scholarly journals Decitabine Compared with Low-Dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed Acute Myeloid Leukemia: A Pilot Study of Safety, Efficacy, and Cost-Effectiveness

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Linu A. Jacob ◽  
S. Aparna ◽  
K. C. Lakshmaiah ◽  
D. Lokanatha ◽  
Govind Babu ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Cost Effectiveness ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Study Groups ◽  
Newly Diagnosed ◽  
Treatment Groups ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

Introduction. The incidence of Acute Myeloid Leukemia (AML) increases progressively with age and its treatment is challenging. This prospective case control study was undertaken to compare the safety, efficacy, and cost-effectiveness of decitabine with those of cytarabine in older patients with newly diagnosed AML who are not fit for intensive chemotherapy.Materials and Methods. 30 eligible patients above 60 years old with newly diagnosed AML were assigned to receive decitabine or cytarabine. The primary end point was overall survival (OS). The secondary objective was to compare adverse events and cost-effectiveness of therapy in the two study groups.Results. In this study, 15 patients received decitabine and 15 patients received cytarabine. The median OS was 5.5 months for each of the treatment groups. The hazard ratio between the treatment groups was 0.811 with 95% CI of 0.390 to 1.687. Toxicity profile was similar in both groups. Cost per cycle of chemotherapy in INR was 24,200 for decitabine and 1,600 for low-dose cytarabine group. Median of simplified cost-effectiveness ratio was 0.00022 for decitabine group and 0.0034 for low-dose cytarabine group.Conclusions. For elderly patients with AML, decitabine and low-dose cytarabine should be chosen based on the patient’s choice and affordability. Our study has shown that both of these agents have similar OS and toxicity. Low-dose cytarabine scores over decitabine in developing countries as it is more cost-effective.

scholarly journals Final results of a phase 2 trial of clofarabine and low-dose cytarabine alternating with decitabine in older patients with newly diagnosed acute myeloid leukemia

Cancer ◽  
2015 ◽  
Vol 121 (14) ◽  
pp. 2375-2382 ◽  
Author(s):  
Tapan M. Kadia ◽  
Stefan Faderl ◽  
Farhad Ravandi ◽  
Elias Jabbour ◽  
Guillermo Garcia-Manero ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Phase 2 Trial ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

Timing of response to venetoclax combination treatment in older patients with acute myeloid leukemia.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7531-7531
Author(s):  
Brian Andrew Jonas ◽  
Courtney Denton Dinardo ◽  
Keith Pratz ◽  
Andrew Wei ◽  
Wan-Jen Hong ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Synergistic Activity ◽  
Newly Diagnosed ◽  
Median Response ◽  
Baseline Characteristics ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

7531 Background: Venetoclax (Ven) has synergistic activity with hypomethylating agents (eg, azacitidine [Aza] or decitabine [Dec]) or low-dose cytarabine (LDAC). These Ven-based combinations have demonstrated rapid median response times. This analysis describes the rapidity and likelihood of response to Ven treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). Methods: Included are data from two open-label trials of Ven, at label recommended doses, in combination with Aza, Dec (NCT02203773; phase 1b), or low-dose cytarabine (NCT02287233; phase 1/2) in newly diagnosed patients with AML. Patients were classified based on CR/CRi timing: within 2 cycles of therapy, after 2 cycles, or never achieving CR/CRi. Within each group, baseline and post-baseline characteristics were evaluated to determine impact on response timing. The percentage of patients in each category and duration of response (DOR) in each category were also evaluated. Results: Data cutoff was August 2018. Of 197 patients, 42% (n = 83) had CR/CRi in ≤2 cycles, 22% (n = 44) had CR/CRi in > 2 cycles, and 36% (n = 70) did not achieve CR/CRi. Median DOR was 21.2 mos. (95% CI 14.1-NR) for ≤2 cycle responders and 8.1 mos. (95% CI 5.3-14.9) for > 2 cycle responders. Baseline characteristics are shown in the Table. Patients with baseline IDH1/2 mutation were more likely to have CR/CRi in ≤2 cycles, while those with secondary AML and no response by the end of cycle 2 were more likely to never achieve CR/CRi. Of the patients who achieved CR/CRi after 2 cycles of therapy, 43% (19/44) achieved MLFS within the first two cycles. Of those who never achieved CR/CRi, 17% (12/70) of patients achieved MLFS within 2 cycles. In depth regression analyses of factors predictive of response, including analysis of biomarkers, will be available upon presentation. Conclusions: Over 1/3rd of patients that achieved CR/CRi on Ven combination therapy within these two studies required more than 2 cycles of treatment. Therefore, prior to discontinuing therapy for nonresponders, it is critical to assess key predictive patient characteristics. Clinical trial information: NCT02203773 and NCT02287233 . [Table: see text]

scholarly journals Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome

Leukemia ◽  
2018 ◽  
Vol 33 (2) ◽  
pp. 379-389 ◽  
Author(s):  
Jorge E. Cortes ◽  
Florian H. Heidel ◽  
Andrzej Hellmann ◽  
Walter Fiedler ◽  
B. Douglas Smith ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
High Risk ◽  
Myelodysplastic Syndrome ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Newly Diagnosed ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

Efficacy Of Azacitidine Versus Low-Dose Cytarabine In Patients With Acute Myeloid Leukemia - A Retrospective Single Center Experience

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3974-3974
Author(s):  
Aleksandar Radujkovic ◽  
Sascha Dietrich ◽  
Alwin Krämer ◽  
Tilmann Bochtler ◽  
Anthony D. Ho ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Cox Regression ◽  
Single Center ◽  
Treatment Groups ◽  
Significant Difference ◽  
Blast Count ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

Abstract Introduction Azacitidine (AZA) treatment has been shown to be superior to conventional care regimens including low dose cytarabine (LD-Ara-C) in acute myeloid leukemia (AML) patients with low bone marrow (BM) blast counts (20-30%). In contrast, data on efficacy of AZA in patients with blast counts exceeding 30% are scarce. Here we present a retrospective, single center analysis, comparing the efficacy and toxicity of AZA versus LD-Ara-C in AML patients with high BM blast counts (≥30%) prior to treatment. Patients and Methods Twenty-seven patients receiving AZA and 38 patients receiving LD-Ara-C met the eligibility criteria for the analysis (age ≥18 years, documented BM blast count ≥30% prior to start of treatment and administration of at least one complete therapy cycle). Patients who underwent allogeneic transplantation following AZA treatment or received stem cell support following LD-Ara-C therapy were excluded from this analysis. Overall survival (OS) was estimated using the method of Kaplan and Meier. Comparison of OS between the AZA and LD-Ara-C group was done using the logrank test and by Cox regression adjusting for known confounders. Results Patient (age, ECOG status) and diseases characteristics (type of AML, cytogenetics, pretreatment, number of treatment cycles) did not differ significantly between the treatment groups, except for BM blast count (median 44% vs. 60% in the AZA and LD-Ara-C group, respectively; p=0.03) and peripheral blood blast count (median 6% vs. 56% in the AZA and LD-Ara-C group, respectively; p<0.01). Response rates to AZA treatment according to international working group (IWG) criteria were low with two patients achieving a complete remission (CR) and one patient showing partial remission (PR) after AZA treatment. In the LD-Ara-C cohort no CR was observed and two patients experienced a PR. Hematologic improvement (HI) rates according to IWG criteria did not differ between both treatment groups (any type of HI 33% vs. 24% in the AZA and LD-Ara-C group, respectively; p=0.41). In both cohorts, most common non-hematologic toxicities (CTCAE grade≥3) included febrile neutropenia, pneumonia and bleedings without significant differences regarding frequencies. As expected, skin involvement was more commonly observed in the AZA group (19% vs. 3%, p=0.04). One year survival rates were only 15% (95% CI 8-22%) and 13% (95% CI 7-19%) in the AZA and LD-Ara-C group, respectively. There was no statistically significant difference between the treatment groups (HR 1.2, p=0.41). Furthermore, there was no difference in hospitalization time (total days spent in hospital during treatment per patient-year of follow-up 29.4 vs. 27.2 in the AZA and LD-Ara-C group, respectively; RR 1.07 95% CI 0.95-1.21, p=0.23). In a multivariate analysis with OS as endpoint adverse cytogenetics (HR 2.24 95% CI 1.17-4.70, p<0.02) were significantly associated with inferior survival, whereas the treatment had no impact (AZA vs. LD-Ara-C HR 1.27 95% CI 0.67-2.40, p=0.46). Conclusion In our center, treatment with AZA showed limited efficacy and no superiority to LD-Ara-C treatment in AML patients with BM blasts ≥30%. Disclosures: Dreger: Riemser Pharma : Consultancy, Honoraria, Research Funding.

scholarly journals Arsenic trioxide and low-dose cytarabine in older patients with untreated acute myeloid leukemia, excluding acute promyelocytic leukemia

Cancer ◽  
2008 ◽  
Vol 113 (9) ◽  
pp. 2504-2511 ◽  
Author(s):  
Gail J. Roboz ◽  
Ellen K. Ritchie ◽  
Tania Curcio ◽  
Juliette Provenzano ◽  
Rebecca Carlin ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Promyelocytic Leukemia ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

scholarly journals Updates in the Management of Newly Diagnosed Acute Myeloid Leukemia

2021 ◽  
Vol 19 (11.5) ◽  
pp. 1358-1361
Author(s):  
Alice S. Mims
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Low Dose ◽  
Gemtuzumab Ozogamicin ◽  
Newly Diagnosed ◽  
Core Binding Factor ◽  
Binding Factor ◽  
Chemotherapy Patients ◽  
Low Dose Cytarabine ◽  
Acute Myeloid

For patients with newly diagnosed acute myeloid leukemia (AML) who are candidates for intensive induction regimens, all therapies include anthracycline- and cytarabine-based backbones. Core-binding factor AML is typically treated with gemtuzumab ozogamicin and 7 + 3 chemotherapy. Patients with FLT3-mutated (ITD or TKD) disease should have midostaurin + 7 + 3 and consolidation, and those with secondary or therapy-related AML should be considered for CPX-351. For patients ineligible for intensive induction regimens, venetoclax has changed the game and should be used in combination with hypomethylating agents or cytarabine. Glasdegib is also approved in combination with low-dose cytarabine. Patients with IDH1/2-mutated disease can be treated with ivosidenib and enasidenib, respectively. Although enasidenib has yet to secure its spot in the up-front setting, data support its use in newly diagnosed AML. An ongoing question in the field concerns how to treat patients with TP53-mutated AML, because most patients do not respond well to currently available therapies and continue to have poor overall outcomes.

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