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Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses.

Kelly J NorsworthyXin GaoChia-Wen KoE Dianne PulteJiaxi ZhouYutao GongYuan Li ShenJonathon VallejoThomas E GwiseRajeshwari SridharaAlbert B DeisserothAnn T FarrellR Angelo de ClaroGideon M BlumenthalRichard Pazdur
Published in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
On a trial level, there is a moderate association between OS and CR rate. A strong association between EFS and OS was observed. However, CIs were wide, and results became moderate using alternative definitions for EFS. Patient-level analyses showed CR responders have better OS compared with CRi or CRp responders and nonresponders. A therapy in newly diagnosed AML with benefit in EFS or substantial benefit in CR rate would be likely to have an OS effect.
Keyphrases
  • newly diagnosed
  • acute myeloid leukemia
  • free survival
  • case report
  • clinical trial
  • study protocol
  • phase iii
  • high intensity
  • phase ii
  • drug administration
  • stem cells
  • risk assessment
  • human health