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The ECHELON-2 Trial: 5-year results of a randomized, phase 3 study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Annals of oncology : official journal of the European Society for Medical Oncology Horwitz, S., O'Connor, O. A., Pro, B., Trumper, L., Iyer, S., Advani, R., Bartlett, N. L., Christensen, J. H., Morschhauser, F., Domingo-Domenech, E., Rossi, G., Kim, W. S., Feldman, T., Menne, T., Belada, D., Illes, A., Tobinai, K., Tsukasaki, K., Yeh, S., Shustov, A., Huttmann, A., Savage, K. J., Yuen, S., Zinzani, P. L., Miao, H., Bunn, V., Fenton, K., Fanale, M., Puhlmann, M., Illidge, T. 1800

Abstract

BACKGROUND: For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with CHOP or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL.PATIENTS AND METHODS: ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase 3 study. We present an exploratory update of the ECHELON-2 study, including an analysis of 5-year PFS per investigator in the intent-to-treat analysis group. This trial is registered with ClinicalTrials.gov (NCT01777152).RESULTS: A total of 452 patients were randomized (1:1) to 6 or 8 cycles of A+CHP (N=226) or CHOP (N=226). At median follow-up of 47.6 months, 5-year PFS rates were 51.4% (95% confidence interval [CI]: 42.8, 59.4) with A+CHP vs 43.0% (95% CI: 35.8, 50.0) with CHOP (hazard ratio=0.70; 95% CI: 0.53, 0.91), and 5-year overall survival (OS) rates were 70.1% (95% CI: 63.3, 75.9) with A+CHP vs 61.0% (95% CI: 54.0, 67.3) with CHOP (hazard ratio=0.72; 95% CI: 0.53, 0.99). Both PFS and OS were generally consistent across key subgroups. Peripheral neuropathy was resolved or improved in 72% (84/117) of patients in the A+CHP arm and 78% (97/124) in the CHOP arm. Among patients who relapsed and subsequently received brentuximab vedotin, the overall response rate was 59% with brentuximab vedotin retreatment after A+CHP and 50% with subsequent brentuximab vedotin after CHOP.CONCLUSIONS: In this 5-year update of ECHELON-2, frontline treatment of patients with PTCL with A+CHP continues to provide clinically meaningful improvement in PFS and OS vs CHOP, with a manageable safety profile, including continued resolution or improvement of PN.

View details for DOI 10.1016/j.annonc.2021.12.002

View details for PubMedID 34921960