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Idasanutlin plus cytarabine in relapsed or refractory acute myeloid leukemia: results of the MIRROS trial.
Konopleva, Marina Y; Röllig, Christoph; Cavenagh, Jamie; Deeren, Dries; Girshova, Larisa; Krauter, Jürgen; Martinelli, Giovanni; Montesinos, Pau; Schäfer, Jonas A; Ottmann, Oliver; Petrini, Mario; Pigneux, Arnaud; Rambaldi, Alessandro; Recher, Christian; Rodriguez-Veiga, Rebeca; Taussig, David; Vey, Norbert; Yoon, Sung-Soo; Ott, Marion; Muehlbauer, Susanne; Beckermann, Benjamin M; Catalani, Olivier; Genevray, Magali; Mundt, Kirsten; Jamois, Candice; Fenaux, Pierre; Wei, Andrew H.
Afiliación
  • Konopleva MY; University of Texas MD Anderson Cancer Center, Houston, TX.
  • Röllig C; Universitätsklinikum Carl Gustav Carus, Dresden, Germany.
  • Cavenagh J; Barts Health National Health Service Trust Hospital, London, United Kingdom.
  • Deeren D; Algemeen Ziekenhuis Delta, Roeselare, Belgium.
  • Girshova L; Almazov Medical Research Centre, St. Petersburg, Russia.
  • Krauter J; Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie, Braunschweig, Germany.
  • Martinelli G; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Istituto Di Ricovero e Cura a Carattere Scientifico, Meldola, Italy;
  • Montesinos P; Hospital Universitari i Politècnic La Fe, Valencia, Spain.
  • Schäfer JA; Universitätsklinikum Marburg, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Immunologie, Marburg, Germany.
  • Ottmann O; Cardiff University, Cardiff, United Kingdom.
  • Petrini M; Hematology Unit Azienda Ospedaliero Universitaria Pisana, University of Pisa, Pisa, Italy.
  • Pigneux A; Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France.
  • Rambaldi A; University of Milan and Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
  • Recher C; Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
  • Rodriguez-Veiga R; Hospital Universitari i Politècnic La Fe, Valencia, Spain.
  • Taussig D; Royal Marsden National Health Service Foundation Trust, Marsden, United Kingdom.
  • Vey N; Institut Paoli-Calmettes, Marseille, France.
  • Yoon SS; Seoul National University Hospital, Seoul, South Korea.
  • Ott M; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Muehlbauer S; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Beckermann BM; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Catalani O; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Genevray M; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Mundt K; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Jamois C; F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
  • Fenaux P; Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; and.
  • Wei AH; The Alfred Hospital and Monash University, Melbourne, Australia.
Blood Adv ; 6(14): 4147-4156, 2022 07 26.
Article en En | MEDLINE | ID: mdl-35413116
The phase 3 MIRROS (MDM2 antagonist Idasanutlin in Relapsed or Refractory acute myeloid leukemia [AML] for Overall Survival) trial (NCT02545283) evaluated the efficacy and safety of the small-molecule MDM2 antagonist idasanutlin plus cytarabine in patients with relapsed/refractory (R/R) AML. Adults (n = 447) with R/R AML whose disease relapsed or was refractory after ≤2 prior induction regimens as initial treatment or following salvage chemotherapy regimen, with Eastern Cooperative Oncology Group performance status ≤2 were enrolled regardless of TP53 mutation status and randomly assigned 2:1 to idasanutlin 300 mg or placebo orally twice daily plus cytarabine 1 g/m2 IV on days 1 to 5 of 28-day cycles. At primary analysis (cutoff, November 2019), 436 patients were enrolled, including 355 in the TP53 wild-type intention-to-treat (TP53WT-ITT) population. The primary endpoint, overall survival in the TP53WT-ITT population, was not met (median, 8.3 vs 9.1 months with idasanutlin-cytarabine vs placebo-cytarabine; stratified hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.81-1.45; P = .58). The complete remission (CR) rate, a key secondary endpoint, was 20.3% vs 17.1% (odds ratio [OR], 1.23; 95% CI, 0.70-2.18). The overall response rate (ORR) was 38.8% vs 22.0% (OR, 2.25; 95% CI, 1.36-3.72). Common any-grade adverse events (≥10% incidence in any arm) were diarrhea (87.0% vs 32.9%), febrile neutropenia (52.8% vs 49.3%), and nausea (52.5% vs 31.5%). In summary, despite improved ORR, adding idasanutlin to cytarabine did not improve overall survival or CR rates in patients with R/R AML.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Leucemia Mieloide Aguda / Citarabina Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Blood Adv Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Leucemia Mieloide Aguda / Citarabina Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: Blood Adv Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos