Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma

Umberto Vitolo, Marek Trneny, David Belada, John M. Burke, Angelo Michele Carella, Neil Chua, Pau Abrisqueta, Judit Demeter, Ian Flinn, Xiaonan Hong, Won Seog Kim, Antonio Pinto, Yuan Kai Shi, Yoichi Tatsumi, Mikkel Z. Oestergaard, Michael Wenger, Gunter Fingerle-Rowson, Olivier Catalani, Tina Nielsen, Maurizio MartelliLaurie H. Sehn

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Abstract

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.

Original languageEnglish
Pages (from-to)3529-3537
Number of pages9
JournalJournal of Clinical Oncology
Volume35
Issue number31
DOIs
Publication statusPublished - Nov 1 2017

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Vitolo, U., Trneny, M., Belada, D., Burke, J. M., Carella, A. M., Chua, N., Abrisqueta, P., Demeter, J., Flinn, I., Hong, X., Kim, W. S., Pinto, A., Shi, Y. K., Tatsumi, Y., Oestergaard, M. Z., Wenger, M., Fingerle-Rowson, G., Catalani, O., Nielsen, T., ... Sehn, L. H. (2017). Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large b-cell lymphoma. Journal of Clinical Oncology, 35(31), 3529-3537. https://doi.org/10.1200/JCO.2017.73.3402