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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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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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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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Rodger J. Winn

Clinical practice guidelines must be outcome driven. Indeed, the validity of a guideline rests on showing that following recommendations will lead to projected health and cost outcomes.1 The primary outcomes proposed for guideline use include survival, toxicity, heath-related quality of life (QOL), and cost effectiveness.2 Patient preferences have also been recognized as factor that must be considered in making guideline recommendations.3 This prescription seems fairly straightforward, and in many instances, determining which outcomes to apply is as well. Recommendations for adjuvant regimens typically use overall or disease-free survival, acceptable toxicity profiles, and costs falling into the accepted range as a constellation of outcomes used to judge whether a regimen should be included. For many guideline users, treatment effectiveness––its impact on a major clinical outcome such as survival––is assumed to trump all other outcomes. In guidelines development, however, this is only true if that treatment's impact on other outcomes is believed to be minimal or inconsequential. In situations in which evaluating multiple outcomes points to opposing views of patient benefit, creating and following guideline recommendations can be problematic. From a purely clinical perspective, balancing effectiveness with toxicity can present difficult value judgments. For example, should adjuvant chemotherapy be recommended to elderly node-negative breast cancer patients; should allogeneic bone marrow procedures be recommended as first-line treatment in several diseases? The NCCN Myeloid Growth Factor Guidelines present a vivid example of the difficulties of attempting to assess “competing” outcomes. The first question that arises for this supportive care algorithm is what is the...
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5 5 2 2 Myeloid Growth Factor Guidelines: Moving Toward a Societal Perspective Winn Rodger J. MD 02 2007 5 5 2 2 117 117 117 117 0050117 10.6004/jnccn.2007.0013 Multiple Myeloma Guidelines 02 2007 5 5 2 2 118 118 118 118 0050118 10

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.2005.0029 Myeloid Growth Factors Clinical Practice Guidelines in Oncology 7 2005 3 3 4 4 540 540 540 540 10.6004/jnccn.2005.0030 Guidelines of the National Comprehensive Cancer Network on the Use of Myeloid Growth Factors with Cancer Chemotherapy

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7 1 1 48 48 57 57 10.6004/jnccn.2009.0004 Limitations of Lymph Node Counts as a Measure of Therapy Gilbert Scott M. a MD, MS Hollenbeck Brent K. b MD, MS 1 2009 7 7 1 1 58 58 61 61 10.6004/jnccn.2009.0005 Myeloid Growth Factors

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9 8 8 902 902 911 911 0090902 10.6004/jnccn.2011.0074 Myeloid Growth Factors Crawford Jeffrey MD Allen Jeffrey MD Armitage James MD Blayney Douglas W. MD Cataland Spero R. MD Heaney Mark L. MD, PhD Htoy Sally

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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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11 11 10 10 xlix xlix xlix xlix 011xlix 10.6004/jnccn.2013.0151 Moving Forward With Myeloid Growth Factors Crawford Jeffrey MD 10 2013 11 11 10 10 1181 1181 1182 1182 0111181 10.6004/jnccn.2013.0139 Imatinib-Induced Bone Edema: Case Report