Universität zu Köln

Schmitz, Norbert, Nickelsen, Maike, Ziepert, Marita, Haenel, Mathias, Borchmann, Peter, Schmidt, Christian, Viardot, Andreas, Bentz, Martin, Peter, Norma, Ehninger, Gerhard, Doelken, Gottfried, Ruebe, Christian, Truemper, Lorenz, Rosenwald, Andreas, Pfreundschuh, Michael, Loeffler, Markus and Glass, Bertram (2012). Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1). Lancet Oncol., 13 (12). S. 1250 - 1260. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1470-2045

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Abstract

Background High-dose therapy (HDT) followed by transplantation of autologous haemopoietic stem cells is frequently done as part of first-line therapy in young patients with high-risk aggressive B-cell lymphoma. We investigated whether HDT with cytotoxic agents identical to those used for conventional therapy followed by autologous stem-cell transplantation (ASCT) improved survival outcome compared with conventional chemotherapy when rituximab was added to both modalities. Methods We did an open-label, randomised trial comparing conventional chemotherapy (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone) and rituximab (R-CHOEP-14) with dose-escalated sequential HDT and rituximab (R-MegaCHOEP) followed by repetitive ASCT in high-risk (age-adjusted International Prognostic Index [IPI] 2 or 3) patients aged 18-60 years with aggressive B-cell lymphoma. Eligible patients received radiotherapy for bulky, extranodal disease, or both. Randomisation (1: 1) used the Pocock minimisation algorithm; patients were stratified by age-adjusted IPI factors, bulky disease, and centre. The primary endpoint was event-free survival. All analyses were done on the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00129090. Findings 136 patients were randomly assigned to R-CHOEP-14 and 139 to R-MegaCHOEP. 130 patients in the R-CHOEP-14 group and 132 in the R-MegaCHOEP group were included in the intention-to-treat population. After a median of 42 months (IQR 29-59), 3-year event-free survival was 69.5% (95% CI 61.3-77.7) in the R-CHOEP-14 group and 61.4% (52.8-70.0) in the R-MegaCHOEP group (p=0.14; hazard ratio 1.3, 95% CI 0.9-2.0). All 128 evaluable patients treated with R-MegaCHOEP had grade 4 leucopenia, as did 48 (58.5%) of 82 patients with documented blood counts in the R-CHOEP-14 group. All 128 evaluable patients in the R-MegaCHOEP group had grade 3-4 thrombocytopenia, as did 26 (33.8%) of 77 patients in the R-CHOEP-14 group with documented blood counts. The most important non-haematological grade 3 or 4 adverse event was infection, which occurred in 96 (75.0%) of 128 patients treated with R-MegaCHOEP and in 40 (31.3%) of 128 patients treated with R-CHOEP-14. Interpretation In young patients with high-risk aggressive B-cell lymphoma, R-MegaCHOEP was not superior to conventional R-CHOEP therapy and was associated with significantly more toxic effects. R-CHOEP-14 with or without radiotherapy remains a treatment option for these patients, with encouraging efficacy.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schmitz, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickelsen, Maike UNSPECIFIED UNSPECIFIED UNSPECIFIED Ziepert, Marita UNSPECIFIED UNSPECIFIED UNSPECIFIED Haenel, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Borchmann, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmidt, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Viardot, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Bentz, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Peter, Norma UNSPECIFIED UNSPECIFIED UNSPECIFIED Ehninger, Gerhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Doelken, Gottfried UNSPECIFIED UNSPECIFIED UNSPECIFIED Ruebe, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Truemper, Lorenz UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenwald, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfreundschuh, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Loeffler, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Glass, Bertram UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-477743
DOI:	10.1016/S1470-2045(12)70481-3
Journal or Publication Title:	Lancet Oncol.
Volume:	13
Number:	12
Page Range:	S. 1250 - 1260
Date:	2012
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1470-2045
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NON-HODGKINS-LYMPHOMA; BONE-MARROW-TRANSPLANTATION; PLUS ETOPOSIDE MEGACHOEP; CHOP CHEMOTHERAPY; RESPONSE CRITERIA; INITIAL TREATMENT; 3-WEEKLY CHOP; PROGNOSIS; THERAPY; CYCLOPHOSPHAMIDE Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/47774