• Media type: E-Article
  • Title: Randomized Study to Evaluate the Use of High-Dose Therapy as Part of Primary Treatment for “Aggressive” Lymphoma
  • Contributor: Kaiser, Ulrich; Uebelacker, Irmgard; Abel, Ulrich; Birkmann, Josef; Trumper, Lorenz; Schmalenberg, Harald; Karakas, Tunca; Metzner, Bernd; Hossfeld, Dieter K.; Bischoff, Helge G.; Franke, Astrid; Reiser, Marcel; Muller, Peter; Mantovani, Luisa; Grundeis, Marc; Rothmann, Frank; von Seydewitz, Cay-Uwe; Mesters, Rolf M.; Steinhauer, Ernst U.; Krahl, Dorothea; Schumacher, Kurt; Kneba, Michael; Baudis, Michael; Schmitz, Norbert; [...]
  • Published: American Society of Clinical Oncology (ASCO), 2002
  • Published in: Journal of Clinical Oncology, 20 (2002) 22, Seite 4413-4419
  • Language: English
  • DOI: 10.1200/jco.2002.07.075
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: PURPOSE: This trial of the German High-Grade Non-Hodgkin’s Lymphoma Study Group compares the use of high-dose therapy (HDT) as part of primary treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus etoposide followed by involved-field (IF) radiotherapy in a randomized, multicenter, phase III study. PATIENTS AND METHODS: Three hundred twelve patients with “aggressive” non-Hodgkin’s lymphoma aged ≤ 60 years with elevated serum lactate dehydrogenase levels were included from 1990 to 1997. Patients with at least a minor response after two cycles of CHOEP (CHOP + etoposide 3 × 100 mg/m2) were to receive three further cycles of CHOEP followed by IF radiotherapy (arm A) or one further cycle of CHOEP followed by autologous stem-cell transplantation and IF radiotherapy (arm B). RESULTS: Among 158 patients randomized to arm B, 103 (65%) received HDT. The complete remission rate at the end of treatment was 62.9% in arm A and 69.9% in arm B. With a median observation time of 45.5 months, overall survival for all 312 patients was 63% after 3 years (63% for arm A, 62% for arm B; P = .68). Event-free survival was 49% for arm A versus 59% for arm B (P = .22). Relapse in arm B was associated with a significantly worse survival rate than relapse in arm A (P < .05). Relapse after HDT occurred early (median interval, 3 months). Six patients developed secondary neoplasia, three in arm A and three in arm B. CONCLUSION: Results of the randomized trial comparing CHOP-like chemotherapy with early HDT do not support the use of HDT with carmustine, etoposide, cytarabine, and melphalan following shortened standard chemotherapy.