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 Journal Article
| Authors: | Sharman, J. P.; Forero-Torres, A.; Costa, L. J.; Flinn, I. W.; Inhorn, L.; Kelly, K.; Bessudo, A.; Fayad, L. E.; Kaminski, M. S.; Evens, A. M.; Flowers, C. R.; Sahin, D.; Mundt, K. E.; Sandmann, T.; Fingerle-Rowson, G.; Vignal, C.; Mobasher, M.; Zelenetz, A. D. |
| Article Title: | 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. © 2019, © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: | adult; controlled study; treatment response; aged; middle aged; major clinical study; prednisone; drug tolerability; neutropenia; doxorubicin; advanced cancer; area under the curve; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; side effect; cancer patient; comparative study; multiple cycle treatment; phase 2 clinical trial; randomized controlled trial; dehydration; cohort analysis; cyclophosphamide; vincristine; febrile neutropenia; pneumonia; hypoxia; lung embolism; cd20 antigen; immunoglobulin g; paracetamol; multicenter study; prophylaxis; drug clearance; mental disease; sepsis; open study; time to maximum plasma concentration; drug half life; corticosteroid; immunoglobulin deficiency; gastrointestinal disease; metabolic disorder; immunoglobulin m; diphenhydramine; filgrastim; immunoglobulin a; efficacy; pharmacokinetic parameters; diffuse large b cell lymphoma; nutritional disorder; safety profile; infusion related reaction; human; male; female; priority journal; article; volume of distribution; obinutuzumab; maximum concentration |
| Journal Title: | Leukemia and Lymphoma |
| Volume: | 60 |
| Issue: | 4 |
| ISSN: | 1042-8194 |
| Publisher: | Taylor & Francis Group |
| Date Published: | 2019-01-01 |
| Start Page: | 894 |
| End Page: | 903 |
| Language: | English |
| DOI: | 10.1080/10428194.2018.1515940 |
| PUBMED: | 30277102 |
| PROVIDER: | scopus |
| PMCID: | PMC6445782 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 May 2019 -- Source: Scopus |
