Bortezomib Provides No Benefit Over R-DHAP Alone in R/R DBLCL

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Adding bortezomib to a chemoimmunotherapy regimen does not improve outcomes before or after transplant in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to research presented at the EHA 2022 Hybrid Congress.

The presentation revealed that the addition of bortezomib to rituximab plus cisplatin, cytarabine, and dexamethasone (R-DHAP) did not improve the rate of complete response (CR) prior to hematopoietic stem cell transplant (HSCT). Likewise, bortezomib did not improve progression-free survival (PFS) or overall survival (OS) in the overall cohort. However, there was a significant improvement in PFS with bortezomib for patients who had refractory disease.

These results come from a phase 2 trial (ClinicalTrials.gov Identifier: NCT01805557), which was presented by Annalisa Chiappella, MD, of Fondazione IRCCS Istituto Nazionale dei Tumori in Italy.

The trial enrolled 107 patients with relapsed/refractory DLBCL. The median age at baseline was 57 years, and 78% of patients had stage III/IV disease. Half of patients had relapsed disease (53 patients) and half had refractory disease (54 patients).


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The patients were randomly assigned to receive R-DHAP (54 patients) or bortezomib plus R-DHAP (53 patients). The CR rate after 4 courses of treatment was 33% in the R-DHAP arm and 32% in the bortezomib/R-DHAP arm (P =.581).

A total of 50 patients went on to HSCT — 24 in the R-DHAP arm and 26 in the bortezomib/R-DHAP arm. Most patients underwent autologous HSCT (39 patients), but 11 received an allogeneic HSCT. Dr Chiappella noted that bortezomib did not affect stem cell mobilization.

At a median follow-up of 60 months, the 2-year OS rate was 43% in the R-DHAP arm and 52% in the bortezomib/R-DHAP arm (P =.2420). The 2-year PFS rate was 33% and 40%, respectively (P =.0594).

When the researchers looked only at patients with refractory disease, there was a significant improvement in PFS with bortezomib. The 2-year PFS rate was 37% in the bortezomib/R-DHAP arm and 11% in the R-DHAP arm (P =.0216).

On the other hand, there was no significant between-arm difference for patients with relapsed disease. The 2-year PFS rate was 45% in the bortezomib/R-DHAP arm and 48% in the R-DHAP arm (P =.8252).

There were no significant differences in hematologic or non-hematologic toxicities between the treatment arms, Dr Chiappella noted. There was 1 on-treatment death due to toxicity in the bortezomib arm.

Disclosures: This research is sponsored by Fondazione Italiana Linfomi ONLUS in collaboration with Janssen-Cilag. The presenter disclosed affiliations with Janssen-Cilag, AstraZeneca, Celgene/Bristol Myers Squibb, Clinigen, Gilead Sciences, Incyte, Novartis, Roche, Secura Bio, and Takeda.

Reference

Chiappella A, Balzarotti M, Botto B, et al. Bortezomib to R-DHAP compared to R-DHAP in relapsed/refractory diffuse large b-cell lymphoma eligible to stem cell transplantation: Final results of phase II randomized FIL-VERAL12. Presented at EHA 2022; June 9-12, 2022. Abstract S221.



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