Literature DB >> 30277102

Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study.

Jeff P Sharman1, Andres Forero-Torres2, Luciano J Costa3, Ian W Flinn4, Lowell Inhorn5, Kevin Kelly6, Alberto Bessudo7, Luis E Fayad8, Mark S Kaminski9, Andrew M Evens10, Christopher R Flowers11, Deniz Sahin12, Kirsten E Mundt12, Thomas Sandmann13, Günter Fingerle-Rowson12, Charlotte Vignal12, Mehrdad Mobasher13, Andrew D Zelenetz14.   

Abstract

This study investigated the safety and efficacy of obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (G-CHOP) in patients with advanced diffuse large B-cell lymphoma (DLBCL) and explored the impact of cell-of-origin (COO) on patient outcomes. Patients (N = 100) received obinutuzumab (1000 mg on the days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-8) plus CHOP (cycles 1-6). For patients without grade ≥3 infusion-related reactions (IRRs) to standard-rate obinutuzumab infusion, a shorter duration of infusion (SDI) was evaluated. Overall and complete response rates, as determined according to the Cheson et al. criteria by investigators/independent radiological facility, were 82.0/75.0% and 55.0/58.0%, respectively. SDI of 120 minutes and 90 minutes were well tolerated with no grade ≥3 IRRs. Among all patients, IRRs typically occurred during cycle 1, day 1. G-CHOP is active and has an acceptable safety profile in the first-line treatment of patients with advanced DLBCL. Clinical Trials: NCT01414855DLBCL.

Entities:  

Keywords:  Efficacy; obinutuzumab; safety profile

Mesh:

Substances:

Year:  2018        PMID: 30277102      PMCID: PMC6445782          DOI: 10.1080/10428194.2018.1515940

Source DB:  PubMed          Journal:  Leuk Lymphoma        ISSN: 1026-8022


  32 in total

1.  Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60).

Authors:  Michael Pfreundschuh; Joerg Schubert; Marita Ziepert; Rudolf Schmits; Martin Mohren; Eva Lengfelder; Marcel Reiser; Christina Nickenig; Michael Clemens; Norma Peter; Carsten Bokemeyer; Hartmut Eimermacher; Anthony Ho; Martin Hoffmann; Roland Mertelsmann; Lorenz Trümper; Leopold Balleisen; Ruediger Liersch; Bernd Metzner; Frank Hartmann; Bertram Glass; Viola Poeschel; Norbert Schmitz; Christian Ruebe; Alfred C Feller; Markus Loeffler
Journal:  Lancet Oncol       Date:  2008-01-15       Impact factor: 41.316

2.  Immunohistochemical methods for predicting cell of origin and survival in patients with diffuse large B-cell lymphoma treated with rituximab.

Authors:  Paul N Meyer; Kai Fu; Timothy C Greiner; Lynette M Smith; Jan Delabie; Randy D Gascoyne; German Ott; Andreas Rosenwald; Rita M Braziel; Elias Campo; Julie M Vose; Georg Lenz; Louis M Staudt; Wing C Chan; Dennis D Weisenburger
Journal:  J Clin Oncol       Date:  2010-12-06       Impact factor: 44.544

3.  The revised International Prognostic Index (R-IPI) is a better predictor of outcome than the standard IPI for patients with diffuse large B-cell lymphoma treated with R-CHOP.

Authors:  Laurie H Sehn; Brian Berry; Mukesh Chhanabhai; Catherine Fitzgerald; Karamjit Gill; Paul Hoskins; Richard Klasa; Kerry J Savage; Tamara Shenkier; Judy Sutherland; Randy D Gascoyne; Joseph M Connors
Journal:  Blood       Date:  2006-11-14       Impact factor: 22.113

4.  Obinutuzumab or Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma.

Authors:  Umberto Vitolo; Marek Trněný; David Belada; John M Burke; Angelo Michele Carella; Neil Chua; Pau Abrisqueta; Judit Demeter; Ian Flinn; Xiaonan Hong; Won Seog Kim; Antonio Pinto; Yuan-Kai Shi; Yoichi Tatsumi; Mikkel Z Oestergaard; Michael Wenger; Günter Fingerle-Rowson; Olivier Catalani; Tina Nielsen; Maurizio Martelli; Laurie H Sehn
Journal:  J Clin Oncol       Date:  2017-08-10       Impact factor: 44.544

5.  Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles.

Authors:  David Cunningham; Eliza A Hawkes; Andrew Jack; Wendi Qian; Paul Smith; Paul Mouncey; Christopher Pocock; Kirit M Ardeshna; John A Radford; Andrew McMillan; John Davies; Deborah Turner; Anton Kruger; Peter Johnson; Joanna Gambell; David Linch
Journal:  Lancet       Date:  2013-04-22       Impact factor: 79.321

6.  A predictive model for aggressive non-Hodgkin's lymphoma.

Authors: 
Journal:  N Engl J Med       Date:  1993-09-30       Impact factor: 91.245

7.  Phase III safety study of rituximab administered as a 90-minute infusion in patients with previously untreated diffuse large B-cell and follicular lymphoma.

Authors:  Shaker Dakhil; Robert Hermann; Marshall T Schreeder; Stephanie A Gregory; Marc Monte; Kevin S Windsor; Deborah Hurst; Akiko Chai; Michael Brewster; Paul Richards
Journal:  Leuk Lymphoma       Date:  2014-03-07

8.  Combination chemotherapy ("CHOP-Bleo") in advanced (non-Hodgkin) malignant lymphoma.

Authors:  V Rodriguez; F Cabanillas; M A Burgess; E M McKelvey; M Valdivieso; G P Bodey; E J Freireich
Journal:  Blood       Date:  1977-03       Impact factor: 22.113

9.  Obinutuzumab for the First-Line Treatment of Follicular Lymphoma.

Authors:  Robert Marcus; Andrew Davies; Kiyoshi Ando; Wolfram Klapper; Stephen Opat; Carolyn Owen; Elizabeth Phillips; Randeep Sangha; Rudolf Schlag; John F Seymour; William Townsend; Marek Trněný; Michael Wenger; Günter Fingerle-Rowson; Kaspar Rufibach; Tom Moore; Michael Herold; Wolfgang Hiddemann
Journal:  N Engl J Med       Date:  2017-10-05       Impact factor: 91.245

10.  Poor concordance among nine immunohistochemistry classifiers of cell-of-origin for diffuse large B-cell lymphoma: implications for therapeutic strategies.

Authors:  Rita Coutinho; Andrew James Clear; Andrew Owen; Andrew Wilson; Janet Matthews; Abigail Lee; Rute Alvarez; Maria Gomes da Silva; José Cabeçadas; Maria Calaminici; John G Gribben
Journal:  Clin Cancer Res       Date:  2013-10-11       Impact factor: 12.531

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  4 in total

1.  A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA.

Authors:  Laurie H Sehn; Maurizio Martelli; Marek Trněný; Wenxin Liu; Christopher R Bolen; Andrea Knapp; Deniz Sahin; Gila Sellam; Umberto Vitolo
Journal:  J Hematol Oncol       Date:  2020-06-06       Impact factor: 17.388

2.  Real world risk of infusion reactions and effectiveness of front-line obinutuzumab plus chlorambucil compared with other frontline treatments for chronic lymphocytic leukemia.

Authors:  Nicole Bourrier; Ivan Landego; Oliver Bucher; Mandy Squires; Erin Streu; Irena Hibbert; Theresa Whiteside; Spencer B Gibson; Marc Geirnaert; James B Johnston; David E Dawe; Versha Banerji
Journal:  BMC Cancer       Date:  2022-02-06       Impact factor: 4.430

Review 3.  Immune targeted therapy for diffuse large B cell lymphoma.

Authors:  Yaxin Zheng; Junqi Si; Tian Yuan; Sa Ding; Chen Tian
Journal:  Blood Sci       Date:  2021-10-29

4.  Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study.

Authors:  Ekaterina Gibiansky; Leonid Gibiansky; Vincent Buchheit; Nicolas Frey; Michael Brewster; Günter Fingerle-Rowson; Candice Jamois
Journal:  Br J Clin Pharmacol       Date:  2019-07-12       Impact factor: 4.335

  4 in total

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