Outcomes of Adult Acute Myeloid Leukemia Treated With Gemtuzumab-Ozogamicin: Cue To Optimized Chemotherapy Backbone

Singh, Abhay; Thota, Swapna; Bradley, Terrence; Griffiths, Elizabeth A.; Faber, Mark G.; Sadek, Sarah; Przespolewski, Amanda; Thompson, James E.; Baron, Jeffrey; Cronin, Tara; Attwood, Kristopher; Madarang, Ellen; Watts, Justin M.; Wang, Eunice S.

doi:10.1016/j.clml.2021.04.007

Cited by 4 publications

(6 citation statements)

References 23 publications

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“… 17 A recent study has confirmed efficacy and safety of GO addition to standard 3 + 7 chemotherapy also in FLT3 mutated AML; furthermore, GO combination with midostaurin‐based induction regimens in FLT3 mutated CD33 + AML has been proposed with clinical benefits and tolerability with slightly prolonged neutropenia. 11 , 18 , 19 In this real‐life multicenter study from Southern Italy, our results are consistent with previously reported studies, indicating a solid benefit for low genetic risk, especially for CBF AML, although not statistically significant likely because of the small number of patients with this genetic alteration in our cohort. Conversely, intermediate‐risk patients might not highly benefit of GO in combination with standard chemotherapy as observed in low‐risk subjects, likely because of different phenotypic features making this AML subset more chemoresistant.…”

Section: Discussionsupporting

confidence: 92%

“…Results from the AMLSG 09‐09 phase III trial have added evidence of clinical benefits of GO addition in NPM1 mutant AML, while not in FLT3 co‐mutated subjects 17 . A recent study has confirmed efficacy and safety of GO addition to standard 3 + 7 chemotherapy also in FLT3 mutated AML; furthermore, GO combination with midostaurin‐based induction regimens in FLT3 mutated CD33 + AML has been proposed with clinical benefits and tolerability with slightly prolonged neutropenia 11,18,19 . In this real‐life multicenter study from Southern Italy, our results are consistent with previously reported studies, indicating a solid benefit for low genetic risk, especially for CBF AML, although not statistically significant likely because of the small number of patients with this genetic alteration in our cohort.…”

Section: Discussionsupporting

confidence: 91%

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Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients

Serio,

Grimaldi,

Ammirati

et al. 2024

Cancer Reports

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BackgroundGemtuzumab‐ozogamycin (GO) is approved in combination with high‐dose chemotherapy for treatment‐naïve low‐ and intermediate‐risk acute myeloid leukemia (AML).AimsIn this retrospective real‐life multicenter study, we reported efficacy and safety of GO plus high‐dose chemotherapy in newly diagnosed AML patients.Methods and ResultsA total of 31 fit low‐ and intermediate‐risk AML patients treated with GO‐based regimens were retrospectively included in this real‐life multicenter study, and results were compared with a control cohort treated with 3 + 7 alone. Complete remission (CR) rate after induction was 77%, and most responders (45%) underwent two GO‐based consolidation, and minimal residual disease (MRD) negativity was observed in 17 cases (55%) after the end of consolidation. Low genetic risk was associated with increased CR rate compared with intermediate‐risk AML (88% vs. 33%; p < .001), as well as prolonged overall survival (OS; hazard ratio, 0.16; 95% confidential interval, 0.02–0.89; p < .001). GO addition resulted in a survival benefit for low‐risk AML (median OS not reached vs. 25 months; p = .19) while not for intermediate‐risk subjects (10 vs. 13 months; p = .92), compared with the control group. Moreover, GO‐treated patients experienced fever of unknown origin or sepsis in 42% or 36% of cases, respectively, with one death during induction due to septic shock, with similar rates compared with the control group (p = .3480 and p = .5297, respectively). No cases of veno‐occlusive disease after allogeneic transplantation were observed.ConclusionsOur real‐life multicenter study confirmed GO‐based treatment efficacy with high MRD negativity rates in fit newly diagnosed AML patients, especially in those with low genetic risk and core binding factor, while limited benefits were observed in intermediate‐risk AML. However, further validation on larger prospective cohorts is required.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients

Serio,

Grimaldi,

Ammirati

et al. 2024

Cancer Reports

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“…A retrospective study published by Singh A et al demonstrated the safety of intensified daunorubicin and GO and the combination with FLT3 inhibitors in patients with favorable-risk AML [ 1 ]. A phase 3 randomized trial by Lee JH et al compared high-dose daunorubicin (HD-DN, 90 mg/m² per day for three days) with standard-dose daunorubicin (SD-DN, 45 mg/m² per day for three days) as induction chemotherapy in addition to cytarabine (200 mg/m² per day times seven days) in adults with AML.…”

Section: Discussionmentioning

confidence: 99%

“…In the dose-intensified GO-based induction group, there were no cases of veno-occlusive disease noted. Additionally, side effects, such as cytopenias, febrile neutropenia, pneumonia, and cardiac toxicities, were comparable in both the intensified and non-intensified arms [ 1 ].…”

Section: Discussionmentioning

confidence: 99%

“…Gemtuzumab-ozogamicin (GO), an anti-CD33 monoclonal antibody linked to a DNA-damaging cytotoxic drug, was developed after the discovery that anti-CD33 antibodies bind selectively to AML cells and are internalized across the tissue membrane. A retrospective study published by Singh A et al demonstrated the safety of intensified daunorubicin and GO and the combination with FLT3 inhibitors in patients with favorable-risk AML [ 1 ]. The optimal chemotherapy combination with these new agents for the management of young AML patients remains unclear.…”

Section: Introductionmentioning

confidence: 99%

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Intensified-Dose Chemotherapy in Combination With Gemtuzumab-Ozogamicin for the Treatment of Favorable-Risk Acute Myeloid Leukemia (AML)

Vegunta¹,

Harel²,

Steinberg³

2022

Cureus

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Chemotherapy has been the standard of treatment for acute myeloid leukemia (AML). With the emergence of new therapies for AML like gemtuzumab-ozogamicin and FLT3 inhibitors, such as sorafenib, midostaurin, and gilteritinib, the optimal dose of chemotherapy and safety profile in different age groups when combined with these new therapies is yet to be established. There are limited data on the treatment of AML by combining intensified daunorubicin (doses of 90 mg/m 2 ) with gemtuzumab-ozogamicin (GO). We report a young adult with favorable-risk AML treated with daunorubicin at a dose of 90 mg/m 2 combined with GO, who had a complete response after induction but had a profound nadir of platelet count after induction and consolidation.

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Antineoplastics

2023

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Outcomes of Adult Acute Myeloid Leukemia Treated With Gemtuzumab-Ozogamicin: Cue To Optimized Chemotherapy Backbone

Cited by 4 publications

References 23 publications

Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients

Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients

Intensified-Dose Chemotherapy in Combination With Gemtuzumab-Ozogamicin for the Treatment of Favorable-Risk Acute Myeloid Leukemia (AML)

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