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24 Publications visible to you, out of a total of 24
CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group.
GLA - German Lymphoma Alliance

Abstract (Expand)

BACKGROUND: The role of rituximab in combination with different CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse … large-B-cell lymphoma remains to be defined. We aimed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients. METHODS: 824 patients who were from 18 countries; aged 18-60 years; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index (IPI), stage II-IV disease, or stage I disease with bulk were enrolled. These patients were randomly assigned to six cycles of CHOP-like chemotherapy and rituximab (n=413) or to six cycles of CHOP-like chemotherapy alone (n=411). Bulky and extranodal sites received additional radiotherapy. The primary endpoint was event-free survival; secondary endpoints were response, progression under therapy, progression-free survival, overall survival, and frequency of toxic effects. Analyses were done by intention to treat and per protocol. This trial is registered at http://www.clinicaltrials.gov, NCT 00064116. FINDINGS: After a median follow-up of 34 months (range 0.03-61), patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone (79% [95% CI 75-83] vs 59% [54-64]; difference between groups 20% [13-27], log-rank p<0.0001), and had increased 3-year overall survival (93% [90-95] vs 84% [80-88]; difference between groups 9% [3-13], log-rank p=0.0001). Event-free survival was affected by treatment group, presence of bulky disease, and age-adjusted IPI: after chemotherapy and rituximab, a favourable subgroup (ie, IPI=0, no bulk) could be defined from a less-favourable subgroup (ie, IPI=1 or bulk, or both). Groups did not differ in the frequency of adverse events. INTERPRETATION: Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma. The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients.

Authors: M. Pfreundschuh, L. Trumper, A. Osterborg, R. Pettengell, M. Trneny, K. Imrie, D. Ma, D. Gill, J. Walewski, P. L. Zinzani, R. Stahel, S. Kvaloy, O. Shpilberg, U. Jaeger, M. Hansen, T. Lehtinen, A. Lopez-Guillermo, C. Corrado, A. Scheliga, N. Milpied, M. Mendila, M. Rashford, E. Kuhnt, M. Loeffler

Date Published: 2nd May 2006

Publication Type: Not specified

Human Diseases: non-Hodgkin lymphoma, diffuse large B-cell lymphoma

Practicability and acute haematological toxicity of 2- and 3-weekly CHOP and CHOEP chemotherapy for aggressive non-Hodgkin's lymphoma: results from the NHL-B trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).
GLA - German Lymphoma Alliance

Abstract (Expand)

BACKGROUND: There is evidence that intensified variants of the classical 3-weekly CHOP-21 chemotherapy [cyclophosphamide (C), doxorubicin (H), vincristine (O), prednisone (P)] may improve treatment … outcome in aggressive lymphoma. Three variants using either an addition of etoposide (CHOEP-21: 100 mg/m(2) on days 1-3), the shortening to 2-week intervals using recombinant human granulocyte colony-stimulating factor (rhG-CSF; CHOP-14) or both (CHOEP-14) are currently compared with CHOP-21 in the NHL-B trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). To enable more extensive testing of these schemes we here characterise their practicability regarding schedule adherence, acute haematotoxicity and need for supportive treatment. PATIENTS AND METHODS: The trial included patients with normal lactate dehydrogenase (LDH) aged </=60 years (NHL-B1) and patients aged 61-75 years (NHL-B2). The data are taken from an interim analysis. Data from 959 patients (CHOP-21: 232; CHOP-14: 238; CHOEP-21: 244; CHOEP-14: 245) from 162 institutions with a total of 5331 therapy cycles were evaluated. RESULTS: The dose adherence in the NHL-B1 trial was excellent. The median relative dose (RD; i.e. actually given compared to planned dose) exceeds 98% for the myelosuppressive drugs in all four regimens. Only </=5% of patients received a relative dose <80% (RD <80). The median treatment duration could be shortened as scheduled for both CHOP-14 by 36 days and CHOEP-14 by 35 days. The dose adherence in the NHL-B2 trial was excellent for CHOP-21 and CHOP-14 for the myelosuppressive drugs (median RD >/=98%, RD <80 </=15%). Addition of etoposide, however, was accompanied by more dose erosion (median RD >/=97%, RD <80 </=17% for CHOEP-21 and </=27% for CHOEP-14). The median treatment duration could be shortened by 34 days with CHOP-14 compared with CHOP-21. Less treatment shortening was feasible for CHOEP-14 compared with CHOP-21 (median of 29 days). CHOP-14 and CHOP-21 were similar regarding toxicity profile, rate of infection, use of antibiotics, rate of transfusions and hospitalisation. CHOEP schemes were associated with a higher rate of infections, more transfusion requirements, more antibiotic use and longer hospitalisation than the CHOP schemes, particularly in patients aged >60 years. Haematopoietic recovery was age- and treatment-related. CONCLUSIONS: CHOP-14 with the addition of rhG-CSF is safe and practicable in a large multicentre setting in patients aged 18-75 years. Despite shorter treatment intervals it can be delivered at the same dose as the classical 3-weekly CHOP with a comparable toxicity profile. The addition of etoposide is feasible and safe for patients </=60 years old in both the CHOEP-21 and CHOEP-14 schemes. For patients >60 years of age the addition of etoposide is associated with marked dose erosion due to increased toxicity. In this age group CHOEP should be used with caution.

Authors: A. Wunderlich, M. Kloess, M. Reiser, C. Rudolph, L. Truemper, S. Bittner, H. Schmalenberg, R. Schmits, M. Pfreundschuh, M. Loeffler

Date Published: 11th Jun 2003

Publication Type: Not specified

Human Diseases: non-Hodgkin lymphoma

Consolidation radiotherapy to bulky disease in aggressive NHL. First results of the NHL B-94 trial of the DSHNHL.
GLA - German Lymphoma Alliance

Abstract (Expand)

The impact of radiotherapy in aggressive NHL is not well defined. In the NHL B-94 trial of the DSHNHL, an irradiation of bulky disease areas was done after completing 6 cycles of CHOP/CHOEP chemotherapy. … In the entire patient group, including those patients with extranodal disease and those who did not receive the complete chemotherapy, bulky disease was a significant independent prognostic factor concerning recurrence-free survival (66.1% (no bulk) vs. 53.3% (bulk), p=0.0001). Out of 366 patients with nodal disease only and 6 cycles of chemotherapy according to the protocol, 84 of 91 patients with bulky disease were irradiated with 36 Gy. In this group of patients the prognostic impact of bulky disease could not be shown any longer (recurrence-free survival 77.3% (no bulk) vs. 74.1% (bulk). Localized radiotherapy of bulky disease areas may therefore have contributed to an improvement in outcome in this high-risk group.

Authors: C. Rube, T. P. Nguyen, M. Kloss, M. Loeffler, L. Trumper, M. Pfreunschuh

Date Published: 5th Jan 2002

Publication Type: Not specified

Human Diseases: non-Hodgkin lymphoma

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