Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) does not prolong progression-free survival (PFS) compared with rituximab plus CHOP (R-CHOP) among treatment-naive patients with diffuse large B cell lymphoma (DLBCL), according to a study published in the Journal of Clinical Oncology.1
R-CHOP is the standard of care for patients with DLBCL and provides significant clinical benefit, but 20% to 40% of patients experience relapse/recurrence and have poor outcomes with salvage therapy.
In the phase 3 GOYA study (ClinicalTrials.gov Identifier: NCT01287741), researchers enrolled 1418 patients with previously untreated DLBCL and randomly assigned them to receive G-CHOP or R-CHOP. The primary outcome was investigator-assessed PFS.
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After a median observation period of 29 months, there was a similar number of occurrences of investigator-assessed PFS events for the G-CHOP arm (28.5%) and the R-CHOP arm (30.2%) (hazard ratio [HR], 0.92; 95% CI, 0.76-1.11; P = .3868). The estimated 3-year PFS rates were 69.6% and 66.9% for the G-CHOP and R-CHOP arms, respectively.
Patients in the G-CHOP arm reported higher frequencies of grade 3 to 5 adverse events (AEs) and serious AEs compared with the R-CHOP arm. The most frequently reported AEs were neutropenia, infusion-related reactions, nausea, and constipation.
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The authors concluded that “G-CHOP did not improve PFS in a large population of patients with previously untreated DLBCL compared with R-CHOP, which remains the standard treatment in these patients.”
Reference
- Vitolo U, Trneny M, Belada D, et al. Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large B-cell lymphoma. J Clin Oncol. doi: 10.1200/JCO.2017.73.3402 [Epub ahead of print]