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Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.

ABSTRACT: The aim of this cohort study was to compare a condensed schedule of consolidation therapy with high-dose cytarabine on days 1, 2 and 3 (HDAC-123) with the HDAC schedule given on days 1, 3 and 5 (HDAC-135) as well as to evaluate the prophylactic use of pegfilgrastim after chemotherapy in younger patients with acute myeloid leukemia in first complete remission. One hundred and seventy-six patients were treated with HDAC-135 and 392 patients with HDAC-123 with prophylactic pegfilgrastim at days 10 and 8, respectively, in the AMLSG 07-04 and the German AML Intergroup protocol. Time from start to chemotherapy until hematologic recovery with white blood cells >1.0?G/l and neutrophils >0.5?G/l was in median 4 days shorter in patients receiving HDAC-123 compared with HDAC-135 (P<0.0001, each), and further reduced by 2 days (P<0.0001) by pegfilgrastim. Rates of infections were reduced by HDAC-123 (P<0.0001) and pegfilgrastim (P=0.002). Days in hospital and platelet transfusions were significantly reduced by HDAC-123 compared with HDAC-135. Survival was neither affected by HDAC-123 versus HDAC-135 nor by pegfilgrastim. In conclusion, consolidation therapy with HDAC-123 leads to faster hematologic recovery and less infections, platelet transfusions as well as days in hospital without affecting survival.

SUBMITTER: Jaramillo S

PROVIDER: S-EPMC5518888 | biostudies-other | 2017 May

REPOSITORIES: biostudies-other

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Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.

Jaramillo S S Benner A A Krauter J J Martin H H Kindler T T Bentz M M Salih H R HR Held G G Köhne C-H CH Götze K K Lübbert M M Kündgen A A Brossart P P Wattad M M Salwender H H Hertenstein B B Nachbaur D D Wulf G G Horst H-A HA Kirchen H H Fiedler W W Raghavachar A A Russ G G Kremers S S Koller E E Runde V V Heil G G Weber D D Göhring G G Döhner K K Ganser A A Döhner H H Schlenk R F RF

Blood cancer journal 20170526 5

The aim of this cohort study was to compare a condensed schedule of consolidation therapy with high-dose cytarabine on days 1, 2 and 3 (HDAC-123) with the HDAC schedule given on days 1, 3 and 5 (HDAC-135) as well as to evaluate the prophylactic use of pegfilgrastim after chemotherapy in younger patients with acute myeloid leukemia in first complete remission. One hundred and seventy-six patients were treated with HDAC-135 and 392 patients with HDAC-123 with prophylactic pegfilgrastim at days 10 ...[more]

PMID: 28548643

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Project description:BackgroundPatients with different karyotypes had different prognosis in t(8;21) acute myeloid leukemia (AML). Cytarabine (Ara-C) plays an important role as consolidation therapy in t(8;21) AML. T(8;21) AML patients with different karyotypes responded differently to post-remission therapy with Ara-C. However, the optimum dose of Ara-C in patients with different karyotypes remains unclear.MethodsFrom January 2002 to September 2018, a total of 188 younger adult (14-60 years) patients with t(8;21) AML were enrolled in this retrospective study. Cytogenetic analysis and aberration descriptions followed the International System for Human Cytogenetic Nomenclature. All the patients achieved first complete remission (CR1) after induction chemotherapy. Patients received low-dose Ara-C [LDAC (<1 g/m2)], intermediate-dose Ara-C [IDAC (1-1.5 g/m2)], or high-dose Ara-c [HiDAC (2-3 g/m2)] regimens as consolidation therapy after CR1. All patients were followed for survival or relapse until death, or study completion. We analyzed the prognosis of LDAC, IDAC, and HiDAC regimens as consolidation therapy in patients with different karyotypes. The primary endpoint was overall survival (OS) and the secondary endpoint was relapse-free survival (RFS).ResultsThe results showed IDAC significantly improved OS compared with LDAC [hazard rate (HR) =0.55, P=0.0375] when the clinical factors were adjusted. However, no significant difference between HiDAC and IDAC was found. Subgroup analysis further showed that the OS advantage of IDAC was focused on patients with additional cytogenetic abnormalities, including loss of X chromosome (-X), del(9q), or complex karyotype (group B, HR =0.21, P=0.0125), but not on patients with t(8;21)-only or additional loss of Y chromosome (-Y) cytogenetics (group A, HR =0.77, P=0.4804) in multivariate analysis. Similarly, better OS was shown after IDAC than LDAC consolidation in patients in group B, whether they received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or not, but not in group A.ConclusionsIDAC was suitable for patients with additional -X, del(9q), or complex karyotype, while LDAC might be sufficient for patients with t(8;21)-only or additional -Y cytogenetics. It suggested that t(8;21) AML patients with different karyotypes should use different consolidation regimens.

Project description:BACKGROUND:Outcomes for patients with relapsed or refractory acute myeloid leukemia (AML) are poor. Guadecitabine, a next-generation hypomethylating agent, could be useful in treating such patients. METHODS:In this multicenter, open-label, phase 2 dose-expansion study, AML patients from 10 North American medical centers were first randomized (1:1) to receive subcutaneous guadecitabine at 60 or 90?mg/m2 on 5 consecutive days in each 28-day cycle (5-day regimen). Subsequently, another cohort was treated for 10 days with 60?mg/m2 (10-day regimen). RESULTS:Between June 15, 2012, and August 19, 2013, 108 patients with previously treated AML consented to enroll in the study, and 103 of these patients were treated; 5 patients did not receive the study treatment. A total of 103 patients were included in the safety and efficacy analyses (24 and 26 patients who were randomly assigned to 60 and 90?mg/m2 /d, respectively [5-day regimen] and 53 patients who were assigned to 60?mg/m2 /d [10-day regimen]). The 90?mg/m2 dose showed no benefit in clinical outcomes in comparison with 60?mg/m2 in the randomized cohort. Composite complete response (CRc) and complete response (CR) rates were higher with the 10-day regimen versus the 5-day regimen (CRc, 30.2% vs 16.0%; P?=?.1061; CR, 18.9% vs 8%; P?=?.15). Adverse events (grade???3) were mainly hematologic, with a higher incidence on the 10-day regimen. Early all-cause mortality was low and similar between regimens. Twenty patients (8 on the 5-day regimen and 12 on the 10-day regimen) were bridged to hematopoietic cell transplantation. CONCLUSIONS:Guadecitabine has promising clinical activity and an acceptable safety profile and thus warrants further development in this population. Cancer 2018;124:325-34. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Dataset Information

Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.

Publications

Condensed versus standard schedule of high-dose cytarabine consolidation therapy with pegfilgrastim growth factor support in acute myeloid leukemia.

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