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oai:docta.ucm.es:20.500.14352/1310942026-01-28T01:03:45Zcom_20.500.14352_14col_20.500.14352_15

Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data Horwitz, Steven M. Scarisbrick, Julia J. Dummer, Reinhard Whittaker, Sean Duvic, Madeleine Kim, Youn H. Quaglino, Pietro Zinzani, Pier Luigi Bechter, Oliver Eradat, Herbert Pinter-Brown, Lauren Akilov, Oleg E. Geskin, Larisa Sanches, Jose A. Ortiz Romero, Pablo Luis Weichenthal, Michael Fisher, David C. Walewski, Jan Trotman, Judith Taylor, Kerry Dalle, Stephane Stadler, Rudolf Lisano, Julie Bunn, Veronica Little, Meredith Prince, H. Miles Clinical Trials and Observations Lymphoid Neoplasia Oncología Dermatología 3201.06 Dermatología 3207.13 Oncología The primary analysis of the phase 3 ALCANZA trial showed significantly improved objective responses lasting ≥4 months (ORR4; primary endpoint) and progression-free survival (PFS) with brentuximab vedotin vs physician's choice (methotrexate or bexarotene) in CD30-expressing mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (C-ALCL). Cutaneous T-cell lymphomas often cause pruritus and pain; brentuximab vedotin improved skin symptom burden with no negative effects on quality of life. We report final data from ALCANZA (median follow-up, 45.9 months). Adults with previously treated CD30-expressing MF/C-ALCL were randomly assigned to brentuximab vedotin (n = 64) or physician's choice (n = 64). Final data demonstrated improved responses per independent review facility with brentuximab vedotin vs physician's choice: ORR4; 54.7% vs 12.5% (P < .001); complete response, 17.2% vs 1.6% (P = .002). Median PFS with brentuximab vedotin vs physician's choice was 16.7 months vs 3.5 months (P < .001). Median time to the next treatment was significantly longer with brentuximab vedotin than with physician's choice (14.2 vs 5.6 months; hazard ratio, 0.27; 95% confidence interval, 0.17-0.42; P < .001). Of 44 patients in the brentuximab vedotin arm who experienced any-grade peripheral neuropathy, (grade 3, n = 6; grade 4, n = 0), 86% (38 of 44) had complete resolution (26 of 44) or improvement to grades 1 and 2 (12 of 44). Peripheral neuropathy was ongoing in 18 patients (all grades 1-2). These final analyses confirm improved, clinically meaningful, durable responses and longer PFS with brentuximab vedotin vs physician's choice in CD30-expressing MF or C-ALCL. This trial was registered at https://www.clinicaltrials.gov as #NCT01578499. Depto. de Medicina Fac. de Medicina TRUE pub 2026-01-27T10:47:19Z 2026-01-27T10:47:19Z 2021-12-06 journal article VoR https://hdl.handle.net/20.500.14352/131094 2473-9529 2473-9537 10.1182/bloodadvances.2021004710 eng Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, et al. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data. Blood Advances 2021;5:5098–106. https://doi.org/10.1182/bloodadvances.2021004710. restricted access application/pdf American Society of Hematology (ASH Publications)