Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study.

Abstract

This study investigated the safety and efficacy of obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (G-CHOP) in patients with advanced diffuse large B-cell lymphoma (DLBCL) and explored the impact of cell-of-origin (COO) on patient outcomes. Patients (N = 100) received obinutuzumab (1000 mg on the days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-8) plus CHOP (cycles 1-6). For patients without grade ≥3 infusion-related reactions (IRRs) to standard-rate obinutuzumab infusion, a shorter duration of infusion (SDI) was evaluated. Overall and complete response rates, as determined according to the Cheson et al. criteria by investigators/independent radiological facility, were 82.0/75.0% and 55.0/58.0%, respectively. SDI of 120 minutes and 90 minutes were well tolerated with no grade ≥3 IRRs. Among all patients, IRRs typically occurred during cycle 1, day 1. G-CHOP is active and has an acceptable safety profile in the first-line treatment of patients with advanced DLBCL. Clinical Trials: NCT01414855DLBCL.

• Authors: Jeff P Sharman, Andres Forero-Torres, Luciano J Costa, Ian W Flinn, Lowell Inhorn, Kevin Kelly, Alberto Bessudo, Luis E Fayad, Mark S Kaminski, Andrew M Evens, Christopher R Flowers, Deniz Sahin, Kirsten E Mundt, Thomas Sandmann, Günter Fingerle-Rowson, Charlotte Vignal, Mehrdad Mobasher, Andrew D Zelenetz
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 60 Issue 4 Pg. 894-903 (04 2019) ISSN: 1029-2403 [Electronic] United States
• PMID: 30277102 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal, Humanized
• Vincristine
• Doxorubicin
• Cyclophosphamide
• obinutuzumab
• Prednisone

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal, Humanized (administration & dosage, adverse effects, pharmacokinetics)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cyclophosphamide (adverse effects, therapeutic use)
• Doxorubicin (adverse effects, therapeutic use)
• Drug Interactions
• Drug Monitoring
• Female
• Humans
• Lymphoma, Large B-Cell, Diffuse (diagnosis, drug therapy, mortality)
• Male
• Middle Aged
• Neoplasm Staging
• Prednisone (adverse effects, therapeutic use)
• Prognosis
• Treatment Outcome
• Vincristine (adverse effects, therapeutic use)
• Young Adult