Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5%) and R (215; 30.2%), stratified hazard ratio was 0.92 (95% CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70% and 67%, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7% v 64.7%, respectively) and serious AEs (42.6% v 37.6%, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8% for G-CHOP and 4.3% for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3%; R-CHOP, 40.7%), infusion-related reactions (G-CHOP, 36.1%; R-CHOP, 23.5%), nausea (G-CHOP, 29.4%; R-CHOP, 28.3%), and constipation (G-CHOP, 23.4%; R-CHOP, 24.5%). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.

Angelo Michele Carella Istituti di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliera e Universitaria San Martino IST Genoa

Antonio Pinto Istituto Nazionale Tumori Fondazione G Pascale IRCCS Naples

David Belada Charles University Hospital Hradec Králové Czech Republic

Ian Flinn Sarah Cannon Research Institute

John M Burke Rocky Mountain Cancer Centers Aurora CO

Judit Demeter Semmelweiss University Budapest Hungary

Laurie H Sehn British Columbia Cancer Agency and the University of British Columbia Vancouver British Columbia Canada

Marek Trněný Charles University General Hospital Prague

Maurizio Martelli Sapienza University Rome Italy

Michael Wenger Genentech South San Francisco CA

Mikkel Z Oestergaard Günter Fingerle Rowson Olivier Catalani and Tina Nielsen F Hoffman La Roche Basel Switzerland

Neil Chua Cross Cancer Institute University of Alberta Edmonton Alberta

Pau Abrisqueta University Hospital Vall d'Hebron Barcelona Spain

Tennessee Oncology Nashville TN

Umberto Vitolo Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Turin

US Oncology Research The Woodlands TX

Won Seog Kim Samsung Medical Center Sunkyunkwan University School of Medicine Seoul Republic of Korea

Xiaonan Hong Fudan University Shanghai Cancer Center Shanghai

Yoichi Tatsumi Kinki University Hospital Osaka Japan

Yuan Kai Shi National Cancer Center Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs Beijing China

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