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Clinical trial information: NCT00278408.STAMATIS J. Supported by Deutsche Krebshilfe, Amgen and Roche. Our results indicate a very favorable 3-year OS of 96% in PMBCL pts treated with R-CHOP.

Testing RT in PET-positive residual tumors in a randomized trial can solve the question, while RT in PET-negative pts is studied in the ongoing randomized IELSG 37 trial. The results suggest a benefit of RT only for pts, who are responding to R-CHOP with PR. Pts assigned to RT had a superior EFS mostly due to a higher PR rate in the no-RT arm triggering RT, with no differences in PFS and OS. The results reveal no differences between R-CHOP-14 vs R-CHOP-21.

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Conclusions: To our knowledge, this is the largest series of PMBCLs so far, which have been treated in a prospective, randomized trial in the rituximab era. Dose-densification of R-CHOP-21 by R-CHOP-14 did not improve EFS, PFS nor OS. In an as treated analysis the difference between the RT and the no-RT arm was not significant (p = 0.136). 78% p = 0.007), mostly due to events caused by initiation of RT (n = 5) in the no-RT arm. 3-year EFS was superior in pts assigned to RT (94% vs.

Response RT vs no-RT were CR/Cru 94% vs 84%, PR 2% vs 10%, PD 2% vs 4%. 96% (79/82) received RT per protocol and 5 pts in the no-RT arm received unplanned RT (4 after PR and 1 after CR/CRu). Results: 131 PMBCLs were included with a median age of 34 years, 54% were female, 79% had elevated LDH > UNV and 24% had E. Response was evaluated by the Internat Standardized Response Criteria, Cheson 1999. Primary endpoint was event-free survival (EFS), secondary endpoints were progression-free (PFS) and overall survival (OS). Pts were randomized in a 2 x 2 factorial design to 6xR-CHOP-14 or 6x-R-CHOP-21 without RT or with RT (39.6 Gy) to Bulk and E. Methods: The UNFOLDER trial included 18-60 year-old pts (aaIPI = 0 with Bulk or aaIPI = 1) qualifying for radiotherapy to Bulk or extralymphatic involvement (E). Therapy is based on R-CHOP or similar regimens, but the role of treatment intensification and consolidative radiotherapy (RT) is controversial, because data from randomized trials are rare. Department Internal Medicine I, Westpfalzklinikum Kaiserslautern, Kaiserslautern, Germany Department Internal Medicine I, Saarland University Medical School, Homburg/Saar, Germany Department of Radiooncology, Saarland University Medical School, Homburg/Saar, Germany Insitute of Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany Department of Medicine III, University Hospital Grosshadern/LMU, Munich, Germany University Hospital of Ulm, Ulm, Germany Department of Haematology and Oncology, University Hospital of Cologne, Cologne, Germany Institute of Haematology, Assuta Medical Centers, Tel Aviv, Israel Onkologie Lerchenfeld, Hamburg, Germany Dept of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy Department of Hematology, Rigshospitalet, Copenhagen, Denmark Universitätsmedizin Göttingen, Goettingen, Germany Department of Radiooncology, University Medical Center, Mainz, Germany Department Internal Medicine A, University Medical School, Muenster, Germany Institute for Medical Informatics, Statistics and Epidemology, University of Leipzig, Leipzig, Germany Institute for Medical Informatics, Statistics and Epidemology, Leipzig University, Leipzig, Germanyīackground: Primary mediastinal B-cell lymphoma (PMBCL) is a distinct entity of aggressive lymphoma, which typically presents in young patients (pts) with a bulky mediastinal mass.