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N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

Obinutuzumab for the First-Line Treatment of Follicular Lymphoma.

Author information

1
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.).

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.

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 .).

PMID:
28976863
DOI:
10.1056/NEJMoa1614598
[Indexed for MEDLINE]

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