Feasibility and efficacy of outpatient therapy with intermediate dose cytarabine, fludarabine and idarubicin for patients with acute myeloid leukaemia aged 70 or older

Vives, Susana; Oriol, Albert; Piernas, Sònia; Brunet, Salut; Clapés, V; Subirà, Maricel; Sierra, Jordi; Ribera, Josep‐Marǐa

doi:10.1111/ejh.12538

Cited by 6 publications

(7 citation statements)

References 23 publications

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“…8,16 Results in the semi-intensive arm were disappointing because similar regimens implemented in phase 2 trials by the Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplásicas (CETLAM group; fludarabine plus LDAC) and MD Anderson Cancer Center (MDACC; cladribine plus LDAC) reported better median OS rates (6 and 13.8 months, respectively). 9,22 In both studies the CR/CRi rate was higher than with LDAC alone (and up to 66% in the MDACC trial), in line with 33% observed after 3 FLUGA cycles in our study. We can hypothesize that the following MDACC trial features could explain their Figure 2.…”

Section: Discussionsupporting

confidence: 90%

“…Since 2011, this regimen has been adopted by PETHEMA institutions as a standard treatment option for this population, and it has shown in a real-life setting an acceptable CR rate, tolerability, and 40% (95% confidence interval [CI], 30%-54%) overall survival (OS) at 1 year. 9,10 This study reports the results of an open-label, randomized, prospective, phase III, multicenter trial comparing the FLUGA versus AZA monotherapy in a large cohort of older patients aged with newly diagnosed AML.…”

Section: Introductionmentioning

confidence: 99%

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A phase 3 trial of azacitidine versus a semi‐intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia

Vives

Martínez‐Cuadrón²,

Burgues

et al. 2021

Cancer

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BACKGROUND: Options to treat elderly patients (≥65 years old) newly diagnosed with acute myeloid leukemia (AML) include intensive and attenuated chemotherapy, hypomethylating agents with or without venetoclax, and supportive care. This multicenter, randomized, open-label, phase 3 trial was designed to assess the efficacy and safety of a fludarabine, cytarabine, and filgrastim (FLUGA) regimen in comparison with azacitidine (AZA). METHODS: Patients (n = 283) were randomized 1:1 to FLUGA (n = 141) or AZA (n = 142). Response was evaluated after cycles 1, 3, 6, and 9. Measurable residual disease (MRD) was assessed after cycle 9. When MRD was ≥0.01%, patients continued with the treatment until relapse or progressive disease. Patients with MRD < 0.01% suspended treatment to enter the follow-up phase. RESULTS: The complete remission (CR) rate after 3 cycles was significantly better in the FLUGA arm (18% vs 9%; P = .04), but the CR/CR with incomplete recovery rate at 9 months was similar (33% vs 29%; P = .41). There were no significant differences between arms in early mortality at 30 or 60 days. Hematologic toxicities were more frequent with FLUGA, especially during induction. The 1-year overall survival (OS) rate and the median OS were superior with AZA versus FLUGA: 47% versus 27% and 9.8 months (95% confidence interval [CI], 5.6-14 months) versus 4.1 months (95% CI, 2.7-5.5 months; P = .005), respectively. The median event-free survival was 4.9 months (95% CI, 2.8-7 months) with AZA and 3 months (95% CI, 2.5-3.5 months) with FLUGA (P = .001). CONCLUSIONS: FLUGA achieved more remissions after 3 cycles, but the 1-year OS rate was superior with AZA. However, long-term outcomes were disappointing in both arms (3-year OS rate, 10% vs 5%). This study supports the use of an AZA backbone for future combinations in elderly patients with AML.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

A phase 3 trial of azacitidine versus a semi‐intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia

Vives

Martínez‐Cuadrón²,

Burgues

et al. 2021

Cancer

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“…Finally, although there are studies showing the safety of outpatient consolidation in elderly patients 31 , 32 using 2 cycles of cytarabine, in our hospital, mortality rates were higher among patients older than 50 years. This is possibly due to a higher prevalence of comorbidities or increased toxicity and infection rates during longer consolidation treatment, evidencing the need for differentiated support strategies and discouraging adoption of this regimen in this specific group of individuals.…”

Section: Discussioncontrasting

confidence: 53%

“…However, there was no significant difference between inpatients or outpatients, possibly reflecting the expected values in the context of the country's population, according to previous surveys (mortality during consolidation of 21-24%) 29,30 . Finally, although there are studies showing the safety of outpatient consolidation in elderly patients 31,32 using 2 cycles of cytarabine, in our hospital, mortality rates were higher among patients older than 50 years. This is possibly due to a higher prevalence of comorbidities or increased toxicity and infection rates during longer consolidation treatment, evidencing the need for differentiated support strategies and discouraging adoption of this regimen in this specific group of individuals.…”

Section: Discussioncontrasting

confidence: 53%

Safety and Feasibility of Outpatient High Dose Cytarabine for Acute Myeloid Leukemia in the Brazilian Amazon

Rodrigues

Nascimento

Lima³

et al. 2020

IJHOSCR

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Background: The attempt to manage patients with acute myeloid leukemia as outpatients has become increasingly common due to high hospitalization costs, low availability for beds and patient preference. Publications on the subject are scarce, especially in low-income regions and the safety in this population remains to be determined. The present study aims to assess the safety of consolidation with high-dose cytarabine in the outpatient setting. Materials and Methods: We retrospectively analyzed 39 patients who underwent consolidation with highdose cytarabine, between 2009 and 2018, at Ophir Loyola Hospital, in Belém, Brazil. Patients treated after 2015 were given high-dose cytarabine as outpatients due to the decision of medical staff. Results: Twenty-seven patients received 76 cycles of cytarabine as outpatients; males were 48.14% of the total population, with a median age of approximately 45 years. The occurrence of delay between cycles was significantly lower among outpatients (48.14% vs. 83.33%, p = 0.04). There was no difference in relapse rates, transfusion requirements and non-relapse mortality between both groups. Hospitalization was required in 40.74% of patients during outpatient cycles and 18.51% of blood cultures were positive for pathogens. Nonrelapse mortality was significantly higher among patients above 50 years old and treated on an outpatient basis (44.4% vs. 5.60%, p = 0.03). Conclusion: High-dose cytarabine administration on an outpatient basis appears to be safe and effective in a low-income population at the Brazilian Amazon region, but toxicity seems to be increased for patients older than 50 years.

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“…Although admission rates during receipt of chemotherapy were not reported, only 13% of patients were managed exclusively as outpatients throughout the sequential induction cycles. 23 No studies have yet focused on outpatient administration of intensive induction chemotherapy. Although patients with active disease have higher infectious complication rates independent of degree of bone marrow suppression, 4,24 we suspected that with effective supportive care, patient morbidity and mortality would not be significantly increased by an outpatient approach; furthermore, we recognized that TRM varies widely among patients and suspected that patients at relatively low risk for adverse effects could safely receive OPI.…”

Section: Discussionmentioning

confidence: 99%

Outpatient intensive induction chemotherapy for acute myeloid leukemia and high-risk myelodysplastic syndrome

et al. 2020

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To improve patient quality of life and reduce health care costs, many conditions formerly thought to require inpatient care are now treated in the outpatient setting. Outpatient induction chemotherapy for acute myeloid leukemia (AML) may confer similar benefits. This possibility prompted a pilot study to explore the safety and feasibility of intensive outpatient initial or salvage induction chemotherapy administration for adults with AML and high-risk myelodysplastic syndrome (MDS). Patients with no significant organ dysfunction and a treatment-related mortality (TRM) score corresponding to a day 28 mortality rate of <5% to 10% were eligible for study. Patients were treated as outpatients with daily evaluation by providers and only admitted to the hospital if mandated by complications. Twenty patients were consented, and 17 were treated. Eight patients received initial induction chemotherapy and 9 received salvage induction chemotherapy. Fourteen patients completed induction chemotherapy administration in the outpatient setting (82.4%; exact 95% confidence interval [CI], 55.8-95.3). Three patients were admitted during the course of chemotherapy administration, 2 for neutropenic fever and 1 for grade 3 mucositis. No patients died within 14 days of the initiation of induction chemotherapy (exact 95% CI, 0-22.9). Results of this pilot study suggest it is feasible to complete outpatient induction chemotherapy in select patients with AML and high-risk MDS. A team including nurses, social workers, medical providers, and pharmacists was key to the successful implementation of outpatient induction.

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Feasibility and efficacy of outpatient therapy with intermediate dose cytarabine, fludarabine and idarubicin for patients with acute myeloid leukaemia aged 70 or older

Abstract: This study demonstrates the tolerability and efficacy of a semi-intensive treatment in elderly de novo patients with AML managed on an outpatient basis, without substantial toxicity.

Cited by 6 publications

References 23 publications

A phase 3 trial of azacitidine versus a semi‐intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia

A phase 3 trial of azacitidine versus a semi‐intensive fludarabine and cytarabine schedule in older patients with untreated acute myeloid leukemia

Safety and Feasibility of Outpatient High Dose Cytarabine for Acute Myeloid Leukemia in the Brazilian Amazon

Outpatient intensive induction chemotherapy for acute myeloid leukemia and high-risk myelodysplastic syndrome

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