRD assessment.

Published
2025
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28. Long-Term Efficacy of a 6-Month Regimen of Rituximab and Lenalidomide in Follicular Lymphoma Patients in Need of First Therapy: Updated Analysis of the SAKK 35/10 Randomized Trial

Author

Zucca, Emanuele, Schaer, Saemi, Vanazzi, Anna, Østenstad, Bjørn, Mey, Ulrich, Rauch, Daniel, Wahlin, Björn E., Hitz, Felicitas, Hernberg, Micaela, Johansson, Ann-Sofie, Brown, Peter de Nully, Hagberg, Hans, Ferreri, Andrés José María, Krasniqi, Fatime, Voegeli, Michèle, Novak, Urban, Zander, Thilo, Bersvendsen, Hanne, Mamot, Christoph, Mingrone, Walter, Stathis, Anastasios, Dirnhofer, Stefan, Hayoz, Stefanie, and Kimby, Eva

Published
2023
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32. Prognostic value of MRD in CLL patients with comorbidities receiving chlorambucil plus obinutuzumab or rituximab

Author

Langerak, Anton W., Ritgen, Matthias, Goede, Valentin, Robrecht, Sandra, Bahlo, Jasmin, Fischer, Kirsten, Steurer, Michael, Trněný, Marek, Mulligan, Stephen P., Mey, Ulrich J.M., Trunzer, Kerstin, Fingerle-Rowson, Günter, Humphrey, Kathryn, Stilgenbauer, Stephan, Böttcher, Sebastian, Brüggemann, Monika, Hallek, Michael, Kneba, Michael, and van Dongen, Jacques J.M.

Published
2019
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40. Leitlinie - Mantelzell-Lymphom : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Österreichische Gesellschaft Für Hämatologie & Medizinische Onkologie, Schweizerische Gesellschaft Für Hämatologie, Dreyling, Martin, Mey, Ulrich Jeremi Manuel, Schweizerische Gesellschaft Für Medizinische Onkologie, Buske, Christian, Herold, Michael, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, and Drach, Johannes

Subjects
Medizin und Gesundheit
Published
2019
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41. Leitlinie - ICD C83.1 : Empfehlungen der Fachgesellschaft zur Diagnostik und Therapie hämatologischer und onkologischer Erkrankungen

Author

Österreichische Gesellschaft Für Hämatologie & Medizinische Onkologie, Schweizerische Gesellschaft Für Hämatologie, Dreyling, Martin, Mey, Ulrich Jeremi Manuel, Schweizerische Gesellschaft Für Medizinische Onkologie, Buske, Christian, Herold, Michael, Deutsche Gesellschaft Für Hämatologie Und Medizinische Onkologie, and Drach, Johannes

Subjects
Medizin und Gesundheit
Published
2019
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42. Triangle: Autologous Transplantation after a Rituximab/Ibrutinib/ara-c Containing Induction in Generalized Mantle Cell Lymphoma - a Randomized European MCL Network Trial

Author

Dreyling, Martin, primary, Ladetto, Marco, additional, Doorduijn, Jeanette K., additional, Gine, Eva, additional, Jerkeman, Mats, additional, Mey, Ulrich, additional, Szymczyk, Michal, additional, Hutchings, Martin, additional, Kolstad, Arne, additional, Verhoef, Gregor, additional, Trneny, Marek, additional, Gomes da Silva, Maria, additional, Pott, Christiane, additional, Klapper, Wolfram, additional, Unterhalt, Michael, additional, and Hoster, Eva, additional

Published
2019
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43. Updated recommendations for diagnosis and treatment of plasma cell myeloma in Switzerland

Author

Samaras, Panagiotis, primary, Bargetzi, Mario, additional, Betticher, Daniel C., additional, Driessen, Christoph, additional, Duchosal, Michel A., additional, Heim, Dominik, additional, Ketterer, Nicolas, additional, Lerch, Erika, additional, Matthes, Thomas, additional, Mey, Ulrich, additional, Pabst, Thomas, additional, Schmidt, Adrian, additional, Taverna, Christian, additional, Zander, Thilo, additional, and Renner, Christoph, additional

Published
2019
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44. Prospective Long-Term Follow-up after First-Line Subcutaneous Cladribine Treatment in Patients with Hairy Cell Leukemia. a Study of the SAKK (Swiss Group for Clinical Cancer Research)

Author

Benz, Rudolf A., primary, Arn, Kornelius, additional, Andres, Martin, additional, Pabst, Thomas, additional, Novak, Urban, additional, Hitz, Felicitas, additional, Zenhäusern, Reinhard, additional, Chalandon, Yves, additional, Mey, Ulrich, additional, Blum, Sabine, additional, Rauch, Daniel, additional, Nettekoven, Willy, additional, Cantoni, Nathan, additional, Bargetzi, Mario, additional, O'Meara, Alix, additional, Lohri, Andreas, additional, Berardi, Simona, additional, Li, Qiyu, additional, and Stussi, Georg, additional

Published
2018
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45. Diagnosis and treatment of follicular lymphoma: an update

Author

Bargetzi, Mario, primary, Baumann, Reto, additional, Cogliatti, Sergio, additional, Dietrich, Pierre-Yves, additional, Duchosal, Michel, additional, Goede, Jeroen, additional, Hitz, Felicitas, additional, Konermann, Carolin, additional, Lohri, Andreas, additional, Mey, Ulrich, additional, Novak, Urban, additional, Papachristofilou, Alexandros, additional, Stenner, Frank, additional, Taverna, Christian, additional, Zander, Thilo, additional, and Renner, Christoph, additional

Published
2018
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47. High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08.

Author

Fehr, Martin, Hawle, Hanne, Hayoz, Stefanie, Thuss-Patience, Peter, Schacher, Sabina, Riera Knorrenschild, Jorge, Dürr, Donat, Knoefel, Wolfram T., Rumpold, Holger, Bitzer, Michael, Zweifel, Martin, Samaras, Panagiotis, Mey, Ulrich, Küng, Marc, Winterhalder, Ralph, Eisterer, Wolfgang, Hess, Viviane, Gérard, Marie-Aline, Templeton, Arnoud, and Stahl, Michael

Subjects
CHEMORADIOTHERAPY, SQUAMOUS cell carcinoma, RECTAL cancer, GASTROINTESTINAL cancer, ESOPHAGEAL cancer, CANCER, GASTROINTESTINAL system, ADVERSE health care events
Abstract

Background: High rates of venous thromboembolic events (VTEs), mainly in advanced disease, are reported for patients with cancer of the upper gastrointestinal tract (stomach, pancreas) and for treatment with cisplatin.Methods: Exploratory analysis of VTEs reported as adverse events and serious adverse events in a prospective, randomised, multicentre, multimodal phase III trial according to VTEs reported as adverse events and severe adverse events. Patients with resectable oesophageal cancer (T2N1-3, T3-4aNx) were randomized to 2 cycles of chemotherapy with docetaxel 75 mg/m2, cisplatin 75 mg/m2 followed by chemo-radiotherapy (CRT) and subsequent surgery (control arm) or the same treatment with addition of cetuximab (investigational arm).Results: VTEs occurred in 26 of 300 patients included in the trial, resulting in an incidence rate (IR) of 8.7% [95% CI 5.7-12.4%]. A total of 29 VTEs were reported:13 (45%) VTEs were grade 2, 13 (45%) grade 3 and three (10%) fatal grade 5 events. 72% (21/29) of all VTEs occurred preoperatively (IR 6.7%): 14% (4/29) during chemotherapy and 59% (17/29) during CRT. In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0-8.4], p = 0.046. Baseline Khorana risk score was 0 in 73% (19/26), 1-2 in 23% (6/26) and 3 in only 4% (1/26) of patients with VTEs.Conclusion: A high incidence of VTEs during preoperative therapy of resectable oesophageal cancer is observed in this analysis, especially in patients with adenocarcinoma. The role of prophylactic anticoagulation during neoadjuvant therapy in resectable esophageal cancer should be further evaluated in prospective clinical trials. According to our data, which are in line with other analysis of VTE-risk in patients with oesophageal cancer patients treated with neoadjuvant cisplatin-based chemotherapy and CRT, prophylactic anticoagluation could be considered balanced against individual bleeding risks, especially in patients with adenocarcinoma. In addition to the established risk factors, oesophageal adenocarcinoma treated with neoadjuvant cisplatin-based therapy may be regarded as a high-risk situation for VTEs.Trial Registration: Registered at clinicaltrials.gov, NCT01107639, on 21 April 2010. [ABSTRACT FROM AUTHOR]

Published
2020
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48. Treatment with the HIV protease inhibitor Nelfinavir triggers the unfolded protein response and may overcome proteasome inhibitor resistance of multiple myeloma in combination with bortezomib: a phase I trial (SAKK 65/08)

Author

Driessen, Christoph, Kraus, Marianne, Joerger, Markus, Rosing, Hilde, Bader, Jürgen, Hitz, Felicitas, Berset, Catherine, Xyrafas, Alexandros, Hawle, Hanne, Berthod, Gregoire, Overkleeft, Hermann S, Sessa, Cristiana, Huitema, Alwin, Pabst, Thomas, von Moos, Roger, Hess, Dagmar, Mey, Ulrich J M, Driessen, Christoph, Kraus, Marianne, Joerger, Markus, Rosing, Hilde, Bader, Jürgen, Hitz, Felicitas, Berset, Catherine, Xyrafas, Alexandros, Hawle, Hanne, Berthod, Gregoire, Overkleeft, Hermann S, Sessa, Cristiana, Huitema, Alwin, Pabst, Thomas, von Moos, Roger, Hess, Dagmar, and Mey, Ulrich J M

Abstract

Downregulation of the unfolded protein response mediates proteasome inhibitor resistance in Multiple Myeloma.The Human Immunodeficieny Virus protease inhibitor nelfinavir activates the unfolded protein response in vitro. We determined dose limiting toxicity and recommended dose for phase II of nelfinavir in combination with the proteasome inhibitor bortezomib. 12 patients with advanced hematological malignancies were treated with nelfinavir (2500 - 5000 mg/d p.o., d 1-14, 3+3 dose escalation) and bortezomib (1.3 mg/m2, d 1, 4, 8, 11; 21 day cycles). A run in phase with nelfinavir monotherapy allowed pharmakokinetic/pharmakodynamic assessment of nelfinavir in the presence or absence of concomittant bortezomib. Endpoints included dose limiting toxicity, activation of the unfolded protein response, proteasome activity, toxicity and response to trial treatment. Nelfinavir 2 x 2500 mg was the recommended phase II dose identified. Nelfinavir alone significantly upregulated expression of proteins related to the unfolded protein response in peripheral blood mononuclear cells and inhibited proteasome activity. Of 10 evaluable patients in the dose escalation cohort, 3 achieved a partial response, 4 stable disease for ≥ 2 cycles, while 3 had progressive disease as best response. In an exploratory extension cohort with 6 relapsed, bortezomib-refractory, lenalidomide-resistant myeloma patients treated at the recommended phase II dose, 3 reached a partial response, 2 a minor response and one progressive disease. The combination of nelfinavir with bortezomib is safe and shows promising signals for activity in advanced, bortezomib-refractory MM. Induction of the unfolded protein response by nelfinavir may overcome the biological features of proteasome inhibitor resistance. (Trial registration NCT01164709).

Published
2016

49. Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2nd-line therapy for relapsed and refractory multiple myeloma - a phase II trial

Author

Mey, Ulrich J. M., primary, Brugger, Wolfram, additional, Schwarb, Heike, additional, Pederiva, Stefanie, additional, Schwarzer, Andreas, additional, Dechow, Tobias, additional, Jehner, Paul, additional, Rauh, Jacqueline, additional, Taverna, Christian J., additional, Schmid, Mathias, additional, Schmidt-Hieber, Martin, additional, Doerfel, Steffen, additional, Fischer, Natalie, additional, Ruefer, Axel, additional, Ziske, Carsten, additional, Knauf, Wolfgang, additional, Cathomas, Richard, additional, von Moos, Roger, additional, Hitz, Felicitas, additional, Sauter, Rafael, additional, Hiendlmeyer, Elke, additional, Cantoni, Nathan, additional, Bargetzi, Mario, additional, and Driessen, Christoph, additional

Published
2016
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50. Rituximab Plus Lenalidomide Versus Rituximab Monotherapy in Untreated Follicular Lymphoma Patients in Need of Therapy. First Analysis of Survival Endpoints of the Randomized Phase-2 Trial SAKK 35/10

Author

Kimby, Eva, primary, Rondeau, Stephanie, additional, Vanazzi, Anna, additional, Ostenstad, Bjorn, additional, Mey, Ulrich J.M., additional, Rauch, Daniel, additional, Wahlin, Björn E, additional, Hitz, Felicitas, additional, Hernberg, Micaela, additional, Johansson, Ann-Sofie, additional, de Nully Brown, Peter, additional, Hagberg, Hans, additional, Ferreri, Andres J.M., additional, Lohri, Andreas, additional, Novak, Urban, additional, Zander, Thilo, additional, Bersvendsen, Hanne, additional, Bergetzi, Mario, additional, Mingrone, Walter, additional, Krasniqi, Fatime, additional, Dirnhofer, Stefan, additional, Hawle, Hanne, additional, Berardi, Simona, additional, Ghielmini, Michele, additional, and Zucca, Emanuele, additional

Published
2016
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