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Title: | Obinutuzumab for the first-line treatment of follicular lymphoma. | Authors: | Moore T.;Seymour J.F.;Townsend W.;Trneny M.;Wenger M.;Fingerle-Rowson G.;Rufibach K.;Herold M.;Hiddemann W.;Marcus R.;Davies A. ;Ando K.;Klapper W.;Opat S. ;Owen C.;Phillips E.;Sangha R.;Schlag R. | 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 | Issue Date: | 12-Oct-2017 | Copyright year: | 2017 | Publisher: | Massachussetts Medical Society | Place of publication: | United States | Publication information: | New England Journal of Medicine. 377 (14) (pp 1331-1344), 2017. Date of Publication: 05 Oct 2017. | Journal: | New England Journal of Medicine | 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. | DOI: | http://monash.idm.oclc.org/login?url=http://acs.hcn.com.au/?acc=36265&url=http://dx.doi.org/10.1056/NEJMoa1614598 | Link to associated publication: | Click here for full text options | PubMed URL: | 28976863 [http://www.ncbi.nlm.nih.gov/pubmed/?term=28976863] | ISSN: | 0028-4793 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/38731 | Type: | Article | Subjects: | infection/si [Side Effect] infusion related reaction/si [Side Effect] intention to treat analysis major clinical study male multiple cycle treatment myelodysplastic syndrome/si [Side Effect] nausea/si [Side Effect] neutropenia/si [Side Effect] non melanoma skin cancer/si [Side Effect] *primary health care priority journal progression free survival cyclophosphamide/cb [Drug Combination] cyclophosphamide/dt [Drug Therapy] doxorubicin/ae [Adverse Drug Reaction] doxorubicin/ct [Clinical Trial] doxorubicin/cb [Drug Combination] doxorubicin/dt [Drug Therapy] *obinutuzumab/ae [Adverse Drug Reaction] *obinutuzumab/ct [Clinical Trial] *obinutuzumab/dt [Drug Therapy] *obinutuzumab/iv [Intravenous Drug Administration] prednisone/ae [Adverse Drug Reaction] prednisone/ct [Clinical Trial] prednisone/cb [Drug Combination] prednisone/dt [Drug Therapy] *rituximab/ae [Adverse Drug Reaction] *rituximab/ct [Clinical Trial] *rituximab/dt [Drug Therapy] vincristine/ae [Adverse Drug Reaction] vincristine/ct [Clinical Trial] vincristine/cb [Drug Combination] vincristine/dt [Drug Therapy] randomized controlled trial second cancer/si [Side Effect] thrombocytopenia/si [Side Effect] treatment outcome treatment response tumor lysis syndrome/si [Side Effect] very elderly bendamustine/ae [Adverse Drug Reaction] bendamustine/ct [Clinical Trial] bendamustine/cb [Drug Combination] bendamustine/dt [Drug Therapy] cyclophosphamide/ae [Adverse Drug Reaction] cyclophosphamide/ct [Clinical Trial] adult aged article bleeding disorder/si [Side Effect] cancer grading cancer growth cancer immunotherapy cancer recurrence cardiovascular disease/si [Side Effect] controlled study digestive system perforation/si [Side Effect] female *follicular lymphoma/dt [Drug Therapy] follicular lymphoma/dt [Drug Therapy] hematologic malignancy/si [Side Effect] human induction chemotherapy *follicular lymphoma / *drug therapy follicular lymphoma / drug therapy hematologic malignancy / side effect human induction chemotherapy infection / side effect infusion related reaction / side effect intention to treat analysis major clinical study male multiple cycle treatment myelodysplastic syndrome / side effect nausea / side effect neutropenia / side effect non melanoma skin cancer / side effect *primary health care priority journal progression free survival randomized controlled trial second cancer / side effect thrombocytopenia / side effect treatment outcome bleeding disorder / side effect tumor lysis syndrome / side effect very elderly Article aged adult treatment response cancer grading cancer growth cancer immunotherapy cancer recurrence cardiovascular disease / side effect controlled study digestive system perforation / side effect female |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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