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Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab.
Seymour, John F; Kipps, Thomas J; Eichhorst, Barbara F; D'Rozario, James; Owen, Carolyn J; Assouline, Sarit; Lamanna, Nicole; Robak, Tadeusz; de la Serna, Javier; Jaeger, Ulrich; Cartron, Guillaume; Montillo, Marco; Mellink, Clemens; Chyla, Brenda; Panchal, Anesh; Lu, Tong; Wu, Jenny Q; Jiang, Yanwen; Lefebure, Marcus; Boyer, Michelle; Kater, Arnon P.
  • Seymour JF; Peter MacCallum Cancer Centre, Royal Melbourne Hospital and University of Melbourne, Melbourne, Australia.
  • Kipps TJ; UCSD Moores Cancer Center, San Diego, CA.
  • Eichhorst BF; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine and Center of Integrated Oncology Aachen, Bonn, Cologne, Dusseldorf (CIO ABCD), Cologne, Germany.
  • D'Rozario J; The John Curtin School of Medical Research, Australian National University, Canberra, Australia.
  • Owen CJ; University of Calgary, Calgary, AB, Canada.
  • Assouline S; Segal Cancer Centre, Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada.
  • Lamanna N; Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.
  • Robak T; Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
  • de la Serna J; Hospital Universitario 12 de Octubre, Madrid, Spain.
  • Jaeger U; Department of Medicine I, Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
  • Cartron G; Department of Hematology, Centre Hospitalier Universitaire de Montpellier (UMR-CNRS 5535), Montpellier, France.
  • Montillo M; Department of Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Mellink C; Department of Human Genetics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
  • Chyla B; AbbVie, North Chicago, IL.
  • Panchal A; Roche Products Ltd., Welwyn Garden City, United Kingdom.
  • Lu T; Genentech, Inc., South San Francisco, CA; and.
  • Wu JQ; Genentech, Inc., South San Francisco, CA; and.
  • Jiang Y; Genentech, Inc., South San Francisco, CA; and.
  • Lefebure M; Roche Products Ltd., Welwyn Garden City, United Kingdom.
  • Boyer M; Roche Products Ltd., Welwyn Garden City, United Kingdom.
  • Kater AP; Department of Hematology, Cancer Center Amsterdam, Lymphoma and Myeloma Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Blood ; 140(8): 839-850, 2022 08 25.
Article en En | MEDLINE | ID: mdl-35605176
ABSTRACT
The MURANO trial (A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia [CLL]; ClinicalTrials.gov identifier #NCT02005471) reported superior progression-free survival (PFS) and overall survival (OS) with venetoclax-rituximab (VenR) vs bendamustine-rituximab (BR) in relapsed/refractory (R/R) CLL. Patients were randomized to 2 years of VenR (n = 194; rituximab for the first 6 months) or 6 months of BR (n = 195). Although undetectable minimal residual disease (uMRD) was achieved more often with VenR, the long-term implications of uMRD with this fixed-duration, chemotherapy-free regimen have not been explored. We report MRD kinetics and updated outcomes with 5 years' follow-up. Survival benefits with VenR vs BR were sustained (median PFS [95% confidence interval] 53.6 [48.4, 57.0] vs 17.0 [15.5, 21.7] months, respectively, P < .0001; 5-year OS [95% confidence interval] 82.1% [76.4, 87.8] vs 62.2% [54.8, 69.6], P < .0001). VenR was superior to BR, regardless of cytogenetic category. VenR-treated patients with uMRD at end of treatment (EOT; n = 83) had superior OS vs those with high-MRD+ (n = 12) 3-year post-EOT survival rates were 95.3% vs 72.9% (P = .039). In those with uMRD at EOT, median time to MRD conversion was 19.4 months. Of 47 patients with documented MRD conversion, 19 developed progressive disease (PD); median time from conversion to PD was 25.2 months. A population-based logistic growth model indicated slower MRD median doubling time post-EOT with VenR (93 days) vs BR (53 days; P = 1.2 × 10-7). No new safety signals were identified. Sustained survival, uMRD benefits, and durable responses support 2-year fixed-duration VenR treatment in R/R CLL.
Asunto(s)

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Leucemia Linfocítica Crónica de Células B Tipo de estudio: Clinical_trials / Etiology_studies Límite: Humans Idioma: En Año: 2022 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Leucemia Linfocítica Crónica de Células B Tipo de estudio: Clinical_trials / Etiology_studies Límite: Humans Idioma: En Año: 2022 Tipo del documento: Article