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  1. Article ; Online: Intravenous Iron-Induced Hypophosphatemia: An Emerging Syndrome.

    Glaspy, John A / Wolf, Myles / Strauss, William E

    Advances in therapy

    2021  Volume 38, Issue 7, Page(s) 3531–3549

    Abstract: Some, but not all, intravenous iron formulations have been recognized to induce renal phosphate wasting syndrome. Most commonly this has been reported following treatment of iron deficiency anemia (IDA) with ferric carboxymaltose (FCM). A search of ... ...

    Abstract Some, but not all, intravenous iron formulations have been recognized to induce renal phosphate wasting syndrome. Most commonly this has been reported following treatment of iron deficiency anemia (IDA) with ferric carboxymaltose (FCM). A search of PubMed identified relevant randomized controlled trials (RCTs), and case studies evaluating hypophosphatemia (HPP) resulting from intravenous iron treatment. While more recent larger comparative RCTs have confirmed that the majority of patients receiving FCM, especially those with normal renal function, may experience severe HPP, complete documentation is hampered by inconsistent reporting of serum phosphate in such trials. Similarly, while case series and RCTs have documented the persistence of HPP for several weeks or even months, the lack of studies lasting beyond 5-6 weeks has constrained full understanding of the duration of effect. Clinical trials have established that the mechanism involves the bone/metabolic axis with the elevation of intact fibroblast growth factor 23 playing the central role. Reports continue to accumulate of the clinical consequences of severe HPP which are, most commonly, bone abnormalities following repetitive dosing. Case reports and studies, however, have also shown that symptomatic hypophosphatemia can occur after a single FCM dose. The frequency of such events remains unknown, in part due to lack of awareness of hypophosphatemia coupled with the fact that the most common acute symptoms of HPP (fatigue and weakness) are the same for IDA and for many of the chronic diseases that cause IDA. Changes to US and European prescribing information for FCM should raise awareness of the potential for HPP and need to monitor patients at risk for it.
    MeSH term(s) Administration, Intravenous ; Anemia, Iron-Deficiency/drug therapy ; Humans ; Hypophosphatemia/chemically induced ; Infusions, Intravenous ; Iron/therapeutic use
    Chemical Substances Iron (E1UOL152H7)
    Language English
    Publishing date 2021-05-30
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 632651-1
    ISSN 1865-8652 ; 0741-238X
    ISSN (online) 1865-8652
    ISSN 0741-238X
    DOI 10.1007/s12325-021-01770-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Financial Toxicity From Generic Specialty Drug Use.

    Fischer, Katrina A / Miller, Robert E / Glaspy, John A

    JAMA oncology

    2020  Volume 7, Issue 2, Page(s) 175–176

    MeSH term(s) Drug Costs ; Drugs, Generic ; Financial Stress ; Humans
    Chemical Substances Drugs, Generic
    Language English
    Publishing date 2020-11-19
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2020.5181
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Risks for Anaphylaxis With Intravenous Iron Formulations.

    Al-Samkari, Hanny / Glaspy, John A / Means, Robert T / Chertow, Glenn M / Auerbach, Michael

    Annals of internal medicine

    2022  Volume 175, Issue 11, Page(s) W143

    MeSH term(s) Humans ; Anaphylaxis/chemically induced ; Iron/adverse effects ; Drug Hypersensitivity
    Chemical Substances Iron (E1UOL152H7)
    Language English
    Publishing date 2022-12-01
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/L22-0282
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Darbepoetin alfa controversies, from dosage issues to safety concerns: the larger lesson.

    Glaspy, John A

    Oncology (Williston Park, N.Y.)

    2011  Volume 25, Issue 5, Page(s) 423–424

    MeSH term(s) Anemia/drug therapy ; Anemia/etiology ; Darbepoetin alfa ; Erythropoietin/analogs & derivatives ; Erythropoietin/therapeutic use ; Hematinics/therapeutic use ; Humans ; Neoplasms/complications ; Randomized Controlled Trials as Topic
    Chemical Substances Hematinics ; Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P)
    Language English
    Publishing date 2011-04-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1067950-9
    ISSN 0890-9091
    ISSN 0890-9091
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Randomized controlled trials of the erythroid-stimulating agents in cancer patients.

    Glaspy, John A

    Cancer treatment and research

    2011  Volume 157, Page(s) 195–215

    MeSH term(s) Anemia/etiology ; Anemia/therapy ; Hematinics/therapeutic use ; Humans ; Neoplasms/complications ; Neoplasms/therapy ; Randomized Controlled Trials as Topic ; Thrombosis/etiology ; Thrombosis/therapy
    Chemical Substances Hematinics
    Language English
    Publishing date 2011
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 0927-3042
    ISSN 0927-3042
    DOI 10.1007/978-1-4419-7073-2_12
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Erythropoietin in cancer patients.

    Glaspy, John A

    Annual review of medicine

    2009  Volume 60, Page(s) 181–192

    Abstract: Therapy with erythropoiesis-stimulating agents (ESAs) is associated with well-documented benefits to anemic cancer patients undergoing chemotherapy, most importantly a reduction in the likelihood of needing red cell transfusions. One challenge in ... ...

    Abstract Therapy with erythropoiesis-stimulating agents (ESAs) is associated with well-documented benefits to anemic cancer patients undergoing chemotherapy, most importantly a reduction in the likelihood of needing red cell transfusions. One challenge in supportive cancer care is a relative resistance to ESAs, requiring high doses with a significant rate of nonresponse. Recent advances in our understanding of iron metabolism in patients with chronic illness and the results of clinical trials indicate that parenteral iron improves ESA response in this setting. Another issue is the safety of ESA treatment in cancer patients. There is an increased risk of venous thrombosis that must be considered in clinical decision making. There are also recent data raising concerns that ESAs may enhance tumor progression or decrease patient survival. Although the preponderance of the data suggests that ESAs do not alter survival when used to treat chemotherapy-induced anemia, large well-controlled trials addressing this issue are needed.
    MeSH term(s) Anemia/drug therapy ; Anemia/epidemiology ; Anemia/etiology ; Cell Hypoxia ; Disease Progression ; Drug Resistance ; Erythropoietin/adverse effects ; Erythropoietin/therapeutic use ; Hematinics/adverse effects ; Hematinics/therapeutic use ; Humans ; Neoplasm Metastasis ; Neoplasms/complications ; Neoplasms/pathology
    Chemical Substances Hematinics ; Erythropoietin (11096-26-7)
    Language English
    Publishing date 2009
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 207930-6
    ISSN 1545-326X ; 0066-4219
    ISSN (online) 1545-326X
    ISSN 0066-4219
    DOI 10.1146/annurev.med.60.050307.110718
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer.

    Nguyen, Vina P / Campbell, Katie M / Nowicki, Theodore S / Elumalai, Nila / Medina, Egmidio / Baselga-Carretero, Ignacio / DiNome, Maggie L / Chang, Helena R / Oseguera, Denise K / Ribas, Antoni / Glaspy, John A

    Cancer research communications

    2023  Volume 3, Issue 8, Page(s) 1628–1637

    Abstract: Purpose: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer.: Experimental design: Eligibility for this pilot phase I trial ... ...

    Abstract Purpose: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer.
    Experimental design: Eligibility for this pilot phase I trial included patients with localized HER2-negative breast cancer who received systemic nivolumab and ipilimumab and intratumor talimogene laherparepvec (T-VEC; NCT04185311). The primary objective was to evaluate the safety and adverse event profile of immunotherapy combined with T-VEC in patients with localized, HER2-negative breast cancer.
    Results: Six patients were enrolled, 4 having relapses after prior neoadjuvant chemotherapy and 2 who were previously untreated. Toxicities included 1 patient having grade 3 hypotension and type 1 diabetes mellitus, 3 patients with hypothyroidism, and all patients having constitutional symptoms known to be associated with the administration of T-VEC. One patient had a pathologic complete response, 3 patients had pathologic partial responses, 1 showed no significant response, and 1 had disease progression. Biopsies demonstrated increased immune cell infiltration in samples from patients who responded to therapy.
    Conclusions: This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities.
    Significance: Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity.
    MeSH term(s) Female ; Humans ; Breast Neoplasms/therapy ; Immune Checkpoint Inhibitors ; Ipilimumab/therapeutic use ; Melanoma ; Neoadjuvant Therapy ; Neoplasm Recurrence, Local ; Nivolumab/therapeutic use ; Oncolytic Virotherapy/adverse effects ; Pilot Projects
    Chemical Substances Immune Checkpoint Inhibitors ; Ipilimumab ; Nivolumab (31YO63LBSN)
    Language English
    Publishing date 2023-08-23
    Publishing country United States
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2767-9764
    ISSN (online) 2767-9764
    DOI 10.1158/2767-9764.CRC-23-0145
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Erythropoiesis-stimulating agents in oncology.

    Glaspy, John A

    Journal of the National Comprehensive Cancer Network : JNCCN

    2008  Volume 6, Issue 6, Page(s) 565–575

    Abstract: Patients who have cancer, particularly those undergoing chemotherapy, frequently become anemic. Therapy with erythropoiesis-stimulating agents (ESAs) is associated with an increase in hemoglobin levels, a reduction in transfusion requirements, and, ... ...

    Abstract Patients who have cancer, particularly those undergoing chemotherapy, frequently become anemic. Therapy with erythropoiesis-stimulating agents (ESAs) is associated with an increase in hemoglobin levels, a reduction in transfusion requirements, and, according to many clinical trialists and experienced clinicians, an improvement in functional status, productivity, and quality of life. Several randomized trials of ESAs in patients who have cancer have recently reported inferior outcomes in tumor progression or survival, raising appropriate concerns about the safety of ESAs in oncology. However, 3 important caveats to these reports exist. First, these clinical trials did not reflect the common use of ESAs in oncology practice (i.e., to treat, rather than prevent, anemia in patients undergoing chemotherapy). Second, the trials were seriously flawed and did not meet reasonable standards for cancer progression or survival trials. Third, during the same period, randomized trials were presented or published that showed no negative impact on tumor progression or survival; these trials have approximately the same shortcomings as trials that suggest a safety issue exists. The lack of definitive answers about the safety of ESAs for treating chemotherapy-related anemia has placed physicians, regulators, and most importantly patients in a difficult position that can only be addressed with additional data. This article reviews relevant preclinical and clinical available data to help improve understanding and guide decision making.
    MeSH term(s) Anemia/drug therapy ; Anemia/etiology ; Antineoplastic Agents/adverse effects ; Erythropoietin/therapeutic use ; Hematinics/therapeutic use ; Humans ; Neoplasms/complications ; Recombinant Proteins
    Chemical Substances Antineoplastic Agents ; Hematinics ; Recombinant Proteins ; Erythropoietin (11096-26-7)
    Language English
    Publishing date 2008-06-11
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2250759-0
    ISSN 1540-1405
    ISSN 1540-1405
    DOI 10.6004/jnccn.2008.0043
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article: Every-three-week erythropoietic support during chemotherapy for cancer: current status and future issues.

    Glaspy, John A

    Supportive cancer therapy

    2008  Volume 3, Issue 1, Page(s) 16–20

    Abstract: Recently, it has been demonstrated that the administration of chemotherapy alters the pharmacology of erythropoietic-stimulating proteins (ESPs), such as endogenous erythropoietin and darbepoetin alfa, with an apparent decrease in clearance and ... ...

    Abstract Recently, it has been demonstrated that the administration of chemotherapy alters the pharmacology of erythropoietic-stimulating proteins (ESPs), such as endogenous erythropoietin and darbepoetin alfa, with an apparent decrease in clearance and substantial prolongation of half-life. This observation, coupled with the popularity of every-3-week chemotherapy regimens, makes it logical to pursue less-frequent dosing schedules for darbepoetin alfa. Two published studies have demonstrated that darbepoeitin alfa administered at a dose of 6.75 mug/kg or every 3 weeks to anemic patients with cancer is associated with improvements in hemoglobin levels. It has also been shown that dosing on the same day as chemotherapy is as efficacious and safe as dosing asynchronously in patients receiving every-3-week chemotherapy. These studies have increased our understanding of the biology of the interplay between chemotherapy, erythropoiesis, and ESPs and should facilitate the development of increasingly convenient and effective approaches to the treatment of chemotherapy-associated anemia. These insights are reviewed in this article. At the same time, evidence is accumulating that earlier initiation of ESP therapy, before severe anemia and symptoms occur, will be associated with further reduction in transfusion requirements, less patient-reported fatigue, and lower required doses of ESPs. In addition, recently presented trials have reported very important improvements in erythropoietic response to ESPs when patients with chemotherapy-associated anemia are treated with parenteral iron. The early initiation and parenteral iron initiatives pose opportunities and challenges for treatment regimens emerging from our increasing biologic understanding, and these are also reviewed.
    Language English
    Publishing date 2008-05-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2193658-4
    ISSN 1543-2912
    ISSN 1543-2912
    DOI 10.3816/SCT.2005.n.020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Entering a new era in the management of tumor-associated involution.

    Glaspy, John A

    The journal of supportive oncology

    2005  Volume 3, Issue 1, Page(s) 51–52

    MeSH term(s) Biomarkers, Tumor/analysis ; Cachexia/diagnosis ; Cachexia/epidemiology ; Cachexia/therapy ; Clinical Trials as Topic ; Combined Modality Therapy ; Cytokines/analysis ; Cytokines/metabolism ; Depressive Disorder/diagnosis ; Depressive Disorder/epidemiology ; Depressive Disorder/therapy ; Female ; Forecasting ; Humans ; Interleukin-1/antagonists & inhibitors ; Male ; Neoplasms/diagnosis ; Neoplasms/epidemiology ; Neoplasms/therapy ; Peer Review ; Prognosis ; Risk Assessment ; Survival Rate ; Tumor Necrosis Factor-alpha/antagonists & inhibitors
    Chemical Substances Biomarkers, Tumor ; Cytokines ; Interleukin-1 ; Tumor Necrosis Factor-alpha
    Language English
    Publishing date 2005-01
    Publishing country United States
    Document type Comment ; Journal Article
    ZDB-ID 2394158-3
    ISSN 1879-596X ; 1544-6794
    ISSN (online) 1879-596X
    ISSN 1544-6794
    Database MEDical Literature Analysis and Retrieval System OnLINE

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