Roughly 45–50% of patients with relapsed or primary refractory Hodgkin lymphoma (HL) are cured with the standard of care of high-dose chemotherapy followed by autologous stem-cell transplantation (ASCT); however, this percentage has been at a plateau for 15 years. Now, Craig Moskowitz and colleagues report the results of the AETHERA trial, indicating that early consolidation therapy with brentuximab vedotin (BV) after ASCT improved the progression-free survival (PFS) of patients with difficult-to-treat HL.
“Two options existed in 2009 for improving HL outcomes,” explains Moskowitz, “improving salvage therapy to increase the number of patients in complete remission pre-ASCT or using an active agent, such as BV, in patients at risk of relapse after ASCT.” This second approach was followed in the AETHERA study, a double-blind, placebo-controlled, randomized phase III trial that randomly assigned 329 patients with unfavourable-risk relapsed or primary refractory classic HL, who had undergone ASCT, to receive 16 cycles of BV or placebo every 3 weeks, starting 30–45 days after transplantation.
The primary end point of the study was PFS; secondary end points were overall survival and safety. Of note, patients who progressed on placebo were allowed to subsequently receive BV on an another trial. At 2 years, the researchers observed significantly improved PFS among patients assigned to BV both as per independent review (63% versus 51%) and per investigator review (65% versus 45%). Overall survival is the same between the two arms, owing to the crossover design (affecting 85% of patients in the placebo cohort) and the treatment was well tolerated.
On the basis of such results, “BV post-ASCT will likely become the standard of care,” says Moskowitz. He continues, “however, one must remember that the patients on this study were BV naive; in 3–5 years this population will no longer exist.” Future studies will need to address this evolving scenario.
References
Moskowitz, C. H. et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 10.1016/S0140-6736(15)60165-9
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Errico, A. AETHERA—brentuximab wings its way as new standard of care in HL. Nat Rev Clin Oncol 12, 312 (2015). https://doi.org/10.1038/nrclinonc.2015.69
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DOI: https://doi.org/10.1038/nrclinonc.2015.69