Side Effects of osimertinib: A Synthesis of Findings from 26 Studies

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Original Abstract of the Article

Major Research Findings

Osimertinib is a third-generation EGFR tyrosine kinase inhibitor (TKI) that has shown significant efficacy in treating EGFR-mutated non-small cell lung cancer (NSCLC). 23 However, osimertinib is associated with various side effects. 23 reports that osimertinib's main side effects are digestive symptoms (diarrhea) and skin symptoms (rash). 2 investigates patient-reported symptoms potentially related to osimertinib use, revealing multiple symptoms associated with both osimertinib and chemotherapy. 19 lists osimertinib's side effects as leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.

reports a new side effect called pigmented purpuric dermatosis caused by osimertinib administration. Additionally, 13 reports interstitial lung disease (ILD) caused by almonertinib, a drug similar to osimertinib.

22 reports life-threatening pneumonitis as a side effect of osimertinib. reports Stevens-Johnson syndrome caused by osimertinib.

Reasons for Side Effects

Osimertinib inhibits EGFR, a critical protein involved in cell growth and differentiation. Osimertinib's inhibition of EGFR suppresses cancer cell growth. However, EGFR also exists in normal cells, so osimertinib can also affect normal cells, potentially causing side effects. According to 16 , diarrhea caused by osimertinib may be due to enhanced calcium-activated chloride secretion and barrier dysfunction in intestinal cells. 18 suggests that skin toxicity caused by osimertinib may be due to EGFR expression in normal cells of the epidermis.

Common Side Effects

Diarrhea

Diarrhea is one of the most common side effects of osimertinib. It is reported in 23 and 19 . 16 suggests that diarrhea caused by osimertinib may be due to enhanced calcium-activated chloride secretion and barrier dysfunction in intestinal cells.

Rash

Osimertinib can cause skin rash. This is reported in 23 and 19 . 1 reports severe rash caused by osimertinib. 18 suggests that skin toxicity caused by osimertinib may be due to EGFR expression in normal cells of the epidermis.

Pneumonitis

Osimertinib can cause pneumonitis. 22 reports life-threatening pneumonitis caused by osimertinib.

Others

Other side effects of osimertinib include leukopenia, lymphopenia, thrombocytopenia, anemia, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough. 19 .

Countermeasures for Side Effects

Diarrhea

Diarrhea caused by osimertinib can often be improved with dietary and drug therapy. Dietary therapy involves avoiding high-fiber foods and staying well-hydrated. Drug therapy involves using antidiarrheal drugs such as loperamide. 16 suggests that inhibiting calcium-activated chloride secretion and barrier dysfunction could potentially reduce diarrhea.

Rash

Rash caused by osimertinib often improves with topical medications such as steroid ointment. In severe cases, oral steroids may be required. 18 reports that oral steroids improved skin toxicity caused by osimertinib.

Pneumonitis

Pneumonitis caused by osimertinib is treated with drug therapy such as antibiotics. Hospitalization may be required in severe cases.

Comparison Between Studies

Commonalities Among Studies

Many studies have shown that osimertinib is effective in treating EGFR-mutant positive NSCLC. Additionally, side effects such as diarrhea and rash have been reported in multiple studies. However, the types and frequencies of side effects reported in each study vary.

Differences Among Studies

The types and frequencies of side effects reported in each study vary. This is thought to be due to differences in study design and participant characteristics. For example, 23 lists the main side effects of osimertinib as gastrointestinal symptoms (diarrhea) and skin symptoms (rash), while 19 reports side effects such as leukopenia, lymphopenia, thrombocytopenia, and anemia.

Precautions Regarding Real-Life Application

While osimertinib is an effective drug for treating EGFR-mutant positive NSCLC, various side effects have been reported. It is crucial to discuss the risks and benefits of osimertinib with your doctor before considering its use. Regular doctor checkups are essential while using osimertinib.

Limitations of Current Research

Research on the side effects of osimertinib is still insufficient. Especially, research on long-term side effects is lacking. Additionally, the types and frequencies of side effects reported in each study vary, making it difficult to accurately understand the side effects of osimertinib.

Future Research Directions

It is crucial to further research the side effects of osimertinib. Especially, research on long-term side effects and the development of new treatments to mitigate side effects are needed. Developing biomarkers to predict the side effects of osimertinib is also important.

Conclusion

Osimertinib is an effective drug for treating EGFR-mutant positive NSCLC, but various side effects have been reported. It is crucial to discuss the risks and benefits of osimertinib with your doctor before considering its use. Regular doctor checkups are essential while using osimertinib. Research on the side effects of osimertinib is still insufficient. Future research is crucial to better evaluate the safety and efficacy of osimertinib.

Literature analysis of 26 papers
Positive Content
26
Neutral Content
0
Negative Content
0
Article Type
1
0
0
3
22
1.

Benefit from Almonertinib after Osimertinib treat EGFR 19 exon deletion NSCLC induced Severe rash: a case report.

Author: ZhangQichen, XiePeng, HouXiaoming, ZhaoChengpeng, DuanLing, QiaoHui

Skin rash reduction
Skin rash

Switching from osimertinib to aumonertinib in NSCLC patients with a skin rash led to resolution of the rash without affecting treatment efficacy.

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

Language : English

2.

Patient-reported symptoms possibly related to treatment with osimertinib or chemotherapy for advanced non-small cell lung cancer.

Author: SebastianMartin, RydénAnna, WaldingAndrew, PapadimitrakopoulouVassiliki

Improved patient reported outcomes
Not applicable

Patient-reported outcomes (PROs) using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) were analyzed in the AURA3 trial of osimertinib and chemotherapy for advanced non-small cell lung cancer. Diarrhea was more common with osimertinib, while fatigue and decreased appetite were less common. Nausea and vomiting were generally mild.

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

Language : English

4.

Successful oral desensitization with osimertinib following osimertinib-induced fever and hepatotoxicity: a case report.

Author: HirabayashiRyosuke, FujimotoDaichi, SatsumaYukari, HirabatakeMasaki, TomiiKeisuke

Osimertinib desensitization
Drug fever
Hepatotoxicity

This case study showed that oral desensitization can be a successful approach to manage severe hepatotoxicity and drug fever caused by the cancer drug osimertinib.

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

6.

Patient Experience of Symptoms and Side Effects when Treated with Osimertinib for Advanced Non-Small-Cell Lung Cancer: A Qualitative Interview Substudy.

Author: RydénAnna, BlackhallFiona, KimHye Ryun, PillaiRathi N, BraamLauren, MartinMona L, WaldingAndrew

Osimertinib treatment
Treatment side effects

This study aims to understand the patient experience with osimertinib treatment for advanced non-small-cell lung cancer. It focuses on identifying the symptoms and side effects patients encounter to better manage treatment expectations and improve patient satisfaction.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

7.

A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer.

Author: WuYi-Long, TsuboiMasahiro, JohnThomas, GroheChristian, MajemMargarita, GoldmanJonathan W, LaktionovKonstantin, KimSang-We, KatoTerufumi, VuHuu-Vinh, LuShun, LeeKye-Young, AkewanlopCharuwan, YuChong-Jen, de MarinisFilippo, BonannoLaura, DomineManuel, ShepherdFrances A, ZengLingmin, HodgeRachel, AtasoyAjlan, RukazenkovYuri, HerbstRoy S

osimertinib benefit
osimertinib side effects

This article summarizes the ADAURA clinical study, which found that osimertinib can benefit patients with a specific type of lung cancer after surgery by keeping them cancer-free longer and reducing the risk of the cancer spreading to the brain and spinal cord.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

8.

A case report of toxic epidermal necrolysis associated with AZD-9291.

Author: WangJie, ChengXianYe, LuYan, ZhouBingRong

Cancer treatment
Skin toxicity

A case of toxic epidermal necrolysis, a severe skin reaction, is reported in a patient after taking AZD-9291, an EGFR-TKI.

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

10.

Afatinib as First-Line Treatment in Asian Patients with EGFR Mutation-Positive NSCLC: A Narrative Review of Real-World Evidence.

Author: LuShun, ShihJin-Yuan, JangTae-Won, LiamChong-Kin, YuYongfeng

Favorable outcomes
NSCLC treatment

Real-world studies have confirmed the effectiveness of afatinib, a second-generation EGFR TKI, as a first-line treatment for EGFR mutation-positive NSCLC in Asian patients. Afatinib has shown favorable outcomes compared to first-generation TKIs and has been effective even in patients with poor prognostic factors.

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

11.

Osimertinib for the treatment of patients with <i>EGFR</i> mutation-positive non-small cell lung cancer.

Author: AlsharediM, BukamurH, ElhamdaniA

NSCLC treatment

EGFR mutations are common in non-small cell lung cancer (NSCLC), particularly in Asian patients. EGFR tyrosine kinase inhibitors (TKIs) are effective, but resistance often develops. Osimertinib is a third-generation TKI that can overcome resistance, particularly in patients with the T790M mutation.

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.

Epidermal Growth Factor Receptor Mutations.

Author: McLoughlinErin M, GentzlerRyan D

EGFR-TKI treatment
Improved outcomes
Less side effects
EGFR-TKI resistance

EGFR-mutant lung cancer has shown significant improvements with the development of EGFR-TKIs. Newer generations of these inhibitors offer better outcomes with fewer side effects. However, resistance to EGFR-TKIs remains a major challenge, and efforts are being made to use targeted therapies in earlier stages of the 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

15.

Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study.

Author: GossGlenwood, TsaiChun-Ming, ShepherdFrances A, BazhenovaLyudmila, LeeJong Seok, ChangGee-Chen, CrinoLucio, SatouchiMiyako, ChuQuincy, HidaToyoaki, HanJi-Youn, JuanOscar, DunphyFrank, NishioMakoto, KangJin-Hyoung, MajemMargarita, MannHelen, CantariniMireille, GhiorghiuSerban, MitsudomiTetsuya

NSCLC treatment

Osimertinib is an effective and safe treatment for non-small cell lung cancer patients with a specific EGFR mutation who have progressed after other EGFR inhibitors.

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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

17.

Osimertinib and dihydroartemisinin: a novel drug combination targeting head and neck squamous cell carcinoma.

Author: ChaibImane, CaiXueting, LligeDavid, SantarpiaMariacarmela, Jantus-LewintreEloisa, FilipskaMartyna, PedrazCarlos, CuiJean, YangJie, MiaoJing, SunRongwei, BrachtJillian Wilhelmina Paulina, ItoMasaoki, Codony-ServatJordi, KarachaliouNiki, AguilarAndrés, RosellRafael, CaoPeng

HNSCC treatment

This study explored the use of osimertinib and dihydroartemisinin in treating head and neck squamous cell carcinoma, both in vitro and in vivo. The research aims to improve treatment outcomes for this cancer type.

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

Language : English

19.

New Adjuvant Drug for Lung Cancer.

Author: AschenbrennerDiane S

Osimertinib treatment
Drug side effects

This study describes osimertinib, a new treatment for certain types of lung cancer, and its common side effects, including leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, and others.

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

Language : English

20.

Combining Three Tyrosine Kinase Inhibitors: Drug Monitoring Is the Key.

Author: ThomasQuentin Dominique, FirminNelly, MbatchiLitaty, EvrardAlexandre, QuantinXavier, LeenhardtFanny

TKI combination
Therapeutic drug monitoring
Drug-drug interaction
TKI toxicity

This case study demonstrates the successful use of three different tyrosine kinase inhibitors (TKIs) to treat a patient with two cancers simultaneously. The patient's progression-free survival was 7 months for both tumors. Therapeutic drug monitoring helped manage drug interactions and side effects, highlighting the importance of this approach when using multiple TKIs.

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.

Language : English

22.

Life-threatening pneumonitis after first-line treatment with osimertinib for primary T790M mutated non-small cell lung cancer.

Author: HäntschelMaik, NieblingJohannes, HäringAlmut, HäringMax-Felix, GroßThorben, HorgerMarius, RiessenReimer, HaapMichael, LewisRichard A, BöckelerMichael, HetzelJürgen

EGFR-TKI treatment
Life-threatening side effects

This study reports a case of life-threatening interstitial lung disease (ILD) during first-line treatment with osimertinib in a patient with EGFR-mutated NSCLC. It emphasizes the importance of recognizing and managing this potential side effect, especially with the increasing use of osimertinib.

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.

Language : English

23.

[Osimertinib (Tagrisso<sup>&#174;</sup>): Activity, indication and modality of use in non-small cell lung cancer].

Author: Giroux LeprieurEtienne, CortotAlexis B, CadranelJacques, WislezMarie

NSCLC treatment

Osimertinib is effective for treating lung cancer patients with a specific EGFR mutation (T790M) who have progressed after other treatments. It has a response rate of up to 61% and acceptable side effects.

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

Language : French

24.

Alterations in the Global Proteome and Phosphoproteome in Third Generation EGFR TKI Resistance Reveal Drug Targets to Circumvent Resistance.

Author: ZhangXu, MaityTapan K, RossKaren E, QiYue, CultraroConstance M, BahtaMeriam, PittsStephanie, KeswaniMeghana, GaoShaojian, NguyenKhoa Dang P, CowartJulie, KirkaliFatos, WuCathy, GuhaUdayan

EGFR TKI resistance

This study investigated the proteomic and phosphoproteomic changes in lung cancer cells resistant to third-generation EGFR TKIs, like osimertinib. It found that inhibiting SHP2 phosphatase could lead to resistance and identified dactolisib, a PI3K/mTOR inhibitor, as a potential combination therapy to overcome this resistance.

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

Language : English

25.

Pulmonary delivery of osimertinib liposomes for non-small cell lung cancer treatment: formulation development and in vitro evaluation.

Author: SawantShruti S, PatilSuyash M, ShuklaSnehal K, KulkarniNishant S, GuptaVivek, KundaNitesh K

inhalable OB liposomes
reduced toxicity
systemic side effects

Inhalable liposomes carrying osimertinib were developed to treat lung cancer locally, reducing systemic side effects. This study shows that these liposomes have the potential to deliver the drug effectively to the tumor site.

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

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