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Unfolder trial lymphoma3/25/2023 ![]() These results highlight the difficulties in interpreting residual masses in DLBCL without a PET which has been shown to identify (elderly) patients with B who can be spared from radiotherapy without compromising their outcome. Patients assigned to observation had a worse EFS because of more events largely due to a higher PR rate triggering additional treatment with no differences in PFS and OS. Conclusions: There were no differences in outcome between R-CHOP-14 and R-CHOP-21. ![]() Results were not different when the analysis was restricted to patients with bulky disease only. 93%, p = 0.506) was not different, which was confirmed in a multivariate analysis adjusting for elevated LDH, stage III/IV, B and E involvement (HR EFS= 0.5, p = 0.001 HR PFS= 0.7, p = 0.174 HR OS= 1.2, p = 0.674). 3-year PFS of pts assigned to RT was not significantly better (89% vs. 2%) triggering additional treatment (mostly RT) as an EFS event. 84% p = 0.001), due to a higher rate of PR (11% vs. After 66 months median observation 3-year EFS was worse in pts not assigned to RT (68% vs. EFS, PFS and OS after R-CHOP-14 and R-CHOP-21 were not different. There were no relevant differences in protocol adherence and toxicity between the two chemotherapy regimens. 305 pts (R-CHOP-21: 155 R-CHOP-14: 150) assigned to RT and 162 (R-CHOP-21: 81, R-CHOP-14: 81) assigned to observation were evaluable for this final analysis. Results: A planned interim analysis of the first 285 patients had revealed a significantly better EFS of patients assigned to RT (p = 0.004) resulting in the pre-defined closing of the non-RT arms. Primary endpoint was event-free survival. Methods: 18-60 year-old patients (aaIPI = 0 with B, aaIPI 1) qualifying for radiotherapy to B or E were randomized to 6xR-CHOP-14 or 6x-R-CHOP-21 followed by RT (39.6 Gy) to B and E sites or observation in a 2x2 factorial design. Medical Department, Technische Universität München, Munich, Germany University Hospital Münster, Münster, Germanyīackground: The role of RT to B and E for young patients with good-prognosis DLBCL is ill-defined. University Saarland Medical School, Homburg Saar, Germany Saarland University Medical School, Homburg, Germany Institute for Medical Informatics, Statistics and Epidemology, Leipzig University, Leipzig, Germany University Hospital of LMU, Munich, Germany Klinikum der Universität zu Köln, Cologne, Germany Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy Department of Hematology, Oncology, and Rheumatology, University of Heidelberg, Heidelberg, Germany University Medical Center Hamburg-Eppendorf, Hamburg, Germany Klinik für Innere Medizin III, Klinikum Chemnitz, Chemnitz, Germany University Medical Center Göttingen, Göttingen, Germany Klinikum Oldenburg AöR, Medical Campus University Oldenburg, Oldenburg, Germany University Hospital, Mannheim, Germany IIII.
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