Randomized study to evaluate the use of high-dose therapy as part of primary treatment for "aggressive" lymphoma.

Abstract

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 <or= 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 x 100 mg/m(2)) 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.

• Authors: Ulrich Kaiser, Irmgard Uebelacker, Ulrich Abel, Josef Birkmann, Lorenz Trümper, Harald Schmalenberg, Tunca Karakas, Bernd Metzner, Dieter K Hossfeld, Helge G Bischoff, Astrid Franke, Marcel Reiser, Peter Müller, Luisa Mantovani, Marc Grundeis, Frank Rothmann, Cay-Uwe von Seydewitz, Rolf M Mesters, Ernst U Steinhauer, Dorothea Krahl, Kurt Schumacher, Michael Kneba, Michael Baudis, Norbert Schmitz, Rüdiger Pfab, Hubert Köppler, Reza Parwaresch, Michael Pfreundschuh, Klaus Havemann
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 20 Issue 22 Pg. 4413-9 (Nov 15 2002) ISSN: 0732-183X [Print] United States
• PMID: 12431962 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Cytarabine
• Vincristine
• Etoposide
• Doxorubicin
• Cyclophosphamide
• Prednisolone
• L-Lactate Dehydrogenase
• Melphalan
• Carmustine

Topics

• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, therapeutic use)
• Carmustine (administration & dosage)
• Chemotherapy, Adjuvant
• Cyclophosphamide (administration & dosage)
• Cytarabine (administration & dosage)
• Doxorubicin (administration & dosage)
• Drug Administration Schedule
• Etoposide (administration & dosage)
• Female
• Germany
• Humans
• L-Lactate Dehydrogenase (blood)
• Lymphoma, Non-Hodgkin (drug therapy, enzymology, radiotherapy, therapy)
• Male
• Melphalan (administration & dosage)
• Middle Aged
• Prednisolone (administration & dosage)
• Prognosis
• Prospective Studies
• Radiotherapy, Adjuvant
• Risk
• Stem Cell Transplantation
• Survival Analysis
• Transplantation, Autologous
• Treatment Outcome
• Vincristine (administration & dosage)