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Leo I. Gordon, MD, FACP


Adding Bortezomib to Standard Treatment in Resistant DLBCL: Final Results From Phase II Trial

By: Joseph Fanelli
Posted: Wednesday, August 31, 2022

The addition of bortezomib to a treatment regimen of rituximab, cisplatin, cytarabine, and dexamethasone (R-DHAP) prior to autologous stem cell transplantation (ASCT) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) did not improve complete response rate, according to the final results of the FIL-VERAL12 phase II trial presented at the European Hematology Association (EHA) 2022 Congress (Abstract S221). However, Annalisa Chiappella, MD, of the Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, and colleagues observed numerically higher 2-year progression-free survival rates for patients treated with bortezomib and R-DHAP.

In this prospective trial, the authors treated 107 patients with relapsed or refractory DLBCL. The patients received either standard salvage therapy of R-DHAP every 28 days for four cycles (n = 54) or the standard regimen plus bortezomib on days 1 and 4 of each 4-week cycle (n = 53). All patients received rituximab and anthracycline-based regimens as first-line treatment.

In total, 52 patients (49%) completed the planned four cycles of therapy, 55 did not complete the therapy because of progressive disease (42 patients) or adverse events/clinician decision (13 patients). At the end of the four courses and prior to ASCT, 27% had a complete response (29 patients) and 17% had a partial response (9 patients). Among those treated with R-DHAP alone, 28% of patients had a complete response, compared with 26% of those treated with bortezomib and R-DHAP. At a median follow-up of 50 months, the 2-year progression-free survival rate for patients treated with R-DHAP was 29%, compared with 41% for those treated with the bortezomib-based regimen. Of note, the addition of bortezomib to the standard regimen did not impact the mobilization of stem cells.

In total, 60 patients died, 49 from lymphoma (82%), 1 from toxicity, 3 from transplant-related mortality, and 7 from other causes. The incidence of adverse events was similar in both treatment groups.

Disclosure: For full disclosures of the study authors, visit

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