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RICOVER-noRTh

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LHA ID: 7WEYGQT00G-0

Projects: GLA - German Lymphoma Alliance

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Creators and Submitter

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Marita Ziepert

Submitter

René Hänsel

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Views: 2038

Created: 16th May 2019 at 14:02

Last updated: 16th May 2019 at 14:02

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GLA - German Lymphoma Alliance

B-cell lymphoma is the most frequent lymphoid neoplasia accounting for one third of all lymphomas. R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) is the current treatment standard, leading to high cure rates especially in younger patients. Although the 3-year event-free survival is about 60% even for elderly patients between 60-80 years old, the remainder of patients eventually relapse and the majority die of their disease. The German Non-Hodgkin's Lymphoma Study ...

Programme: NHL

Public web page: https://www.dshnhl.org

Organisms: Homo sapiens

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

RICOVER-noRTh

GLA - German Lymphoma Alliance

All creators

Marita Ziepert

Demographics, reference pathology diagnosis, Outcome (Event-free survival, Progression-free survival, Overall survival)

Submitter: René Hänsel

Investigation: RICOVER-noRTh

Resources: RICOVER-noRTh metadata, RICOVER-noRTh trial data

Study type: Not specified

Snapshots: No snapshots

Created: 16th May 2019 at 15:43, Last updated: 16th May 2019 at 15:43

RICOVER-noRTh trial data

GLA - German Lymphoma Alliance

All creators

Marita Ziepert

Demographics, reference pathology diagnosis, Outcome (Event-free survival, Progression-free survival, Overall survival)

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: RICOVER-noRTh

Study: RICOVER-noRTh

Human Diseases: B-cell lymphoma

Data files: RICOVER-noRTh trial data-CSV, RICOVER-noRTh trial data-ODM, RICOVER-noRTh trial data-SPSS

Snapshots: No snapshots

Created: 16th May 2019 at 15:46, Last updated: 29th Oct 2019 at 10:56

RICOVER-noRTh metadata

GLA - German Lymphoma Alliance

All creators

Marita Ziepert

No description specified

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: RICOVER-noRTh

Study: RICOVER-noRTh

Human Diseases: B-cell lymphoma

Data files: RICOVER-noRTh metadata-ODM, RICOVER-noRTh metadata-XLSX

Snapshots: No snapshots

Created: 16th May 2019 at 15:44, Last updated: 29th Oct 2019 at 10:56

Obesity negatively impacts outcome in elderly female patients with aggressive B-cell lymphomas treated with R-CHOP: results from prospective trials of the German high grade non-Hodgkin's lymphoma trial group.

GLA - German Lymphoma Alliance

(Show All)

All authors

Markus Löffler

Bettina Altmann

Marita Ziepert

Abstract (Expand)

To study if obesity is a risk factor in elderly patients (>60 years) with aggressive B-cell lymphoma, the outcomes of 576 elderly patients treated with rituximab in the RICOVER-60 trial were analysed … in a retrospective study with regard to body mass index (BMI) and gender. Of the 576 patients, 1% had low body weight (BMI < 18.5), 38% were normal weight (18.5 </= BMI < 25), 42% were overweight (25 </= BMI < 30) and 19% were obese (BMI >/= 30). Event-free (EFS), progression-free (PFS) and overall survival (OS) according to BMI showed no significant differences for all and for male patients. EFS (P = 0.041), PFS (P = 0.038) and OS (P = 0.031) were significantly better for female non-obese patients. A multivariate analysis adjusted for International Prognostic Index risk factors confirmed these results, with the following hazard ratios (HR) for obesity (BMI >/= 30) for EFS/PFS/OS: all patients - 1.4/1.4/1.4 (not significant); male patients - 1.2/1.2/1.0 (not significant) and female patients - 1.7 (P = 0.032)/1.9 (P = 0.022)/2.0 (P = 0.017). In conclusion, obesity is a risk factor that influences treatment outcome in elderly female patients with aggressive B-cell lymphoma treated with R-CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, prednisolone). The inferior outcomes in obese female patients may be due to faster rituximab clearance in obese females.

Authors: K. Hohloch, B. Altmann, M. Pfreundschuh, M. Loeffler, N. Schmitz, F. Zettl, M. Ziepert, L. Trumper

Date Published: 2nd Dec 2017

Publication Type: Not specified

Human Diseases: obesity, B-cell lymphoma

PubMed ID: 29193018

Citation: Br J Haematol. 2018 Jan;180(2):236-245. doi: 10.1111/bjh.15029. Epub 2017 Nov 28.

Created: 17th Apr 2019 at 12:58, Last updated: 7th Dec 2021 at 17:58

Vitamin D deficiency impairs rituximab-mediated cellular cytotoxicity and outcome of patients with diffuse large B-cell lymphoma treated with but not without rituximab.

GLA - German Lymphoma Alliance

All authors

Bettina Altmann

Marita Ziepert

Abstract (Expand)

PURPOSE: To investigate the impact and mechanisms of vitamin D deficiency (VDD) on the outcome of elderly patients with diffuse large B-cell lymphoma (DLBCL). PATIENTS AND METHODS: Three hundred … fifty-nine pretreatment 25-hydroxyvitamin D3 (25[OH]D3) serum levels from the RICOVER-60 study (Six Versus Eight Cycles of Biweekly CHOP-14 With or Without Rituximab in Elderly Patients With Aggressive CD20+ B-Cell Lymphomas) and 63 from the RICOVER-noRTh study (an amendment to the RICOVER-60 study in which patients received six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone administered at an interval of 2 weeks plus two cycles of rituximab [R-CHOP-14], but without radiotherapy) were determined by chemoluminescent immunoassay. Rituximab-mediated cellular cytotoxicity (RMCC) was assessed by lactate dehydrogenase release assay of CD20+ Daudi cells. RESULTS: RICOVER-60 patients with VDD (</= 8 ng/mL) and vitamin D levels more than 8 ng/mL treated with rituximab had 3-year event-free survival (EFS) of 59% and 79% and 3-year overall survival (OS) of 70% and 82%, respectively. These differences were significant in a multivariable analysis adjusting for International Prognostic Index risk factors with a hazard ratio (HR) of 2.1 (P = .008) for EFS and 1.9 (P = .040) for OS. EFS was not significantly different in patients with vitamin D levels </= 8 or more than 8 ng/mL (HR, 1.2; P = .388) treated without rituximab. This was confirmed in an independent validation set of 63 RICOVER-noRTh patients. RMCC increased significantly (P < .001) in seven of seven individuals with VDD after substitution and normalization of their vitamin D levels. CONCLUSION: VDD is a risk factor for elderly patients with DLBCL treated with R-CHOP. That VDD impairs RMCC and substitution improves RMCC strongly suggests that vitamin D substitution enhances rituximab efficacy, which must be confirmed in appropriately designed prospective trials addressing VDD and substitution not only in DLBCL, but also in malignancies treated with other antibodies, of which the major mechanism of action is antibody-dependent cellular cytotoxicity (eg, trastuzumab in breast cancer and cetuximab in colorectal cancer).

Authors: J. T. Bittenbring, F. Neumann, B. Altmann, M. Achenbach, J. Reichrath, M. Ziepert, J. Geisel, E. Regitz, G. Held, M. Pfreundschuh

Date Published: 10th Oct 2014

Publication Type: Not specified

Human Diseases: diffuse large B-cell lymphoma

PubMed ID: 25135997

Citation: J Clin Oncol. 2014 Oct 10;32(29):3242-8. doi: 10.1200/JCO.2013.53.4537. Epub 2014 Aug 18.

Created: 17th Apr 2019 at 12:05, Last updated: 7th Dec 2021 at 17:58

Elevated serum free light chains do not predict outcome of elderly patients with aggressive CD20(+) B-cell lymphomas.

GLA - German Lymphoma Alliance

All authors

Bettina Altmann

Marita Ziepert

Abstract

Not specified

Authors: M. Achenbach, J. T. Bittenbring, M. Ziepert, E. Regitz, G. Ott, A. Rosenwald, M. Pfreundschuh, B. Altmann, G. Held

Date Published: 1st Jul 2014

Publication Type: Not specified

Human Diseases: B-cell lymphoma

PubMed ID: 24974897

Citation: Br J Haematol. 2014 Nov;167(3):430-4. doi: 10.1111/bjh.13001. Epub 2014 Jun 27.

Created: 16th Apr 2019 at 15:02, Last updated: 7th Dec 2021 at 17:58

Suboptimal dosing of rituximab in male and female patients with DLBCL.

GLA - German Lymphoma Alliance

All authors

Samira Zeynalova

Abstract (Expand)

To determine the effect of gender on outcome, the male hazard ratio for progression-free survival (HRPFS-male) was determined in patients with diffuse large B-cell lymphoma (DLBCL). In young patients … (MapThera International Trial study), HRPFS-male was 1.3 (P = .092) without and 1.1 (P = .660) with rituximab. In elderly patients (RICOVER-60 study), HRPFS-male was 1.1 (P = .348) with CHOP but increased to 1.6 (P = .004) with R-CHOP. The similar improvements of outcome in young patients were associated with similar rituximab clearances in young males and females (9.89 vs 10.38 mL/h; P = .238), whereas the greater benefit for elderly females was associated with a slower rituximab clearance (8.47 vs 10.59 mL/h; P = .005) and hence higher serum levels and longer exposure times, attributable to an age-dependent (P = .004) decrease of rituximab clearance in females but not males. Compared with elderly females, all other subgroups had significantly faster rituximab clearances and hence appear to be suboptimally dosed when rituximab is given at 375 mg/m(2). Although early results of pharmacokinetic-based prospective trials designed to exploit the full therapeutic potential of rituximab suggest that increased doses and/or prolonged exposure times can improve the outcome of elderly males with DLBCL, further studies are warranted that address the optimization of rituximab dose and schedule in all subgroups of DLBCL patients.

Authors: M. Pfreundschuh, C. Muller, S. Zeynalova, E. Kuhnt, M. H. Wiesen, G. Held, T. Rixecker, V. Poeschel, C. Zwick, M. Reiser, N. Schmitz, N. Murawski