Obinutuzumab or Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial
- MeSH
- Cyclophosphamide administration & dosage MeSH
- Lymphoma, Large B-Cell, Diffuse drug therapy MeSH
- Adult MeSH
- Doxorubicin administration & dosage MeSH
- Antibodies, Monoclonal, Humanized administration & dosage MeSH
- Kaplan-Meier Estimate MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Antibodies, Monoclonal, Murine-Derived administration & dosage MeSH
- Prednisone administration & dosage MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage therapeutic use MeSH
- Rituximab administration & dosage MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Vincristine administration & dosage MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Cyclophosphamide MeSH
- Doxorubicin MeSH
- Antibodies, Monoclonal, Humanized MeSH
- Antibodies, Monoclonal, Murine-Derived MeSH
- obinutuzumab MeSH Browser
- Prednisone MeSH
- R-CHOP protocol MeSH Browser
- Rituximab MeSH
- Vincristine MeSH
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.
References provided by Crossref.org
The EHA Research Roadmap: Malignant Lymphoid Diseases
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA
The regulation and function of CD20: an "enigma" of B-cell biology and targeted therapy
BCL-2 Proteins in Pathogenesis and Therapy of B-Cell Non-Hodgkin Lymphomas
