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Biosimilars: Are They Ready for Primetime in the United States?

Bradford R. Hirsch and Gary H. Lyman

agent over another should be minimized, allowing them to choose the agent they feel is best for a patient and the clinical community. Case Study: Myeloid Growth Factors The myeloid growth factors were among the initial biosimilars introduced in Europe

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A Patient Risk Model of Chemotherapy-Induced Febrile Neutropenia: Lessons Learned From the ANC Study Group

Gary H. Lyman and Marek S. Poniewierski

treatment delays, and subsequently compromise disease control and overall survival. 2 – 6 The myeloid growth factors (MGFs), including granulocyte colony-stimulating factor (G-CSF), have been shown to decrease the risk of neutropenic complications

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Growth Factors in Leukemia

Olga Frankfurt and Martin S. Tallman

The role of myeloid growth factors, such as granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor, in the management of acute myeloid and acute lymphoblastic leukemias has been evaluated extensively in multiple clinical trials. Growth factors have been given before, concurrently, or sequentially with chemotherapy with the goal of reducing the duration of neutropenia and consequently the incidence and severity of infections, and improving the rate of remissions and overall survival. They also have been studied as chemotherapy-sensitizing agents in an effort to recruit dormant myeloid stem cells into the sensitive phase of the cycle. Additionally, growth factors, shown to stimulate proliferation and differentiation of leukemia cells in vitro, were evaluated as monotherapy in patients with acute leukemia. Most studies show modest improvement in the duration of the neutropenia, which does not consistently correlate with the severity of infection, rate or duration of remissions, or disease-free and overall survival. Attempts to enhance the chemosensitivity of the leukemic cells and decrease drug resistance failed to improve the rate of remission and survival in several large series. However, more recent reports suggested an improved outcome in younger patients with acute myeloid leukemia with normal karyotype. Several anecdotal case reports have shown that growth factor monotherapy can induce a complete remission in patients with acute leukemia. Data from the published clinical trials do not seem to support emergence of drug-resistant leukemia, worsening toxicity, and bone marrow failure with growth factor administration.

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Competing Outcomes

Rodger J. Winn

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BPI20-011: Prescriber-Assigned Febrile Neutropenia and Emetic Risks Compared to the NCCN Risk Classification for Cancer Treatment Regimens

Kimberly Rose Hedstrom, Margaret Rausa, Eric Gratias, and Stephen Hamilton

-assigned risks across a broad range of treatment regimens. Methods: Authorizations for prophylactic use of long-acting myeloid growth factors (MGF), NK-1 receptor antagonists, and select 5-HT3 receptor antagonists from 3/2018 - 4/2019 were included. Cases with

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HSR21-073: Febrile Neutropenia Outcomes Among Patients With Breast Cancer and Non-Hodgkin’s Lymphoma Receiving Pegfilgrastim Prophylaxis: A Real-World Analysis of Commercial and Medicare Claims From 2017-2018

Weijia Wang, Edward Li, Kim Campbell, and Ali McBride

still at risk of developing FN. Real-world studies evaluating the comparative effectiveness of myeloid growth factors must apply statistical methods to mitigate bias by considering these variables when adjusting the cohorts.

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Risk and Timing of Neutropenic Events in Adult Cancer Patients Receiving Chemotherapy: The Results of a Prospective Nationwide Study of Oncology Practice

Jeffrey Crawford, David C. Dale, Nicole M. Kuderer, Eva Culakova, Marek S. Poniewierski, Debra Wolff, and Gary H. Lyman

Armitage J . Myeloid growth factors clinical practice guidelines in oncology . J Natl Compr Canc Netw 2005 ; 3 : 540 – 555 . 26. Smith TJ Khatcheressian J Lyman GH . 2006 update of recommendations for the use of white blood cell growth

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Antiemesis, Head and Neck Cancers, and Myeloid Growth Factors NCCN is pleased to offer a pocket-sized version of the following NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Antiemesis Head and Neck Cancers Myeloid Growth

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Real-World Impact of a Decision Support Tool on Colony-Stimulating Factor Use and Chemotherapy-Induced Febrile Neutropenia Among Patients With Breast Cancer

Abiy Agiro, Andrea DeVries, Jennifer Malin, and Michael J. Fisch

support tool implemented by one national payer across 9 intervention states for patients with breast cancer. This tool was developed using NCCN and ASCO guidelines pertaining to myeloid growth factor use. We present differences in population-level changes

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Impact of Chemotherapy Dose Intensity on Cancer Patient Outcomes

Gary H. Lyman

Guidelines in Oncology: Myeloid Growth Factors . J Natl Compr Canc Netw 2007 ; 5 : 188 – 202 . 10 Smith TJ Khatcheressian J Lyman GH . 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical