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Idasanutlin plus cytarabine in relapsed or refractory acute myeloid leukemia: results of the MIRROS trial
DC Field | Value | Language |
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dc.contributor.author | Konopleva, Marina Y. | - |
dc.contributor.author | Röllig, Christoph | - |
dc.contributor.author | Cavenagh, Jamie | - |
dc.contributor.author | Deeren, Dries | - |
dc.contributor.author | Girshova, Larisa | - |
dc.contributor.author | Krauter, Jürgen | - |
dc.contributor.author | Martinelli, Giovanni | - |
dc.contributor.author | Montesinos, Pau | - |
dc.contributor.author | Schäfer, Jonas A. | - |
dc.contributor.author | Ottmann, Oliver | - |
dc.contributor.author | Petrini, Mario | - |
dc.contributor.author | Pigneux, Arnaud | - |
dc.contributor.author | Rambaldi, Alessandro | - |
dc.contributor.author | Recher, Christian | - |
dc.contributor.author | Rodriguez-Veiga, Rebeca | - |
dc.contributor.author | Taussig, David | - |
dc.contributor.author | Vey, Norbert | - |
dc.contributor.author | Yoon, Sung-Soo | - |
dc.contributor.author | Ott, Marion | - |
dc.contributor.author | Muehlbauer, Susanne | - |
dc.contributor.author | Catalani, Olivier | - |
dc.contributor.author | Genevray, Magali | - |
dc.contributor.author | Mundt, Kirsten | - |
dc.contributor.author | Jamois, Candice | - |
dc.contributor.author | Fenaux, Pierre | - |
dc.contributor.author | Wei, Andrew H. | - |
dc.contributor.author | Beckermann, Benjamin M. | - |
dc.date.accessioned | 2022-09-30T05:53:52Z | - |
dc.date.available | 2022-09-30T05:53:52Z | - |
dc.date.created | 2022-08-19 | - |
dc.date.issued | 2022-07 | - |
dc.identifier.citation | Blood Advances, Vol.6 No.14, pp.4147-4156 | - |
dc.identifier.issn | 2473-9529 | - |
dc.identifier.uri | https://hdl.handle.net/10371/184957 | - |
dc.description.abstract | © 2022 by The American Society of Hematology.The phase 3MIRROS (MDM2 antagonist Idasanutlin in Relapsed or Refractory acute myeloid leukemia [AML] for Overall Survival) trial (NCT02545283) evaluated the efficacy and safety of the small-moleculeMDM2 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 notmet (median, 8.3 vs 9.1months 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. | - |
dc.language | 영어 | - |
dc.publisher | AMER SOC HEMATOLOGY | - |
dc.title | Idasanutlin plus cytarabine in relapsed or refractory acute myeloid leukemia: results of the MIRROS trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1182/bloodadvances.2021006303 | - |
dc.citation.journaltitle | Blood Advances | - |
dc.identifier.scopusid | 2-s2.0-85134833443 | - |
dc.citation.endpage | 4156 | - |
dc.citation.number | 14 | - |
dc.citation.startpage | 4147 | - |
dc.citation.volume | 6 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Yoon, Sung-Soo | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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