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

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Original Abstract of the Article

Major Findings

Dacomitinib is a second-generation irreversible HER tyrosine kinase inhibitor (TKI) that has shown anti-tumor activity in preclinical studies against lung cancer cell lines with sensitive and resistant EGFR mutations, including the T790 mutation. 10 Phase I studies demonstrated that dacomitinib was well-tolerated with stomatitis, diarrhea and skin toxicities being the dose-limiting toxicities. 10 The maximum tolerated dose was established to be 45 mg/day. 10 Phase II and III studies have shown clinical activity in both HER tyrosine kinase-naive and HER tyrosine kinase failure settings. 10 Furthermore, dacomitinib-based EGFR degraders have been discovered which effectively induce degradation of EGFRdel19 with a DC50 value of 3.57 nM in HCC-827 cells. 12 This novel compound, 13, is the first EGFR-PROTAC to demonstrate antitumor effect in vivo, exhibiting excellent antitumor efficacy (TGI = 90%) at a dose of 30 mg/kg without causing observable toxic effects. 12

Reasons for Side Effects

Dacomitinib, like other EGFR inhibitors, targets EGFR, a protein involved in cell growth and division. By inhibiting EGFR, dacomitinib blocks the growth of cancer cells. However, EGFR is also found in other parts of the body, such as skin, digestive system, and blood vessels, which can explain the side effects that some patients experience. 12

Common Side Effects

Skin

Dacomitinib can cause skin-related side effects like rash, dryness, itching, and eczema. 10 These side effects are common, occurring in about half of patients taking dacomitinib. 7 They are usually mild to moderate, but can be severe in some cases. 7

Digestive System

Dacomitinib can also cause side effects in the digestive system, including diarrhea, nausea, vomiting, and stomatitis (inflammation of the mouth). 10 These side effects are common, occurring in about half of patients taking dacomitinib. 7 They are usually mild to moderate, but can be severe in some cases. 7

Liver

Dacomitinib can cause liver side effects like abnormal liver function tests. 6 These side effects occur in about 10% of patients taking dacomitinib. 6

Other Side Effects

Dacomitinib can cause other side effects, which vary from person to person. 10

Side Effect Management

Skin

To manage skin side effects, doctors may recommend using moisturizers and applying steroid creams. 10

Digestive System

To manage digestive side effects, doctors may prescribe medications like antidiarrheals and antiemetics. 10 Dietary changes and staying hydrated can also be helpful. 7

Liver

If liver side effects occur, doctors may stop dacomitinib and monitor the patient's condition. 6

Other Side Effects

If any other side effects occur, consult with your doctor. 10

Comparison of Studies

Commonalities of Studies

The studies reviewed all explored the effectiveness and safety of dacomitinib in treating advanced or metastatic non-small-cell lung cancer. 10 Dacomitinib has shown promise in treating this type of cancer, but it's important to understand the potential side effects. 10 , 7

Differences of Studies

The specific side effects associated with dacomitinib varied slightly across the studies. 10 , 7 This could be due to differences in the characteristics of the patients enrolled in the studies or differences in the research design. 10 , 7

Considerations for Real-World Application

Dacomitinib has shown promise in clinical trials for treating non-small-cell lung cancer. However, it is important to be aware of its potential side effects and to discuss any concerns with your doctor. 10 , 7

Limitations of Current Research

The long-term side effects of dacomitinib are not yet fully understood. 10 Additionally, side effects can vary significantly from person to person. 10

Future Research Directions

Further research is needed to fully understand the long-term side effects of dacomitinib. 10 Developing new treatments to manage dacomitinib-related side effects is also essential. 10

Conclusion

Dacomitinib is a promising treatment option for non-small-cell lung cancer. 10 , 7 , 6 While it has shown effectiveness in clinical trials, it is essential to understand and manage the potential side effects. 10 , 7 , 6 Open communication with your doctor is crucial to ensure you receive the best possible care while using dacomitinib. 10

Literature analysis of 15 papers
Positive Content
14
Neutral Content
1
Negative Content
0
Article Type
3
0
0
2
14
1.

Low-dose short-term cyclosporine versus etretinate in psoriasis: improvement of skin, nail, and joint involvement.

Author: MahrleG, SchulzeH J, FärberL, WeidingerG, SteiglederG K

Nail and joint improvement
Psoriasis treatment
Cyclosporine side effects
Relapse risk

Low-dose short-term cyclosporine therapy was highly effective and well tolerated for psoriasis, compared to etretinate. Remission was better preserved by tapering the drug than by discontinuing treatment abruptly.

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.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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.
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

3.

Bevacizumab plus dacomitinib combination therapy for L858R-mutated metastatic lung adenocarcinoma: A report of two cases.

Author: TengChi-Kang, ChenChieh-Lung, ChenTing-Han, ChengWen-Chien, TuChih-Yen

EGFR-mutated NSCLC treatment

Combining dacomitinib (an EGFR TKI) with bevacizumab (antiangiogenic therapy) showed promising results in two patients with EGFR-mutated, metastatic non-small cell lung cancer. Both patients experienced significant tumor reduction with minimal side effects.

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

6.

Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer.

Author: NishioMakoto, KatoTerufumi, NihoSeiji, YamamotoNoboru, TakahashiToshiaki, NogamiNaoyuki, KanedaHiroyasu, FujitaYuka, WilnerKeith, YoshidaMizuki, IsozakiMitsuhiro, WadaShinsuke, TsujiFumito, NakagawaKazuhiko

Effective first-line treatment
Improved PFS
Dermatitis acneiform
Increased alanine aminotransferase

Dacomitinib was more effective than gefitinib in Japanese patients with EGFR-positive advanced NSCLC. PFS was longer with dacomitinib than gefitinib (HR 0.544, P=0.0327). The most common Grade 3 AEs were dermatitis acneiform with dacomitinib (27.5%) and increased alanine aminotransferase with gefitinib (12.2%). Dacomitinib was more likely to lead to dose reduction (85.0%) than gefitinib (24.4%). The incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were reduced after dacomitinib dose reductions.

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

8.

A Pre-Clinical Assessment of the Pan-ERBB Inhibitor Dacomitinib in Pediatric and Adult Brain Tumors.

Author: EndersbyRaelene, WhitehouseJacqueline, HiiHilary, GreenallSameer A, JohnsTerrance G, GottardoNicholas G

EGFR inhibition
Extended survival (glioblastoma)
Antagonistic effects (medulloblastoma)

Dacomitinib, an EGFR pathway blocker, showed efficacy in glioblastoma and medulloblastoma in vitro and in vivo, but showed antagonism when combined with standard chemotherapies for medulloblastoma.

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.

A phase II study (ARCHER 1042) to evaluate prophylactic treatment of dacomitinib-induced dermatologic and gastrointestinal adverse events in advanced non-small-cell lung cancer.

Author: LacoutureM E, KeefeD M, SonisS, JatoiA, GernhardtD, WangT, DohertyJ P, GiriN, NadanacivaS, O'ConnellJ, SbarE, PiperdiB, GaronE B

Treat lung cancer
Dermatologic adverse events
Diarrhea
Mucositis

This randomized phase II trial explored the impact of prophylactic treatment on select dermatologic adverse events of interest (SDAEI), diarrhea, and mucositis associated with dacomitinib, an oral irreversible pan-human epidermal growth factor receptor (HER) inhibitor.

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

12.

Discovery of novel potent covalent inhibitor-based EGFR degrader with excellent in vivo efficacy.

Author: ShiShi, DuYu, HuangLei, CuiJiaqi, NiuJing, XuYungen, ZhuQihua

Antitumor efficacy
EGFR degradation

This study reports the discovery of Dacomitinib-based EGFR degraders, specifically compound 13, which effectively induces degradation of EGFRdel19 in HCC-827 cells.

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.

Complete remission in leptomeningeal metastasis of NSCLC with rare EGFR-SEPT14 fusion treated with osimertinib combined with intrathecal chemotherapy with pemetrexed.

Author: ZhengShengnan, LiHuiying, FengJie, JiangCheng, LinYongjuan, XieYu, YuTingting, QianXiaoping, YinZhenyu

Long-term survival
NSCLC-LM treatment
None reported

This study reports a case of a patient with Leptomeningeal metastasis (LM) from non-small cell lung cancer (NSCLC) harboring EGFR-SEPT14 fusions. The patient showed a durable response to osimertinib combined with intrathecal pemetrexed chemotherapy. This case study provides a potential therapeutic option for NSCLC-LM patients with this particular mutation.

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

14.

A Phase I Clinical Trial and Independent Patient-Derived Xenograft Study of Combined Targeted Treatment with Dacomitinib and Figitumumab in Advanced Solid Tumors.

Author: CalvoEmiliano, SoriaJean-Charles, MaWen Wee, WangTao, BahledaRastilav, TolcherAnthony W, GernhardtDiana, O'ConnellJoseph, MillhamRobert, GiriNagdeep, WickMichael J, AdjeiAlex A, HidalgoManuel

Cancer treatment
Diarrhea
Mucosal inflammation

Dacomitinib-figitumumab combination therapy was tolerable in patients with advanced solid tumors, with dose reductions of both agents. Preliminary clinical activity was observed in adenoid cystic carcinoma, a potential target tumor.

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.

Language : English

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