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J Clin Oncol. 2017 Nov 1;35(31):3538-3546. doi: 10.1200/JCO.2017.73.2784. Epub 2017 Sep 1.

Randomized Phase II Study of R-CHOP With or Without Bortezomib in Previously Untreated Patients With Non-Germinal Center B-Cell-Like Diffuse Large B-Cell Lymphoma.

Author information

1
John P. Leonard, Weill Cornell Medicine and New York Presbyterian Hospital, New York, NY; Kathryn S. Kolibaba, Compass Oncology, Vancouver, WA; Kathryn S. Kolibaba and Nicholas J. DiBella, US Oncology Research, The Woodlands; Robert Collins, University of Texas Southwestern Medical Center, Dallas, TX; James A. Reeves, Florida Cancer Specialists, Fort Myers; Julio Hajdenberg, University of Florida Health Cancer Center at Orlando Health, Orlando, FL; Anil Tulpule, Keck Medicine of University of Southern California; Sven de Vos, University of California at Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles; Tatjana Kolevska, Kaiser Permanente Medical Center Northern California, Vallejo; Robert Robles, Bay Area Cancer Research Group (Diablo Valley Medical Group), Pleasant Hill; Andrew Horodner, Cancer Care Associates Medical Group, Redondo Beach, CA; Ian W. Flinn, Sarah Cannon Research Institute, Nashville, TN; Christopher R. Flowers, Winship Cancer Institute of Emory University, Atlanta, GA; Nicholas J. DiBella, Rocky Mountain Cancer Centers, Aurora, CO; Steven W. Papish, Summit Medical Group MD Anderson Cancer Center, Camden, NJ; Parameswaran Venugopal, Rush University Medical Center, Chicago, IL; Amir Tabatabai, York Cancer Center/Cancer Care Associates of York, York, PA; and Jaehong Park, Rachel Neuwirth, George Mulligan, Kaveri Suryanarayan, and Dixie-Lee Esseltine, Millennium Pharmaceuticals, Cambridge, MA.

Abstract

Purpose To evaluate the impact of the addition of bortezomib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on outcomes in previously untreated patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). Patients and Methods After real-time determination of non-GCB DLBCL using the Hans immunohistochemistry algorithm, 206 patients were randomly assigned (1:1; stratified by International Prognostic Index [IPI] score) to six 21-day cycles of standard R-CHOP alone or R-CHOP plus bortezomib 1.3 mg/m2 intravenously on days 1 and 4 (VR-CHOP). The primary end point, progression-free survival (PFS), was evaluated in 183 patients with centrally confirmed non-GCB DLBCL who received one or more doses of study drug (91 R-CHOP, 92 VR-CHOP). Results After a median follow-up of 34 months, with 25% (R-CHOP) and 18% (VR-CHOP) of patients having had PFS events, the hazard ratio (HR) for PFS was 0.73 (90% CI, 0.43 to 1.24) with VR-CHOP ( P = .611). Two-year PFS rates were 77.6% with R-CHOP and 82.0% with VR-CHOP; they were 65.1% versus 72.4% in patients with high-intermediate/high IPI (HR, 0.67; 90% CI, 0.34 to 1.29), and 90.0% versus 88.9% (HR, 0.85; 90% CI, 0.35 to 2.10) in patients with low/low-intermediate IPI. Overall response rate with R-CHOP and VR-CHOP was 98% and 96%, respectively. The overall survival HR was 0.75 (90% CI, 0.38 to 1.45); 2-year survival rates were 88.4% and 93.0%, respectively. In the safety population (100 R-CHOP and 101 VR-CHOP patients), grade ≥ 3 adverse events included neutropenia (53% v 49%), thrombocytopenia (13% v 29%), anemia (7% v 15%), leukopenia (26% v 25%), and neuropathy (1% v 5%). Conclusion Outcomes for newly diagnosed, prospectively enrolled patients with non-GCB DLBCL were more favorable than expected with R-CHOP and were not significantly improved by adding bortezomib.

PMID:
28862883
DOI:
10.1200/JCO.2017.73.2784
[Indexed for MEDLINE]

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