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4. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study

Author

Fink, Anna Maria, Bahlo, Jasmin, Robrecht, Sandra, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Dörfel, Steffen, Fischer, Kirsten, Wendtner, Clemens-Martin, Nösslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P, Döhner, Hartmut, Kneba, Michael, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Ritgen, Matthias, Böttcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Published
2017
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5. Pomalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of the non‐interventional study POSEIDON and comparison with the pivotal phase 3 clinical trials

Author

Dechow, Tobias, primary, Aldaoud, Ali, additional, Behlendorf, Timo, additional, Knauf, Wolfgang, additional, Eschenburg, Henning, additional, Groschek, Matthias, additional, Hansen, Richard, additional, Söling, Ulrike, additional, Grebhardt, Sina, additional, Siebenbach, Hans Ulrich, additional, Vannier, Corinne, additional, and Potthoff, Karin, additional

Published
2021
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6. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia

Author

Fürstenau, Moritz, primary, Giza, Adam, additional, Stumpf, Thomas, additional, Robrecht, Sandra, additional, Maurer, Christian, additional, Linde, Hartmut, additional, Jacobasch, Lutz, additional, Dörfel, Steffen, additional, Aldaoud, Ali, additional, Tresckow, Julia, additional, Koenigsmann, Michael, additional, Gaska, Tobias, additional, Kaiser, Ulrich, additional, Harich, Hanns‐Detlev, additional, Fischer, Kirsten, additional, Eichhorst, Barbara, additional, Hallek, Michael, additional, and Fink, Anna‐Maria, additional

Published
2021
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7. Quality of life and outcome of patients with metastatic pancreatic cancer receiving first‐line chemotherapy with nab‐paclitaxel and gemcitabine: Real‐life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry

Author

Al‐Batran, Salah‐Eddin, Hofheinz, Ralf‐Dieter, Reichart, Alexander, Pauligk, Claudia, Schönherr, Caroline, Schlag, Rudolf, Siegler, Gabriele, Dörfel, Steffen, Koenigsmann, Michael, Zahn, Mark‐Oliver, Schubert, Jörg, Aldaoud, Ali, Höffkes, Heinz‐Gert, Schulz, Holger, Hahn, Lars, Uhlig, Jens, Blau, Wolfgang, Stauch, Martina, Weniger, Jörg, Wolf, Martin, Jacobasch, Lutz, Bildat, Stephan, Wehmeyer, Jürgen, Homann, Nils, Trojan, Jörg, Waidmann, Oliver, Fietz, Thomas, Feustel, Hans‐Peter, Groschek, Matthias, Wierecky, Jan, Waibel, Karin, Mahlmann, Stefan, Schwindel, Uwe, Peters, Uwe, Schuch, Gunter, Pink, Daniel, Eschenburg, Henning, Wörns, Marcus‐A., Harich, Hans‐Detlev, Weikersthal, Ludwig Fischer, Däßler, Klaus‐Ulrich, Behringer, Dirk M., Messmann, Helmut, Kretzschmar, Albrecht, Gallmeier, Eike, Forstbauer, Helmut, Kunzmann, Volker, Papke, Jens, Büchner‐Steudel, Petra, Vehling‐Kaiser, Ursula, Springfeld, Christoph, Vogel, Arndt, Ettrich, Thomas J., Schaaf, Marina, Hausen, Gerrit zur, and Götze, Thorsten Oliver

Published
2021

8. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia

Author

Fuerstenau, Moritz, Giza, Adam, Stumpf, Thomas, Robrecht, Sandra, Maurer, Christian, Linde, Hartmut, Jacobasch, Lutz, Doerfel, Steffen, Aldaoud, Ali, von Tresckow, Julia, Koenigsmann, Michael, Gaska, Tobias, Kaiser, Ulrich, Harich, Hanns-Detlev, Fischer, Kirsten, Eichhorst, Barbara, Hallek, Michael, Fink, Anna-Maria, Fuerstenau, Moritz, Giza, Adam, Stumpf, Thomas, Robrecht, Sandra, Maurer, Christian, Linde, Hartmut, Jacobasch, Lutz, Doerfel, Steffen, Aldaoud, Ali, von Tresckow, Julia, Koenigsmann, Michael, Gaska, Tobias, Kaiser, Ulrich, Harich, Hanns-Detlev, Fischer, Kirsten, Eichhorst, Barbara, Hallek, Michael, and Fink, Anna-Maria

Published
2021

10. Long-term efficacy and safety of maintenance with lenalidomide in patients with chronic lymphocytic leukaemia and a high risk of progression after first-line immunochemotherapy

Author

Fink, Anna-Maria, Robrecht, Sandra, Bahlo, Jasmin, Fuerstenau, Moritz, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Kater, Arnon, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Rittgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, Hallek, Michael, Fink, Anna-Maria, Robrecht, Sandra, Bahlo, Jasmin, Fuerstenau, Moritz, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Kater, Arnon, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Rittgen, Matthias, Boettcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Published
2020

11. Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial

Author

Knauf, Wolfgang U., Lissitchkov, Toshko, Aldaoud, Ali, Liberati, Anna M., Loscertales, Javier, Herbrecht, Raoul, Juliusson, Gunnar, Postner, Gerhard, Gercheva, Liana, Goranov, Stefan, Becker, Martin, Fricke, Hans-Joerg, Huguet, Francoise, Del Giudice, Ilaria, Klein, Peter, Merkle, Karlheinz, and Montillo, Marco

Published
2012
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13. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network

Author

Dreyling, Martin, Lenz, Georg, Hoster, Eva, Van Hoof, Achiel, Gisselbrecht, Christian, Schmits, Rudolf, Metzner, Bernd, Truemper, Lorenz, Reiser, Marcel, Steinhauer, Hjalmar, Boiron, Jean-Michel, Boogaerts, Marc A., Aldaoud, Ali, Silingardi, Vittorio, Kluin-Nelemans, Hanneke C., Hasford, Joerg, Parwaresch, Reza, Unterhalt, Michael, and Hiddemann, Wolfgang

Published
2005
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14. Pomalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of the non‐interventional study POSEIDON and comparison with the pivotal phase 3 clinical trials.

Author

Dechow, Tobias, Aldaoud, Ali, Behlendorf, Timo, Knauf, Wolfgang, Eschenburg, Henning, Groschek, Matthias, Hansen, Richard, Söling, Ulrike, Grebhardt, Sina, Siebenbach, Hans Ulrich, Vannier, Corinne, and Potthoff, Karin

Subjects
*MULTIPLE myeloma, *CLINICAL trials, *DEXAMETHASONE, *PROGRESSION-free survival, *OVERALL survival
Abstract

Background: Prognosis of patients with multiple myeloma (MM) who have relapsed on or become refractory to immunomodulators and bortezomib is poor, and treatment options are limited. While pomalidomide plus low‐dose dexamethasone (POM/DEX) has demonstrated efficacy in clinical trials, real‐world evidence is scarce. Patients and Methods: POSEIDON was a prospective non‐interventional study designed to evaluate effectiveness, safety and quality of life (QoL) of POM/DEX in patients with relapsed or refractory MM (R/RMM) pretreated with at least two prior therapy lines including both lenalidomide and bortezomib in real world in Germany. Patients received POM/DEX according to physicians' choice. Data were analyzed descriptively. Results: Between 2014 and 2017, 151 patients were enrolled, 144 patients with a median of three prior therapy lines qualified for effectiveness analysis. Median age was 73.2 years. Median progression‐free and overall survival were 6.3 months [95% confidence interval (CI) 5.2, 8.6] and 12.9 months [95% CI 10.6, 15.1]. Most frequent grade 3/4 adverse events were leukopenia (8.2%), pneumonia (7.5%) and anemia (5.5%). QoL was maintained after start of POM/DEX. Conclusion: The results of POSEIDON support the effectiveness and safety of POM/DEX in R/RMM patients pretreated with lenalidomide and bortezomib and highlight the clinical value of the POM/DEX regimen in the real‐world setting. Registered at clinicaltrials.gov (NCT02075996). [ABSTRACT FROM AUTHOR]

Published
2022
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15. Immunochemotherapy With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Significantly Improves Response and Time to Treatment Failure, But Not Long-Term Outcome in Patients With Previously Untreated Mantle Cell Lymphoma: Results of a Prospective Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG)

Author

Lenz, Georg, Dreyling, Martin, Hoster, Eva, Wörmann, Bernhard, Dührsen, Ulrich, Metzner, Bernd, Eimermacher, Hartmut, Neubauer, Andreas, Wandt, Hannes, Steinhauer, Hjalmar, Martin, Sonja, Heidemann, Else, Aldaoud, Ali, Parwaresch, Reza, Hasford, Joerg, Unterhalt, Michael, and Hiddemann, Wolfgang

Published
2005
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16. Real life data of 601 patients from the QoliXane pancreatic cancer study.

Author

Schoenherr, Caroline, primary, Goetze, Thorsten Oliver, additional, zur Hausen, Gerrit, additional, Reichart, Alexander, additional, Pauligk, Claudia, additional, Schlag, Rudolf, additional, Siegler, Gabriele Margareta, additional, Doerfel, Steffen, additional, Aldaoud, Ali, additional, Hahn, Lars, additional, Schubert, Joerg Ernst Albert, additional, Zahn, Mark-Oliver, additional, Hoeffkes, Heinz-Gert, additional, Reiser, Marcel, additional, Koenigsmann, Michael, additional, Blau, Wolfgang, additional, Uhlig, Jens, additional, Homann, Nils, additional, Trojan, Jorg, additional, and Al-Batran, Salah-Eddin, additional

Published
2018
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17. Lenalidomide Maintenance after Front Line Therapy Substantially Prolongs Progression Free Survival in High Risk CLL: Interim Results of a Phase 3 Study (CLL M1 study of the German CLL Study Group)

Author

Fink, Anna Maria, primary, Bahlo, Jasmin, additional, Sandra, Robrecht, additional, Al-Sawaf, Othman, additional, Aldaoud, Ali, additional, Hebart, Holger, additional, Jentsch-Ulrich, Kathleen, additional, Doerfel, Steffen, additional, Fischer, Kirsten, additional, Wendtner, Clemens Martin, additional, Noesslinger, Thomas, additional, Ghia, Paolo, additional, Bosch, Francesc, additional, Kater, Arnon P., additional, Kreuzer, Karl-Anton, additional, Dohner, Hartmut, additional, Kneba, Michael, additional, Stilgenbauer, Stephan, additional, Boettcher, Sebastian, additional, Eichhorst, Barbara, additional, and Hallek, Michael, additional

Published
2016
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18. Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma.

Author

Hegewisch‐Becker, Susanna, Aldaoud, Ali, Wolf, Thomas, Krammer‐Steiner, Beate, Linde, Hartmut, Scheiner‐Sparna, Renate, Hamm, David, Jänicke, Martina, and Marschner, Norbert

Abstract

Pancreatic cancer is a highly lethal malignancy. Developments in recent years have broadened our therapeutic armamentarium. Novel drugs such as nab‐paclitaxel, liposomal irinotecan and chemotherapy regimens such as FOLFIRINOX have been successfully tested in clinical trials. Data on patients outside of clinical trials are scarce but necessary to assess and improve the standard of care. We present data on treatment and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Between February 2014 and June 2017, patients were recruited by 104 sites at start of first‐line therapy into the ongoing, prospective clinical cohort study TPK (Tumour Registry Pancreatic Cancer). As first‐line therapy, 89% of patients received one of the three treatment regimens: gemcitabine monotherapy (23%), nab‐paclitaxel plus gemcitabine (42%), or FOLFIRINOX (24%). The corresponding subgroups differed: Patients receiving gemcitabine monotherapy were older and more comorbid (median age 78 years, 73% ECOG ≥ 1) than patients receiving nab‐paclitaxel plus gemcitabine (median age 71, 64% ECOG ≥ 1) or patients receiving FOLFIRINOX (median age 60, 52% ECOG ≥ 1). At least 40% of patients died before receiving second‐line treatment. First‐line progression‐free survival was 4.6 months (95% CI: 3.7–5.2) for gemcitabine, 5.6 months (95% CI: 5.0–6.2) for nab‐paclitaxel plus gemcitabine, and 6.3 months (95% CI: 5.5–6.9) for FOLFIRINOX. Our data represent the treatment reality in a German community setting. Although there are no stringent inclusion criteria for our cohort study, overall survival is comparable to that reported by randomised clinical trials. What's new? More than four‐fifths of patients with pancreatic cancer present with locally advanced, inoperable (LAPC) or metastatic (MPC) disease at diagnosis. Beyond clinical trials, relatively little data is available on survival outcomes for these patients. Here, real‐world data, derived from an unselected cohort of 1,174 patients enrolled between 2014 and 2017 in a prospective study in Germany, show that the vast majority of first‐line therapies given to LAPC/MPC patients consisted of either gemcitabine monotherapy, nab‐paclitaxel plus gemcitabine, or FOLFIRINOX. About 40 percent of the patients received second‐line therapy. Overall cohort survival was comparable to that reported for randomized clinical trials. [ABSTRACT FROM AUTHOR]

Published
2019
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19. Survival of non-transplant patients with multiple myeloma in routine care differs from that in clinical trials—data from the prospective German Tumour Registry Lymphatic Neoplasms.

Author

and the TLN-Group (Tumour Registry Lymphatic Neoplasms), Knauf, Wolfgang, Aldaoud, Ali, Hutzschenreuter, Ulrich, Klausmann, Martine, Dille, Stephanie, Wetzel, Natalie, Jänicke, Martina, and Marschner, Norbert

Abstract

Despite increasing treatment options, multiple myeloma (MM) remains incurable for most patients. Data on improvement of outcomes are derived from selected patient populations enrolled in clinical trials and might not be conferrable to all patients. Therefore, we assessed the trial eligibility, sequential treatment, and survival of non-transplant patients with MM treated in German routine care. The prospective clinical cohort study TLN (Tumour Registry Lymphatic Neoplasms) recruited 285 non-transplant patients with symptomatic MM at start of first-line treatment in 84 centres from 2009 to 2011. Demographic and clinical data were collected until August 2016. Trial-ineligibility was determined by presence of at least one of the common exclusion criteria: heart/renal failure, liver/renal diseases, polyneuropathy, HIV positivity. All other patients were considered potentially trial-eligible. Thirty percent of the patients in our study were classified as trial-ineligible. Median first-line progression-free survival (PFS) and overall survival (OS) of trial-ineligible patients were inferior to that of potentially trial-eligible patients: PFS 16.2 months (95% CI (confidence interval) 11.1-20.4) vs. 27.3 months (95% CI 23.3-33.0); OS 34.2 months (95% CI 21.6-48.1) vs. 58.6 months (95% CI 48.6-64.4). A high percentage of non-transplant patients with MM in German routine care would be ineligible for participation in clinical trials. Despite similar treatment algorithms, their first-line PFS and OS were shorter than those of potentially trial-eligible patients; the survival data of the latter were similar to results from clinical trials. Physicians should be aware of the fact that results from clinical trials may not mirror “real world” patient outcomes when discussing outcome expectations with patients. Trial registration: Clinicaltrials.gov identifier: NCT00889798. [ABSTRACT FROM AUTHOR]

Published
2018
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20. Lenalidomide Maintenance after Front Line Therapy Substantially Prolongs Progression Free Survival in High Risk CLL: Interim Results of a Phase 3 Study (CLL M1 study of the German CLL Study Group)

Author

Fink, Anna Maria, Bahlo, Jasmin, Sandra, Robrecht, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ulrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Kreuzer, Karl-Anton, Dohner, Hartmut, Kneba, Michael, Stilgenbauer, Stephan, Boettcher, Sebastian, Eichhorst, Barbara, Hallek, Michael, Fink, Anna Maria, Bahlo, Jasmin, Sandra, Robrecht, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ulrich, Kathleen, Doerfel, Steffen, Fischer, Kirsten, Wendtner, Clemens Martin, Noesslinger, Thomas, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P., Kreuzer, Karl-Anton, Dohner, Hartmut, Kneba, Michael, Stilgenbauer, Stephan, Boettcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Published
2016

21. Nab-paclitaxel/gemcitabine first-line therapy in patients with metastatic pancreatic carcinoma and high-bilirubin levels: Data from the German QoliXane Pancreatic Cancer Registry.

Author

zur Hausen, Gerrit, primary, Waidmann, Oliver, additional, Woerns, Marcus A., additional, Hoeffkes, Heinz-Gert, additional, Doerfel, Steffen, additional, Zahn, Mark-Oliver, additional, Aldaoud, Ali, additional, Stauch, Martina, additional, Springfeld, Christoph, additional, Haertel, Nicolai, additional, Reichart, Alexander, additional, Pauligk, Claudia, additional, Roemmler-Zehrer, Josefine, additional, Hofheinz, Ralf, additional, and Al-Batran, Salah-Eddin, additional

Published
2016
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22. Outcomes and Treatment Sequences of Therapies with BCL2- and BTK Inhibitors in Chronic Lymphocytic Leukemia (CLL): An Analysis of Patient Data within the German CLL Study Group (GCLLSG) Registry

Author

Kutsch, Nadine, Ligtvoet, Rudy, Robrecht, Sandra, Linde, Hartmut, Illmer, Thomas, Doerfel, Steffen, Lipke, Joerg, Aldaoud, Ali, Schlag, Rudolf, Dengler, Jolanta, Al-Sawaf, Othman, Langerbeins, Petra, Cramer, Paula, Eichhorst, Barbara F., Hallek, Michael, Fischer, Kirsten, and Fink, Anna Maria

Abstract

Introduction:Targeted agents, in particular BCL2-inhibitors (BCL2i) and BTK-inhibitors (BTKi), have profoundly improved the outcome of patients (pts) with chronic lymphocytic leukemia (CLL) and are considered standard treatment. However, the transition from treatments evaluated within clinical trials into routine clinical practice can be complex. We here present real-world data from the German CLL Study Group (GCLLSG) registry and report outcomes and treatment sequences of pts treated with either BCL2i (venetoclax) or BTKi (acalabrutinib, ibrutinib, spebrutinib, tirabrutinib, or zanubrutinib) as first administered targeted agent.

Published
2023
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26. Bendamustine Induces Higher Remission Rates, Prolongs Progression Free Survival as Well as Time to Next Treatment, and Improves Overall Survival for Patients In Complete Remission without Compromising Quality of Life When Compared to Chlorambucil In First Line Treatment of Chronic Lymphocytic Leukemia

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, additional, Aldaoud, Ali, additional, Liberati, Anna Marina, additional, Loscertales, Javier, additional, Herbrecht, Raoul, additional, Juliusson, Gunnar, additional, Postner, Gerhard, additional, Gercheva, Liana, additional, Goranov, Stefan, additional, Becker, Martin, additional, Fricke, Hans-Joerg, additional, Huguet, Françoise, additional, Del Guidice, Ilaria, additional, Klein, Peter, additional, Merkle, Karlheinz, additional, and Montillo, Marco, additional

Published
2010
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27. Bendamustine in the Treatment of Chronic Lymphocytic Leukemia -Consistent Superiority Over Chlorambucil in Elderly Patients and Across Clinically Defined Risk Groups.

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, additional, Aldaoud, Ali, additional, Liberati, Anna, additional, Loscertales, Javier, additional, Herbrecht, Raoul, additional, Juliusson, Gunnar, additional, Postner, Gerhard, additional, Gercheva, Liana, additional, Goranov, Stefan, additional, Becker, Martin, additional, Fricke, Hans-Joerg, additional, Huguet, Francoise, additional, Del Giudice, Ilaria, additional, Klein, Peter, additional, Merkle, Karlheinz, additional, and Montillo, Marco, additional

Published
2009
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28. Phase III Randomized Study of Bendamustine Compared With Chlorambucil in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Author

Knauf, Wolfgang U., primary, Lissichkov, Toshko, additional, Aldaoud, Ali, additional, Liberati, Anna, additional, Loscertales, Javier, additional, Herbrecht, Raoul, additional, Juliusson, Gunnar, additional, Postner, Gerhard, additional, Gercheva, Liana, additional, Goranov, Stefan, additional, Becker, Martin, additional, Fricke, Hans-Joerg, additional, Huguet, Francoise, additional, Del Giudice, Ilaria, additional, Klein, Peter, additional, Tremmel, Lothar, additional, Merkle, Karlheinz, additional, and Montillo, Marco, additional

Published
2009
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29. Rituximab in Combination with CHOP in Patients with Follicular Lymphoma: Analysis of Treatment Outcome of 552 Patients Treated in a Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG) after a Follow up of 58 Months

Author

Buske, Christian, primary, Hoster, Eva, primary, Dreyling, Martin, primary, Forstpointner, Roswitha, primary, Kneba, Michael, primary, Schmitz, Norbert, primary, Schmits, Rudolf, primary, Metzner, Bernd, primary, Reiser, Marcel, primary, Lengfelder, Eva, primary, Woermann, Bernhard J, primary, Harder, Harriet, primary, Hegewisch-Becker, Susanna, primary, Berdel, Wolfgang E., primary, Hess, Georg, primary, Eimermacher, Hartmut, primary, Aldaoud, Ali, primary, Planker, Manfred, primary, Unterhalt, Michael, primary, and Hiddemann, Wolfgang, primary

Published
2008
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30. Bendamustine Versus Chlorambucil as First-Line Treatment in B Cell Chronic Lymphocytic Leukemia: An Updated Analysis from An International Phase III Study.

Author

Knauf, Wolfgang Ulrich, primary, Lissitchkov, Toshko, primary, Aldaoud, Ali, primary, Liberati, Anna, primary, Loscertales, Javier, primary, Herbrecht, Roul, primary, Juliusson, Gunnar, primary, Postner, Gerhard, primary, Gercheva, Liana, primary, Goranov, Stefan, primary, Becker, Martin, primary, Hoeffken, Klaus, primary, Huguet, Francoise, primary, Foa, Robert, primary, Merkle, Karlheinz, primary, and Montillo, Marco, primary

Published
2008
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31. The Addition of Rituximab to First-Line Chemotherapy (R-CHOP) Results in Superior Response Rates, Time to Treatment Failure and Response Duration in Patients with Advanced Stage Mantle Cell Lymphoma: Long Term Results of a Randomized GLSG Trial

Author

Hoster, Eva, primary, Unterhalt, Michael, primary, Wörmann, Bernhard, primary, Dührsen, Ulrich, primary, Metzner, Bernd, primary, Eimermacher, Hartmut, primary, Neubauer, Andreas, primary, Wandt, Hannes, primary, Steinhauer, Hjalmar, primary, Martin, Sonja, primary, Heidemann, Else, primary, Aldaoud, Ali, primary, Hiddemann, Wolfgang, primary, and Dreyling, Martin, primary

Published
2008
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33. High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in rituximab pretreated relapsed or refractory indolent lymphomas and mantle cell lymphomas. A multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG)

Author

Weide, Rudolf, primary, Hess, Georg, additional, Köppler, Hubert, additional, Heymanns, Jochen, additional, Thomalla, Jörg, additional, Aldaoud, Ali, additional, Losem, Christoph, additional, Schmitz, Stefan, additional, Haak, Ursula, additional, Huber, Christoph, additional, Unterhalt, Michael, additional, Hiddemann, Wolfgang, additional, and Dreyling, Martin, additional

Published
2007
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34. High Anti-Lymphoma Activity of Bendamustine/Mitoxantrone/Rituximab (BMR) in Rituximab Pretreated Relapsed or Refractory Indolent Lymphomas. A Multicentre Phase II Study of the German Low Grade Lymphoma Study Group (GLSG).

Author

Weide, Rudolf, primary, Hess, Georg, additional, Koeppler, Hubert, additional, Heymanns, Jochen, additional, Thomalla, Joerg, additional, Aldaoud, Ali, additional, Losem, Christoph, additional, Schmitz, Stefan, additional, Haak, Ursula, additional, Huber, Christoph, additional, Unterhalt, Michael, additional, Hiddemann, Wolfgang, additional, and Dreyling, Martin, additional

Published
2006
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35. The Addition of Rituximab to Combination Chemotherapy with CHOP Has a Long Lasting Impact on Subsequent Treatment in Remission in Follicular Lymhoma but Not in Mantle Cell Lymphoma: Results of Two Prospective Randomized Studies of the German Low Grade Lymphoma Study Group (GLSG).

Author

Hiddemann, Wolfgang, primary, Forstpointner, Roswitha, additional, Kneba, Michael, additional, Schmitz, Norbert, additional, Schmits, Rudolf, additional, Metzner, Bernd, additional, Reiser, Marcel, additional, Lengfelder, Eva, additional, Woermann, Bernhard, additional, Harder, Hariett, additional, Hegewisch-Becker, Susanna, additional, Berdel, Wolfgang, additional, Hess, Georg, additional, Eimermacher, Hartmut, additional, Aldaoud, Ali, additional, Planker, Manfred, additional, Parwaresch, Reza, additional, Dreyling, Martin, additional, and Unterhalt, Michael, additional

Published
2004
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36. Bendamustine/Mitoxantrone/Rituximab (BMR): A Very Effective and Well Tolerated Immuno-Chemotherapy for Relapsed and Refractory Indolent Lymphomas - Results of a Multicentre Phase-II-Study of the German Low Grade Lymphoma Study Group (GLSG).

Author

Weide, Rudolf, primary, Koeppler, Hubert, primary, Heymanns, Jochen, primary, Thomalla, Joerg, primary, Hess, Georg, primary, Gamm, Heinhold, primary, Aldaoud, Ali, primary, Schmitz, Stephan, primary, Haak, Ursula, primary, Plewe, Dirk, primary, Burkhard, Oswald, primary, Gaede, Bernd, primary, Hinrichs, Fokke, primary, Pflueger, Karl-Heinz, primary, Dreyling, Martin, primary, Unterhalt, Michael, primary, and Hiddemann, Wolfgang, primary

Published
2004
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38. Early Consolidation with Myeloablative Radiochemotherapy Followed by Autologous Stem Cell Transplantation in First Remission Significantly Prolongs Progression-Free Survival in Mantle Cell Lymphoma - Long Term Follow up of a Prospective Randomized Trial of the European MCL Network.

Author

Dreyling, Martin H., primary, Lenz, Georg, additional, Schiegnitz, Eva, additional, van Hoof, Achiel, additional, Gisselbrecht, Christian, additional, Pfreundschuh, Michael, additional, Metzner, Bernd, additional, Truemper, Lorenz H., additional, Reiser, Marcel, additional, Steinhauer, Hjalmar B., additional, Boiron, Jean-Michel, additional, Boogaerts, Marc A., additional, Aldaoud, Ali, additional, Silingardi, Vittorio, additional, Kluin-Nelemans, Hanneke C., additional, Hasford, Joerg, additional, Parwaresch, Reza, additional, Michael, Unterhalt, additional, and Wolfgang, Hiddemann, additional

Published
2004
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39. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group

Author

Hiddemann, Wolfgang, Kneba, Michael, Dreyling, Martin, Schmitz, Norbert, Lengfelder, Eva, Schmits, Rudolf, Reiser, Marcel, Metzner, Bernd, Harder, Harriet, Hegewisch-Becker, Susanna, Fischer, Thomas, Kropff, Martin, Reis, Hans-Edgar, Freund, Mathias, Wörmann, Bernhard, Fuchs, Roland, Planker, Manfred, Schimke, Jörg, Eimermacher, Hartmut, Trümper, Lorenz, Aldaoud, Ali, Parwaresch, Reza, and Unterhalt, Michael

Abstract

Phase 2 studies suggest that the monoclonal antibody rituximab may improve the prognosis of patients with follicular lymphoma (FL) when it is added to chemotherapy. In the current study, 428 patients with untreated, advanced-stage FL were randomly assigned for therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone (n = 205) or CHOP combined with rituximab (R-CHOP) (n = 223). R-CHOP reduced the relative risk for treatment failure by 60% and significantly prolonged the time to treatment failure (P< .001). In addition, a significantly higher overall response rate (96% vs 90%; P= .011) and a prolonged duration of remission (P= .001) were achieved. In spite of a relatively short observation time, these beneficial effects even translated to superior overall survival (P= .016), with 6 deaths in the R-CHOP group compared with 17 deaths in the CHOP group within the first 3 years. The predominant treatment-related adverse effect was myelosuppression. Severe granulocytopenia was more frequently observed after R-CHOP (63% vs 53%; P= .01). However, severe infections were rare and of similar frequency after R-CHOP and CHOP (5% and 7%). Hence, adding rituximab to CHOP significantly improves the outcome for patients with previously untreated advanced-stage FL and does not induce major adverse effects.

Published
2005
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40. Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study

Author

Michael Kneba, Holger Hebart, Stephan Stilgenbauer, Anna-Maria Fink, Kirsten Fischer, Othman Al-Sawaf, Matthias Ritgen, Hartmut Döhner, Francesc Bosch, Sebastian Böttcher, Arnon P. Kater, Eugen Tausch, Ali Aldaoud, Sandra Robrecht, Clemens-Martin Wendtner, Steffen Dörfel, Kathleen Jentsch-Ullrich, Michael Hallek, Jasmin Bahlo, Barbara Eichhorst, Thomas Nösslinger, Paolo Ghia, Karl-Anton Kreuzer, Clinical Haematology, Cancer Center Amsterdam, CCA - Cancer Treatment and Quality of Life, Fink, Anna Maria, Bahlo, Jasmin, Robrecht, Sandra, Al-Sawaf, Othman, Aldaoud, Ali, Hebart, Holger, Jentsch-Ullrich, Kathleen, Dörfel, Steffen, Fischer, Kirsten, Wendtner, Clemens-Martin, Nösslinger, Thoma, Ghia, Paolo, Bosch, Francesc, Kater, Arnon P, Döhner, Hartmut, Kneba, Michael, Kreuzer, Karl-Anton, Tausch, Eugen, Stilgenbauer, Stephan, Ritgen, Matthia, Böttcher, Sebastian, Eichhorst, Barbara, and Hallek, Michael

Subjects
Male, medicine.medical_specialty, Neoplasm, Residual, Antineoplastic Agents, Placebo, Maintenance Chemotherapy, 03 medical and health sciences, 0302 clinical medicine, Maintenance therapy, Chemoimmunotherapy, Internal medicine, Clinical endpoint, medicine, Humans, Lenalidomide, Aged, Aged, 80 and over, Intention-to-treat analysis, business.industry, Hematology, Middle Aged, Interim analysis, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Analysis, Minimal residual disease, Thalidomide, Surgery, Treatment Outcome, 030220 oncology & carcinogenesis, Disease Progression, Female, business, 030215 immunology, medicine.drug
Abstract

Summary Background The combined use of genetic markers and detectable minimal residual disease identifies patients with chronic lymphocytic leukaemia with poor outcome after first-line chemoimmunotherapy. We aimed to assess lenalidomide maintenance therapy in these high-risk patients. Methods In this randomised, double-blind, phase 3 study (CLLM1; CLL Maintenance 1 of the German CLL Study Group), patients older than 18 years and diagnosed with immunophenotypically confirmed chronic lymphocytic leukaemia with active disease, who responded to chemoimmunotherapy 2–5 months after completion of first-line therapy and who were assessed as having a high risk for an early progression with at least a partial response after four or more cycles of first-line chemoimmunotherapy, were eligible if they had high minimal residual disease levels or intermediate levels combined with an unmutated IGHV gene status or TP53 alterations. Patients were randomly assigned (2:1) to receive either lenalidomide (5 mg) or placebo. Randomisation was done with a fixed block size of three, and was stratified according to the minimal residual disease level achieved after first-line therapy. Maintenance was started with 5 mg daily, and was escalated to the target dose of 15 mg. If tolerated, medication was administered until disease progression. The primary endpoint was progression-free survival according to an independent review. The pre-planned interim analysis done by intention to treat was done after 20% of the calculated progression-free survival events. This study is registered with ClinicalTrials.gov, number NCT01556776; treatment in the lenalidomide group is still ongoing. Findings Between July 5, 2012, and March 15, 2016, 468 previously untreated patients with chronic lymphocytic leukaemia were screened for the study; 379 (81%) were not eligible. Recruitment was closed prematurely due to poor accrual after 89 of 200 planned patients were randomly assigned: 60 (67%) enrolled patients were assigned to the lenalidomide group and 29 (33%) to the placebo group, of whom 56 (63%) received lenalidomide and 29 (33%) placebo, with a median of 11·0 (IQR 4·5–20·5) treatment cycles at data cutoff. After a median observation time of 17·9 months (IQR 9·1–28·1), the hazard ratio for progression-free survival assessed by an independent review was 0·168 (95% CI 0·074–0·379). Median progression-free survival was 13·3 months (95% CI 9·9–19·7) in the placebo group and not reached (95% CI 32·3–not evaluable) in the lenalidomide group. The most frequent adverse events were skin disorders (35 patients [63%] in the lenalidomide group vs eight patients [28%] in the placebo group), gastrointestinal disorders (34 [61%] vs eight [28%]), infections (30 [54%] vs 19 [66%]), haematological toxicity (28 [50%] vs five [17%]), and general disorders (28 [50%] vs nine [31%]). One fatal adverse event was reported in each of the treatment groups (one [2%] patient with fatal acute lymphocytic leukaemia in the lenalidomide group and one patient (3%) with fatal multifocal leukoencephalopathy in the placebo group). Interpretation Lenalidomide is an efficacious maintenance therapy reducing the relative risk of progression in first-line patients with chronic lymphocytic leukaemia who do not achieve minimal residual disease negative disease state following chemoimmunotherapy approaches. The toxicity seems to be acceptable considering the poor prognosis of the eligible patients. The trial independently confirms the clinical significance of a novel, minimal residual disease-based algorithm to predict short progression-free survival, which might be incorporated in future clinical trials to identify candidates for additional maintenance treatment. Funding Celgene Corporation.

Published
2017

41. Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry.

Author

Al-Batran SE, Hofheinz RD, Reichart A, Pauligk C, Schönherr C, Schlag R, Siegler G, Dörfel S, Koenigsmann M, Zahn MO, Schubert J, Aldaoud A, Höffkes HG, Schulz H, Hahn L, Uhlig J, Blau W, Stauch M, Weniger J, Wolf M, Jacobasch L, Bildat S, Wehmeyer J, Homann N, Trojan J, Waidmann O, Fietz T, Feustel HP, Groschek M, Wierecky J, Waibel K, Mahlmann S, Schwindel U, Peters U, Schuch G, Pink D, Eschenburg H, Wörns MA, Harich HD, von Weikersthal LF, Däßler KU, Behringer DM, Messmann H, Kretzschmar A, Gallmeier E, Forstbauer H, Kunzmann V, Papke J, Büchner-Steudel P, Vehling-Kaiser U, Springfeld C, Vogel A, Ettrich TJ, Schaaf M, Hausen GZ, and Götze TO

Subjects
Adult, Aged, Aged, 80 and over, Albumins therapeutic use, Deoxycytidine analogs & derivatives, Deoxycytidine therapeutic use, Female, Humans, Male, Middle Aged, Paclitaxel therapeutic use, Registries, Treatment Outcome, Gemcitabine, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pancreatic Neoplasms drug therapy, Quality of Life
Abstract

Few data exist on health-related quality of life (QoL) in patients with metastatic pancreatic cancer (mPC) receiving first-line chemotherapy (Awad L ZE, Mesbah M Boston, MA. Applying survival data methodology to analyze quality of life data, in Mesbah M, Cole BF, Ting Lee M-L (eds): Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis. Kluwer Academic Publishers 2002). The QOLIXANE study is a prospective, noninterventional, multicenter substudy of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with mPC receiving first-line gemcitabine and nab-paclitaxel chemotherapy in real-life setting. QoL was prospectively measured via EORTC QLQ-C30 questionnaires at baseline and every month thereafter. Therapy and efficacy parameters were prospectively collected. Main objectives were the rate of patients without deterioration of Global Health Status/QoL (GHS/QoL) at 3 and 6 months. Six hundred patients were enrolled in 95 German study sites. Median progression-free survival was 5.9 months (95% confidence interval [CI], 5.2-6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9-10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0-5.6). With a baseline GHS/QoL score of 46 (SD, 22.8), baseline QoL of the patients was severely impaired, in most cases due to loss in role functioning and fatigue. In the Kaplan-Meier analysis, 61% and 41% of patients had maintained GHS/QoL after 3 and 6 months, respectively. However, in the QoL response analysis, 35% and 19% of patients had maintained (improved or stable) GHS/QoL after 3 and 6 months, respectively, while 14% and 9% had deteriorated GHS/QoL with the remaining patients being nonevaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a hazard ratio of 0.86 (P < .0001). Patients with mPC have poor QoL at baseline that deteriorates within a median of 4.7 months. Treatment with gemcitabine and nab-paclitaxel is associated with maintained QoL in relevant proportions of patients. However, overall, results remain poor, reflecting the aggressive nature of the disease., (© 2020 Union for International Cancer Control.)

Published
2021
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42. Long-term bexarotene monotherapy in large cell CD30+ pleomorphic T-cell lymphoma.

Author

Aldaoud A

Subjects
Bexarotene, Humans, Ki-1 Antigen metabolism, Lymphoma, T-Cell, Cutaneous pathology, Male, Middle Aged, Skin Neoplasms pathology, Time Factors, Antineoplastic Agents therapeutic use, Lymphoma, T-Cell, Cutaneous drug therapy, Skin Neoplasms drug therapy, Tetrahydronaphthalenes therapeutic use
Published
2008

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