5/16/19 1 1 Christine S. Yun, MSN, PNP, CPON CHOC Children’s Hospital Lauren Bristow Guidry, MSN, CPNP, CPHON Children’s Hospital Los Angeles Breaking News: Paradigm Shift in Pre-B Acute Lymphoblastic Leukemia – COG Update 2 Disclosure ▪ Christine Yun has no industry relationships to disclose. § Lauren Bristow Guidry has no industry relationships to disclose. ▪ Off label use will be discussed 3 COG Disclosure The information in this presentation is intended for educational purposes only and is solely for the use of the individual nurse learner. This information is not intended as the sole source of guidance in providing Children’s Oncology Group (COG) protocol-directed nursing care, and current COG protocols should always be consulted prior to making patient care decisions for any patient enrolled on a COG protocol. Learners should also be aware that COG protocols are research plans designed to investigate particular study questions, that recommendations for treatment and dosing are made within the context of specific research aims, and that these recommendations are intended only for use within a structured research setting. Although every attempt has been made to assure that the informational content contained herein is as accurate and complete as possible as of the date of presentation, no warranty or representation, express or implied, is made as to the accuracy, reliability, completeness, relevance, or timeliness of this content. This information may not be copied or redistributed in any form, or used for any purpose other than nursing education. 4 Objectives § Describe COG’s updated risk classifications and definitions of remission and relapse in ALL § Discuss immunotherapy versus conventional chemotherapy in the treatment of ALL patients § Identify new treatment strategies, including immunotherapy, for frontline treatment in ALL patients 5 Incidence of Childhood Cancer 6 Survival in Childhood Leukemia 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% ALL Ages 0-14 Ages 0-19 66% 92%
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5/16/19
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Christine S. Yun, MSN, PNP, CPONCHOC Children’s Hospital
Lauren Bristow Guidry, MSN, CPNP, CPHONChildren’s Hospital Los Angeles
▪ Christine Yun has no industry relationships to disclose.
§Lauren Bristow Guidry has no industry relationships to disclose.
▪ Off label use will be discussed
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COG DisclosureThe information in this presentation is intended for educational purposes only and is solely for the use of the individual nurse learner. This information is not intended as the sole source of guidance in providing Children’s Oncology Group (COG) protocol-directed nursing care, and current COG protocols should always be consulted prior to making patient care decisions for any patient enrolled on a COG protocol. Learners should also be aware that COG protocols are research plans designed to investigate particular study questions, that recommendations for treatment and dosing are made within the context of specific research aims, and that these recommendations are intended only for use within a structured research setting. Although every attempt has been made to assure that the informational content contained herein is as accurate and complete as possible as of the date of presentation, no warranty or representation, express or implied, is made as to the accuracy, reliability, completeness, relevance, or timeliness of this content. This information may not be copied or redistributed in any form, or used for any purpose other than nursing education.
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Objectives
§Describe COG’s updated risk classifications and definitions of remission and relapse in ALL
§Discuss immunotherapy versus conventional chemotherapy in the treatment of ALL patients
§ Identify new treatment strategies, including immunotherapy, for frontline treatment in ALL patients
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Incidence of Childhood Cancer
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Survival in Childhood Leukemia
0%10%20%30%40%50%60%70%80%90%
100%
ALLAges 0-14 Ages 0-19
66%92%
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Prognostic factors
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Minimal Residual Disease (MRD)§ Identification of presence or absence of residual
disease§Most important prognostic factor in childhood
ALL§Submicroscopic MRD can be measured 3 ways
Morphologic Molecular
The difference between traditional assessments of blood
cancer and MRD is like the difference between a classic
detective and a modern crime scene investigator.
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Flow cytometry§Technique for detecting specific proteins on the
surface of cells§Quick turn around time§Detects 1:10,000 cells
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Polymerase Chain Reaction (PCR)§Amplification of clonotypic IGH or TcR gene
rearrangement§Original clone needed§More sensitive as detects up to 1 in 100,000 cells
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Next Generation Sequencing (NGS)
§Also known as high throughput sequencing (HTS)§Clonality and dominant sequence identification via
parallel analysis§Must have at least 500,000 cells analyzed to be
considered determinate§Sensitivity can reach up to 1 in 1,000,000 cells
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MRD Timepoints:
End of Consolidation
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Modernized COG DefinitionsRemission 1§< 1% blasts by MRD by end consolidation
♦ Early Rem-1: If you reach this level by EOI♦ Late Rem-1: If you reach this level by EOC
Consolidation failure§ ≥ 1% MRD at EOC or persistent EM disease
Note: Perform marrow when absolute phagocyte recovery (ANC + AMC) > 500/μL after day 56 of consolidation therapy
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Modernized COG DefinitionsMarrow Relapse (must have achieved remission)
§For the next 5-7 years, the majority of 1st relapse patients will not have received immunotherapy.♦ Need for efficacy data.
§Many/most ≥ 2nd relapses will likely receive commercial or investigational CAR T-cells
§ Long term complications of immunotherapy unknown
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What’s New?§Immunotherapy as frontline
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RUXOLITINIB (Jakafi)
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§ Interferes with the JAK pathway to prevent cell reproduction
§ JAK pathway is important for cell growth and regulation
Janus Associated Kinase (JAK) Inhibitor
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How is it used in pediatric leukemia?
§Still considered experimental§Used in Ph-like leukemia§Used in conjunction with standard chemotherapy
backbone
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§ Similar cytogenetics as Ph+, but may not have the BCR-ABL fusion♦ May just have ABL fusions
§ May have CRLF2 mutations with or without JAK1/JAK2 mutations
§ Have similarly poorer outcomes§ More common in adolescent Hispanics§ About 10% of standard risk patients will have this marker§ About 13% of high risk patients will have this marker
§Use prophylactic agents like ursodiol§Avoid hepatotoxic agents (e.g. azoles)§When proceeding to transplant
♦ Avoid conditioning regimens with dual alkylating agents♦ No more than 2 cycles of InO pre-transplant
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BLINATUMOMAB
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• A monoclonal antibody that is part of a new class called bi-specific T-cell receptor engaging (BITE) antibodies, which are made by linking two different monoclonal antibodies
• Targets the CD 19 antigen on B-ALL blast cells and normal B cells
• Redirects CD3+ T-cells for selective lysis of B cells
Mechanism of Action
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How is Blinatumomab given?
§Continuous IV infusion over 28 days§Pre-medicate first cycle with dexamethasone