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.
Keywords:
Efficacy; obinutuzumab; safety profile.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Aged
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Aged, 80 and over
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Antibodies, Monoclonal, Humanized / administration & dosage*
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Antibodies, Monoclonal, Humanized / adverse effects
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Antibodies, Monoclonal, Humanized / pharmacokinetics
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Cyclophosphamide / adverse effects
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Cyclophosphamide / therapeutic use
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Doxorubicin / adverse effects
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Doxorubicin / therapeutic use
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Drug Interactions
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Drug Monitoring
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Female
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Humans
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Lymphoma, Large B-Cell, Diffuse / diagnosis
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Lymphoma, Large B-Cell, Diffuse / drug therapy*
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Lymphoma, Large B-Cell, Diffuse / mortality
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Male
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Middle Aged
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Neoplasm Staging
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Prednisone / adverse effects
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Prednisone / therapeutic use
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Prognosis
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Treatment Outcome
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Vincristine / adverse effects
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Vincristine / therapeutic use
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Young Adult
Substances
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Antibodies, Monoclonal, Humanized
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Vincristine
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Doxorubicin
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Cyclophosphamide
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obinutuzumab
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Prednisone
Associated data
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ClinicalTrials.gov/NCT01414855