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Obinutuzumab for the First-Line Treatment of Follicular Lymphoma

Marcus, Robert
Author Marcus, Robert From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Davies, Andrew
Author Davies, Andrew From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Ando, Kiyoshi
Author Ando, Kiyoshi From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Klapper, Wolfram
Author Klapper, Wolfram From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Opat, Stephen
Author Opat, Stephen From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Owen, Carolyn
Author Owen, Carolyn From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Phillips, Elizabeth
Author Phillips, Elizabeth From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Sangha, Randeep
Author Sangha, Randeep From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Schlag, Rudolf
Author Schlag, Rudolf From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Seymour, John F
Author Seymour, John F From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Townsend, William
Author Townsend, William From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Trněný, Marek
Author Trněný, Marek From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Wenger, Michael
Author Wenger, Michael From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Fingerle-Rowson, Günter
Author Fingerle-Rowson, Günter From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Rufibach, Kaspar
Author Rufibach, Kaspar From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Moore, Tom
Author Moore, Tom From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Herold, Michael
Author Herold, Michael From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)
Hiddemann, Wolfgang
Author Hiddemann, Wolfgang From King's College Hospital (R.M.) and the Cancer Research UK and University College London Cancer Trials Centre (E.P., W.T.), London, and the Cancer Research UK Centre, University of Southampton, Southampton (A.D.) - all in the United Kingdom; the Tokai University School of Medicine, Isehara, Japan (K.A.); the University of Kiel, Kiel (W.K.), Gemeinschaftspraxis, Würzburg (R. Schlag), HELIOS Klinikum Erfurt, Erfurt (M.H.), and the Ludwig-Maximilians-University Hospital Grosshadern, Munich (W.H.) - all in Germany; Monash Health and Monash University (S.O.) and the Peter MacCallum Cancer Centre and University of Melbourne (J.F.S.), Melbourne, VIC, Australia; Foothills Medical Centre and Tom Baker Cancer Centre, Calgary, AB (C.O.), and the Cross Cancer Institute, Edmonton, AB (R. Sangha) - both in Canada; Charles University, Prague, Czech Republic (M.T.); and F. Hoffmann-La Roche, Basel, Switzerland (M.W., G.F.-R., K.R., T.M.)

The New England journal of medicine. 2017 Oct 05 ; 377 (14) : 1331-1344.

N Engl J Med
ISSN 1533-4406 | 0028-4793
Source

Language English Country United States Media print

Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link https://www.medvik.cz/link/pmid28976863

Grant support
15953 Cancer Research UK - United Kingdom

PubMed 28976863
DOI 10.1056/nejmoa1614598
Knihovny.cz E-resources

MeSH
Adult MeSH
Lymphoma, Follicular drug therapy mortality MeSH
Antibodies, Monoclonal, Humanized administration & dosage adverse effects MeSH
Immunologic Factors administration & dosage adverse effects MeSH
Induction Chemotherapy MeSH
Kaplan-Meier Estimate MeSH
Leukopenia chemically induced MeSH
Middle Aged MeSH
Humans MeSH
Nausea chemically induced MeSH
Disease-Free Survival MeSH
Antineoplastic Agents administration & dosage adverse effects MeSH
Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
Rituximab administration & dosage adverse effects MeSH
Aged, 80 and over MeSH
Aged MeSH
Check Tag
Adult MeSH
Middle Aged MeSH
Humans MeSH
Male MeSH
Aged, 80 and over MeSH
Aged MeSH
Female MeSH
Publication type
Journal Article MeSH
Multicenter Study MeSH
Research Support, Non-U.S. Gov't MeSH
Randomized Controlled Trial MeSH
Comparative Study MeSH
Names of Substances
Antibodies, Monoclonal, Humanized MeSH
Immunologic Factors MeSH
obinutuzumab MeSH Browser
Antineoplastic Agents MeSH
Rituximab MeSH

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. METHODS: 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. CONCLUSIONS: 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. (Funded by F. Hoffmann-La Roche; GALLIUM ClinicalTrials.gov number, NCT01332968 .).

From King's College Hospital

Comment In

N Engl J Med. 2017 Oct 5;377(14):1389-1390. doi: 10.1056/NEJMe1706154. PubMed

Comment In

N Engl J Med. 2017 Dec 28;377(26):2605. doi: 10.1056/NEJMc1714337. PubMed

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