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    Brentuximab vedotin plus chemotherapy for patients with previously untreated, stage III or IV Lclassical Hodgkin lymphoma: 5-year update of the phase 3 ECHELON-1 STUDY (NCT01712490)

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    Authors
    Picardi, M.
    Straus, J.
    Dlugosz-Danecka, M.
    Connors, J. M.
    Illes, A.
    Lech-Maranda, E.
    Feldman, T.
    Smolewski, P.
    Savage, K. J.
    Bartlett, N. L.
    Walewski, J.
    Ramchandren, R.
    Zinzani, P. L.
    Hutchings, M.
    Munoz, J.
    Kim, W. S.
    Advani, R.
    Ansell, S. M.
    Gallamini, A.
    Liu, R.
    Little, M.
    Fenton, K.
    Fanale, M.
    Radford, John A
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    Affiliation
    Department of Clinical Medicine and Surgery, Federico II University
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    In the ECHELON-1 study, brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) significantly improved modified progression-free survival (PFS) per independent review in patients (pts) with newly diagnosed Stage III/IV classical Hodgkin lymphoma (cHL) vsdoxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) (Connors, NEJM 2018) and durable PFS per investigator (INV) benefits with A+AVD vs ABVD were seen with extended follow-up (Bartlett, Blood 2019; Straus, Blood 2020). We report updated efficacy and safety data after 5 years’ follow-up (cutoff date 18 Sep 2020). Pts with newly diagnosed Stage III/IV cHL were randomised 1:1 to up to 6 cycles of A+AVD (n=664) or ABVD (n=670) on days 1 and 15 of a 28-day cycle. Interim PET scan after cycle 2 (PET2) was mandated. Analyses were performed for PFS per INV, peripheral neuropathy (PN) resolution and improvement (improvement by ≥1 grade [G] from worst G by latest assessment) in pts with ongoing PN at end of treatment, rate of secondary malignancies, and pregnancy incidence and outcomes among pts and partners. After 60.9 months median follow-up (95% confidence interval [CI] 55.2–56.7), estimated 5-year PFS per INV was 82.2% (95% CI 79.0– 85.0) for A+AVD and 75.3% (95% CI 71.7–78.5) for ABVD, favouring A+AVD vs ABVD (hazard ratio [HR] 0.681; 95% CI 0.534–0.867; p=0.002). Estimated 5-year PFS with A+AVDvsABVD in the intention to treat population was 84.9% vs 78.9% in PET2– pts (HR 0.663; 95% CI 0.502–0.876; p=0.004) and 60.6%vs 45.9% in PET2+ pts (HR 0.702; 95% CI 0.393–1.255; p=0.229). In A+AVD and ABVD arms, 85% and 86% of pts with treatment-emergent PN had complete resolution or improvement of symptoms. In A+AVD and ABVD arms, PN was ongoing in 29% and 21% of pts, respectively, most of which were G1–2. In total, 131 pregnancies were reported; the proportion of ongoing pregnancies or live births in female pts was similar in both arms (A+AVD arm 85%, ABVD arm 74%). With 5 years’ follow-up, sustained PFS benefit was observed with A+AVD vs ABVD that was independent of disease stage and PET2 status. In addition, treatment adaptation by interim PET2 status is not required for A+AVD and bleomycin exposure is avoided. As most historical cHL relapses occur within the first 5 years (Radford, BMJ 1997), the durable and robust treatment benefit and manageable safety profile of A+AVD in ECHELON-1, suggest that A+AVD is an attractive treatment option for all pts with previously untreated Stage III/IV cHL.
    Citation
    Picardi M, Straus J, Dlugosz-Danecka M, Connors JM, Illes A, Lech-Maranda E, et al. BRENTUXIMAB VEDOTIN PLUS CHEMOTHERAPY FOR PATIENTS WITH PREVIOUSLY UNTREATED, STAGE III OR IV CLASSICAL HODGKIN LYMPHOMA: 5-YEAR UPDATE OF THE PHASE 3 ECHELON-1 STUDY (NCT01712490). Haematologica. 2021;106(10):44-.
    Journal
    Haematologica
    URI
    http://hdl.handle.net/10541/624847
    Type
    Meetings and Proceedings
    Language
    en
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