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Soluble interleukin-2 receptor ? activation in a Children's Oncology Group randomized trial of interleukin-2 therapy for pediatric acute myeloid leukemia.

ABSTRACT: PURPOSE:To assess associations of soluble IL-2 receptor alpha (sIL-2r?) concentration with outcomes in pediatric acute myeloid leukemia (AML) in a phase 3 trial of IL-2 therapy. PROCEDURES:We randomized 289 children with AML in first remission after intensive chemotherapy to receive IL-2 infused on days 0-3 and 8-17 (IL-2 group) or no further therapy (AML control group). We measured sequential serum sIL-2r? concentrations in both groups before, during and after therapy in both groups and in reference controls without AML. RESULTS:Before treatment, mean sIL-2r? concentrations were similar in the IL-2 group and AML controls, but significantly higher than in reference controls. Both AML groups experienced reduction in sIL-2r? concentration after chemotherapy. Thereafter in the IL-2 group, mean sIL-2r? concentration increased from 2,669?pg/ml before IL-2 to 15,534?pg/ml on day 4 (P?

SUBMITTER: Lange BJ

PROVIDER: S-EPMC3172052 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Soluble interleukin-2 receptor α activation in a Children's Oncology Group randomized trial of interleukin-2 therapy for pediatric acute myeloid leukemia.

Lange Beverly J BJ Yang Richard K RK Gan Jacek J Hank Jaquelyn A JA Sievers Eric L EL Alonzo Todd A TA Gerbing Robert B RB Sondel Paul M PM

Pediatric blood & cancer 20110616 3

<h4>Purpose</h4>To assess associations of soluble IL-2 receptor alpha (sIL-2rα) concentration with outcomes in pediatric acute myeloid leukemia (AML) in a phase 3 trial of IL-2 therapy.<h4>Procedures</h4>We randomized 289 children with AML in first remission after intensive chemotherapy to receive IL-2 infused on days 0-3 and 8-17 (IL-2 group) or no further therapy (AML control group). We measured sequential serum sIL-2rα concentrations in both groups before, during and after therapy in both gro ...[more]

PMID: 21681921

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Project description:BackgroundPediatric acute myeloid leukemia (AML) therapy is associated with substantial short- and long-term treatment-related cardiotoxicity mainly due to high-dose anthracycline exposure. Early left ventricular systolic dysfunction (LVSD) compromises anthracycline delivery and is associated with inferior event-free and overall survival in de novo pediatric AML. Thus, effective cardioprotective strategies and cardiotoxicity risk predictors are critical to optimize cancer therapy delivery and enable early interventions to prevent progressive LVSD. While dexrazoxane-based cardioprotection reduces short-term cardiotoxicity without compromising cancer survival, liposomal anthracycline formulations have the potential to mitigate cardiotoxicity while improving antitumor efficacy. This overview summarizes the rationale and methodology of cardiac substudies within AAML1831, a randomized Children's Oncology Group Phase 3 study of CPX-351, a liposomal formulation of daunorubicin and cytarabine, in comparison with standard daunorubicin/cytarabine with dexrazoxane in the treatment of de novo pediatric AML.Methods/designChildren (age <22 years) with newly diagnosed AML were enrolled and randomized to CPX-351-containing induction 1 and 2 (Arm A) or standard daunorubicin and dexrazoxane-containing induction (Arm B). Embedded cardiac correlative studies aim to compare the efficacy of this liposomal anthracycline formulation to dexrazoxane for primary prevention of cardiotoxicity by detailed core lab analysis of standardized echocardiograms and serial cardiac biomarkers throughout AML therapy and in follow-up. In addition, AAML1831 will assess the ability of early changes in sensitive echo indices (e.g., global longitudinal strain) and cardiac biomarkers (e.g., troponin and natriuretic peptides) to predict subsequent LVSD. Finally, AAML1831 establishes expert consensus-based strategies in cardiac monitoring and anthracycline dose modification to balance the potentially competing priorities of cardiotoxicity reduction with optimal leukemia therapy.DiscussionThis study will inform diagnostic, prognostic, preventative, and treatment strategies regarding cardiotoxicity during pediatric AML therapy. Together, these measures have the potential to improve leukemia-free and overall survival and long-term cardiovascular health in children with AML. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT04293562.

Dataset Information

Soluble interleukin-2 receptor ? activation in a Children's Oncology Group randomized trial of interleukin-2 therapy for pediatric acute myeloid leukemia.

Publications

Soluble interleukin-2 receptor α activation in a Children's Oncology Group randomized trial of interleukin-2 therapy for pediatric acute myeloid leukemia.

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