Negative / Null Result ReportOpen accessMedicine· cited by 57

Sorafenib or placebo in patients with newly diagnosed acute myeloid leukaemia: long-term follow-up of the randomized controlled SORAML trial

Christoph Röllig; Hubert Serve; Richard Noppeney; Maher Hanoun; Utz Krug; Claudia D. Baldus; Christian Brandts; Volker Kunzmann · 2021 · Leukemia

WASTE classifies this as Negative / Null Result Report · AI classification, approximate

The study found no significant effect — useful as a negative control or null benchmark for your own design.

Abstract

Early results of the randomized placebo-controlled SORAML trial showed that, in patients with newly diagnosed acute myeloid leukaemia (AML), sorafenib led to a significant improvement in event-free (EFS) and relapse-free survival (RFS). In order to describe second-line treatments and their implications on overall survival (OS), we performed a study after a median follow-up time of 78 months. Newly diagnosed fit AML patients aged ≤60 years received sorafenib (n = 134) or placebo (n = 133) in addition to standard chemotherapy and as maintenance treatment. The 5-year EFS was 41 versus 27% (HR 0.6

Abstract by Christoph Röllig; Hubert Serve; Richard Noppeney; Maher Hanoun; Utz Krug; Claudia D. Baldus; Christian Brandts; Volker Kunzmann, Leukemia (2021) — licensed CC BY 4.0.

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