April 2015 – Moving Forward

Table of Contents

Frontline chemoimmunotherapy with FCR shows superior efficacy in comparison to BR in previously untreated and physically fit patients with advanced CLL: final analysis of the CLL10 study from the German CLL Study Group

NE Oncology Issue - April 2015 Eichhorst B, et al. ASH 2014:19 Background Fludarabine, cyclophosphamide, and rituximab (FCR) is the standard frontline therapy for physically fit patients with chronic lymphocytic leukemia (CLL) that have a...

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Noninferior pharmacokinetics with comparable safety and response rates for subcutaneous, compared with intravenous, rituximab in combination with FC in patients with untreated CLL: part 2 of the phase Ib SAWYER study

NE Oncology Issue - April 2015 Assouline S, et al. ASH 2014:1995 Background SAWYER is a two-part, phase Ib study investigating subcutaneous (sc) rituximab compared with intravenous (iv) rituximab, both in combination with fludarabine and...

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In vivo evidence that ibrutinib deregulates chemokine receptor CXCR4 surface membrane expression and signaling, along with inhibiting B-cell antigen receptor signaling, as causes for defective homing and impaired retention of CLL cells in tissues

NE Oncology Issue - April 2015 Chen S-S, et al. ASH 2014:1948 Background The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib is approved by the U.S. Food and Drug Administration for the treatment of chronic lymphocytic leukemia (CLL) and...

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Improved outcome with all-trans retinoic acid (ATRA) plus arsenic trioxide vs. ATRA plus chemotherapy in non-high-risk acute promyelocytic leukemia: updated results of the Italian-German APL0406 trial on the extended final series

NE Oncology Issue - April 2015 Platzbecker U, et al. ASH 2014:12 Background The combination of ATRA and arsenic trioxide (ATO) has recently been shown to be at least noninferior and possibly superior to standard ATRA plus chemotherapy (CHT)...

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Frontline therapy with the RiBVD regimen elicits high clinical and molecular response rates and long PFS in elderly patients with mantle cell lymphoma: final results of a prospective phase II trial by the LYSA group

NE Oncology Issue - April 2015 Gressin R, et al. ASH 2014:148 Background The standard of care for first-line therapy in elderly patients with mantle cell lymphoma (MCL) in Europe is eight cycles of rituximab plus cyclophosphamide,...

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Single-agent ibrutinib demonstrates safety and durability of response at 2 years follow-up in patients with relapsed or refractory mantle cell lymphoma: updated results of an international, multicentre, open-label phase II study

NE Oncology Issue - April 2015 Wang M, et al. ASH 2014:4453 Background Bruton’s tyrosine kinase (BTK) is a critical signaling molecule in the B-cell receptor (BCR) signaling pathway essential for B-cell development, survival, and function....

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Bendamustine plus rituximab versus fludarabine plus rituximab in patients with relapsed follicular, indolent, or mantle cell lymphomas: 8-year follow-up results of the randomized phase III study NHL 2-2003 on behalf of the StiL

NE Oncology Issue - April 2015 Rummel MJ, et al. ASH 2014:145 Background Fludarabine plus rituximab (FR) is an established treatment option for patients with relapsed/refractory follicular lymphoma (FL), other indolent lymphomas, or mantle...

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Canadian Perspectives

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Carolyn Owen, MD

Dr. Carolyn Owen completed postgraduate training in internal medicine and hematology at the University of Ottawa and the University of British Columbia, respectively, followed by a research fellowship in molecular genetics at Barts and the London School of Medicine and Dentistry in London, UK. Her research focused on familial myelodysplasia and acute myeloid leukemia. She is currently an Assistant Professor at the Foothills Medical Centre & Tom Baker Cancer Centre, and her clinical interests are low-grade lymphoma and chronic lymphocytic leukemia. She is also the local principal investigator in Calgary for several clinical trials in these areas.

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Cynthia L. Toze, MD, MHSc, FRCPC, ABIM
Dr. Cynthia Toze studied biochemistry at Queen’s University in Kingston, Ontario, and obtained her MD degree in 1986. She completed her Internal Medicine residency at the Royal Victoria Hospital, McGill University, in Montreal, Quebec, and at the University of Ottawa, Ontario. She obtained her FRCPC and Specialist Certificate in Internal Medicine from the Corporation professionnelle des médecins du Québec in 1990. Her Fellowship in Hematology and Leukemia/Bone Marrow Transplantation (BMT) was performed at the University of British Columbia (UBC) in Vancouver, from 1991 to 1994, followed by a Master’s degree in Epidemiology from UBC in 1995. Dr. Toze joined the Leukemia/BMT Program of B.C. in 1995, and is a Senior Hematologist at Vancouver General Hospital/BC Cancer Agency and Clinical Professor of Medicine at UBC. Her research interests focus on chronic lymphocytic leukemia (CLL), including population-based outcomes research, CLL genetics, and allogeneic hematopoietic stem cell transplantation for lymphoid malignancies. She has been active in clinical trials with the Canadian Blood and Marrow Transplant Group, including a leading role in quality of life studies.

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Sujaatha Narayanan, MBBS, MRCP, FRCPath

Dr. Sujaatha Narayanan trained as a hematologist and completed her bone marrow transplant fellowship in the United Kingdom prior to moving to Canada in 2006. She completed a second fellowship in leukemia and stem cell transplantation in Vancouver before joining the Leukemia/ Bone Marrow Transplant Program of British Columbia as an attending physician in December 2007.

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Isabelle Bence-Bruckler, MD, FRCPC

Dr. Isabelle Bence-Bruckler is an Associate Professor of Medicine at the University of Ottawa and a hematologist at the Ottawa Hospital, General Campus. She is a member of the Blood and Marrow Transplant Program at the Ottawa Hospital and serves on the Scientific Advisory Board for Lymphoma Canada.

Investigator Commentaries

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Torben Plesner, MD, Doc. Med. Sci.

Dr. Torben Plesner is currently a Consultant of Hematology and Head of the Department of Hematology, Section of Internal Medicine, at Vejle Hospital in Denmark, as well as a Professor of Hematology at the University of Southern Denmark. He is also the founder and has been the leader of the Clinical Research Unit (CRU) at the Department of Hematology at Vejle Hospital since 2003. Dr. Plesner received his medical training and Doctor of Medical Sciences degree from the University of Copenhagen and was certified as a specialist in clinical chemistry, internal medicine, and hematology in Denmark. He is a member of the Danish Society for Good Clinical Practice, a member of the national board of coordinators of the CRUs of the Hematological Departments in Denmark, and a member of the Clinical Trial Subcommittee of the European Myeloma Network. Dr. Plesner has published 90 scientific articles that are indexed in PubMed.

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Philippe Moreau, MD

Dr. Philippe Moreau is Head of the Hematology Department at the University Hospital of Nantes, France. He specializes in clinical hematology, with a particular focus on multiple myeloma and its treatment with high-dose therapy and novel agents. Dr. Moreau was appointed University Professor of Clinical Hematology at Nantes Faculty of Medicine in 2003. As the lead researcher in multiple myeloma, Dr. Moreau is head of the unit for early phase I and phase II trials in clinical hematology at the University Hospital of Nantes. Additionally, he was a member of the organizing committee for the 2011 International Myeloma Workshop, in Paris. Dr. Moreau is currently a member of the administration council of the Intergroupe Francophone du Myélome (IFM), and he was chairman of the IFM from 2006 through 2009. Dr. Moreau is widely published, with more than 300 peer-reviewed articles and reviews that have appeared in high impact factor journals. He is member of the Editorial Board of the Journal of Clinical Oncology, Blood, and Blood Cancer Journal.

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Uwe Platzbecker, MD

Dr. Uwe Platzbecker graduated from medical school in 1996, and first started his medical training in heart surgery. Since 1998, he has been working at the Department of Hematology and Oncology at the University Hospital “Carl Gustav Carus” in Dresden, Germany. Between 2001 and 2003 he completed a 2-year Postdoctoral Fellowship provided by the Humboldt-foundation at the Fred Hutchinson Cancer Research Center in Seattle, USA. Since 2012, he holds the position of Professor of Hematology at the University Hospital “Carl Gustav Carus” and is Head of the MDS program. Dr. Platzbecker`s clinical expertise lies in hematological malignancies with a focus on MDS and AML. His main scientific interest is to explore innovative treatment options for these patients involving the use of allogeneic hematopoietic stem cell transplantation. Dr. Platzbecker is also co-chair of the European Hematology Assocication (EHA) MDS working group. Since 2012 he has been appointed by the European Leukemia Net (ELN) MDS group as one of the coordinators of the European MDS Study Coordinating Office (EMSCO).

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Clemens-Martin Wendtner, MD
Clemens-Martin Wendtner, M.D., is Professor of Medicine and Director of the Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine at the Klinikum Schwabing, Munich — an academic hospital of the University of Munich. He completed his M.D. at the University of Münster in 1993. Thereafter, he received postdoctoral training at the Max-Planck-Institute in Martinsried, Germany and at the National Institutes of Health (NIH) in Bethesda, USA, until 1995. After a clinical fellowship at the University of Munich, he gained his German and US licence (ECFMG) in Internal Medicine before specialising as a Hematologist and Oncologist at the same institution. Dr. Wendtner received his postdoctoral lecture qualification at the University of Munich in 2002, and since 2004, he is a full professor of Internal Medicine, Hematology, and Medical Oncology at the University of Cologne. Dr. Wendtner is a member of multiple national and international societies in the field of Medicine and has won several research awards, including first prize at the 6th International Symposium Biological Therapy of Cancer in Munich, and a merit award from the American Society of Clinical Oncology. As a founding member of the German CLL Study Group (GCLLSG), he participates on the Steering Committee and is Secretary of GCLLSG. He has been principal investigator for numerous phase I-III clinical studies, and his interests focus on the development of new therapies in the field of CLL.

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Susan M. O’Brien, MD
Dr. Susan M. O’Brien is a Professor of Medicine at the University of California, Irvine, the Associate Director for Clinical Science at the Chao Family Comprehensive Cancer Center, and the Medical Director at the Sue & Ralph Stern Center for Cancer Clinical Trials & Research. She is a leader in the research of treatments for acute and chronic leukemia and has been a principal investigator for more than 40 funded protocols. Dr. O’Brien is a Hematology member of the SWOG Executive Committee and has authored more than 600 articles in peer-reviewed journals, 30 invited articles, and numerous book chapters. Dr. O’Brien serves on the executive editorial board of the Journal of the National Comprehensive Cancer Network (JNCCN) in addition to being an Editor and Reviewer for top scientific journals such as Blood, Cancer, and the Journal of Clinical Oncology.

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Mathias J. Rummel, MD, PhD
Mathias J. Rummel is the head of the Department for Hematology at the Clinic for Hematology and Medical Oncology at the Justus-Liebig University-Hospital, Giessen, Germany. Professor Rummel studied medicine at J.W. Goethe University Hospital in Frankfurt, Germany, obtaining his licence to practice medicine in 1995. Following this, he completed his doctoral degree and residency, obtained board certification in internal medicine, and was awarded his PhD from J.W. Goethe University Hospital. Professor Rummel’s current research focuses on novel treatment approaches in hematological malignancies, most notably follicular and other indolent lymphomas as well as hairy cell leukemia and also immune thrombocytopenic purpura (ITP). He is the chair of the Study group indolent Lymphomas (StiL) and principal investigator of several ongoing clinical trials in leukemias, lymphomas, and ITP. He is actively involved in a number of professional scientific societies, he is a reviewer for a number of journals, and has several published book chapters and papers to his credit.

Expert Commentaries

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Wolfgang Knauf, MD
Dr. Wolfgang Knauf is Head of the chronic lymphocytic leukemia (CLL) and multiple myeloma registries of the German Community Centre of Haematologists. He studied medicine in Germany at the Universities of Regensburg, Hamburg, Heidelberg, and Freiburg, achieving his medical degree with an experimental doctoral thesis on exocrine pancreatic function. As a fellow of the German Research Foundation, he trained in cancer molecular biology at the German Cancer Research Centre in Heidelberg, Germany. He received his board certification in internal medicine, hematology and medical oncology, and transfusion medicine at Charité University Hospital in Berlin. His Ph.D. research involved risk factor evaluation and cytogenetics in CLL. His ongoing interest is optimizing treatment for patients with CLL. He has participated as the principal investigator in many clinical trials in malignant hematological disorders, and he was Head of a pivotal clinical trial in CLL conducted across seven European countries.