Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical Practice Guideline Update

Bohlius, Julia; Bohlke, Kari; Lazo‐Langner, Alejandro

doi:10.1200/jop.19.00111

Cited by 24 publications

(38 citation statements)

References 9 publications

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“…Furthermore, clinical concerns raised by CIM commonly lead to chemotherapy dose reductions and/or delays, which limit therapeutic dose intensity and, potentially, its intended antitumor efficacy [ 6 – 8 ]. CIM is currently managed with supportive care interventions such as hematopoietic growth factors and transfusions [ 9 – 12 ]. However, these are often administered reactively when signs or symptoms appear, are specific to individual hematopoietic lineages and impart their own set of risks for adverse reactions, highlighting the need for alternative approaches that can proactively prevent CIM.…”

Section: Introductionmentioning

confidence: 99%

Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

et al. 2020

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Introduction Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation). Methods In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m 2 or placebo before topotecan 1.5 mg/m 2 on days 1–5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy. Results Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms. Conclusions Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy. Trial Registration ClinicalTrials.gov: NCT02514447 Electronic Supplementary Material The online version of this article (10.1007/s12325-020-01538-0) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

et al. 2020

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“…Biosimilar epoetin prescribing is addressed in the most recent European Society of Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) guidelines [26,27]. The 2019 ESMO guidelines warn against switching from any one erythropoiesis-stimulating agent to another agent (including a biosimilar epoetin) if the patient with cancer and chemotherapy-induced anemia has a stable hemoglobin.…”

Section: Guideline Statements On Biosimilar Epoetin Use In the Oncolomentioning

confidence: 99%

“…Automatic substitution is supported only if the patient is erythropoiesis-stimulating agent naïve and the clinician accepts the concept of equivalence. ESMO does not address the formal concept of interchangeability as European regulatory agencies have not addressed this designation [26]. The 2019 ASCO/ASH Guideline's recommendation 5 indicates that the panel considered all erythropoiesisstimulating agents to be equivalent based on informal consensus but judging that evidence was of intermediate quality (meaning that the panel had moderate confidence that the available evidence reflects the true magnitude and direction of the net effect) [27].…”

Section: Guideline Statements On Biosimilar Epoetin Use In the Oncolomentioning

confidence: 99%

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

et al. 2021

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Biosimilars are biologic drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety, and efficacy. Biosimilar epoetin received Food and Drug Administration (FDA) approval in 2018. The manufacturer received an FDA nonapproval letter in 2017, despite receiving a favorable review by FDA's Oncologic Drugs Advisory Committee (ODAC), and an FDA nonapproval letter in 2015 for an earlier formulation. We discuss the 2018 FDA approval, the 2017 FDA ODAC Committee review, and the FDA complete response letters in 2015 and 2017; review concepts of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance; review European and U.S. oncology experiences with biosimilar epoetin; and review the safety of erythropoiesis-stimulating agents. In 2020, policy statements from AETNA, United Health Care, and Humana indicated that new epoetin oncology starts must be for biosimilar epoetin unless medical need for other epoetins is documented. Empirical studies report that

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“…The use of erythropoiesis‐stimulating agents (ESA) in acute leukaemia remains controversial. Currently, ESA can be used to treat anaemia only in patients with non‐myeloid malignancies (Bohlius et al ., ). Meaningful responses to ESA may take weeks to months and are usually not sufficient for relief of acute anaemia‐associated symptoms.…”

Section: Managementmentioning

confidence: 99%

Treatment of acute leukaemia in adult Jehovah's Witnesses

Chaer

Ballen

2019

Br J Haematol

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Summary Since Jehovah’s Witness (JW) patients diagnosed with leukaemia refuse blood transfusions, they are often denied intensive chemotherapy for fear they could not survive myeloablation without blood transfusion support. Treatment of JW patients with acute leukaemia is challenging and carries a higher morbidity and mortality; however, the refusal of blood products should not be an absolute contraindication to offer multiple treatment modalities including haematopoietic stem cell transplantation. In this review we discuss their optimal management and describe alternative modalities to blood transfusions to provide sufficient oxygenation and prevent bleeding.

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Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical Practice Guideline Update

Cited by 24 publications

References 9 publications

Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study

The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions

Treatment of acute leukaemia in adult Jehovah's Witnesses

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