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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

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    Authors
    Horwitz, S.
    O'Connor, O. A.
    Pro, B.
    Trümper, 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.
    Illés, Á.
    Tobinai, K.
    Tsukasaki, K.
    Yeh, S. P.
    Shustov, A.
    Hüttmann, A.
    Savage, K. J.
    Yuen, S.
    Zinzani, P. L.
    Miao, H.
    Bunn, V.
    Fenton, K.
    Fanale, M.
    Puhlmann, M.
    Illidge, T.
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    Affiliation
    Memorial Sloan Kettering Cancer Center, New York
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (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 versus 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 III 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. Results A total of 452 patients were randomized (1 : 1) to six or eight 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% to 59.4%] with A+CHP versus 43.0% (95% CI: 35.8% to 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% to 75.9%) with A+CHP versus 61.0% (95% CI: 54.0% to 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 objective 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 versus CHOP, with a manageable safety profile, including continued resolution or improvement of peripheral neuropathy.
    Citation
    Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, et al. 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. Ann Oncol. 2021.
    Journal
    Ann Oncol
    URI
    http://hdl.handle.net/10541/625011
    DOI
    10.1016/j.annonc.2021.12.002
    PubMed ID
    34921960
    Additional Links
    https://dx.doi.org/10.1016/j.annonc.2021.12.002
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.annonc.2021.12.002
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