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Jeffrey Crawford

, the NCCN Guidelines Panel initially established the febrile neutropenia threshold for use of myeloid growth factors at 20%; this standard has now been adopted by virtually all other guidelines committees. Moreover, it was the NCCN Panel who stressed

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Gary H. Lyman

. NCCN Clinical Practice Guidelines in Oncology: Myeloid Growth Factors in Cancer Treatment. Version 2.2005. Available at: www. nccn.org . Accessed June 2005 . 24 Bodey GP Buckley M Sathe YS . Quantitative relationships between circulating

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Martha Wadleigh and Richard M. Stone

Myeloid growth factors granulocyte-colony stimulating and granulocyte macrophage colony-stimulating factors have been extensively studied in acute leukemias. Whether administered before, during, or after chemotherapy for acute myeloid leukemia and acute lymphoblastic leukemia, these agents reduce the duration of neutropenia and seem to be safe and well tolerated. Despite consistently showing a shorter duration of neutropenia, multiple, prospective, randomized trials have documented only modest benefits in terms of reduction in the incidence and severity of infections, without substantial gains or impact in complete remission, overall survival, and disease-free survival rates. Growth factors have also been used to recruit quiescent leukemia cells into the S-phase of the cell cycle to increase their susceptibility to chemotherapy with the goal to reduce relapse and resistance. Randomized trials evaluating this priming strategy have consistently shown improvement in disease- or event-free survival in the intermediate-risk group of patients with acute myeloid leukemia, but no overall survival benefit. This article focuses on the clinical experience with these agents as adjuncts to the treatment of acute leukemias.

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Rodger J. Winn

The Myeloid Growth Factors guidelines in this month's issue are in some ways a paradigm for successful guidelines—guidelines that support clinical decision-making. The algorithm comes down to the level of actual administration, with specific thresholds for beginning, dosages, and stopping. This granularity is possible, of course, because of the extraordinary number of trials meticulously designed to answer specific drug-related questions. For example, Frankfurt and Tallman's article on using these agents in leukemia describes trials that have investigated not only the efficacy of these stimulating factors but also their potential deleterious effects. I'm reassured to learn from Lyman and Kleiner of the consistency found across 3 well-known guidelines for these agents. A major recommendation in all 3 guidelines is that growth factors be initiated for primary prophylaxis if the expected rate of febrile neutropenia is 20%. This new threshold varies considerably from the initial American Society of Clinical Oncology (ASCO) guidelines in 1994, which used a 40% threshold. The new mark is based on results from several randomized clinical trials and meta-analyses that confirm the efficacy of these agents in significantly diminishing the incidence of febrile neutropenia at this level. In what will likely become a major issue for guidelines developers in the future, economic considerations emerged in these discussions. Although NCCN and ASCO state that decisions were based on proven clinical benefit, both groups acknowledge the potentially large economic impact that using these agents may have—both their capacity to save in-hospital expenses and the financial burden they could impose if...
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Andrew D. Zelenetz and Pamela S. Becker

The Debut of Biosimilar Agents: Myeloid Growth Factors Are the First Act As cancer biologics move off-patent, biosimilars are coming on board. In March 2015, the first biosimilar agent was approved for an oncology indication: the recombinant

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Huntsman Cancer Institute at the University of Utah

Chemotherapy-induced neutropenia can cause complications that result in dose reductions or treatment delays that can, in turn, compromise clinical outcomes. Although the prophylactic use of colony-stimulating factors (CSFs) can reduce the risk, severity, and duration of severe and febrile neutropenia, they are not routinely administered to all patients undergoing myelosuppressive chemotherapy because of the costs. Selective use may, however, enhance their cost-effectiveness. These guidelines discuss the preventative or prophylactic use of recombinant human granulocyte-CSF to reduce the incidence, length, and severity of chemotherapy-related neutropenia and and prevent life-threatening complications.

For the most recent version of the guidelines, please visit NCCN.org

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Derek Weycker, Xiaoyan Li, Rich Barron, Hongsheng Wu, P.K. Morrow, Hairong Xu, Maureen Reiner, Jacob Garcia, Shivani K. Mhatre and Gary H. Lyman

. 1 – 5 For adult patients receiving chemotherapy for solid tumors or nonmyeloid malignancies, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Myeloid Growth Factors 6 recommend prophylaxis against FN with a colony

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Chemotherapy-induced neutropenia is the major dose-limiting toxicity of systemic cancer chemotherapy, associated with substantial morbidity, mortality, and cost. Although prophylactic colony-stimulating factors (CSFs), can reduce this complication, their routine use in all patients on myelosuppressive chemotherapy is prohibitively costly. Selective use in patients most at risk for neutropenia may enhance cost-effectiveness, but determining the actual risk is complicated by issues in reporting myelosuppression and dose intensity, among other factors. For this reason, NCCN experts developed these guidelines to assist practitioners in the appropriate prophylactic use of CSFs.

For the most recent version of the guidelines, please visit NCCN.org

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Gary H. Lyman

Biosimilars are here to stay, but whether they will enjoy widespread uptake remains to be seen. The FDA sets a high bar for approval of biosimilar products, yet many clinicians remain skeptical about the efficacy and safety of these agents. Favorable experience with >30 biosimilars in Europe provides some reassurance that these agents are safe and effective and can be substituted for the reference product.

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Michaela A. Dinan, Bradford R. Hirsch and Gary H. Lyman

), administered after the first cycle of chemotherapy and before the development of neutropenia, can reduce the risk, severity, and duration of FN. The appropriate prophylactic use of myeloid growth factors has been shown in meta-analyses to reduce the relative