Obinutuzumab vs Rituximab Plus CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma
The phase III GOYA trial has shown no progression-free survival advantage with obinutuzumab (Gazyva) vs rituximab (Rituxan) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated patients with advanced diffuse large B-cell lymphoma (DLBCL). The results were reported by Vitolo et al in the Journal of Clinical Oncology.
Study Details
In the open-label trial, 1,418 patients from 207 sites in 29 countries were randomized between July 2011 and June 2014 to receive eight 21-day cycles of obinutuzumab (G-CHOP; n = 706) or rituximab (R-CHOP; n = 712) plus six or eight cycles of CHOP. Randomization was stratified by the number of planned chemotherapy cycles, the International Prognostic Index score, and the geographic region (Western Europe, Eastern Europe, South and Central America, North America, and Asia and others). The primary endpoint was investigator-assessed progression-free survival.
Progression-Free Survival
Median follow-up was 29 months. Investigator-assessed progression-free survival events occurred in 28.5% of the G-CHOP group vs 30.2% of the R-CHOP group (stratified hazard ratio [HR] = 0.92, P = .39), with 3-year progression-free survival of 70% vs 67%. On independent review committee assessment, progression-free survival events occurred in 24.2% vs 26.1% (HR = 0.89, P = .2736), with 3-year progression-free survival of 72.5% vs 70.6%. Three-year overall survival was 81.2% vs 81.4% (HR = 1.00, 95% confidence interval = 0.78–1.28). In exploratory subgroup analysis, patients with germinal-center B-cell–like subtype had better progression-free survival vs patients with activated B-cell–like subtype irrespective of treatment.
Adverse Events
Grade ≥ 3 adverse events occurred in 73.7% of the G-CHOP group vs 64.7% of the R-CHOP group, with the most common being neutropenia (46.2% vs 38.1%), infection (19.2% vs 15.5%), and febrile neutropenia (17.5% vs 15.2%). Infusion-related reactions of any grade occurred in 36.1% vs 23.5%. Serious adverse events occurred in 42.6% vs 37.6%. Fatal adverse events occurred in 5.8% vs 4.3%.
The investigators concluded: “G-CHOP did not improve [progression-free survival] compared with R-CHOP in patients with previously untreated DLBCL. [Adverse events] reported with [obinutuzumab] were consistent with the known safety profile. Biomarker analyses may help define a future role for [obinutuzumab] in DLBCL.”
The study was supported by F. Hoffmann-La Roche, with scientific support from the Fondazione Italiana Linfomi.
Umberto Vitolo, MD, of AOU Città della Salute e della Scienza di Torino, is the corresponding author of the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
