Clinical Efficacy and Safety in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Systematic Literature Review |
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| Affiliation: | 1. Department of Health Sciences Research, Mayo Clinic, Rochester, USA;2. Division of Hematology, Mayo Clinic, Rochester, USA;3. Department of Hematology, Oncology and Stem Cell Transplantation, Asklepios Hospital St. Georg, Hamburg, Germany;4. Department of Medicine, The Royal Marsden Hospital, Surrey, UK;5. Internal Medicine I, University of the Saarland, Homberg, Germany;6. Peter MacCallum Cancer Centre, Melbourne, Australia;7. Department of Internal Medicine I, Medical University of Vienna, Vienna, Austria;8. Lymphoid Malignancies Unit, AP-HP Hôpital Henri Mondor, Créteil, France;9. Henri Becquerel Centre, University of Rouen, Rouen, France;10. Department of Hematology, Centre Hospitalier Lyon-Sud, Pierre-Benite, France;11. Hematology, Azienda Ospedaliera Santa Maria Nuova-IRCCS, Reggio Emilia, Italy;12. Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Leipzig, Germany;13. Department of Oncology and Hematology, Hôpital de Hautepierre, Strasbourg, France;14. Celgene Corporation, Boudry, Switzerland;15. Celgene Corporation, Summit;16. Department of Bone Marrow and Stem Cell Transplantation, Winship Cancer Institute of Emory University, Atlanta, USA;1. Analysis Group, Inc, Boston, MA, USA;2. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;1. Clinic for Hematology and Stem Cell Transplantation, Helios Klinikum Berlin-Buch, Berlin;;2. Department of Hematology, Oncology and Stem Cell Transplantation, Asklepios Hospital, St. Georg, Hamburg;;3. Department of Hematology and Oncology, University Medicine Goettingen, Göttingen;;4. Internal Medicine, Saarland University Medical School, Homburg;;5. Institute of Pathology, University of Würzburg, Würzburg;;6. Institute of Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig;;7. Department of Internal Medicine A, Hematology Oncology and Pneumology, University Hospital Münster, Münster, Germany;1. Kite, A Gilead Company, Santa Monica, California;2. IBM Watson Health, Cambridge, Massachusetts;3. Wade Outcomes Research and Consulting, Salt Lake City, Utah |
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| Abstract: | This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a meta-analysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL. |
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| Keywords: | Chemotherapy Diffuse large B-cell lymphoma Refractory Relapsed |
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