Fractionated doses of gemtuzumab ozogamicin combined with 3 + 7 induction chemotherapy as salvage treatment for young patients with acute myeloid leukemia in first relapse

Malfuson, Jean-Valère; Konopacki, Johanna; Thepenier, Cédric; Eddou, Hicham; Foissaud, Vincent; Revel, Thierry de

doi:10.1007/s00277-012-1528-9

Cited by 10 publications

(8 citation statements)

References 29 publications

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“…These results are similar to a matched cohort of 440 patients treated on salvage studies at our institution. Of note, the combination of GO with “3+7’ as first salvage in a small group of younger patients with AML has shown promising results(44). These results need to be confirmed in larger studies in this patient population.…”

Section: Discussionmentioning

confidence: 99%

A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

et al. 2015

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Background Decitabine may open the chromatin structure of leukemia cells making them accessible to the calicheamicin epitope of gemtuzumab ozogamicin (GO). Methods 110 patients (median age 70 years; range 27–89 years) were treated with decitabine and GO in a trial designed on model based futility to accommodate subject heterogeneity: Group 1: relapsed/refractory AML with complete remission duration (CRD) < 1 year (N=28, 25%); Group 2: relapsed/refractory AML with CRD ≥1 year (N=5, 5%); Group 3: untreated AML unfit for intensive chemotherapy or untreated MDS or untreated MF (N=57, 52%); and Group 4: AML evolving from MDS or relapsed/refractory MDS or MF (N=20, 18%). Treatment consisted of decitabine 20mg/m2 daily for 5 days and GO 3 mg/m2 on day 5. Post-induction therapy included 5 cycles of decitabine+GO followed by decitabine alone. Results CR/CRi was achieved in 39 (35%) patients; Group 1= 5/28 (17%), Group 2 = 3/5 (60%), Group 3 = 24/57 (42%), and Group 4 = 7/20 (35%). The 8-week mortality in Groups 3 and 4 was 16% and 10%, respectively. Common drug-related adverse events included nausea, mucositis and hemorrhage. Conclusion Decitabine and GO improved the response rate but not OS compared to historical outcomes in untreated AML ≥60 years.

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Section: Discussionmentioning

confidence: 99%

A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

et al. 2015

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“…GO is the only compound for which there are a number of phase II/III studies in the literature 9–13. In the phase III MRC AML15 study, a single dose of GO at 3 mg/m 2 during the first and third course of chemotherapy was associated with a significant survival benefit in the subset of patients with favourable cytogenetics.…”

Section: Discussionmentioning

confidence: 99%

Ara-C, Idarubicine and Gentuzumab Ozogamicin (Aim) as Salvage Treatment in Advanced Acute Myeloid Leukemia Patients

Capria

Trisolini

Minotti

et al. 2012

Mediterr J Hematol Infect Dis

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Long-term survival of relapsed/refractory acute myeloid leukemia (AML) remains a major problem, particularly in patients not eligible for transplantation.We hereby evaluated the feasibility and efficacy of adding Gemtuzumab Ozogamicin to salvage chemotherapy (Ara-C, Idarubicine, Peg-Filgrastim) in relapsed/refractory AML. The main endpoints were: the rate of complete remissions (CR) and the proportion of patients capable of undergoing a stem cell transplant.Fourty-two patients were enrolled. The overall CR rate was 76% and no induction deaths were reported. In 56% of patients, a transplant procedure could be performed. The treatment schedule proved feasible and well tolerated, providing a high CR rate and a useful bridge to transplant.

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“…SWOG S016: The Southwest Oncology Group conducted a phase III randomized trial to evaluate the clinical benefit of adding GO (6 mg/mq on day 4) to the standard 3 + 7 induction regimen in AML patients at first relapse. To balance toxicities patients allocated to the GO arm received lower dose of daunorubicin (45 mg/mq vs. 60 mg/mq) in comparison with patient treated with conventional induction regimen [ 41 ]. The interim analysis reported a higher number of fatal toxicities in the GO arm compared to the other, causing the premature end of the study and the withdrawal of GO from the market on June 2010.…”

Section: Clinical Trials and Clinical Experience Of Go In Amlmentioning

confidence: 99%

Therapeutic Targeting of Acute Myeloid Leukemia by Gemtuzumab Ozogamicin

Gottardi

Simonetti

Sperotto

et al. 2021

Cancers

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Acute myeloid leukemia (AML) is a complex hematological malignancy characterized by genetic and clinical heterogeneity and high mortality. Despite the recent introduction of novel pharmaceutical agents in hemato-oncology, few advancements have been made in AML for decades. In the last years, the therapeutic options have rapidly changed, with the approval of innovative compounds that provide new opportunities, together with new challenges for clinicians: among them, on 1 September, 2017 the Food and Drug Administration granted approval for Gemtuzumab Ozogamicin (GO) in combination with daunorubicin and cytarabine for the treatment of adult patients affected by newly diagnosed CD33+ AML. Benefits of GO-based regimens were also reported in the pre- and post-transplantation settings. Moreover, several biomarkers of GO response have been suggested, including expression of CD33 and multidrug resistance genes, cytogenetic and molecular profiles, minimal residual disease and stemness signatures. Among them, elevated CD33 expression on blast cells and non-adverse cytogenetic or molecular risk represent largely validated predictors of good response.

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Fractionated doses of gemtuzumab ozogamicin combined with 3 + 7 induction chemotherapy as salvage treatment for young patients with acute myeloid leukemia in first relapse

Cited by 10 publications

References 29 publications

A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

A phase II study of decitabine and gemtuzumab ozogamicin in newly diagnosed and relapsed acute myeloid leukemia and high-risk myelodysplastic syndrome

Ara-C, Idarubicine and Gentuzumab Ozogamicin (Aim) as Salvage Treatment in Advanced Acute Myeloid Leukemia Patients

Therapeutic Targeting of Acute Myeloid Leukemia by Gemtuzumab Ozogamicin

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