Side Effects of sargramostim: A Synthesis of Findings from 15 Studies

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Original Abstract of the Article

Major Research Findings

Sargramostim is a medication that stimulates the immune system, making it a potential treatment for various cancers. It has been used as an adjuvant therapy for cancers like melanoma, breast cancer, prostate cancer, and others. However, several studies have revealed that sargramostim can cause side effects related to immune system activation, known as immune-related adverse events (irAEs). 1 highlights that these side effects can impact various organs, including skin, gastrointestinal tract, liver, and the endocrine system. 12 specifically reports on the side effects observed in a prostate cancer vaccine trial where sargramostim was administered alongside a vaccine. 3 provides a broader overview of side effects associated with various cytokines, including sargramostim. 15 focuses on the use of sargramostim for myelodysplastic syndromes (MDS), examining both its effectiveness and side effects. 2 explores the relationship between certain psychotropic drugs and leukopenia, suggesting that sargramostim might contribute to this side effect. 8 investigates the long-term safety and tolerability of sargramostim in patients with Parkinson's disease, suggesting it is generally safe and well-tolerated. Research examining the combination of sargramostim with immune checkpoint inhibitors, specifically for treating metastatic melanoma, is explored in 6 . This study highlights the potential of combining these therapies to enhance effectiveness and reduce toxicity. 11 and 7 provide insights into the side effects and effectiveness of sargramostim as adjuvant therapy for melanoma and various other cancers, respectively. Additionally, 4 examines the long-term administration of sargramostim as an adjuvant therapy for melanoma, emphasizing its safety and potential benefits. 5 investigates the combination of sargramostim with ipilimumab, a CTLA-4 inhibitor, in treating metastatic melanoma, demonstrating its potential to prolong survival and reduce serious side effects compared to using ipilimumab alone. 13 delves into the use of sargramostim to manage neutropenic fever following high-dose chemotherapy and stem cell transplantation. 10 examines the use of inhaled sargramostim as a treatment for a rare lung condition, pulmonary alveolar proteinosis (PAP), specifically in individuals with lysinuric protein intolerance (LPI). Despite the promising potential of sargramostim, it is crucial to acknowledge the potential for side effects and their implications for patient health.

Reasons for Side Effects

Sargramostim stimulates the immune system, aiming to fight cancer cells. However, this stimulation can sometimes lead to unintended consequences. The immune system, while targeting cancer cells, might also attack healthy cells, leading to various side effects. 1 points out that the impact of sargramostim and other immune checkpoint inhibitors can extend to various organ systems, causing diverse side effects. This suggests that the immune system's heightened activity due to sargramostim might not always differentiate between harmful and healthy cells, leading to complications. 3 emphasizes the pleiotropic nature of sargramostim and its potent effects, implying that its action on multiple cell types, while beneficial for cancer treatment, can also lead to undesired consequences.

Common Side Effects

Fever

Sargramostim can lead to fever, a common side effect due to the stimulation of the immune system. 13 describes sargramostim's potential to cause fever in patients who have undergone high-dose chemotherapy and stem cell transplantation, highlighting its role in the development of neutropenic fever.

Leukocytosis

Sargramostim can cause an increase in white blood cell count, known as leukocytosis. This is a direct consequence of its effect on bone marrow, where white blood cells are produced. This side effect is documented in 7 , where leukocytosis was observed in patients treated with sargramostim.

Fatigue

Sargramostim can cause fatigue, likely due to the body's increased energy expenditure in response to the stimulated immune system. 7 reports fatigue as a side effect observed in patients treated with sargramostim.

Myelosuppression

Sargramostim can suppress bone marrow function, potentially leading to a decrease in blood cell production, a condition called myelosuppression. 2 highlights the connection between certain drugs and leukopenia, suggesting a possible role of sargramostim in this side effect. The immune system's heightened activity might inadvertently affect bone marrow function, resulting in myelosuppression.

Skin Reactions

Sargramostim can cause skin reactions, likely due to inflammation triggered by the activated immune system. 1 reports skin reactions as a common side effect of immune checkpoint inhibitors, including sargramostim.

Gastrointestinal Symptoms

Sargramostim can lead to gastrointestinal symptoms, possibly due to the immune system's activation causing inflammation in the digestive tract. 1 documents gastrointestinal symptoms as a potential side effect of immune checkpoint inhibitors, including sargramostim.

Liver Damage

Sargramostim might cause liver damage, potentially resulting from inflammation in the liver triggered by the activated immune system. 1 reports liver damage as a possible side effect associated with immune checkpoint inhibitors, including sargramostim.

Endocrine Disorders

Sargramostim can lead to endocrine disorders, possibly due to the immune system's activation affecting the endocrine system. 1 indicates endocrine disorders as a potential side effect related to immune checkpoint inhibitors, including sargramostim.

Countermeasures for Side Effects

Fever

Fever caused by sargramostim can often be managed with over-the-counter pain relievers and fever reducers. If the fever persists or becomes severe, consult a doctor immediately.

Leukocytosis

Leukocytosis usually resolves after stopping sargramostim. If it persists or if you experience any concerning symptoms, seek medical advice.

Fatigue

Fatigue caused by sargramostim can be managed with adequate rest and a healthy diet. However, if fatigue is severe or persistent, consult a doctor for further evaluation and potential treatment options.

Myelosuppression

Myelosuppression might require adjusting the dosage of sargramostim or temporarily halting treatment. In severe cases, bone marrow transplantation may be necessary. Regular blood tests are crucial to monitor blood cell counts and guide treatment decisions.

Skin Reactions

Skin reactions can often be managed with topical medications like steroid creams. If they worsen or become severe, it's important to seek immediate medical attention.

Gastrointestinal Symptoms

Gastrointestinal symptoms can often be managed with anti-nausea medications and dietary adjustments. If these symptoms are severe or persistent, consult a doctor.

Liver Damage

Liver damage can be managed with medications and lifestyle changes. In severe cases, a liver transplant may be necessary. Regular liver function tests are crucial to monitor liver health.

Endocrine Disorders

Endocrine disorders can be managed with hormone replacement therapy or other treatment options depending on the specific disorder. Regular monitoring and management by an endocrinologist are essential.

Comparison Between Studies

Commonalities Between Studies

Several studies highlight the potential benefits of sargramostim in treating various cancers by stimulating the immune system. However, these studies consistently demonstrate that sargramostim can cause side effects related to immune system activation. These side effects can affect various organs and systems in the body, requiring careful monitoring and management.

Differences Between Studies

While all studies recognize the potential for sargramostim-related side effects, the specific types and severity of side effects can vary depending on the study's focus, patient population, and treatment protocol. Some studies concentrate on specific cancers, while others investigate the long-term safety and efficacy of sargramostim in different contexts. The methodologies and endpoints assessed also vary, making direct comparisons between studies challenging.

Precautions for Application in Real Life

Sargramostim is a powerful medication with both potential benefits and risks. When considering sargramostim treatment, a thorough discussion with your doctor is essential to understand the potential benefits, risks, and potential side effects. Regular monitoring of your overall health and blood cell counts is crucial to ensure safe and effective treatment.

Limitations of Current Research

Research on sargramostim's side effects is ongoing, and further investigation is needed to fully understand the long-term implications of this medication. More research is required to identify individuals who might be at higher risk of specific side effects. Additionally, research into developing strategies to prevent or manage these side effects more effectively is ongoing.

Future Research Directions

Future research should focus on identifying the underlying mechanisms responsible for sargramostim-related side effects. This knowledge can help develop more targeted therapies to prevent or mitigate these side effects. Additional research is necessary to optimize treatment protocols, potentially combining sargramostim with other therapies to enhance its effectiveness and minimize side effects.

Conclusion

Sargramostim holds promise as a treatment for various cancers by boosting the immune system. However, it is crucial to be aware of the potential side effects associated with this medication. While these side effects can be managed with appropriate treatment and monitoring, further research is essential to fully understand the long-term implications and to develop strategies for minimizing their occurrence. Open communication with your doctor about your individual health situation and treatment options is key to making informed decisions about sargramostim therapy.

Literature analysis of 15 papers
Positive Content
14
Neutral Content
1
Negative Content
0
Article Type
1
0
0
6
15
1.

Managing immune checkpoint-blocking antibody side effects.

Author: PostowMichael A

Treats cancer
Immune-related adverse events

Immune checkpoint inhibitors, such as ipilimumab (anti-CTLA-4) and nivolumab/pembrolizumab (anti-PD-1/PD-L1), are effective treatments for cancer but can cause immune-related adverse events (irAEs). This article describes the side effects and management of irAEs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Side effects of cytokines approved for therapy.

Author: BaldoBrian A

Immune modulation
Infection treatment
Inflammation treatment
Malignancy treatment
Cytokine side effects

This study provides an overview of the 20 FDA-approved cytokine preparations, including their physicochemical features, approved indications, mechanisms of action, and side effects. The study highlights the importance of understanding the pleiotropism and potential for cytokine cocktails to manage adverse events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered for 3 years as adjuvant therapy of stages II(T4), III, and IV melanoma.

Author: SpitlerLynn E, WeberRobert W, AllenRobert E, MeyerJohn, CruickshankScott, GarbeEdeltraut, LinHui-Yi, SoongSeng-jaw

Melanoma
Leukemia

Prolonged administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) for 3 years as adjuvant therapy after surgical resection of melanoma at high risk of recurrence is safe and well-tolerated. The 5-year melanoma-specific survival rate was 60%. However, two patients developed acute myelogenous leukemia after completing 3 years of treatment.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Sargramostim and immune checkpoint inhibitors: combinatorial therapeutic studies in metastatic melanoma.

Author: TarhiniAhmad A, JoshiIla, GarnerFiona

Melanoma treatment
Immune-related adverse events

This study reviews the use of sargramostim, a recombinant human GM-CSF, for treating advanced melanoma. Sargramostim may enhance the efficacy and reduce the toxicity of immune checkpoint inhibitors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Continuous low-dose GM-CSF as salvage therapy in refractory recurrent breast or female genital tract carcinoma.

Author: KurbacherChristian M, KurbacherJutta A, CramerEva-Maria, RhiemKerstin, MallmanPeter K, ReicheltRalf, ReinholdUwe, StierUrsula, CreeIan A

Prolonged survival
Tumor response
Fatigue
Injection site reaction

This pilot study explored the efficacy and tolerability of continuous low-dose GM-CSF as a salvage therapy for various chemotherapy-refractory carcinomas. The treatment was well-tolerated and showed significant activity in heavily pretreated patients with metastatic breast cancer or female genital tract cancer.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

An open-label multiyear study of sargramostim-treated Parkinson's disease patients examining drug safety, tolerability, and immune biomarkers from limited case numbers.

Author: OlsonKatherine E, AbdelmoatyMai M, NammingaKrista L, LuYaman, ObaroHelen, SantamariaPamela, MosleyR Lee, GendelmanHoward E

Alzheimer's disease treatment
Autoimmune disease treatment
Cancer treatment
Inflammatory condition treatment
Radiation syndrome treatment

Sargramostim has been reported to be clinically useful and safe for cancer, acute radiation syndrome, autoimmune disease, inflammatory conditions, and Alzheimer's disease. The safety, tolerability, and mechanisms of action in Parkinson's disease (PD) during extended use have not been evaluated.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

GM-CSF and IL-2 combination as adjuvant therapy in cutaneous melanoma: early results of a phase II clinical trial.

Author: EliasE George, ZapasJohn L, BeamSandra L, BrownSally D

Melanoma treatment

This study investigated the combined use of GM-CSF and IL-2, two cytokines, as adjuvant therapy for high-risk melanoma patients after surgery. The combination therapy was well-tolerated and showed promising results, suggesting further clinical evaluation is warranted.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

GM-CSF as a systemic adjuvant in a phase II prostate cancer vaccine trial.

Author: SimmonsS J, TjoaB A, RogersM, ElgamalA, KennyG M, RagdeH, TroychakM J, BoyntonA L, MurphyG P

Enhances immune response

This phase II clinical trial investigated the effects of GM-CSF on immune responses in prostate cancer patients undergoing treatment with DC pulsed with HLA-A2-specific prostate-specific membrane antigen (PSMA) peptides.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Neutropenic fever in patients after high-dose chemotherapy followed by autologous haematopoietic progenitor cell transplantation and human recombinant granulocyte-macrophage colony stimulating factor.

Author: GlückS, GagnonA

Neutropenic fever treatment

Neutropenic fever without signs of infection was observed in some patients treated with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation, possibly due to sargramostim.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

A randomized, phase II trial of adjuvant immunotherapy with durable TKI-free survival in patients with chronic phase CML.

Author: WebsterJonathan A, RobinsonTara M, BlackfordAmanda L, WarlickErica, FergusonAnna, BorrelloIvan, ZahurakMarianna, JonesRichard J, SmithB Douglas

CML disease control
TKI discontinuation

Adjuvant immunotherapy with TKIs could facilitate TKI discontinuation in CP-CML patients who achieve undetectable minimal residual disease. This suggests a potential strategy for improving long-term outcomes in CML.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

15.

Hematopoietic growth factors in myelodysplastic syndromes.

Author: SteensmaDavid P

Increase blood count
Alter disease history

Hematopoietic growth factors (HGFs) are commonly prescribed for patients with myelodysplastic syndromes (MDS), but there is no MDS-specific US Food and Drug Administration (FDA)-approved indication for any of the HGFs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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