AML-284 Feasibility of Outpatient Induction in Adolescent and Adult Acute Patients With Myeloid Leukemia in a High-Volume Centre

<h3>Context & Objective</h3> Delayed treatment initiation in patients with AML often leads to detrimental outcomes. In our high-volume center, there is an average 3-week delay in treatment initiation, reflecting the substantial burden in resource-constrained settings (Jain H, JGO. 2020). To overcome this problem, our study aimed to evaluate the safety and feasibility of an outpatient induction model, hoping to minimize time from diagnosis to treatment (TDT) and lower hospital-acquired infections, thereby reducing induction mortality. <h3>Design & Setting</h3> This is a single-center, prospective, open-label trial conducted from March 2021 to May 2023. Ethics approval and informed consent were obtained, and the study was registered in the Clinical Trials Registry–India (CTRI/2020/09/027654). Newly diagnosed patients with AML aged 15-65 years, performance score ≤1, baseline WBC count <20 × 10<sup>9</sup>/L, and no active infection or bleeding were enrolled either before induction or on day 9-10. All patients received standard 7+3 (daunorubicin/idarubicin and cytarabine) induction with prophylactic antifungals. The primary endpoint was 28-day induction mortality. Secondary endpoints were remission rates, readmission rates, TDT, compliance, length of hospital stay, complications, infection rates, and 2-year survival outcomes. <h3>Results</h3> The study enrolled 30 patients (20 prior to induction and 10 after day 8) with a median age of 25 years (range, 15-46); males comprised 63.3% of the cohort. The time-to-treatment initiation was 4.5 days (range, 0-23), and only one patient had induction mortality due to COVID-19 infection. Post induction, 14 patients (46.7%) achieved complete remission (CR+CRi). The majority of patients had febrile neutropenia (n=28, 93.3%), while 6 patients (20%) had documented bloodstream infections. Invasive fungal infections were probable in 2 patients (6.7%) and possible in 6 patients (20%). With regard to readmissions post-enrollment, 10% had none, 76.7% had one, and 13.3% had two readmissions. The median length of hospital stay was 15 days (range, 0-26) with none requiring ICU admission, and 2 patients (6.7%) received inotropic support. After a median follow-up of 19 months, the 2-year progression-free survival was 43.8%, and the 2-year overall survival was 51.5%. <h3>Conclusion</h3> Outpatient induction model was feasible in reducing time-to-treatment initiation without any additional induction mortality.

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Journal
Clinical Lymphoma Myeloma & Leukemia
Published
2024-08-26
DOI
https://doi.org/10.1016/s2152-2650(24)01180-7
Primary Topic
Neutropenia and Cancer Infections
Type
article
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article

AML-284 Feasibility of Outpatient Induction in Adolescent and Adult Acute Patients With Myeloid Leukemia in a High-Volume Centre

Hasmukh Jain, Lingaraj Nayak, Alok Shetty, Bhausaheb Bagal et al.
Clinical Lymphoma Myeloma & Leukemia
Neutropenia and Cancer Infections
article

AML-284 Feasibility of Outpatient Induction in Adolescent and Adult Acute Patients With Myeloid Leukemia in a High-Volume Centre

Hasmukh Jain, Lingaraj Nayak, Alok Shetty, Bhausaheb Bagal, Manju Sengar, Thomas Eipe
article en

Abstract

<h3>Context & Objective</h3> Delayed treatment initiation in patients with AML often leads to detrimental outcomes. In our high-volume center, there is an average 3-week delay in treatment initiation, reflecting the substantial burden in resource-constrained settings (Jain H, JGO. 2020). To overcome this problem, our study aimed to evaluate the safety and feasibility of an outpatient induction model, hoping to minimize time from diagnosis to treatment (TDT) and lower hospital-acquired infections, thereby reducing induction mortality. <h3>Design & Setting</h3> This is a single-center, prospective, open-label trial conducted from March 2021 to May 2023. Ethics approval and informed consent were obtained, and the study was registered in the Clinical Trials Registry–India (CTRI/2020/09/027654). Newly diagnosed patients with AML aged 15-65 years, performance score ≤1, baseline WBC count <20 × 10<sup>9</sup>/L, and no active infection or bleeding were enrolled either before induction or on day 9-10. All patients received standard 7+3 (daunorubicin/idarubicin and cytarabine) induction with prophylactic antifungals. The primary endpoint was 28-day induction mortality. Secondary endpoints were remission rates, readmission rates, TDT, compliance, length of hospital stay, complications, infection rates, and 2-year survival outcomes. <h3>Results</h3> The study enrolled 30 patients (20 prior to induction and 10 after day 8) with a median age of 25 years (range, 15-46); males comprised 63.3% of the cohort. The time-to-treatment initiation was 4.5 days (range, 0-23), and only one patient had induction mortality due to COVID-19 infection. Post induction, 14 patients (46.7%) achieved complete remission (CR+CRi). The majority of patients had febrile neutropenia (n=28, 93.3%), while 6 patients (20%) had documented bloodstream infections. Invasive fungal infections were probable in 2 patients (6.7%) and possible in 6 patients (20%). With regard to readmissions post-enrollment, 10% had none, 76.7% had one, and 13.3% had two readmissions. The median length of hospital stay was 15 days (range, 0-26) with none requiring ICU admission, and 2 patients (6.7%) received inotropic support. After a median follow-up of 19 months, the 2-year progression-free survival was 43.8%, and the 2-year overall survival was 51.5%. <h3>Conclusion</h3> Outpatient induction model was feasible in reducing time-to-treatment initiation without any additional induction mortality.

Clinical Lymphoma Myeloma & LeukemiaVol. 24
Tata Memorial Hospital (IN)
Openalex Percentile: Top 76%
Neutropenia and Cancer Infections
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