> Details

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 L.; Weichenthal, Michael; Fisher, David C.; Walewski, Jan; Trotman, Judith; Taylor, Kerry; Dalle, Stephane; Stadler, Rudolf; Lisano, Julie; Bunn, Veronica; [...]

Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data

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  • Media type: E-Article
  • Title: Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data
  • Contributor: 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 L.; Weichenthal, Michael; Fisher, David C.; Walewski, Jan; Trotman, Judith; Taylor, Kerry; Dalle, Stephane; Stadler, Rudolf; Lisano, Julie; Bunn, Veronica; [...]
  • imprint: American Society of Hematology, 2021
  • Published in: Blood Advances
  • Language: English
  • DOI: 10.1182/bloodadvances.2021004710
  • ISSN: 2473-9529; 2473-9537
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title> <jats:p>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 &amp;lt; .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 &amp;lt; .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 &amp;lt; .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.</jats:p>
  • Access State: Open Access