Effects of idelalisib: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major Research Findings

Idelalisib is a drug used to treat certain types of blood cancers, particularly chronic lymphocytic leukemia (CLL). It works by blocking a specific enzyme called PI3Kδ, which helps to control the growth and survival of B cells. 4 18 6 9

Several studies have shown that idelalisib can improve progression-free survival (PFS) and overall survival (OS) in patients with relapsed or refractory CLL. 4 11 15 16

However, idelalisib can also cause autoimmune toxicity, which is a condition where the immune system attacks healthy tissues. 18 15 13

Researchers have found that patients who have higher levels of Th17 T cells in their blood before starting idelalisib treatment are more likely to experience autoimmune toxicity. 18

Idelalisib has also shown synergistic effects when used in combination with other cancer drugs, such as selinexor or venetoclax. 8 21 22 19 1

Benefits and Risks

Benefit Summary

Idelalisib can improve survival and help control the spread of CLL in some patients. Idelalisib may be more effective when combined with other cancer treatments.

Risk Summary

Idelalisib can cause autoimmune reactions, leading to the immune system attacking healthy tissues. Idelalisib may increase the risk of infections. Idelalisib may interact with other medications. Idelalisib should not be used during pregnancy.

Comparison of Studies

Similarities

Multiple studies have found idelalisib to be effective in treating CLL. Idelalisib has shown promising results in improving survival and controlling the progression of CLL in some patients.

Differences

The effectiveness and safety of idelalisib can vary between studies. Some studies have found idelalisib to be more effective than other treatments in improving survival and controlling CLL progression. However, other studies have found idelalisib to be similarly effective to other treatments. Additionally, the frequency and type of side effects reported for idelalisib can differ between studies.

Consistency and Contradictions in Results

There are some inconsistencies in the results of studies on idelalisib. These differences can be explained by a variety of factors, such as different research designs, the specific patient populations studied, and other factors that may affect the study results.

Implications for Real-Life Applications

Idelalisib can be a helpful treatment for CLL, but it is important to be aware of the potential risks. If you are considering idelalisib, it is essential to discuss your individual situation and potential risks with your doctor.

Limitations of Current Research

More research is needed to better understand idelalisib's effectiveness and safety. Further studies are needed to develop ways to reduce side effects and improve the effectiveness of idelalisib.

Future Research Directions

Future research should focus on understanding the mechanisms by which idelalisib works and the factors that contribute to its effectiveness and safety. Studies should also explore ways to improve the treatment of CLL and minimize the risk of side effects.

Conclusion

Idelalisib is a promising drug for treating CLL, but it is important to be aware of the potential risks. If you are considering idelalisib, it is essential to discuss your individual situation and potential risks with your doctor. More research is needed to better understand idelalisib's effectiveness and safety and develop ways to improve the treatment of CLL.

Literature analysis of 25 papers
Positive Content
21
Neutral Content
3
Negative Content
1
Article Type
1
1
1
5
25
2.

Immune modulatory effects of Idelalisib in stromal cells of chronic lymphocytic leukemia.

Author: HandlSarah, von HeydebrandFranziska, VoelklSimon, OostendorpRobert A J, WilkeJochen, KremerAnita N, MackensenAndreas, Lutzny-GeierGloria

Improved therapies
Side effects

Idelalisib, a PI3K inhibitor, activates the NF-κB pathway in stromal cells in contact with CLL cells, potentially contributing to patient side effects. The study also investigated a 3D-stroma/leukemia model, which could improve therapeutic strategies, especially for minimal-residual disease.

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

3.

Combination of the PI3K inhibitor Idelalisib with the conventional cytostatics cytarabine and dexamethasone leads to changes in pathway activation that induce anti-proliferative effects in B lymphoblastic leukaemia cell lines.

Author: SklarzL-M, GladbachY S, ErnstM, HamedM, RoolfC, SenderS, BeckJ, SchützE, FischerS, StruckmannS, JunghanssC, FuellenG, Murua EscobarH

Cancer treatment

This study emphasizes the need to understand the molecular mechanisms of combined conventional cytostatics and pathway-specific inhibitors for cancer treatment, particularly in hematologic neoplasia.

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

Language : English

4.

Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial.

Author: MontilloMarco, IllésÁrpád, RobakTadeusz, PristupaAlexander S, WachMalgorzata, EgyedMiklós, DelgadoJulio, JurczakWojciech, MorschhauserFranck, SchuhAnna, EradatHerbert, ShreaySanatan, BarrientosJacqueline C, ZelenetzAndrew D

Improved OS
Improved PFS

This study reports on the health-related quality of life (HRQL) outcomes from a phase 3 trial of idelalisib + bendamustine/rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL).

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
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.

Language : English

5.

A novel <i>ex vivo</i> high-throughput assay reveals antiproliferative effects of idelalisib and ibrutinib in chronic lymphocytic leukemia.

Author: PrimoDaniel, ScarfòLydia, XochelliAliki, MattssonMattias, RanghettiPamela, EspinosaAna Belén, RoblesAlicia, GorrochateguiJulian, Martínez-LópezJoaquín, de la SernaJavier, GonzálezMarcos, GilAlberto Chaparro, AnguitaEduardo, IrahetaSandra, MunugalavadlaVeerendra, QuévaChristophe, TannheimerStacey, RosenquistRichard, StamatopoulosKostas, BallesterosJoan, GhiaPaolo

Ex vivo model
Ibrutinib activity
Idelalisib activity

This study developed an *ex vivo* model to reproduce the effects of the microenvironment on CLL apoptosis and proliferation.

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

Language : English

6.

Idelalisib may have the potential to increase radiotherapy side effects.

Author: GrycThomas, PutzFlorian, GoerigNicole, ZieglerSonia, FietkauRainer, DistelLuitpold V, SchusterBarbara

Cancer treatment

This study focuses on idelalisib, a potent and selective phosphatidylinositol 3-kinase-δ (PI3K-δ) inhibitor, and its application in treating relapsed chronic lymphocytic leukemia, follicular B-cell non-Hodgkin's lymphoma, and small lymphocytic lymphoma. The study highlights idelalisib's selective targeting of PI3K-δ, which is primarily expressed in B-cells, and its potential for effectively inhibiting proliferation in malignant B-cells.

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

Language : English

8.

Anti-tumor activity of selinexor in combination with antineoplastic agents in chronic lymphocytic leukemia.

Author: VitaleCandida, GriggioValentina, TodaroMaria, RigantiChiara, JonesRebecca, BoccellatoElia, PerutelliFrancesca, ArrugaFrancesca, VaisittiTiziana, EfremovDimitar G, DeaglioSilvia, LandesmanYosef, BrunoBenedetto, CosciaMarta

In vivo efficacy
Increased tumor suppressor activity
Synergistic effects

The study evaluated the anti-tumor effects of selinexor, an oral inhibitor of the nuclear export protein XPO1, in combination with chemotherapy drugs or with the PI3Kδ inhibitor idelalisib in chronic lymphocytic leukemia (CLL). Selinexor demonstrated synergistic cytotoxic effects in combination with fludarabine, bendamustine, and idelalisib, and was effective in potentiating the in vivo anti-tumor effects of idelalisib.

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

9.

Metabolic and toxicological considerations for phosphoinositide 3-kinase delta inhibitors in the treatment of chronic lymphocytic leukemia.

Author: WitkowskaMagdalena, MajchrzakAgata, RobakPaweł, Wolska-WasherAnna, RobakTadeusz

Effective B-cell lymphoma treatment

PI3Kδ inhibitors, such as idelalisib, are new drugs that are used to treat B-cell malignancies. These drugs work by blocking a specific enzyme called PI3Kδ. Idelalisib is the first PI3Kδ inhibitor that has been approved for use in patients with B-cell lymphoid malignancies.

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

10.

Mechanism and therapeutic implications of pomalidomide-induced immune surface marker upregulation in EBV-positive lymphomas.

Author: JaegerHannah K, DavisDavid A, NairAshwin, ShresthaPrabha, StreamAlexandra, YaparlaAmulya, YarchoanRobert

EBV lymphoma treatment

Pomalidomide increases the expression of immune surface markers in EBV-infected cells, potentially enhancing immune recognition and making it a useful treatment for EBV-positive lymphomas.

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.
Research Support, N.I.H., IntramuralFunding provided by the NIH for research projects within the NIH.

Language : English

11.

Current Treatment Options in Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: a Review.

Author: IslamPrioty

CLL treatment

This review discusses the current treatment landscape for relapsed and refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL), outlining different therapeutic approaches based on prior therapies and highlighting the importance of clinical trial enrollment for patients with complex 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

12.

Lymphadenopathy as a predictor of progression during venetoclax treatment in chronic lymphocytic leukemia. A campus chronic lymphocytic leukemia study.

Author: AutoreFrancesco, InnocentiIdanna, RedaGianluigi, VisentinAndrea, VitaleCandida, PiciocchiAlfonso, FresaAlberto, LeoneMonica M A, FarinaLucia, QuaresminiGiulia, BaratèClaudia, GiordanoAnnamaria, FerrariAngela, AngelettiIlaria, De PaolisMaria Rosaria, MalerbaLara, ChiurazziFederico, LosetoGiacomo, CataniaGioacchino, SportolettiPaolo, ScortechiniIlaria, MoiaRiccardo, GentileMassimo, RigolinGian Matteo, MattielloVeronica, GatteiValter, CosciaMarta, TrentinLivio, FoàRobin, CuneoAntonio, LaurentiLuca

Prolonged PFS
Venetoclax efficacy
Lymph node diameter risk
Progression risk

This study looked at factors that could predict treatment progression in chronic lymphocytic leukemia (CLL) patients switched to venetoclax after receiving ibrutinib or idelalisib. A lymph node diameter greater than 56.5 mm was associated with a higher risk of progression during venetoclax treatment.

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

Language : English

13.

Management of Gastro-Intestinal Toxicity of the Pi3 Kinase Inhibitor: Optimizing Future Dosing Strategies.

Author: BrealClaire, BeuvonFrederic, de Witasse-ThezyThibault, DermineSolene, Franchi-RezguiPatricia, Deau-FisherBenedicte, WillemsLise, GrignanoEric, ContejeanAdrien, BouscaryDidier, FaillieJean Luc, TreluyerJean-Marc, GuerinCorinne, ChouchanaLaurent, VignonMarguerite

Cancer treatment
Colitis

This review examines the use of phosphatidylinositol 3-kinase (PI3K) inhibitors for hematological malignancies, focusing on the incidence and toxicity of PI3K inhibitor-induced colitis. It discusses the side effects reported in clinical trials and pharmacovigilance data, and provides real-world experience in managing idelalisib-induced colitis.

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

14.

Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: A Systematic Review and Meta-analysis.

Author: BanerjeeTitas, KimMyung Sun, HaslamAlyson, PrasadVinay

FL treatment
SLL treatment
Serious adverse effects

This study describes the history of idelalisib, a phosphatidylinositol 3-kinase inhibitor that received accelerated approval for relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) but was later withdrawn due to serious adverse effects.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

PI3k Inhibitors in NHL and CLL: An Unfulfilled Promise.

Author: Bou ZeidNaji, YazbeckVictor

CLL treatment
iNHL treatment
Adverse effects
Decreased survival

This mini-review revisits the clinical successes, the failures, and the promising aspect of PI3K inhibitors in the treatment of hematologic malignancies. It also presents possible ways that could benefit its successful development.

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

16.

Real-world outcomes upon second-line treatment in patients with chronic lymphocytic leukaemia.

Author: VainerNoomi, AarupKathrine, AndersenMichael Asger, Wind-HansenLise, NielsenTine, FrederiksenHenrik, EnggaardLisbeth, PoulsenChristian Bjørn, NiemannCarsten U, RotbainEmelie C

Improved survival
Improved treatment-free survival
Hematological adverse events
Infections

This study compares targeted drugs with chemoimmunotherapy for second-line treatment of chronic lymphocytic leukemia (CLL). Targeted drugs show higher treatment-free survival and a tendency towards higher overall survival, but also have more adverse events.

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

18.

Circulating Th17 T cells at treatment onset predict autoimmune toxicity of PI3Kδ inhibitors.

Author: GadiDeepti, MartindaleStephen P, ChiuPui Yan, KhalsaJasneet, ChenPei-Hsuan, FernandesStacey M, WangZixu, TyekuchevaSvitlana, MachadoJohn-Hanson, FisherDavid C, ArmandPhilippe, DavidsMatthew S, RodigScott, SherryBarbara, BrownJennifer R

B cell malignancy therapy
PI3K inhibitor toxicity
autoimmune toxicity

This study investigates the in vitro effects of PI3Kδ inhibitors (idelalisib and duvelisib) on T cell differentiation and proliferation. The study found that these inhibitors can promote Th17 differentiation while inhibiting Treg differentiation, potentially contributing to autoimmune toxicity.

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

21.

A ROR1 Small Molecule Inhibitor (KAN0441571C) Induced Significant Apoptosis of Mantle Cell Lymphoma (MCL) Cells.

Author: GhaderiAmineh, ZhongWen, OkhovatMohammad Ali, AschanJohanna, SvenssonAnn, SanderBirgitta, SchultzJohan, OlinThomas, ÖsterborgAnders, Hojjat-FarsangiMohammad, MellstedtHåkan

Apoptotic effects on MCL cells

This study investigated the apoptotic effects of a novel ROR1 inhibitor, KAN0441571C, on human mantle cell lymphoma (MCL) cells. The inhibitor showed significant anti-cancer activity, both alone and in combination with other inhibitors. Further research is needed to assess its potential as a therapeutic approach for MCL.

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

Language : English

23.

Real-life efficacy and safety of idelalisib in 55 double-refractory follicular lymphoma patients.

Author: IsidoriAlessandro, LoscoccoFederica, VisaniGiuseppe, PaolasiniSara, ScalzulliPotito, MustoPellegrino, PerroneTommasina, GuariniAttilio, PastoreDomenico, MazzaPatrizio, TonialiniLorenzo, PavoneVincenzo, De SantisGaetano, TarantiniGiuseppe

High response rate
Manageable toxicities

Idelalisib is a PI3Kδ inhibitor approved for relapsed/refractory follicular lymphoma (FL). This study evaluated the efficacy and safety of idelalisib in a real-life setting, demonstrating a high response rate and manageable side effects, confirming its value in FL treatment.

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

24.

Functional Testing to Characterize and Stratify PI3K Inhibitor Responses in Chronic Lymphocytic Leukemia.

Author: YinYanping, AthanasiadisPaschalis, KarlsenLinda, UrbanAleksandra, XuHaifeng, MuraliIshwarya, FernandesStacey M, ArribasAlberto J, HilliAbdul K, TaskénKjetil, BertoniFrancesco, MatoAnthony R, NormantEmmanuel, BrownJennifer R, TjønnfjordGeir E, AittokallioTero, SkånlandSigrid S

CLL treatment
Resistance
Treatment intolerance

PI3Ki are used to treat relapsed CLL but often have side effects and resistance. This study aimed to identify actionable biomarkers to predict individual treatment responses and overcome these challenges.

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

25.

Current status of phosphoinotiside-3 kinase inhibitors in blood cancers.

Author: ShouseGeoffrey, DanilovaOlga V, DanilovAlexey V

CLL treatment
NHL treatment

PI3K inhibitors have been approved by the FDA for the treatment of NHL and CLL and are proving to be effective treatments, but they also present unique challenges in routine practice.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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