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DC Field | Value | Language |
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dc.contributor.author | Moore T. | en |
dc.contributor.author | Seymour J.F. | en |
dc.contributor.author | Townsend W. | en |
dc.contributor.author | Trneny M. | en |
dc.contributor.author | Wenger M. | en |
dc.contributor.author | Fingerle-Rowson G. | en |
dc.contributor.author | Rufibach K. | en |
dc.contributor.author | Herold M. | en |
dc.contributor.author | Hiddemann W. | en |
dc.contributor.author | Marcus R. | en |
dc.contributor.author | Davies A. | en |
dc.contributor.author | Ando K. | en |
dc.contributor.author | Klapper W. | en |
dc.contributor.author | Opat S. | en |
dc.contributor.author | Owen C. | en |
dc.contributor.author | Phillips E. | en |
dc.contributor.author | Sangha R. | en |
dc.contributor.author | Schlag R. | en |
dc.date.accessioned | 2021-05-14T13:13:21Z | en |
dc.date.available | 2021-05-14T13:13:21Z | en |
dc.date.copyright | 2017 | en |
dc.date.created | 20171012 | en |
dc.date.issued | 2017-10-12 | en |
dc.identifier.citation | New England Journal of Medicine. 377 (14) (pp 1331-1344), 2017. Date of Publication: 05 Oct 2017. | en |
dc.identifier.issn | 0028-4793 | en |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/38731 | en |
dc.description.abstract | BACKGROUND: Rituximab-based immunochemotherapy has improved outcomes in patients with follicular lymphoma. Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody. We compared rituximab-based chemotherapy with obinutuzumab-based chemotherapy in patients with previously untreated advanced-stage follicular lymphoma. METHOD(S): We randomly assigned patients to undergo induction treatment with obinutuzumab-based chemotherapy or rituximab-based chemotherapy. Patients with a response received maintenance treatment for up to 2 years with the same antibody that they had received in induction. The primary end point was investigator-assessed progression-free survival. RESULTS: A total of 1202 patients with follicular lymphoma underwent randomization (601 patients in each group). After a median follow-up of 34.5 months (range, 0 to 54.5), a planned interim analysis showed that obinutuzumab-based chemotherapy resulted in a significantly lower risk of progression, relapse, or death than rituximab-based chemotherapy (estimated 3-year rate of progression-free survival, 80.0% vs. 73.3%; hazard ratio for progression, relapse, or death, 0.66; 95% confidence interval [CI], 0.51 to 0.85; P=0.001). Similar results were seen with regard to independently reviewed progression-free survival and other time-to-event end points. Response rates were similar in the two groups (88.5% in the obinutuzumab group and 86.9% in the rituximab group). Adverse events of grade 3 to 5 were more frequent in the obinutuzumab group than in the rituximab group (74.6% vs. 67.8%), as were serious adverse events (46.1% vs. 39.9%). The rates of adverse events resulting in death were similar in the two groups (4.0% in the obinutuzumab group and 3.4% in the rituximab group). The most common adverse events were infusion-related events that were considered by the investigators to be largely due to obinutuzumab in 353 of 595 patients (59.3%; 95% CI, 55.3 to 63.2) and to rituximab in 292 of 597 patients (48.9%; 95% CI, 44.9 to 52.9; P<0.001). Nausea and neutropenia were common. A total of 35 patients (5.8%) in the obinutuzumab group and 46 (7.7%) in the rituximab group died. CONCLUSION(S): Obinutuzumab-based immunochemotherapy and maintenance therapy resulted in longer progression-free survival than rituximab-based therapy. High-grade adverse events were more common with obinutuzumab-based chemotherapy.Copyright © 2017 Massachusetts Medical Society. | en |
dc.language | English | en |
dc.language | en | en |
dc.publisher | Massachussetts Medical Society | en |
dc.relation.ispartof | New England Journal of Medicine | en |
dc.title | Obinutuzumab for the first-line treatment of follicular lymphoma. | en |
dc.type | Article | en |
dc.type.studyortrial | Randomised controlled trial | - |
dc.identifier.doi | http://monash.idm.oclc.org/login?url=http://acs.hcn.com.au/?acc=36265&url=http://dx.doi.org/10.1056/NEJMoa1614598 | en |
dc.publisher.place | United States | en |
dc.identifier.pubmedid | 28976863 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28976863] | en |
dc.identifier.source | 618525534 | en |
dc.identifier.institution | (Marcus) King's College Hospital, London, United Kingdom (Phillips, Townsend) Cancer Research UK, University College London Cancer Trials Centre, London, United Kingdom (Davies) Cancer Research UK Centre, University of Southampton, Southampton, United Kingdom (Ando) Tokai University School of Medicine, Isehara, Japan (Klapper) University of Kiel, Kiel, Germany (Schlag) Gemeinschaftspraxis, Wurzburg, Germany (Herold) HELIOS Klinikum Erfurt, Erfurt, Germany (Hiddemann) Ludwig-Maximilians-University Hospital Grosshadern, Munich, Germany (Opat) Monash Health and Monash University, Australia (Seymour) Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia (Owen) Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB, Canada (Sangha) Cross Cancer Institute, Edmonton, AB, Canada (Trneny) Charles University, Prague, Czechia (Wenger, Fingerle-Rowson, Rufibach, Moore) F. Hoffmann-La Roche, Basel, Switzerland | en |
dc.description.address | R. Marcus, King's College Hospital, Denmark Hill, London SE5 9RS, United Kingdom. E-mail: marcus.re@googlemail.com | en |
dc.description.publicationstatus | Embase | en |
dc.rights.statement | Copyright 2017 Elsevier B.V., All rights reserved. | en |
dc.identifier.authoremail | Marcus R.; marcus.re@googlemail.com | en |
dc.description.grant | Organization: *AbbVie* Organization No: 100006483 Country: United States Organization: *Amgen* Organization No: 100002429 Country: United States Organization: *Bayer* Organization No: 100004326 Country: Germany Organization: *Celgene* Organization No: 100006436 Country: United States No: NCT01332968 Organization: *F. Hoffmann-La Roche* Organization No: 100007013 Country: Switzerland Organization: *F. Hoffmann-La Roche* Organization No: 100007013 Country: Switzerland Organization: *Gilead Sciences* Organization No: 100005564 Country: United States Organization: (GSK) *GlaxoSmithKline* Organization No: 100004330 Country: United Kingdom Organization: *Janssen Pharmaceuticals* Organization No: 100008897 Country: United States Organization: *Lundbeckfonden* Organization No: 501100003554 Country: Denmark Organization: *Novartis* Organization No: 100004336 Country: Switzerland Organization: *Roche* Organization No: 100004337 Country: Switzerland Organization: (TPUSA) *Takeda Pharmaceuticals U.S.A.* Organization No: 100007723 Country: United States | en |
item.cerifentitytype | Publications | - |
item.fulltext | No Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | none | - |
item.openairetype | Article | - |
crisitem.author.dept | Oncology | - |
crisitem.author.dept | Haematology | - |
Appears in Collections: | Articles |
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