scholarly journals Implementation of a High-Dose Cytarabine Outpatient Program for Acute Myeloid Leukemia Patients in a Limited-Source Setting

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4981-4981
Author(s):  
Juan C Haro ◽  
Evelyn Espinoza-Morales ◽  
Johan Espino ◽  
Fátima Jiménez-Mozo ◽  
Nathaly Poma ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Pilot Study ◽  
Myeloid Leukemia ◽  
Conflicts Of Interest ◽  
High Dose ◽  
Caregiver Support ◽  
Outpatient Program ◽  
High Dose Cytarabine ◽  
Acute Myeloid

Abstract Background: The management of acute myeloid leukemia (AML) patients usually requires long inpatient treatments that can affect the limited care facilities, the quality of life, and increases healthcare costs. Additionally, leukemia treating centers in developing countries face limited sources to deliver high-dose chemotherapies as inpatient treatments. Therefore, several reports have established the feasibility and safety of outpatient consolidation. We aimed to implement a high-dose cytarabine outpatient program for AML in a limited-source institution at a public center in Peru.Methods: We conducted a prospective pilot study starting in January 2019 and ending before the COVID-19 Pandemic in March 2020. Eligible patients were ≥ age 14, met inclusion criteria for inpatient induction regimens, were without active infection, and had the following: normal chest x-ray and biochemistry, complete remission after one cycle of 7+3 induction. Logistical requirements included a 3-hours distance residence near the treatment center, caregiver support, trained nursing staff, infusion room capacity, and participation in follow-up. Patients received prophylactic antimicrobials such as oral levofloxacin, fluconazole, and acyclovir and were admitted to the hospital for predetermined complications of therapy (fever, G3-4 toxicity, febrile neutropenia, bleeding or refractory thrombocytopenia). Risk stratification was based on conventional cytogenetics and multiplex PCR using Leukemia.net criteria. Results: Forty-two patients were included during the study period. The median age was 38 years (16-63) and Female/Male ratio 4:3. According to Leukemia.net, 24% were classified as high, 50% intermediate and 26% as low risk group. Including FLT3 mutations in 26% of cases. Twenty-two and 20 subjects received 1-2 and 3-4 cycles of ambulatory HiDAC, respectively. About one-third of cases had emergency admissions during consolidation and 74% complete at least 3 cycles of cytarabine. Only 4 patients underwent sibling-donor allo-SCT. Sixty-four percent experienced relapses, and at 2 years follow-up only 21 subjects were alive. Median OS was 15 months, a better survival was shown among patients who received 3-4 cycles of ambulatory HiDAC (2-year OS 18 vs 23%, p=0.031). Conclusion: Our pilot study shows the feasibility to deliver HiDAC as outpatient consolidation in selected AML cases in a limited setting. Additionally, a high rate of relapses and poor survival was noted in our cohort that requires further consideration. Disclosures No relevant conflicts of interest to declare.

High-dose cytarabine and daunorubicin as consolidation therapy for acute myeloid leukemia in first remission: long-term follow-up and results.

1989 ◽  
Vol 7 (9) ◽  
pp. 1260-1267 ◽  
Author(s):  
S N Wolff ◽  
R H Herzig ◽  
J W Fay ◽  
G L Phillips ◽  
H M Lazarus ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Complete Remission ◽  
Myeloid Leukemia ◽  
High Dose ◽  
Allogeneic Bone ◽  
Consolidation Therapy ◽  
High Dose Cytarabine ◽  
Acute Myeloid

In an effort to increase the proportion of patients with acute myeloid leukemia (AML) remaining in continued complete remission (CCR), we administered intensive postremission consolidation therapy with high-dose cytarabine (Ara-C) and daunorubicin. Eighty-seven patients, with a median age of 38 years (range, 7 to 71), received consolidation therapy after first complete remission was obtained with standard induction chemotherapy that included conventional doses of Ara-C. Consolidation therapy consisted of from one to three cycles of high-dose Ara-C (3 g/m2 intravenously [IV] over 1 hour every 12 hours for 12 doses) followed by daunorubicin (30 mg/m2/d IV bolus for 3 days). After completion of the high-dose Ara-C and daunorubicin, no further therapy was administered. Myelosuppression encountered with consolidation resulted in a median duration of neutropenia and thrombocytopenia of 3 weeks. Four patients (5%) died during consolidation due to infection and/or hemorrhage; 59% of patients experienced severe but nonfatal infectious or extramedullary organ toxicity. With a median follow-up of more than 3.5 years from diagnosis, the proportion of patients, by Kaplan-Meier product-limit estimate, remaining in CCR is 49% (95% confidence limits, 37% to 61%). In a Cox multivariate analysis, only age significantly (P less than .001) influenced the probability of remaining in CCR. The probability of remaining in CCR was 83%, 50%, and 23% for age groups of 25 or less, 26 to 45, and more than 45 years, respectively. These survival curves all have stable long-term plateaus, suggesting cure. In this study, the administration of brief, intensive nonmarrow ablative chemotherapy resulted in a large proportion of patients with AML remaining in CCR, results similar to those reported with allogeneic bone marrow transplantation. Relapse of acute leukemia was still the major reason for therapy failure, suggesting that more effective or additional postremission therapy will be required to further improve the likelihood of cure especially for older patients.

Prognosis of Acute Myeloid Leukemia in the General Population: Data from Southern Switzerland

2009 ◽  
Vol 95 (3) ◽  
pp. 303-310 ◽  
Author(s):  
Erika Lerch ◽  
Vittoria Espeli ◽  
Emanuele Zucca ◽  
Leda Leoncini ◽  
Giancarlo Scali ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
High Dose ◽  
Time To Progression ◽  
Curative Intent ◽  
High Dose Cytarabine ◽  
Acute Myeloid

Aims and background To evaluate the outcome of adult patients with de novo acute myeloid leukemia in the Italian-speaking part of Switzerland and to identify prognostic factors, time to progression and overall survival. Methods and study design Data of all adult patients diagnosed with acute myeloid leukemia from January 1984 to December 2003 were collected retrospectively. Univariate and multivariate analysis for time to progression and overall survival were performed. Results The incidence of acute myeloid leukemia in the adult population in southern Switzerland is 2.6/100,000 per year. Complete clinical and pathological data and follow-up information were available for 128 patients. The median age was 67 years (range, 18 to 94). The median follow-up was 97 months. Median overall survival was 6 months, with a 2-year overall survival of 16%. Median time to progression was 3 months. Thirty-five patients (median age, 80 years) were given best supportive care and/or palliative chemotherapy. The median survival in this subset was 2 months. Of the 93 patients treated with a curative intent, 48 were older than 60 years. The complete remission rate after induction chemotherapy was 80% for patients younger than 60 years and 31% for those older than 60 years (P <0.0001). Overall survival at 2 years was 40% and 12%, respectively (P <0.0005). The relapse rate was 61%, and only 28% of the patients who were given reinduction chemotherapy reached a second complete remission. Of the patients treated with curative intent, 52% were treated in a clinical trial. Their median age was significantly lower than those not included in a trial: 57 vs 66 years (P <00001). Patients treated in a trial had a significantly better prognosis than those not so treated (median survival, 12 vs 6 months). Patients treated with high-dose cytarabine as first-line therapy (given to 25 of 93 patients treated with a curative intent) had a better survival than those given standard cytarabine doses (P <0.0005). The outcome of the patients treated after 1993 was significantly better (P = 0.026) than that of the previously treated cohort. In multivariate analysis (not including cytogenetic data), only age (P = 0.005), performance status >1 (P = 0.001) and treatment given before/after 1993 (P = 0.044) were found to be independent prognostic factors for both overall survival and time to progression. Conclusions Most patients with acute myeloid leukemia are older than 60 years, and their outcome is still disappointing. For younger patients, the prognosis is better if they receive high-dose cytarabine as post-remission therapy and if they are treated in the setting of a clinical trial.

scholarly journals Varying intensity of postremission therapy in acute myeloid leukemia

Blood ◽  
1992 ◽  
Vol 79 (8) ◽  
pp. 1924-1930 ◽  
Author(s):  
PA Cassileth ◽  
E Lynch ◽  
JD Hines ◽  
MM Oken ◽  
JJ Mazza ◽  
...  
Keyword(s):  
Acute Myeloid Leukemia ◽  
Mortality Rate ◽  
Maintenance Therapy ◽  
Myeloid Leukemia ◽  
High Dose ◽  
Allogeneic Bone ◽  
Consolidation Therapy ◽  
High Dose Cytarabine ◽  
Postremission Therapy ◽  
Acute Myeloid

The Eastern Cooperative Oncology Group (ECOG) conducted a randomized trial in patients less than or equal to 65 years old (median, 44 years) to determine whether increasing the intensity of postremission therapy in acute myeloid leukemia (AML) would improve the outcome. After uniform induction therapy, patients in complete remission (CR) who were less than 41 years old and who had a histocompatible sibling underwent allogeneic bone marrow transplantation (alloBMT) (54 patients). The remainder of patients in CR were randomized to receive either 2 years of continuous outpatient maintenance therapy with cytarabine and 6- thioguanine (83 patients) or a single course of inpatient consolidation therapy consisting of 6 days of high-dose cytarabine plus 3 days of amsacrine (87 patients). The median duration of follow-up is now 4 years, and patients are included in the analyses of outcome regardless of whether they relapsed before starting the intended treatment. Four- year event-free survival (EFS) was 27% +/- 10% for consolidation therapy versus 16% +/- 8% for maintenance therapy (P = .068) and 28% +/- 11% versus 15% +/- 9% (P = .047) in patients less than 60 years old. The outcome for patients receiving alloBMT was compared with the subset of patients less than 41 years old who received consolidation therapy (N = 29) or maintenance therapy (N = 21). Four-year EFS was 42% +/- 13% for alloBMT, 30% +/- 17% for consolidation therapy, and 14% +/- 15% for maintenance therapy. AlloBMT had a significantly better EFS (P = .013) than maintenance therapy, but was not different from consolidation therapy. In patients less than 41 years old, 4-year survival after alloBMT (42% +/- 14%) did not differ from consolidation therapy (43% +/- 18%), but both were significantly better than maintenance therapy (19% +/- 17%), P = .047 and .043, respectively. The mortality rate for maintenance therapy was 0%, consolidation therapy, 21%; and alloBMT, 36%. Consolidation therapy caused an especially high mortality rate in the patients greater than or equal to 60 years old (8 of 14 or 57%). The toxicity of combined high-dose cytarabine and amsacrine is unacceptable, especially in older patients, and alternative approaches to consolidation therapy such as high-dose cytarabine alone need to be tested. In AML, a single course of consolidation therapy or alloBMT after initial CR produces better results than lengthy maintenance therapy. Although EFS and survival of alloBMT and consolidation therapy do not differ significantly, a larger number of patients need to be studied before concluding that they are equivalent.

Safety and feasibility of outpatient high-dose cytarabine and intermediate-dose cytarabine for consolidation therapy in acute myeloid leukemia

2021 ◽  
pp. 107815522110465
Author(s):  
Wenhui Li ◽  
Katherine Richter ◽  
Jamie Lee ◽  
Kevin McCarthy ◽  
Timothy Kubal
Keyword(s):  
Acute Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Outpatient Setting ◽  
Cancer Center ◽  
High Dose ◽  
Consolidation Therapy ◽  
High Dose Cytarabine ◽  
Incidence Of Hospitalization ◽  
Acute Myeloid ◽  
Intermediate Dose

Introduction The standard of care consolidation therapy for acute myeloid leukemia is high-dose cytarabine or intermediate-dose cytarabine, which are traditionally given inpatient. At Moffitt Cancer Center, we have moved the administration of high-dose cytarabine and intermediate-dose cytarabine to the outpatient setting through the inpatient/outpatient program. To facilitate outpatient administration, high-dose cytarabine and intermediate-dose cytarabine are given in a shorter interval of every 10 h instead of 12 h. The safety of a shorter duration interval of high-dose cytarabine and intermediate-dose cytarabine is unknown. This study aims to assess the safety and feasibility of administering high-dose cytarabine and intermediate-dose cytarabine consolidation therapy in the inpatient/outpatient setting. Methods This is a retrospective chart review to analyze acute myeloid leukemia patients treated with inpatient/outpatient high-dose cytarabine or intermediate-dose cytarabine consolidation therapy at Moffitt Cancer Center from January 1, 2015, through November 1, 2018. The primary objective was to determine the incidence of hospitalization during the inpatient/outpatient administration of high-dose cytarabine or intermediate-dose cytarabine. Results Two hundred fifty-three of 255 cycles of high-dose cytarabine/intermediate-dose cytarabine were delivered outpatient over the reviewed time period to 118 patients. No patients receiving outpatient high-dose cytarabine/intermediate-dose cytarabine consolidation required hospitalization during chemotherapy. Our incidence of hospitalization (24%) after chemotherapy is consistent with the reported literature. Through the inpatient/outpatient administration of high-dose cytarabine and intermediate-dose cytarabine, 1265 inpatient days were saved with an approximate revenue of $3,135,176 generated in our study period. Conclusion Inpatient/outpatient administration of high-dose cytarabine and intermediate-dose cytarabine is both safe and feasible. Moving high-dose cytarabine/intermediate-dose cytarabine administration to the outpatient setting resulted in significant additional revenue vs. inpatient administration.

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