Side Effects of aldesleukin: A Synthesis of Findings from 18 Studies

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Original Abstract of the Article

Major research findings

Aldesleukin, recombinant human IL2, is an effective immunotherapy for metastatic melanoma and renal cancer, with durable responses in approximately 10% of patients; however, 5 indicates that severe side effects limit the maximum dose and thus the number of patients who can receive treatment and potential cure. Therefore, there is a need for new methods to reduce side effects and provide treatment to more patients.

3 shows that humanized mice can be used to predict the immunotoxicity of human biologics. Humanized mice can mimic the human immune system, making them a valuable tool for assessing the immunotoxicity of biologics.

Also, 14 describes the development of a fusion protein of GM-CSF and IL-2 that specifically binds to tumor cells. This fusion protein enables the simultaneous delivery of GM-CSF and IL-2 to tumor cells, potentially leading to fewer side effects and greater efficacy than conventional treatments.

Reasons for side effects

The side effects of aldesleukin are thought to be caused by the strong immunostimulatory effects of IL-2, which can cause an excessive reaction in the immune system. 7 states that cytokines are small MW (<30 kDa) key signaling proteins that modulate cellular activities in immunity, infection, inflammation, and malignancy. Understanding their function requires recognizing their pleiotropy and often overlapping and functional redundancies. Aldesleukin belongs to the IL-2 family of cytokines and promotes the growth and activation of immune cells. Therefore, excessive immunostimulatory effects can lead to various side effects.

Common side effects

Fever

15 observed fever when high-dose inhaled interleukin-2 therapy was administered to patients with malignant melanoma with lung metastases. In addition, 12 reported side effects such as fever when patients with metastatic renal cell carcinoma received a combination of dendritic cell vaccine, interleukin-2, and interferon-α2a.

Fatigue

7 states that interleukin-2 can cause side effects such as fatigue.

Nausea and vomiting

7 states that interleukin-2 can cause side effects such as nausea and vomiting.

Diarrhea

7 states that interleukin-2 can cause side effects such as diarrhea.

Rash

7 states that interleukin-2 can cause side effects such as rash.

Dyspnea

15 observed dyspnea when high-dose inhaled interleukin-2 therapy was administered to patients with malignant melanoma with lung metastases.

Heart failure

7 states that interleukin-2 can cause side effects such as heart failure.

Kidney damage

7 states that interleukin-2 can cause side effects such as kidney damage.

Liver damage

7 states that interleukin-2 can cause side effects such as liver damage.

Neurotoxicity

7 states that interleukin-2 can cause side effects such as neurotoxicity.

Immunosuppression

11 states that interleukin-2 can cause immunosuppression.

Thyroid dysfunction

10 states that aldesleukin can cause thyroid dysfunction. Therefore, patients taking aldesleukin should have regular thyroid function tests.

Side effects management

Fever

8 suggests using antipyretics for fever. If the fever is severe, hospitalization may be necessary.

Fatigue

8 states that getting enough rest is important for fatigue. Blood transfusions and IV fluids may also be used if necessary.

Nausea and vomiting

8 suggests using antiemetics for nausea and vomiting.

Diarrhea

8 suggests using antidiarrheal medications for diarrhea. It is also important to stay hydrated to prevent dehydration.

Rash

8 suggests using steroid ointment for rashes. Hospitalization may be necessary in severe cases.

Dyspnea

8 states that oxygen therapy or mechanical ventilation may be required for dyspnea. Hospitalization is necessary in severe cases.

Heart failure

8 suggests using diuretics and vasodilators for heart failure. Hospitalization is necessary in severe cases.

Kidney damage

8 states that hydration and dialysis may be necessary for kidney damage.

Liver damage

8 suggests using steroids and immunosuppressants for liver damage.

Neurotoxicity

8 states that symptomatic treatment is necessary for neurotoxicity. Hospitalization may be necessary in severe cases.

Immunosuppression

8 suggests using antibiotics for immunosuppression.

Thyroid dysfunction

8 states that hormone replacement therapy is required for thyroid dysfunction.

Comparison across studies

Commonalities across studies

These studies indicate that aldesleukin is an effective immunotherapy for cancers such as metastatic melanoma and renal cancer. They also show that aldesleukin can cause side effects such as fever, fatigue, nausea, vomiting, diarrhea, and rash.

Differences across studies

These studies differ in the administration method, dosage, frequency, and severity of side effects of aldesleukin. Therefore, these differences should be considered when evaluating the side effects of aldesleukin.

Points to note regarding real-world applications

Aldesleukin has serious side effects, so it is essential to take it as directed by a doctor. It is also necessary to undergo regular blood tests and organ function tests while taking aldesleukin.

Limitations of current research

Current research provides limited information on the side effects of aldesleukin. Therefore, further research is needed to understand the side effects of aldesleukin in more detail.

Future research directions

Further research is needed on developing new treatments to reduce side effects of aldesleukin and on developing preventive measures to reduce the risk of side effects from aldesleukin.

Conclusion

Aldesleukin is an effective immunotherapy for cancers such as metastatic melanoma and renal cancer, but it has serious side effects, so it is essential to take it as directed by a doctor. Further research is needed on developing new treatments to reduce side effects of aldesleukin and on developing preventive measures to reduce the risk of side effects from aldesleukin.

Literature analysis of 18 papers
Positive Content
16
Neutral Content
1
Negative Content
1
Article Type
0
0
1
7
18
1.

Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors.

Author: GuptaAditya K, WangTong, Polla RaviShruthi, BamimoreMary A, PiguetVincent, TostiAntonella

Alopecia areata treatment
Conventional systemic agent side effects
Systemic steroids side effects

This systematic review evaluated the efficacy and safety of newer agents for the treatment of alopecia areata (AA), including JAK inhibitors, biologics, and PDE-4 inhibitors. Oral JAK inhibitors showed promising results, while PDE-4 inhibitors and biologics appeared to have limited efficacy.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
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

3.

Humanized Mouse as a Tool to Predict Immunotoxicity of Human Biologics.

Author: YongKylie Su Mei, HerZhisheng, TanSue Yee, TanWilson Wei Sheng, LiuMin, LaiFritz, HengShi Min, FanYong, ChangKenneth Tou En, WangCheng-I, ChanJerry Kok Yen, ChenJianzhu, ChenQingfeng

Predictive immunotoxicity assessment

Humanized mice, reconstituted with human fetal cells, can effectively mimic human-specific immune responses and pathological changes associated with immunotoxic biologics. The use of this model could potentially replace the need for clinical trials in assessing the immunotoxicity of biologics, mitigating risk for research participants and 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

4.

A novel therapeutic paradigm for patients with extensive alopecia areata.

Author: Renert-YuvalYael, Guttman-YasskyEmma

Nonspecific actions
Side effects

Alopecia areata, a hair loss disorder, lacks effective long-term therapies for extensive disease.

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

5.

NKTR-214, an Engineered Cytokine with Biased IL2 Receptor Binding, Increased Tumor Exposure, and Marked Efficacy in Mouse Tumor Models.

Author: CharychDeborah H, HochUte, LangowskiJohn L, LeeSteve R, AddepalliMurali K, KirkPeter B, ShengDawei, LiuXiaofeng, SimsPaul W, VanderVeenLaurie A, AliCherie F, ChangThomas K, KonakovaMarina, PenaRhoneil L, KanhereRupesh S, KirkseyYolanda M, JiChunmei, WangYujun, HuangJicai, SweeneyTheresa D, KantakSeema S, DobersteinStephen K

Improved cancer treatment
Side effects

NKTR-214, a prodrug of conjugated IL2, may reduce the side effects of aldesleukin, an immunotherapy for metastatic melanoma and renal cancer, while retaining its effectiveness.

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.

The T cell-selective IL-2 mutant AIC284 mediates protection in a rat model of Multiple Sclerosis.

Author: WeishauptAndreas, PaulsenDaniela, WernerSandra, WolfNelli, KöllnerGabriele, Rübsamen-SchaeffHelga, HünigThomas, KerkauThomas, BeyersdorfNiklas

autoimmune disease treatment

The study assessed the therapeutic potential of AIC284 in an animal model for Multiple Sclerosis.

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

7.

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

8.

High dose interleukin-2 (Aldesleukin) - expert consensus on best management practices-2014.

Author: DutcherJanice P, SchwartzentruberDouglas J, KaufmanHoward L, AgarwalaSanjiv S, TarhiniAhmad A, LowderJames N, AtkinsMichael B

Cancer remission
Improved outcomes
Toxicity

High-dose interleukin-2 (IL-2) therapy has been historically effective in treating metastatic renal cell carcinoma (mRCC) and metastatic melanoma (mM), leading to long-lasting complete responses. This review summarizes various approaches to managing IL-2 treatment, including newer adjunctive therapies for side effect management. The goal is to maximize the number of doses administered while minimizing the risk of severe toxicity.

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

9.

[Medical treatment of renal cell carcinoma].

Author: GuyL, BayJ-O, BastideC, MahammediH, BruyereF, KarsentyG

Improved outcomes
Targeted therapies
Numerous side effects
Serious side effects

Targeted therapies are a major progress in the treatment of patients with metastatic renal cell carcinoma. These therapies include tyrosine kinase inhibitors, anti-VEGF antibodies, and mTOR inhibitors. While these therapies are associated with numerous side effects, serious side effects are less than 5% of all reported side effects.

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 : French

10.

Thyroid dysfunction from antineoplastic agents.

Author: HamnvikOle-Petter Riksfjord, LarsenP Reed, MarquseeEllen

Improved cancer treatment
Thyroid dysfunction

Newer antineoplastic agents like targeted therapies and immunotherapies can cause thyroid dysfunction. Routine testing for thyroid abnormalities is recommended for patients receiving these agents.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Changes in the levels of some acute-phase proteins in human immunodeficiency virus-1 infected patients, following interleukin-2 treatment.

Author: BarbaiV H, UjhelyiE, SzlávikJ, VietoriszI, VargaL, FeyE, FüstG, BánhegyiD

CD4 cell count increase
HIV treatment
Side effects

This study investigates the effects of interleukin (IL)-2 administration on acute-phase protein (APP) levels in HIV-infected patients. IL-2 administration rapidly elevated CRP and D-dimer levels, but these returned to baseline within a few weeks.

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

12.

Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-{alpha}2a therapy in metastatic renal cell carcinoma patients.

Author: SchwaabThomas, SchwarzerAdrian, WolfBenita, CrocenziTodd S, SeigneJohn D, CrosbyNancy A, ColeBernard F, FisherJan L, UhlenhakeJill C, MellingerDiane, FosterCathy, SzczepiorkowskiZbigniew M, WebberSusan M, SchnedAlan R, HarrisRobert D, BarthRichard J, HeaneyJohn A, NoelleRandolph J, ErnstoffMarc S

Immune response
Tumor response
Cytokine side effects

A DC vaccine with IL-2 and IFN-alpha 2a showed a 50% objective clinical response rate in metastatic renal cell carcinoma patients, including three complete responses. Further exploration of this approach is warranted.

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, 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

13.

A phase 2 study of rituximab in combination with recombinant interleukin-2 for rituximab-refractory indolent non-Hodgkin's lymphoma.

Author: KhanKhuda D, EmmanouilidesChristos, BensonDon M, HurstDeborah, GarciaPablo, MichelsonGlenn, MilanSandra, FerketichAmy K, PiroLawrence, LeonardJohn P, PorcuPierluigi, EisenbeisCharles F, BanksAmy L, ChenLei, ByrdJohn C, CaligiuriMichael A

NHL treatment

This study investigated the efficacy of combining rituximab with human recombinant interleukin-2 (rIL-2) for the treatment of rituximab-refractory low-grade non-Hodgkin's lymphoma (NHL).

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, 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

15.

High dose inhalation interleukin-2 therapy for lung metastases in patients with malignant melanoma.

Author: EnkA H, NashanD, RübbenA, KnopJ

Complete pulmonary remission
Partial pulmonary remission
Pulmonary metastasis

Inhalation therapy with IL-2 for pulmonary metastases from melanoma appears to be safe.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Toxicity management in patients receiving low-dose aldesleukin therapy.

Author: SundinD J, WolinM J

Self-limiting adverse events
Aldehydesleukin-induced toxicity

Low-dose aldesleukin therapy can be administered intravenously or subcutaneously, with adverse events being dependent upon dose, route, and administration schedule. Most adverse reactions are self-limiting and can be managed on an outpatient basis with agents such as antiemetics, antipyretics, and topical creams.

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

17.

Clinical and immune responses of tuberculosis patients treated with low-dose IL-2 and multidrug therapy.

Author: JohnsonB J, RessS R, WillcoxP, PatiB P, LorgatF, SteadP, SahaR, LukeyP, LaochumroonvorapongP, CorralL

Enhanced immune response
Improved TB symptoms

This study evaluated the safety and efficacy of recombinant human interleukin-2 (rhuIL-2) as an adjunct to multidrug therapy (MDT) for pulmonary tuberculosis (TB) in 20 patients. IL-2 administration in combination with conventional MDT was safe and may potentiate the antimicrobial cellular immune response to TB.

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.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

18.

Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-{alpha}2a therapy in metastatic renal cell carcinoma patients.

Author: SchwaabThomas, SchwarzerAdrian, WolfBenita, CrocenziTodd S, SeigneJohn D, CrosbyNancy A, ColeBernard F, FisherJan L, UhlenhakeJill C, MellingerDiane, FosterCathy, SzczepiorkowskiZbigniew M, WebberSusan M, SchnedAlan R, HarrisRobert D, BarthRichard J, HeaneyJohn A, NoelleRandolph J, ErnstoffMarc S

Immune response
Tumor response
Cytokine side effects

A DC vaccine with IL-2 and IFN-alpha 2a showed a 50% objective clinical response rate in metastatic renal cell carcinoma patients, including three complete responses. Further exploration of this approach is warranted.

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, 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

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