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    Home > Active Ingredient News > Blood System > Chemotherapy combined with sorafenib may bring more benefits to young newly diagnosed AML patients

    Chemotherapy combined with sorafenib may bring more benefits to young newly diagnosed AML patients

    • Last Update: 2021-12-06
    • Source: Internet
    • Author: User
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    Sorafenib is the first-generation type II multikinase inhibitor.
    Because the drug has good efficacy data in preclinical and non-randomized clinical studies in acute myeloid leukemia (AML), the Leukemia Research Alliance (SAL) has launched a A randomized trial to evaluate the efficacy and tolerability of sorafenib combined with standard induction therapy as the main treatment for adults with AML less than 60 years old


    The results of the first study analysis after 36 months of follow-up showed that the addition of sorafenib treatment can significantly prolong the event-free survival (EFS) and recurrence-free survival (RFS) of adult AML patients, and have overall survival The trend of prolonged period (OS)

    Based on this, the researchers further analyzed this study to explore the type and efficacy of second-line treatment for patients with relapse in the study, including the proportion and method of allogeneic stem cell transplantation (Allo-SCT), and the effect after the second complete remission (CR) Cumulative recurrence rate (CIR) and OS after the first recurrence

    Research method SORAML is a randomized placebo-controlled double-blind trial conducted in Germany

    Newly diagnosed AML patients aged 18-60 years (without regard to FLT3 mutation status, ECOG score ≤ 2 points, and sufficient heart, kidney, and liver functions) are eligible for inclusion in the trial

    After enrollment, the patients were randomly divided into groups at a ratio of 1:1 through randomization of the central group, and the allocation of placebo or sorafenib treatment was hidden

    Study Results Baseline Distribution of Patients and Treatment Response The study included 276 patients from 25 German research centers from March 27, 2009 to November 28, 2011

    Nine patients did not receive the study drug, and a total of 267 patients constituted the full analysis set of the intention-to-treat analysis, including 134 in the sorafenib group and 133 in the placebo group

    A total of 46/267 (17%) AML patients had FLT3 internal tandem duplication (ITD) positive, and 86/267 (33%) AML patients had NPM1 mutations (Table 1)

    The CR rates of sorafenib and placebo control patients were 60% and 59%, respectively

    The proportions of patients in the sorafenib and placebo groups who received Allo-SCT at CR1 were 31% and 26%, respectively

    The median duration of treatment in the sorafenib group was 37.
    5 days and that in the placebo group was 41 days (p=0.


    The induction treatment mortality rates for sorafenib and placebo groups were 3% and 1.
    5%, respectively


    Table 1: Patients with baseline characteristics.
    After a median follow-up of 78 months, the 5-year EFS rates of sorafenib and placebo groups were 41% (95% CI 34%-51%) and 27% (95%).
    CI 21%-36%), the unadjusted hazard ratio (HR) was 0.
    68 (95% CI 0.
    91; p=0.
    011 (Figure 1)


    In the multivariate Cox model, the established prognostic parameters age, cell Genetic risk, NPM1 and FLT3-ITD mutation status, lactate dehydrogenase (LDH), white blood cell (WBC) and secondary AML.
    Sorafenib treatment still has a significant effect on EFS.
    The adjusted HR is 0.
    61 (95% CI 0.
    87; p=0.


    Favorable cytogenetics and NPM1 mutations are associated with patients with better EFS, while patients with poor cytogenetic abnormalities have a poor prognosis (Table 2)

    Subgroup analysis showed that patients with FLT3-ITD benefited more from sorafenib treatment than patients without FLT3-ITD, and the corresponding HR was 0.
    55 (95% CI 0.
    08) vs 0.
    71 (95% CI 0.
    99 )


    If patients with FLT3-ITD mutations are excluded from the study population, sorafenib still has significant EFS and RFS advantages over the placebo treatment group

    Figure 1: EFS status of patients since randomization Table 2: EFS, RFS and OS risk ratio of patients according to multivariate Cox regression model RFS, recurrence after CR, and OS status Among 159 patients who achieved CR, sorafenib The 5-year RFS rates of patients in the placebo group and the placebo group were 53% and 36%, respectively, and the unadjusted HR was 0.
    64 (95% CI 0.
    97; p=0.
    035) (Figure 2)


    Multivariate analysis showed that after adjusting for other prognostic variables such as age, cytogenetic risk, NPM1 and FLT3-ITD mutation status, LDH, WBC, and secondary AML, the HR was 0.
    57 (95% CI 0.
    92, p=0.


    In patients who did not receive Allo-SCT as post-remission consolidation therapy at CR1, the obvious benefit of RFS did not translate into OS benefit; in patients who received Allo-SCT at CR1, OS benefit was obvious

    Figure 2: Patients with RFS from CR1 have a higher rate of recurrence after CR than those in the sorafenib-treated group

    The CIR of patients in the sorafenib and placebo groups after 5 years was 36% (95% CI 25-47) and 50% (95% CI 39-61) (p=0.
    087), respectively


    In the recurrence rate and non-recurrence mortality (NRM) analysis of salvage transplantation, it was observed that the difference in the frequency of the second transplantation and haploidentical SCT did not affect the NRM

    88% of relapsed patients underwent Allo-HSCT.
    The 4-year CIR of sorafenib and placebo patients were 54% and 35%, respectively, and the 4-year OS rate after transplantation was 32% and 50%, respectively; The 5-year OS rates of patients from randomization were 61% and 53% (HR 0.
    82; P=0.
    282) (Figure 3)


    Compared with patients in the placebo group, patients who relapsed after sorafenib treatment had a lower 2-year OS rate of 35% and 54% (p=0.


    Figure 3: The results of the study of the OS status of patients since randomization.
    The results of the study showed that the long-term follow-up results of the treatment of young newly diagnosed AML patients with sorafenib on the basis of standard intensive treatment showed that the patients' EFS and RFS were significantly prolonged


    References: Christoph Röllig, Hubert Serve, Richard Noppeney,et al.
    Sorafenib or placebo in patients with newly diagnosed acute myeloid leukaemia: long-term follow-up of the randomized controlled SORAML trial.
    2021 Sep;35(9): 2517-2525.
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