Evidence map›Paper›PMID 26232170›Full record

Trial reportBlood2015

Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL.

Fritz Offner, Olga Samoilova, Evgenii Osmanov, Hyeon-Seok Eom, Max S Topp, João Raposo, Viacheslav Pavlov, Deborah Ricci, Shalini Chaturvedi, Eugene Zhu and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01040871 (A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma), which is not on this map. Cited by 64 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 4 pooled it
11.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01040871 phase2completednot on this map

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

TypeinterventionalSponsorMillennium Pharmaceuticals, Inc.Ran2010 to 2012Enrolled164ConditionsDiffuse Large B-Cell LymphomaArmsVELCADE, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 4 syntheses or guidelines pooled it, 135 citations in OpenAlex.

  1. Pooled it
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  4. International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017).Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Guideline
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  10. Cost-effectiveness of HLX01 (HanlikangFrontiers in pharmacology · 2025
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 7 countries.

Fritz OffnerDepartment of Hematology, University Hospital Ghent, Ghent, Belgium;
Olga SamoilovaNizhniy Novgorod Region Clinical Hospital, Nizhniy Novgorod, Russian Federation;
Evgenii OsmanovN.N. Blokhin Cancer Research Center, Russian Academy of National Sciences, Moscow, Russian Federation;
Hyeon-Seok EomNational Cancer Center, Goyang Gyeonggi, Republic of Korea;
Max S ToppMedizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany;
João RaposoServicio de Hematologia, Santa Maria Hospital, Lisbon, Portugal;
Viacheslav PavlovMedical Scientific Radiology Center, Obninsk, Russian Federation;
Deborah RicciJanssen Research & Development, LLC, Raritan, NJ;
Shalini ChaturvediJanssen Research & Development, LLC, Spring House, PA;
Eugene ZhuJanssen Research & Development, LLC, Raritan, NJ;
Helgi van de VeldeJanssen Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium; and.
Christopher EnnyJanssen Research & Development, LLC, Raritan, NJ;
Aleksandra RizoJanssen Research & Development, LLC, Raritan, NJ;
Burhan FerhanogluDepartment of Internal Medicine, Division of Hematology, Koc University, Istanbul, Turkey.
Janssen (United States) · USGhent University Hospital · BEHospital de Santa Maria · PTJanssen (Belgium) · BEKoç University · TRMedical Radiological Research Center · RUNational Cancer Center · KRNizhny Novgorod Regional Clinical Hospital named after Semashko · RURussian Cancer Research Center NN Blokhin · RUUniversitätsklinikum Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 2 study evaluated whether substituting bortezomib for vincristine in frontline rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) therapy could improve efficacy in non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL), centrally confirmed by immunohistochemistry (Hans method). In total, 164 patients were randomized 1:1 to receive six 21-day cycles of rituximab 375 mg/m(2), cyclophosphamide 750 mg/m(2), and doxorubicin 50 mg/m(2), all IV day 1, prednisone 100 mg/m(2) orally days 1-5, plus either bortezomib 1.3 mg/m(2) IV days 1, 4, 8, 11 (rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib [VR-CAP]; n = 84) or vincristine 1.4 mg/m(2) (maximum 2 mg) IV day 1 (R-CHOP; n = 80). There were no significant differences between VR-CAP and R-CHOP in complete response rate (64.5%, 66.2%; odds ratio [OR], 0.91; P = .80), overall response rate (93.4%, 98.6%; OR, 0.21; P = .11), progression-free survival (hazard ratio [HR], 1.12; P = .76), or overall survival (HR, 0.89; P = .75). Rates of grade ≥3 adverse events (AEs; 88%, 89%), serious AEs (38%, 34%), discontinuations due to AEs (7%, 3%), and deaths due to AEs (2%, 5%) were similar with VR-CAP and R-CHOP. Grade ≥3 peripheral neuropathy rates were 6% and 3%, respectively. VR-CAP did not improve efficacy vs R-CHOP in non-GCB DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT01040871.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBortezomibCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPrednisoneRituximabAntibodies, Monoclonal, Murine-DerivedBortezomibCyclophosphamideDoxorubicinPrednisoneR-CHOP protocolRituximabVincristine

Identifiers

PMID26232170
PMCPMC4616024
OpenAlexW1094999820

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.