24 results on '"De Wit, Maike"'
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2. AFM13 in patients with relapsed or refractory classical Hodgkin lymphoma: final results of an open-label, randomized, multicenter phase II trial
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Sasse, Stephanie, Brockelmann, Paul Jan, Momotow, Jesko, Plutschow, Annette, Huttmann, Andreas, Basara, Nadezda, Koenecke, Christian, Martin, Sonja, Bentz, Martin, Grosse-Thie, Christina, Thorspecken, Sven, de Wit, Maike, Kobe, Carsten, Dietlein, Markus, v Tresckow, Bastian, Fuchs, Michael, Borchmann, Peter, Engert, Andreas, Sasse, Stephanie, Brockelmann, Paul Jan, Momotow, Jesko, Plutschow, Annette, Huttmann, Andreas, Basara, Nadezda, Koenecke, Christian, Martin, Sonja, Bentz, Martin, Grosse-Thie, Christina, Thorspecken, Sven, de Wit, Maike, Kobe, Carsten, Dietlein, Markus, v Tresckow, Bastian, Fuchs, Michael, Borchmann, Peter, and Engert, Andreas
- Abstract
In patients with relapse of classical Hodgkin lymphoma (cHL) after autologous stem cell transplant, brentuximab vedotin and anti-PD1 treatment, the outcome is poor. To assess the efficacy of the bispecific anti-CD30/CD16A, NK-cell engaging antibody AFM13 and to select the optimal treatment schedule (arm A-C), we initiated a randomized two-stage phase II trial (NCT02321592). Due to slow recruitment, the trial was terminated after treatment of 25 patients. Treatment with AFM13 was well tolerated: only two treatment-associated serious adverse events (SAEs) were reported; all SAEs resolved completely. With an objective response rate (ORR) of 16.7% (1/5 in arm A, 1/11 in arm B, and 2/8 in arm C) and a 12-month progression-free survival (PFS) of 12.6% (95% CI 3.2-28.9), treatment efficacy of AFM13 monotherapy in all evaluable patients was modest. The continuous application schedule (arm C) might be more effective, but the visit schedule should be better aligned with patients' daily life.
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- 2022
3. Anticoagulation Practice in Patients with Cancer-Associated Thrombosis: Insights from GeCAT, a German Prospective Registry Study
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Klamroth, Robert, Sinn, Marianne, Pollich, Christiane, Bischoff, Sven, Lohneis, Anja, Orlovic, Ana-Marija, Wislocka, Lilianna, Habbel, Piet, de Wit, Maike, Spaeth-Schwalbe, Ernst, Scholz, Christian W., Riess, Hanno, Klamroth, Robert, Sinn, Marianne, Pollich, Christiane, Bischoff, Sven, Lohneis, Anja, Orlovic, Ana-Marija, Wislocka, Lilianna, Habbel, Piet, de Wit, Maike, Spaeth-Schwalbe, Ernst, Scholz, Christian W., and Riess, Hanno
- Abstract
Introduction: Cancer-associated venous thrombosis (CAT) is a common and serious complication of active malignancies, increasing in frequency during systemic treatment and radiotherapy. Due to a high risk of recurrence and bleeding, the administration of anticoagulants for initial treatment and secondary prevention of CAT is challenging. We conducted a prospective registry study of patients with acute CAT to evaluate the way treatment is given to these patients in routine practice. Methods: From May 2015 to May 2017, all consecutive patients with acute venous thromboembolism (VTE) admitted to specialty or emergency departments of the participating hospitals in Berlin, Germany, were entered into the registry. Patients with cancer underwent extensive baseline evaluation including the type and location of thrombosis and use of anticoagulant therapy. Follow-up assessments were made at discharge and by telephone interviews at 3 and 6 months. Results: A total of 382 patients with acute CAT were enrolled in the study, representing 24.5% of all patients with thrombosis. 70.4% of CAT patients had deep vein thromboses (DVT), 48.2% had pulmonary embolism (PE), and 18.6% had concurrent PE and DVT. A significant proportion of VTE (27%) was asymptomatic and was diagnosed only incidentally. At baseline, 97.9% of the patients received anticoagulant therapy, predominantly with low-molecular-weight heparin (LMWH) (n = 334, 87.4%). Direct oral anticoagulants (DOACs) were given to 5.8% of patients, and vitamin K antagonists were rarely used (<2% of patients). Changes in the prescription of antithrombotic agents were seen at discharge from hospital and during follow-up. Overall, the use of LMWH declined during follow-up, while the proportion of patients treated with DOACs increased to 32.4% at 6 months. At baseline, the most frequently used LMWH were enoxaparin and nadroparin, but many patients were switched to once daily tinzaparin prior to discharge. Initially and after discharge, the
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- 2022
4. Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II - Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, De Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Joerg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, D. H., Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, De Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Joerg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, D. H., Zillmann, Roger, and Albers, Peter
- Abstract
Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes therecommendations for the treatment of advanced disease stages and for the management of follow-up and late effects. Materials and Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements. Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy. Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication.
- Published
- 2021
5. Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jorg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jorg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic's background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classific
- Published
- 2021
6. Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic’s background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group
- Published
- 2021
7. Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II – Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes the recommendations for the treatment of advanced disease stages and for the management of follow-up and late effects. Materials and Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements. Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy. Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication
- Published
- 2021
8. Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic’s background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group
- Published
- 2021
9. Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II – Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy
- Author
-
Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Göckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jörg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Müller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruff, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes the recommendations for the treatment of advanced disease stages and for the management of follow-up and late effects. Materials and Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements. Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy. Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication
- Published
- 2021
10. Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II - Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, De Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Joerg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, D. H., Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, De Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Joerg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, D. H., Zillmann, Roger, and Albers, Peter
- Abstract
Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes therecommendations for the treatment of advanced disease stages and for the management of follow-up and late effects. Materials and Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements. Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy. Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication.
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- 2021
11. Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages
- Author
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Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jorg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, Albers, Peter, Kliesch, Sabine, Schmidt, Stefanie, Wilborn, Doris, Aigner, Clemens, Albrecht, Walter, Bedke, Jens, Beintker, Matthias, Beyersdorff, Dirk, Bokemeyer, Carsten, Busch, Jonas, Classen, Johannes, de Wit, Maike, Dieckmann, Klaus-Peter, Diemer, Thorsten, Dieing, Anette, Gockel, Matthias, Goeckel-Beining, Bernt, Hakenberg, Oliver W., Heidenreich, Axel, Heinzelbecker, Julia, Herkommer, Kathleen, Hermanns, Thomas, Kaufmann, Sascha, Kornmann, Marko, Kotzerke, Jorg, Krege, Susanne, Kristiansen, Glen, Lorch, Anja, Mueller, Arndt-Christian, Oechsle, Karin, Ohloff, Timur, Oing, Christoph, Otto, Ulrich, Pfister, David, Pichler, Renate, Recken, Heinrich, Rick, Oliver, Rudolph, Yvonne, Ruf, Christian, Schirren, Joachim, Schmelz, Hans, Schmidberger, Heinz, Schrader, Mark, Schweyer, Stefan, Seeling, Stefanie, Souchon, Rainer, Winter, Christian, Wittekind, Christian, Zengerling, Friedemann, Zermann, Dirk-Henrik, Zillmann, Roger, and Albers, Peter
- Abstract
Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic's background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages. Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements. Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma. Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classific
- Published
- 2021
12. Dihydropyrimidine Dehydrogenase Testing prior to Treatment with 5-Fluorouracil, Capecitabine, and Tegafur: A Consensus Paper
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Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, Hofheinz, Ralf-Dieter, Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, and Hofheinz, Ralf-Dieter
- Abstract
Background: 5-Fluorouracil (FU) is one of the most commonly used cytostatic drugs in the systemic treatment of cancer. Treatment with FU may cause severe or life-threatening side effects and the treatment-related mortality rate is 0.2–1.0%. Summary: Among other risk factors associated with increased toxicity, a genetic deficiency in dihydropyrimidine dehydrogenase (DPD), an enzyme responsible for the metabolism of FU, is well known. This is due to variants in the DPD gene (DPYD). Up to 9% of European patients carry a DPD gene variant that decreases enzyme activity, and DPD is completely lacking in approximately 0.5% of patients. Here we describe the clinical and genetic background and summarize recommendations for the genetic testing and tailoring of treatment with 5-FU derivatives. The statement was developed as a consensus statement organized by the German Society for Hematology and Medical Oncology in cooperation with 13 medical associations from Austria, Germany, and Switzerland. Key Messages: (i) Patients should be tested for the 4 most common genetic DPYD variants before treatment with drugs containing FU. (ii) Testing forms the basis for a differentiated, risk-adapted algorithm with recommendations for treatment with FU-containing drugs. (iii) Testing may optionally be supplemented by therapeutic drug monitoring
- Published
- 2020
13. Dihydropyrimidine Dehydrogenase Testing prior to Treatment with 5-Fluorouracil, Capecitabine, and Tegafur: A Consensus Paper
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Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, Hofheinz, Ralf-Dieter, Wörmann, Bernhard, Bokemeyer, Carsten, Burmeister, Thomas, Köhne, Claus-Henning, Schwab, Matthias, Arnold, Dirk, Blohmer, Jens-Uwe, Borner, Markus, Brucker, Sara, Cascorbi, Ingolf, Decker, Thomas, de Wit, Maike, Dietz, Andreas, Einsele, Hermann, Eisterer, Wolfgang, Folprecht, Gunnar, Hilbe, Wolfgang, Hoffmann, Jürgen, Knauf, Wolfgang, Kunzmann, Volker, Largiadèr, Carlo R., Lorenzen, Sylvie, Lüftner, Diana, Moehler, Markus, Nöthen, Markus M., Pox, Christian, Reinacher-Schick, Anke, Scharl, Anton, Schlegelberger, Brigitte, Seufferlein, Thomas, Sinn, Marianne, Stroth, Matthias, Tamm, Ingo, Trümper, Lorenz, Wilhelm, Martin, Wöll, Ewald, and Hofheinz, Ralf-Dieter
- Abstract
Background: 5-Fluorouracil (FU) is one of the most commonly used cytostatic drugs in the systemic treatment of cancer. Treatment with FU may cause severe or life-threatening side effects and the treatment-related mortality rate is 0.2–1.0%. Summary: Among other risk factors associated with increased toxicity, a genetic deficiency in dihydropyrimidine dehydrogenase (DPD), an enzyme responsible for the metabolism of FU, is well known. This is due to variants in the DPD gene (DPYD). Up to 9% of European patients carry a DPD gene variant that decreases enzyme activity, and DPD is completely lacking in approximately 0.5% of patients. Here we describe the clinical and genetic background and summarize recommendations for the genetic testing and tailoring of treatment with 5-FU derivatives. The statement was developed as a consensus statement organized by the German Society for Hematology and Medical Oncology in cooperation with 13 medical associations from Austria, Germany, and Switzerland. Key Messages: (i) Patients should be tested for the 4 most common genetic DPYD variants before treatment with drugs containing FU. (ii) Testing forms the basis for a differentiated, risk-adapted algorithm with recommendations for treatment with FU-containing drugs. (iii) Testing may optionally be supplemented by therapeutic drug monitoring
- Published
- 2020
14. Imatinib dose reduction in major molecular response of chronic myeloid leukemia: results from the German Chronic Myeloid Leukemia-Study IV
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Michel, Christian, Burchert, Andreas, Hochhaus, Andreas, Saussele, Susanne, Neubauer, Andreas, Lauseker, Michael, Krause, Stefan W., Kolb, Hans-Jochem, Hossfeld, Dieter Kurt, Nerl, Christoph, Baerlocher, Gabriela M., Heim, Dominik, Bruemmendorf, Tim H., Fabarius, Alice, Haferlach, Claudia, Schlegelberger, Brigitte, Balleisen, Leopold, Goebeler, Maria-Elisabeth, Haenel, Mathias, Ho, Anthony, Dengler, Jolanta, Falge, Christiane, Moehle, Robert, Kremers, Stephan, Kneba, Michael, Stegelmann, Frank, Koehne, Claus-Henning, Lindemann, Hans-Walter, Waller, Cornelius F., Spiekermann, Karsten, Berdel, Wolfgang E., Mueller, Lothar, Edinger, Matthias, Mayer, Jiri, Beelen, Dietrich W., Bentz, Martin, Link, Hartmut, Hertenstein, Bernd, Fuchs, Roland, Wernli, Martin, Schlegel, Frank, Schlag, Rudolf, de Wit, Maike, Truemper, Lorenz, Hebart, Holger, Hahn, Markus, Thomalla, Joerg, Scheid, Christof, Schafhausen, Philippe, Verbeek, Walter, Eckart, Michael J., Gassmann, Winfried, Schenk, Michael, Brossart, Peter, Wuendisch, Thomas, Geer, Thomas, Bildat, Stephan, Schaefer, Erhardt, Hasford, Joerg, Hehlmann, Ruediger, Pfirrmann, Markus, Michel, Christian, Burchert, Andreas, Hochhaus, Andreas, Saussele, Susanne, Neubauer, Andreas, Lauseker, Michael, Krause, Stefan W., Kolb, Hans-Jochem, Hossfeld, Dieter Kurt, Nerl, Christoph, Baerlocher, Gabriela M., Heim, Dominik, Bruemmendorf, Tim H., Fabarius, Alice, Haferlach, Claudia, Schlegelberger, Brigitte, Balleisen, Leopold, Goebeler, Maria-Elisabeth, Haenel, Mathias, Ho, Anthony, Dengler, Jolanta, Falge, Christiane, Moehle, Robert, Kremers, Stephan, Kneba, Michael, Stegelmann, Frank, Koehne, Claus-Henning, Lindemann, Hans-Walter, Waller, Cornelius F., Spiekermann, Karsten, Berdel, Wolfgang E., Mueller, Lothar, Edinger, Matthias, Mayer, Jiri, Beelen, Dietrich W., Bentz, Martin, Link, Hartmut, Hertenstein, Bernd, Fuchs, Roland, Wernli, Martin, Schlegel, Frank, Schlag, Rudolf, de Wit, Maike, Truemper, Lorenz, Hebart, Holger, Hahn, Markus, Thomalla, Joerg, Scheid, Christof, Schafhausen, Philippe, Verbeek, Walter, Eckart, Michael J., Gassmann, Winfried, Schenk, Michael, Brossart, Peter, Wuendisch, Thomas, Geer, Thomas, Bildat, Stephan, Schaefer, Erhardt, Hasford, Joerg, Hehlmann, Ruediger, and Pfirrmann, Markus
- Abstract
Standard first-line therapy of chronic myeloid leukemia is treatment with imatinib. In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800 mg ('high-dose') imatinib accelerated achievement of a deep molecular remission. However, whether and when a de-escalation of the dose intensity under high-dose imatinib can be safely performed without increasing the risk of losing deep molecular response is unknown. To gain insights into this clinically relevant question, we analyzed the outcome of imatinib dose reductions from 800 mg to 400 mg daily in the Chronic Myeloid Leukemia-Study IV. Of the 422 patients that were randomized to the 800 mg arm, 68 reduced imatinib to 400 mg after they had achieved at least a stable major molecular response. Of these 68 patients, 61 (90%) maintained major molecular remission on imatinib at 400 mg. Five of the seven patients who lost major molecular remission on the imatinib standard dose regained major molecular remission while still on 400 mg imatinib. Only two of 68 patients had to switch to more potent kinase inhibition to regain major molecular remission. Importantly, the lengths of the intervals between imatinib high-dose treatment before and after achieving major molecular remission were associated with the probabilities of maintaining major molecular remission with the standard dose of imatinib. Taken together, the data support the view that a deep molecular remission achieved with high-dose imatinib can be safely maintained with standard dose in most patients.
- Published
- 2019
15. Imatinib dose reduction in major molecular response of chronic myeloid leukemia: results from the German Chronic Myeloid Leukemia-Study IV
- Author
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Michel, Christian, Burchert, Andreas, Hochhaus, Andreas, Saussele, Susanne, Neubauer, Andreas, Lauseker, Michael, Krause, Stefan W., Kolb, Hans-Jochem, Hossfeld, Dieter Kurt, Nerl, Christoph, Baerlocher, Gabriela M., Heim, Dominik, Bruemmendorf, Tim H., Fabarius, Alice, Haferlach, Claudia, Schlegelberger, Brigitte, Balleisen, Leopold, Goebeler, Maria-Elisabeth, Haenel, Mathias, Ho, Anthony, Dengler, Jolanta, Falge, Christiane, Moehle, Robert, Kremers, Stephan, Kneba, Michael, Stegelmann, Frank, Koehne, Claus-Henning, Lindemann, Hans-Walter, Waller, Cornelius F., Spiekermann, Karsten, Berdel, Wolfgang E., Mueller, Lothar, Edinger, Matthias, Mayer, Jiri, Beelen, Dietrich W., Bentz, Martin, Link, Hartmut, Hertenstein, Bernd, Fuchs, Roland, Wernli, Martin, Schlegel, Frank, Schlag, Rudolf, de Wit, Maike, Truemper, Lorenz, Hebart, Holger, Hahn, Markus, Thomalla, Joerg, Scheid, Christof, Schafhausen, Philippe, Verbeek, Walter, Eckart, Michael J., Gassmann, Winfried, Schenk, Michael, Brossart, Peter, Wuendisch, Thomas, Geer, Thomas, Bildat, Stephan, Schaefer, Erhardt, Hasford, Joerg, Hehlmann, Ruediger, Pfirrmann, Markus, Michel, Christian, Burchert, Andreas, Hochhaus, Andreas, Saussele, Susanne, Neubauer, Andreas, Lauseker, Michael, Krause, Stefan W., Kolb, Hans-Jochem, Hossfeld, Dieter Kurt, Nerl, Christoph, Baerlocher, Gabriela M., Heim, Dominik, Bruemmendorf, Tim H., Fabarius, Alice, Haferlach, Claudia, Schlegelberger, Brigitte, Balleisen, Leopold, Goebeler, Maria-Elisabeth, Haenel, Mathias, Ho, Anthony, Dengler, Jolanta, Falge, Christiane, Moehle, Robert, Kremers, Stephan, Kneba, Michael, Stegelmann, Frank, Koehne, Claus-Henning, Lindemann, Hans-Walter, Waller, Cornelius F., Spiekermann, Karsten, Berdel, Wolfgang E., Mueller, Lothar, Edinger, Matthias, Mayer, Jiri, Beelen, Dietrich W., Bentz, Martin, Link, Hartmut, Hertenstein, Bernd, Fuchs, Roland, Wernli, Martin, Schlegel, Frank, Schlag, Rudolf, de Wit, Maike, Truemper, Lorenz, Hebart, Holger, Hahn, Markus, Thomalla, Joerg, Scheid, Christof, Schafhausen, Philippe, Verbeek, Walter, Eckart, Michael J., Gassmann, Winfried, Schenk, Michael, Brossart, Peter, Wuendisch, Thomas, Geer, Thomas, Bildat, Stephan, Schaefer, Erhardt, Hasford, Joerg, Hehlmann, Ruediger, and Pfirrmann, Markus
- Abstract
Standard first-line therapy of chronic myeloid leukemia is treatment with imatinib. In the randomized German Chronic Myeloid Leukemia-Study IV, more potent BCR-ABL inhibition with 800 mg ('high-dose') imatinib accelerated achievement of a deep molecular remission. However, whether and when a de-escalation of the dose intensity under high-dose imatinib can be safely performed without increasing the risk of losing deep molecular response is unknown. To gain insights into this clinically relevant question, we analyzed the outcome of imatinib dose reductions from 800 mg to 400 mg daily in the Chronic Myeloid Leukemia-Study IV. Of the 422 patients that were randomized to the 800 mg arm, 68 reduced imatinib to 400 mg after they had achieved at least a stable major molecular response. Of these 68 patients, 61 (90%) maintained major molecular remission on imatinib at 400 mg. Five of the seven patients who lost major molecular remission on the imatinib standard dose regained major molecular remission while still on 400 mg imatinib. Only two of 68 patients had to switch to more potent kinase inhibition to regain major molecular remission. Importantly, the lengths of the intervals between imatinib high-dose treatment before and after achieving major molecular remission were associated with the probabilities of maintaining major molecular remission with the standard dose of imatinib. Taken together, the data support the view that a deep molecular remission achieved with high-dose imatinib can be safely maintained with standard dose in most patients.
- Published
- 2019
16. Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study
- Author
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Braess, Jan, Amler, Susanne, Kreuzer, Karl-Anton, Spiekermann, Karsten, Lindemann, Hans Walter, Lengfelder, Eva, Graeven, Ullrich, Staib, Peter, Ludwig, Wolf-Dieter, Biersack, Harald, Ko, Yon-Dschun, Uppenkamp, Michael J., De Wit, Maike, Korsten, Stefan, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M., Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Massenkeil, Gero, Hindahl, Heidrun, Schwerdtfeger, Rainer, Trenn, Guido, Sauerland, Cristina, Koch, Raphael, Lablans, Martin, Faldum, Andreas, Goerlich, Dennis, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Braess, Birgit, Unterhalt, Michael, Baumgartner, Anja, Woermann, Bernhard, Beelen, Dietrich, Hiddemann, Wolfgang, Braess, Jan, Amler, Susanne, Kreuzer, Karl-Anton, Spiekermann, Karsten, Lindemann, Hans Walter, Lengfelder, Eva, Graeven, Ullrich, Staib, Peter, Ludwig, Wolf-Dieter, Biersack, Harald, Ko, Yon-Dschun, Uppenkamp, Michael J., De Wit, Maike, Korsten, Stefan, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M., Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Massenkeil, Gero, Hindahl, Heidrun, Schwerdtfeger, Rainer, Trenn, Guido, Sauerland, Cristina, Koch, Raphael, Lablans, Martin, Faldum, Andreas, Goerlich, Dennis, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Braess, Birgit, Unterhalt, Michael, Baumgartner, Anja, Woermann, Bernhard, Beelen, Dietrich, and Hiddemann, Wolfgang
- Abstract
Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 - dose-dense) and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21 - standard). 387 evaluable patients were randomly assigned to S-HAM (N - 203) and to standard double induction (N - 184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P = 0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P = 0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)-P < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)-P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks.
- Published
- 2018
17. Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study
- Author
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Braess, Jan, Amler, Susanne, Kreuzer, Karl-Anton, Spiekermann, Karsten, Lindemann, Hans Walter, Lengfelder, Eva, Graeven, Ullrich, Staib, Peter, Ludwig, Wolf-Dieter, Biersack, Harald, Ko, Yon-Dschun, Uppenkamp, Michael J., De Wit, Maike, Korsten, Stefan, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M., Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Massenkeil, Gero, Hindahl, Heidrun, Schwerdtfeger, Rainer, Trenn, Guido, Sauerland, Cristina, Koch, Raphael, Lablans, Martin, Faldum, Andreas, Goerlich, Dennis, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Braess, Birgit, Unterhalt, Michael, Baumgartner, Anja, Woermann, Bernhard, Beelen, Dietrich, Hiddemann, Wolfgang, Braess, Jan, Amler, Susanne, Kreuzer, Karl-Anton, Spiekermann, Karsten, Lindemann, Hans Walter, Lengfelder, Eva, Graeven, Ullrich, Staib, Peter, Ludwig, Wolf-Dieter, Biersack, Harald, Ko, Yon-Dschun, Uppenkamp, Michael J., De Wit, Maike, Korsten, Stefan, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M., Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Massenkeil, Gero, Hindahl, Heidrun, Schwerdtfeger, Rainer, Trenn, Guido, Sauerland, Cristina, Koch, Raphael, Lablans, Martin, Faldum, Andreas, Goerlich, Dennis, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Braess, Birgit, Unterhalt, Michael, Baumgartner, Anja, Woermann, Bernhard, Beelen, Dietrich, and Hiddemann, Wolfgang
- Abstract
Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 - dose-dense) and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21 - standard). 387 evaluable patients were randomly assigned to S-HAM (N - 203) and to standard double induction (N - 184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P = 0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P = 0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)-P < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)-P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks.
- Published
- 2018
18. Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer
- Author
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Antonia, Scott, Villegas, Augusto, Daniel, Davey, Vicente, David, Murakami, Shuji, Hui, Rina, Yokoi, Takashi, Chiappori, Alberto, Lee, Ki, de Wit, Maike, O'Byrne, Ken, other, and, Antonia, Scott, Villegas, Augusto, Daniel, Davey, Vicente, David, Murakami, Shuji, Hui, Rina, Yokoi, Takashi, Chiappori, Alberto, Lee, Ki, de Wit, Maike, O'Byrne, Ken, and other, and
- Abstract
Background Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy. Methods We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective response rate, the duration of response, the time to death or distant metastasis, and safety. Results Of 713 patients who underwent randomization, 709 received consolidation therapy (473 received durvalumab and 236 received placebo). The median progression-free survival from randomization was 16.8 months (95% confidence interval [CI], 13.0 to 18.1) with durvalumab versus 5.6 months (95% CI, 4.6 to 7.8) with placebo (stratified hazard ratio for disease progression or death, 0.52; 95% CI, 0.42 to 0.65; P<0.001); the 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The response rate was higher with durvalumab than with placebo (28.4% vs. 16.0%; P<0.001), and the median duration of response was longer (72.8% vs. 46.8% of the patients had an ongoing response at 18 months). The median time to death or distant metastasis was longer with durvalumab than with placebo (23.2 months vs.
- Published
- 2017
19. Exercise training in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy: a pilot study
- Author
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Jensen, Wiebke, Baumann, Freerk T., Stein, Alexander, Bloch, Wilhelm, Bokemeyer, Carsten, de Wit, Maike, Oechsle, Karin, Jensen, Wiebke, Baumann, Freerk T., Stein, Alexander, Bloch, Wilhelm, Bokemeyer, Carsten, de Wit, Maike, and Oechsle, Karin
- Abstract
This pilot study aimed to investigate the feasibility of two different training programs in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy. Potential effects of training programs on the patients' quality of life, physical performance, physical activity in daily living, and biological parameters were exploratorily evaluated. Patients were randomly assigned to a resistance (RET) and aerobic exercise training group (AET). Both underwent supervised training sessions twice a week for 12 weeks. RET was performed at 60-80 % of the one-repetition maximum and consisted of 2-3 sets of 15-25 repetitions. The AET group performed endurance training at 60-80 % of their predetermined pulse rate (for 10 to 30 min). A total of 26 gastrointestinal cancer patients could be randomized. Twenty-one patients completed the 12 weeks of intervention. The median adherence rate to exercise training of all 26 patients was 65 %, while in patients who were able to complete 12 weeks, adherence was 75 %. The fatigue score of all patients decreased from 66 to 43 post-intervention. Sleeping duration increased in both groups and muscular strength increased in the RET group. A higher number of steps in daily living was associated with higher levels of physical and social functioning as well as lower scores for pain and fatigue. RET and AET are feasible in gastrointestinal cancer patients undergoing palliative chemotherapy. Both training programs seem to improve cancer-related symptoms as well as the patient's physical activities of daily living.
- Published
- 2014
20. Exercise training in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy: a pilot study
- Author
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Jensen, Wiebke, Baumann, Freerk T., Stein, Alexander, Bloch, Wilhelm, Bokemeyer, Carsten, de Wit, Maike, Oechsle, Karin, Jensen, Wiebke, Baumann, Freerk T., Stein, Alexander, Bloch, Wilhelm, Bokemeyer, Carsten, de Wit, Maike, and Oechsle, Karin
- Abstract
This pilot study aimed to investigate the feasibility of two different training programs in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy. Potential effects of training programs on the patients' quality of life, physical performance, physical activity in daily living, and biological parameters were exploratorily evaluated. Patients were randomly assigned to a resistance (RET) and aerobic exercise training group (AET). Both underwent supervised training sessions twice a week for 12 weeks. RET was performed at 60-80 % of the one-repetition maximum and consisted of 2-3 sets of 15-25 repetitions. The AET group performed endurance training at 60-80 % of their predetermined pulse rate (for 10 to 30 min). A total of 26 gastrointestinal cancer patients could be randomized. Twenty-one patients completed the 12 weeks of intervention. The median adherence rate to exercise training of all 26 patients was 65 %, while in patients who were able to complete 12 weeks, adherence was 75 %. The fatigue score of all patients decreased from 66 to 43 post-intervention. Sleeping duration increased in both groups and muscular strength increased in the RET group. A higher number of steps in daily living was associated with higher levels of physical and social functioning as well as lower scores for pain and fatigue. RET and AET are feasible in gastrointestinal cancer patients undergoing palliative chemotherapy. Both training programs seem to improve cancer-related symptoms as well as the patient's physical activities of daily living.
- Published
- 2014
21. European consensus conference on diagnosis and treatment of germ cell cancer: a report of the second meeting of the European Germ Cell Cancer Consensus group (EGCCCG): part I
- Author
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Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Ares, Luis Paz, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, von der Maase, Hans, Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Ares, Luis Paz, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, and von der Maase, Hans
- Abstract
OBJECTIVES: The first consensus report presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in the year 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the Amsterdam Medical Center, Amsterdam, The Netherlands. METHODS: Medical oncologists, urological surgeons, radiation oncologists as well as pathologists from several European countries reviewed and discussed the data that had emerged since the 2002 conference, and incorporated the new data into updated and revised guidelines. As for the first meeting, the methodology of evidence-based medicine (EBM) was applied. The results of the discussion were compiled by the writing committee. All participants have agreed to this final update. RESULTS: The first part of the consensus paper describes the clinical presentation of the primary tumor, its treatment, the importance and treatment of testicular intraepithelial neoplasia (TIN), histological classification, staging and prognostic factors, and treatment of stage I seminoma and non-seminoma. CONCLUSIONS: Whereas the vast majority of the recommendations made in 2004 remain valid 3 yr later, refinements in the treatment of early- and advanced-stage testicular cancer have emerged from clinical trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer. In addition, the particular needs of testicular cancer survivors have been acknowledged Udgivelsesdato: 2008/3
- Published
- 2007
22. European consensus conference on diagnosis and treatment of germ cell cancer: a report of the second meeting of the European Germ Cell Cancer Consensus Group (EGCCCG): part II
- Author
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Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Paz-Ares, Luis, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, von der Maase, Hans, Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Paz-Ares, Luis, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, and von der Maase, Hans
- Abstract
OBJECTIVES: The first consensus report that had been presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the Amsterdam Medical Center, The Netherlands. METHODS: Medical oncologists, urologic surgeons, radiation oncologists as well as pathologists from several European countries reviewed and discussed the data that had emerged since the 2002 conference and incorporated the new data into updated and revised guidelines. As for the first meeting the methodology of evidence-based medicine (EBM) was applied. The results of the discussion were compiled by the writing committee. All participants have agreed to this final update. RESULTS: The second part of the consensus paper includes the treatment of metastasised disease, residual tumour resection, salvage therapy, follow-up, and late toxicities. CONCLUSIONS: Whereas the vast majority of the recommendations made in 2004 remain valid 3 yr later, refinements in the treatment of early-stage as well as of advanced-stage testicular cancer have emerged from clinical trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer. In addition, the particular needs of testicular cancer survivors have been acknowledged Udgivelsesdato: 2008/3
- Published
- 2007
23. European consensus conference on diagnosis and treatment of germ cell cancer: a report of the second meeting of the European Germ Cell Cancer Consensus Group (EGCCCG): part II
- Author
-
Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Paz-Ares, Luis, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, von der Maase, Hans, Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Paz-Ares, Luis, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, and von der Maase, Hans
- Abstract
OBJECTIVES: The first consensus report that had been presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the Amsterdam Medical Center, The Netherlands. METHODS: Medical oncologists, urologic surgeons, radiation oncologists as well as pathologists from several European countries reviewed and discussed the data that had emerged since the 2002 conference and incorporated the new data into updated and revised guidelines. As for the first meeting the methodology of evidence-based medicine (EBM) was applied. The results of the discussion were compiled by the writing committee. All participants have agreed to this final update. RESULTS: The second part of the consensus paper includes the treatment of metastasised disease, residual tumour resection, salvage therapy, follow-up, and late toxicities. CONCLUSIONS: Whereas the vast majority of the recommendations made in 2004 remain valid 3 yr later, refinements in the treatment of early-stage as well as of advanced-stage testicular cancer have emerged from clinical trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer. In addition, the particular needs of testicular cancer survivors have been acknowledged Udgivelsesdato: 2008/3
- Published
- 2007
24. European consensus conference on diagnosis and treatment of germ cell cancer: a report of the second meeting of the European Germ Cell Cancer Consensus group (EGCCCG): part I
- Author
-
Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Ares, Luis Paz, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, von der Maase, Hans, Krege, Susanne, Beyer, Jörg, Souchon, Rainer, Albers, Peter, Albrecht, Walter, Algaba, Ferran, Bamberg, Michael, Bodrogi, István, Bokemeyer, Carsten, Cavallin-Ståhl, Eva, Classen, Johannes, Clemm, Christoph, Cohn-Cedermark, Gabriella, Culine, Stéphane, Daugaard, Gedske, De Mulder, Pieter H M, De Santis, Maria, de Wit, Maike, de Wit, Ronald, Derigs, Hans Günter, Dieckmann, Klaus-Peter, Dieing, Annette, Droz, Jean-Pierre, Fenner, Martin, Fizazi, Karim, Flechon, Aude, Fosså, Sophie D, del Muro, Xavier Garcia, Gauler, Thomas, Geczi, Lajos, Gerl, Arthur, Germa-Lluch, Jose Ramon, Gillessen, Silke, Hartmann, Jörg T, Hartmann, Michael, Heidenreich, Axel, Hoeltl, Wolfgang, Horwich, Alan, Huddart, Robert, Jewett, Michael, Joffe, Johnathan, Jones, William G, Kisbenedek, László, Klepp, Olbjørn, Kliesch, Sabine, Koehrmann, Kai Uwe, Kollmannsberger, Christian, Kuczyk, Markus, Laguna, Pilar, Galvis, Oscar Leiva, Loy, Volker, Mason, Malcolm D, Mead, Graham M, Mueller, Rolf, Nichols, Craig, Nicolai, Nicola, Oliver, Tim, Ondrus, Dalibor, Oosterhof, Gosse O N, Ares, Luis Paz, Pizzocaro, Giorgio, Pont, Jörg, Pottek, Tobias, Powles, Tom, Rick, Oliver, Rosti, Giovanni, Salvioni, Roberto, Scheiderbauer, Jutta, Schmelz, Hans-Ulrich, Schmidberger, Heinz, Schmoll, Hans-Joachim, Schrader, Mark, Sedlmayer, Felix, Skakkebaek, Niels E, Sohaib, Aslam, Tjulandin, Sergei, Warde, Padraig, Weinknecht, Stefan, Weissbach, Lothar, Wittekind, Christian, Winter, Eva, Wood, Lori, and von der Maase, Hans
- Abstract
OBJECTIVES: The first consensus report presented by the European Germ Cell Cancer Consensus Group (EGCCCG) in the year 2004 has found widespread approval by many colleagues throughout the world. In November 2006, the group met a second time under the auspices of the Department of Urology of the Amsterdam Medical Center, Amsterdam, The Netherlands. METHODS: Medical oncologists, urological surgeons, radiation oncologists as well as pathologists from several European countries reviewed and discussed the data that had emerged since the 2002 conference, and incorporated the new data into updated and revised guidelines. As for the first meeting, the methodology of evidence-based medicine (EBM) was applied. The results of the discussion were compiled by the writing committee. All participants have agreed to this final update. RESULTS: The first part of the consensus paper describes the clinical presentation of the primary tumor, its treatment, the importance and treatment of testicular intraepithelial neoplasia (TIN), histological classification, staging and prognostic factors, and treatment of stage I seminoma and non-seminoma. CONCLUSIONS: Whereas the vast majority of the recommendations made in 2004 remain valid 3 yr later, refinements in the treatment of early- and advanced-stage testicular cancer have emerged from clinical trials. Despite technical improvements, expert clinical skills will continue to be one of the major determinants for the prognosis of patients with germ cell cancer. In addition, the particular needs of testicular cancer survivors have been acknowledged Udgivelsesdato: 2008/3
- Published
- 2007
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