Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis.

Gisselbrecht, Christian; Glaß, Bertram; Laurent, G.; Gill, Devinder; Linch, Mark; Trněný, Marek; Bron, Dominique; Shpilberg, Ofer; Hagberg, H; Bargetzi, Mario; Ma, Deliang; Brière, Josette; Moskowitz, Craig H.; Schmitz, N.

doi:10.1200/jco.2011.29.15_suppl.8004

Cited by 19 publications

(10 citation statements)

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“…Another important issue that needs clarification is related to maintenance therapy after transplant. While the CORAL study has reported the failure of rituximab maintenance in NHL 9 , the AETHERA study has demonstrated success with brentuximab after ASCT in HL. [62] Finally, in an era of inexpensive high-throughput sequencing, in which diagnostics technology and basic sciences are providing a deep and comprehensive picture of these diseases, we do not have a biomarker able to provide us guidance in the choice of treatment; be it salvage, preparative, or maintenance.…”

Section: Discussionmentioning

confidence: 95%

“…The Collaborative Trial in the Relapsed Aggressive Lymphoma (CORAL) study, in patients with diffuse large B-cell lymphoma (DLBCL), reported a four-year EFS of 53% in 477 patients receiving high-dose carmustine, etoposide, cytarabine and melphalan (BEAM) followed by ASCT. [9] Subsequently, the LY.12 study, in 619 patients with aggressive lymphomas, reported ORRs of around 45% following ASCT. [10] Finally, the ORCHARRD study, in 447 patients with DLBCL, reported a 2-year EFS of around 15% and two-year OS of around 40% following ASCT.…”

Section: Introductionmentioning

confidence: 99%

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Novel regimens prior to autologous stem cell transplantation for the management of adults with relapsed/refractory non-Hodgkin lymphoma and Hodgkin lymphoma: alternatives to BEAM conditioning

Isidori¹,

Christofides

Visani³

2016

Leukemia & Lymphoma

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High-dose therapy (HDT) followed by autologous stem cell transplant (ASCT) is the standard treatment for relapsed or refractory non-Hodgkin and Hodgkin lymphoma. Until recently, carmustine, etoposide, cytarabine and melphalan (BEAM) was the most commonly used conditioning regimen in this setting, given its acceptable efficacy and tolerability. Despite reasonable success with BEAM, carmustine is associated with a number of acute and late toxicities. Moreover, recent supply and cost issues for this agent have created an urgent need for alternative conditioning regimens. As such, etoposide and melphalan (VP16/MEL) or busulfan, cyclophosphamide, and etoposide (BuCyE) are currently being used with limited success. A number of novel conditioning regimens that replace carmustine with other agents are under investigation, which may provide effective alternatives to BEAM. In considering novel agents to replace carmustine, bendamustine may provide the best alternative, as demonstrated by the results of a number of phase II, multicenter, controlled studies.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

Novel regimens prior to autologous stem cell transplantation for the management of adults with relapsed/refractory non-Hodgkin lymphoma and Hodgkin lymphoma: alternatives to BEAM conditioning

Isidori¹,

Christofides

Visani³

2016

Leukemia & Lymphoma

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“…That rituximab pharmacokinetics might also have an impact on outcome when combined with chemotherapy regimens other than CHOP-14 is suggested by a recent observation of patients with relapsed DLBCL, in whom rituximab maintenance treatment had a beneficial effect in younger (18-65 years of age) females, but not in males. 30 Because of this and to address the role of lower rituximab serum levels in male patients, a phase 2 study, the SEXIE-R-CHOP-14 study of the DSHNHL, is currently ongoing. This trial is investigating whether male patients receiving a dose of 500 mg/m 2 per cycle achieve serum levels similar to those observed in female patients receiving the standard dose of 375 mg/m 2 , and whether the increased rituximab dose translates into better results in elderly male patients with DLBCL.…”

Section: Discussionmentioning

confidence: 99%

The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL

Müller

Murawski

Wiesen

et al. 2012

Blood

216

183

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Pharmacokinetics of 8 doses of rituximab (375 mg/m 2 ) given in combination with 2-week cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisone/ prednisolone (CHOP-14) was determined by ELISA in 20 elderly patients with diffuse large B-cell lymphoma (DLBCL) 10 minutes before and after each infusion and 1 week and 1, 2, 3, 6, and 9 months after the last infusion. Population pharmacokinetic modeling was performed with nonlinear mixed-effect modeling software (NONMEM VI). Concentration-time data were fitted into an open 2-compartment model and total clearance, central compartment volume, intercompartment clearance, and volume of distribution at steady-state (Vd ss ) were investigated. Total clearance was 9.43 mL/h and Vd ss was 9.61 l. Rituximab clearance was reduced (8.21 mL/h vs 12.68 mL/h; P ‫؍‬ .003) and elimination half-life was prolonged in women compared with men (t 1/2␤ ‫؍‬ 30.7 vs 24.7 days; P ‫؍‬ .003). Body weight also affected Vd ss (0.1 l increase of Vd ss per kilogram above median of 75 kg). A sexdependent effect and the higher weight of males contribute to their faster rituximab clearance, which might explain why elderly males benefit less from the addition of rituximab to CHOP than females. This trial was registered on www.clinicaltrials. gov as numbers NCT00052936, EU-20243

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“…The patients studied in the present biologic analyses were a subset of the 477 patients analyzed in the CORAL study, 15 which enrolled patients aged 18 to 65 years of age who presented a relapsed/refractory CD20 ϩ DLBCL to compare the efficacy of R-ICE and R-DHAP followed by HDT/ASCT (part 1) and to test maintenance with or without rituximab (part 2). The study was registered under European Union Drug Regulating Authorities Clinical Trials (EudraCT; no.…”

Section: Methodsmentioning

confidence: 99%

MYC + diffuse large B-cell lymphoma is not salvaged by classical R-ICE or R-DHAP followed by BEAM plus autologous stem cell transplantation

Cuccuini

Brière

Mounier

et al. 2012

Blood

147

116

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Approximately 5-10% of diffuse large Bcell lymphomas (DLBCL) harbor a 8q24/ MYC rearrangement (MYC ؉ ). We determined the prognostic significance of MYC rearrangement in patients with relapsed/ refractory DLBCL prospectively treated by R-ICE or R-DHAP followed by highdose therapy and autologous stem cell transplantation. Twenty-eight (17%) of the 161 patients analyzed presented a MYC ؉ rearrangement, targeted as either simple hit (25%) or complex hits (n‫)%57؍‬ including MYC/BCL2, MYC/BCL6, and MYC/ BCL2/BCL6. Results were statistically highly concordant in matched primary and relapsed biopsies (n ‫؍‬ 45). Compared to the MYC ؊ DLBCL patients, the MYC ؉ DLBCL patients presented with a more elevated lactico-deshydrogenase level (P ‫؍‬ .0006) and a more advanced age adjusted international prognostic index (P ‫؍‬ .0039). The 4-year PFS and OS were significantly lower in the MYC ؉ DLBCL patients than those in the MYC ؊ DLBCL patients, with rates of 18% vs 42% (P ‫؍‬ .0322), and of 29% vs 62% (P ‫؍‬ .0113), respectively. Type of treatment, R-DHAP or R-ICE, had no impact on survivals, with 4-year PFS rates of 17% vs 19% and 4-year OS rates of 26% vs 31%. In conclusion, MYC rearrangement is an early event in DLBCL. MYC ؉ DLBCL patients have a significant inferior prognosis than MYC ؊ DLBCL patients. Their outcome was not influenced by the proposed salvage therapy.

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Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis.

Cited by 19 publications

References 0 publications

Novel regimens prior to autologous stem cell transplantation for the management of adults with relapsed/refractory non-Hodgkin lymphoma and Hodgkin lymphoma: alternatives to BEAM conditioning

Novel regimens prior to autologous stem cell transplantation for the management of adults with relapsed/refractory non-Hodgkin lymphoma and Hodgkin lymphoma: alternatives to BEAM conditioning

The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL

MYC + diffuse large B-cell lymphoma is not salvaged by classical R-ICE or R-DHAP followed by BEAM plus autologous stem cell transplantation

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