High-dose therapy followed by autologous stem-cell transplantation with and without rituximab for primary treatment of high-risk diffuse large B-cell lymphoma.
BACKGROUND
We aimed to determine safety and efficacy of rituximab (R) in combination with repetitive high-dose therapy (HDT) as primary treatment for diffuse large B-cell lymphoma (DLBCL).


METHODS
Patients aged 18-60 years and elevated lactate dehydrogenase were treated with four cycles of MegaCHOEP and transplantation of autologous stem cells after cycles 2, 3 and 4. Rituximab (375 mg/m²) was given before each cycle and 12 and 33 days after start of the last cycle of chemotherapy. Sixty-four patients given R-MegaCHOEP were compared with 29 patients who had received identical treatment without rituximab.


RESULTS
Overall survival (OS) and event-free survival (EFS) after 3 years were significantly improved in patients treated with R-MegaCHOEP (OS: 78.7% versus 55.0%, P = 0.045; EFS: 72.7% versus 47.2%, P = 0.013). In a Cox regression model adjusted for performance status and stage, relative risk of treatment failure was lower (relative risk 0.5, P = 0.041) and OS was better (relative risk 0.4, P = 0.054) for patients given R-MegaCHOEP. Grade 3/4 infections were more frequent in the R-MegaCHOEP group (18.5% versus 6.0%, P = 0.003).


CONCLUSIONS
The addition of rituximab to MegaCHOEP significantly improved outcome in young patients with high-risk DLBCL. The higher incidence of grade 3/4 infections needs consideration when rituximab and HDT regimens are combined.
Glass
B
B
Department of Hematology and Stem Cell Transplantation, Asklepios Hospital St. Georg, Hamburg. Electronic address: b.glass@asklepios.com.
Ziepert
M
M
Institute of Medical Informatics, Statistics, and Epidemiology, University of Leipzig, Leipzig.
Reiser
M
M
Department of Internal Medicine I, University Hospital Cologne, Cologne.
Freund
M
M
Hospital of Internal Medicine III, Rostock University Hospital, Rostock.
Trümper
L
L
Department of Hematology and Oncology, University Hospital Göttingen, Göttingen.
Metzner
B
B
Department of Hematology and Oncology, Oldenburg Community Hospital, Oldenburg.
Feller
A
A
Institute of Pathology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck.
Loeffler
M
M
Institute of Medical Informatics, Statistics, and Epidemiology, University of Leipzig, Leipzig.
Pfreundschuh
M
M
Saarland University Medical School, Hospital of Medicine I, Homburg, Saar, Germany.
Schmitz
N
N
Department of Hematology and Stem Cell Transplantation, Asklepios Hospital St. Georg, Hamburg.
D000293:Adolescent; D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011239:Prednisolone / Q000008:administration & dosage; D012189:Retrospective Studies; D000069283:Rituximab; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D011239:Prednisolone