Side Effects of afatinib: A Synthesis of Findings from 27 Studies

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Original Abstract of the Article

Main Research Findings

Afatinib is a novel drug that inhibits the ErbB family. Afatinib was evaluated in a Phase I, open-label, dose-escalation study of continuous once-daily oral treatment with afatinib in patients with advanced solid tumors. 4 . This study evaluated the safety, tolerability and maximum tolerated dose (MTD) of afatinib, a novel ErbB Family Blocker. 4 .

Afatinib is an effective treatment for patients with advanced non-small cell lung cancer (NSCLC). 5 . However, afatinib can cause side effects such as hypotension. 5 . Afatinib also shows promise as a treatment for HER2-positive breast cancer. 1 . Afatinib was investigated in a case report and literature review to evaluate the safety and efficacy of combining afatinib with whole-brain radiation therapy in treating brain metastases from EGFR-mutated NSCLC. 2 . Afatinib is suggested to be a more effective EGFR-TKI that can more efficiently cross the blood-brain barrier (BBB) than other EGFR-TKIs. 2 .

Afatinib is expected to play a role in managing central nervous system (CNS) metastases in patients with EGFR mutation-positive NSCLC, because it has better BBB permeability compared to existing chemotherapeutic agents and first- (erlotinib and gefitinib) and second (afatinib)-generation EGFR tyrosine kinase inhibitors (TKIs). 8 . Afatinib was investigated as a pilot study for prophylactic dermatologic treatment of afatinib-induced skin toxicities in patients with metastatic lung cancer, as severe skin rash is listed among important side effects of EGFR tyrosine kinase inhibitors. 16 .

Afatinib was evaluated in real-world experience of afatinib as a first-line therapy for advanced EGFR mutation-positive lung adenocarcinoma. 7 .

Reasons for Side Effects

Afatinib inhibits EGFR, suppressing the growth of cancer cells. 1 . However, EGFR is present in normal cells, so afatinib can affect normal cells and cause side effects. 1 .

Common Side Effects

Skin

The most common side effects of afatinib occur in the skin. 1 . Skin side effects include rash, dryness, itching, pain, redness, blisters, and pustules. 1 . Afatinib can cause severe skin toxicity when used in combination with radiation therapy. 2 .

Gastrointestinal

Afatinib is also commonly associated with gastrointestinal side effects. 1 . Gastrointestinal side effects include diarrhea, nausea, vomiting, loss of appetite, and abdominal pain. 1 . Afatinib can cause severe diarrhea. 10 . Afatinib can cause severe diarrhea. 17 .

Heart

Cardiac side effects have been reported with afatinib. 12 . Cardiac side effects include QT interval prolongation, left ventricular dysfunction, and hypertension. 12 .

Eyes

Eye side effects have also been reported with afatinib. 25 . Eye side effects include conjunctivitis and uveitis. 25 .

Other

Other side effects have been reported with afatinib. 3 . Other side effects include anemia and pneumonia. 3 .

Side Effect Management

Skin

Polydatin may be effective in preventing afatinib-induced skin toxicity. 16 . Minocycline may be effective in preventing and repairing skin disorders associated with afatinib. 21 .

Gastrointestinal

Measures to manage afatinib-induced diarrhea include hydration, administration of antidiarrheal drugs, and reduction of afatinib dosage. 10 .

Heart

Measures to manage afatinib-induced QT interval prolongation include monitoring with electrocardiograms and reducing or discontinuing afatinib as needed. 12 .

Eyes

Measures to manage afatinib-induced eye side effects include examination by an ophthalmologist and reducing or discontinuing afatinib as needed. 25 .

Comparison Between Studies

Similarities

Several studies have shown that afatinib is an effective treatment for patients with advanced solid tumors. 4 . However, afatinib can cause various side effects, including skin, gastrointestinal, heart, and eye side effects. 4 .

Differences

The severity and frequency of afatinib side effects vary among studies. 4 . This may be due to differences in study design, patient characteristics, and afatinib dosage. 4 .

Points to Note Regarding Application to Real Life

Afatinib may be an effective treatment for patients with advanced solid tumors, but there are also side effect risks. 4 . It is important to consult with a doctor before taking afatinib and to understand the risks and benefits of side effects. 4 .

Limitations of Current Research

There is still insufficient data on the long-term side effects of afatinib. 4 .

Future Research Directions

Further research is needed on the long-term side effects of afatinib and measures to reduce side effects. 4 .

Conclusion

Afatinib may be an effective treatment for patients with advanced solid tumors, but there are also side effect risks. 4 . It is important to consult with a doctor before taking afatinib and to understand the risks and benefits of side effects. 4 .

Literature analysis of 27 papers
Positive Content
20
Neutral Content
1
Negative Content
6
Article Type
1
0
0
7
24
1.

Potential of afatinib in the treatment of patients with HER2-positive breast cancer.

Author: GeunaElena, MontemurroFilippo, AgliettaMassimo, ValabregaGiorgio

Targeted therapy for HER2-positive breast cancer
Toxicities
Tumor resistance

Afatinib, an oral EGFR inhibitor, shows promise in treating HER2-positive breast cancer. Clinical trials indicate encouraging efficacy with manageable side effects like skin issues and diarrhea. Afatinib can cross the blood-brain barrier, potentially benefiting patients with brain metastases. Further research is needed to optimize its use and identify resistance predictors.

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

2.

Safety and efficacy of combining afatinib and whole-brain radiation therapy in treating brain metastases from EGFR-mutated NSCLC: a case report and literature review.

Author: MaramponFrancesco, GelibterAlain J, CiccoPier Rodolfo, ParisiMartina, SerponeMaria, De FeliceFrancesca, BulzonettiNadia, MusioDaniela, CortesiEnrico, TomboliniVincenzo

Brain metastases treatment
Skin toxicity

This study reports a case of a patient with brain metastases from lung cancer who was successfully treated with afatinib and whole-brain radiation therapy. While the treatment resulted in a good outcome, it also caused severe skin toxicity, highlighting a potential side effect of this combination therapy.

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

3.

Stimulation of Eryptosis by Afatinib.

Author: Al Mamun BhuyanAbdulla, LangFlorian

Cancer treatment
Anemia

This study investigated whether the cancer drug afatinib induces eryptosis (suicidal erythrocyte death) and the potential mechanisms involved, including calcium influx, oxidative stress, and ceramide.

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

Language : English

4.

A Phase I, open-label, dose-escalation study of continuous once-daily oral treatment with afatinib in patients with advanced solid tumors.

Author: GordonMichael S, MendelsonDavid S, GrossMitchell, Uttenreuther-FischerMartina, Ould-KaciMahmoud, ZhaoYihua, StopferPeter, AgusDavid B

Stable disease
Diarrhea
Mucosal inflammation

Afatinib, a novel ErbB Family Blocker, was well-tolerated and safe when administered orally, once-daily at a dose of 40 mg.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Hypotension from afatinib in epidermal growth factor receptor-mutated non-small cell lung cancer: a case report and literature review.

Author: TangZhiwei, JiXiuHai, ZhouGuanghui, ChenRuhua, FenYan, DingHui

Hypotension

This case report describes a patient with non-small cell lung cancer who developed hypotension after starting afatinib treatment. This emphasizes the importance of being aware of hypotension as a potential side effect of afatinib in this patient population.

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.

Effects of pharmacokinetics-related genetic polymorphisms on the side effect profile of afatinib in patients with non-small cell lung cancer.

Author: HayashiHideki, IiharaHirotoshi, HiroseChiemi, FukudaYoshihisa, KitahoraMika, KaitoDaizo, YanaseKomei, EndoJunki, OhnoYasushi, SuzukiAkio, SugiyamaTadashi

Lung cancer treatment
Diarrhea
Skin disorders

Afatinib, an EGFR-TKI, is effective in treating lung cancer but can cause severe diarrhea and skin disorders, impacting quality of life and leading to treatment interruption. This study aims to understand the association between individual variations, pharmacokinetics, and genetic polymorphisms to predict the occurrence of these side effects.

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.

Gefitinib and Afatinib Show Potential Efficacy for Fanconi Anemia-Related Head and Neck Cancer.

Author: MontanuyHelena, Martínez-BarriocanalÁgueda, Antonio CasadoJosé, RovirosaLlorenç, RamírezMaria José, NietoRocío, Carrascoso-RubioCarlos, RieraPau, GonzálezAlan, LermaEnrique, LasaAdriana, Carreras-PuigvertJordi, HelledayThomas, BuerenJuan A, ArangoDiego, MinguillónJordi, SurrallésJordi

HNSCC treatment

This study explored potential new therapies for head and neck squamous cell carcinoma in Fanconi anemia patients. Two currently approved drugs were identified as possible treatment options.

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

10.

Afatinib Therapy: Practical Management of Adverse Events With an Oral Agent for Non-Small Cell Lung Cancer Treatment.

Author: EdwardsRebecca L, AndanChristine, LallaRajesh V, LacoutureMario E, O'BrienDennis, SequistLecia V

Lung cancer treatment
Dermatologic
Gastrointestinal

Afatinib, an oral EGFR inhibitor, is approved for first-line treatment of certain lung cancers with specific EGFR mutations and for metastatic squamous non-small cell lung cancer after platinum-based chemotherapy. Common side effects include gastrointestinal and skin problems.

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.

Functionalized gold nanoparticles improve afatinib delivery into cancer cells.

Author: CoelhoSílvia Castro, AlmeidaGabriela M, PereiraMaria Carmo, Santos-SilvaFilipe, CoelhoManuel A N

Enhanced drug activity
PEGAuNPs-afatinib conjugate

This study suggests that conjugating pegylated gold nanoparticles (PEGAuNPs) with afatinib is a promising antitumor delivery system for cancer therapy, as it improves drug efficacy and may reduce the required drug dose, minimizing potential toxicity-related side effects.

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.

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

14.

Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.

Author: ParkKeunchil, TanEng-Huat, O'ByrneKen, ZhangLi, BoyerMichael, MokTony, HirshVera, YangJames Chih-Hsin, LeeKi Hyeong, LuShun, ShiYuankai, KimSang-We, LaskinJanessa, KimDong-Wan, ArvisCatherine Dubos, KölbeckKarl, LaurieScott A, TsaiChun-Ming, ShahidiMehdi, KimMiyoung, MasseyDan, ZazulinaVictoria, Paz-AresLuis

Improved progression-free survival
Improved time-to-treatment failure
Diarrhea
Liver enzyme elevation
Rash

This international, randomized, open-label phase 2B trial compared afatinib and gefitinib in treatment-naive patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC). Afatinib was found to significantly improve progression-free survival and time-to-treatment failure compared to gefitinib, with manageable side effects.

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.

Language : English

16.

Prophylactic Dermatologic Treatment of Afatinib-Induced Skin Toxicities in Patients with Metastatic Lung Cancer: A Pilot Study.

Author: FuggettaMaria Pia, MigliorinoMaria Rita, RicciardiSerena, OsmanGiorgia, IaconoDaniela, LeoneAlvaro, LombardiAlessandra, RavagnanGiampietro, GrecoStefania, RemottiDaniele, RomanoMaria Concetta Pucci

Reduced skin rash

Topical application of a moisturizer containing polydatin (PD) reduced the incidence of grade ≥2 skin toxicities in patients with mutated non-small cell lung cancer (NSCLC) treated with afatinib. None of the patients discontinued therapy for toxicity.

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

Language : English

17.

Sleeve lobectomy for lung adenocarcinoma treated with neoadjuvant afatinib.

Author: SakanoueIchiro, HamakawaHiroshi, KajiReiko, ImaiYukihiro, KatakamiNobuyuki, TakahashiYutaka

Lung cancer treatment
Reduced risk of pneumonectomy
Diarrhea

This case report described a lung cancer patient successfully treated with neoadjuvant afatinib followed by sleeve lobectomy, demonstrating that this approach can minimize the risk of pneumonectomy while managing side effects like diarrhea.

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

18.

Real-world treatment of over 1600 Japanese patients with EGFR mutation-positive non-small cell lung cancer with daily afatinib.

Author: TamuraKazuo, NukiwaToshihiro, GemmaAkihiko, YamamotoNobuyuki, MizushimaMasaya, OchaiKaori, IkedaRie, AzumaHisaya, NakanishiYoichi

Cancer response
Diarrhea
Interstitial lung disease
Nail effects
Rash
Stomatitis

Afatinib was associated with a predictable ADR profile in Japanese patients with EGFR mutation-positive NSCLC. The most common ADRs were diarrhea, rash/acne, stomatitis, and nail effects. The objective response rate was 40.1%.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

19.

Long-Term Effect of Erlotinib Therapy in the Third Line of Anticancer Treatment in a Patient with Non-Small-Cell Lung Cancer - a Case Report.

Author: ŠťastnáNela, JakubíkováLenka, BratKristián

Improved prognosis

This article discusses the treatment of malignant tumors of the trachea, lungs, and bronchus in the Czech Republic, focusing on the use of tyrosine kinase inhibitors (TKIs). TKIs are targeted therapies that can be effective in treating non-small-cell lung cancer with specific mutations. The article highlights the importance of early diagnosis and treatment with appropriate TKIs to improve prognosis for patients with these tumors.

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

20.

Afatinib-Induced Acute Fatal Pneumonitis in Metastatic Lung Adenocarcinoma.

Author: YooSang Hoon, RyuJin Ah, KimSeo Ree, OhSu Yun, JungGu Sung, LeeDong Jae, KwakBong Gyu, NamYu Hyun, KimKyung Hyun, YangYoung Jun

Pneumonitis

Afatinib can cause severe pneumonitis. Although less common, afatinib, an EGFR tyrosine kinase inhibitor, can cause severe and potentially fatal pneumonitis. This case report and literature review highlight the importance of monitoring patients for this side effect.

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

Language : English

22.

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting.

Author: KhrystolubovaNatasha, ShiehMonica, PatelAnjan J, BaileyRay

Diarrhea
Rash

This study describes the outcomes of a pharmacist-led patient education and proactive adverse event management program for patients receiving afatinib treatment for non-small cell lung cancer. 13% of patients discontinued treatment due to afatinib-related adverse events, most commonly diarrhea, rash/skin reactions, stomatitis/mucositis, and paronychia. The program was associated with increased dose reductions and longer treatment duration in patients who continued on afatinib.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Pragmatic Clinical TrialA trial conducted in a real-world clinical setting. It evaluates the effectiveness of interventions in everyday healthcare environments.

Language : English

23.

Recent Progress in Drug Delivery Systems for Tyrosine Kinase Inhibitors in the Treatment of Lung Cancer.

Author: Korucu AktasPelinsu, BaysalIpek, Yabanoglu-CiftciSamiye, LamprechtAlf, AricaBetul

Enhanced lung cancer treatment
Improved drug delivery

This review focuses on advancements in drug delivery systems for tyrosine kinase inhibitors (TKIs) used in lung cancer treatment. Nanoparticle-based delivery systems enhance bioavailability, stability, and retention, potentially improving treatment efficacy.

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

24.

A phase Ib, open-label study to assess the safety of continuous oral treatment with afatinib in combination with two chemotherapy regimens: cisplatin plus paclitaxel and cisplatin plus 5-fluorouracil, in patients with advanced solid tumors.

Author: VermorkenJ B, RotteyS, EhrnroothE, PellingK, LahogueA, WindS, MachielsJ-P

Solid Tumors

This phase Ib study investigated the combination of afatinib, an ErbB family blocker, with cisplatin and either paclitaxel or 5-fluorouracil in patients with advanced solid tumors.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

25.

Anterior Uveitis Caused by Ocular Side Effects of Afatinib: A Case Report.

Author: TodokoroDaisuke, ItakuraHirotaka, IbeTakashi, KishiShoji

Granulomatous anterior uveitis

Afatinib, a lung cancer drug, can cause eye inflammation, including iridocyclitis. This report highlights the first case of this side effect.

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

26.

Targeted therapies for the treatment of non-small-cell lung cancer: Monoclonal antibodies and biological inhibitors.

Author: SilvaAna P S, CoelhoPriscila V, AnazettiMaristella, SimioniPatricia U

NSCLC treatment

Monoclonal antibodies and biological inhibitors are promising treatment options for non-small-cell lung cancer. While some are already approved, others are still under investigation. These treatments offer potential benefits with manageable side effects compared to traditional methods, but further research is needed to assess long-term outcomes.

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

27.

A phase II trial to assess efficacy and safety of afatinib in extensively pretreated patients with HER2-negative metastatic breast cancer.

Author: SchulerMartin, AwadaAhmad, HarterPhilipp, CanonJean Luc, PossingerKurt, SchmidtMarcus, De GrèveJacques, NevenPatrick, DirixLuc, JonatWalter, BeckmannMatthias W, SchütteJochen, FaschingPeter A, GottschalkNina, Besse-HammerTatiana, FleischerFrank, WindSven, Uttenreuther-FischerMartina, PiccartMartine, HarbeckNadia

Breast cancer treatment
Gastrointestinal effects
Skin effects

Afatinib, a drug targeting the ErbB family of proteins, showed limited effectiveness in treating HER2-negative metastatic breast cancer. In a phase II study, no patients achieved a complete or partial response. Median progression-free survival was less than 8 weeks. The most common side effects were gastrointestinal and skin-related, but generally manageable with symptom relief and dose adjustments.

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

Language : English

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