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Randomized Phase II Study of R-CHOP With or Without Bortezomib in Previously Untreated Patients With Non-Germinal
John P Leonard1, Kathryn S Kolibaba1, James A Reeves1
1John 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.
Adding bortezomib to R-CHOP chemotherapy did not significantly improve outcomes for previously untreated non-germinal center B-cell-like diffuse large B-cell lymphoma patients. Standard R-CHOP demonstrated favorable results, suggesting bortezomib addition is not essential for this patient group.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Diffuse large B-cell lymphoma (DLBCL) is an aggressive non-Hodgkin lymphoma.
- Non-germinal center B-cell-like (non-GCB) DLBCL is a subtype with distinct prognostic implications.
- Standard treatment involves rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
Purpose of the Study:
- To assess the efficacy of adding bortezomib to R-CHOP (VR-CHOP) in previously untreated non-GCB DLBCL.
- To evaluate progression-free survival (PFS) and overall survival (OS) in this patient cohort.
- To compare outcomes between standard R-CHOP and VR-CHOP regimens.
Main Methods:
- Prospective randomized controlled trial involving 206 patients with non-GCB DLBCL.
- Patients were stratified by International Prognostic Index (IPI) and assigned to R-CHOP or VR-CHOP.
- Central confirmation of non-GCB DLBCL and drug administration were performed.
Main Results:
- No significant improvement in PFS or OS was observed with the addition of bortezomib (HR for PFS 0.73, HR for OS 0.75).
- Two-year PFS rates were 77.6% for R-CHOP and 82.0% for VR-CHOP.
- Increased rates of thrombocytopenia and anemia were noted in the VR-CHOP arm.
Conclusions:
- Standard R-CHOP treatment yielded favorable outcomes for newly diagnosed non-GCB DLBCL patients.
- The addition of bortezomib to R-CHOP did not significantly enhance treatment efficacy.
- Further investigation into bortezomib's role in DLBCL subtypes may be warranted.
