Side Effects of encorafenib: A Synthesis of Findings from 14 Studies

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Original Abstract of the Article

Main Research Findings

Encorafenib, a targeted therapy for advanced melanoma with BRAF mutations, has been shown to be effective in treating this disease. However, research has identified several side effects associated with its use, both as monotherapy and in combination with other medications.

  • Studies suggest that the frequency of skin side effects differs between encorafenib monotherapy and combination therapy with binimetinib. 12
  • Combined therapy with encorafenib and binimetinib has been demonstrated to improve progression-free survival in melanoma patients. 14
  • Encorafenib and binimetinib, used together, have shown promising results in terms of safety and efficacy compared to other BRAF inhibitor/MEK inhibitor combinations. 3

Reasons for Side Effects

Encorafenib targets BRAF mutations, a gene crucial for cell growth and division. BRAF gene mutations can lead to abnormal cell growth, potentially causing cancers like melanoma. By inhibiting these mutations, encorafenib controls cancer cell growth. However, it can also impact normal cells, potentially leading to side effects.

Common Side Effects

Skin Side Effects

Skin side effects are among the most common side effects associated with encorafenib. These occur due to the drug's influence on the growth of skin cells. 12 4 10 7 5

  • Localized hyperkeratosis
  • Verrucous keratosis
  • Photosensitivity
  • Squamous cell carcinoma
  • Keratoacanthoma

Gastrointestinal Side Effects

Encorafenib can also affect the digestive system, leading to side effects. This is because encorafenib can influence the growth of cells in the gastrointestinal tract. 4 10

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Abdominal pain

Eye Side Effects

Eye side effects can also occur due to encorafenib's impact on the growth of cells in the eye. 4 10 7 5

  • Uveitis
  • Dry eye
  • Central serous chorioretinopathy

Heart Side Effects

Encorafenib's effects on heart cell growth can lead to heart-related side effects. 4 10

  • QTc prolongation

Liver Side Effects

Liver cell growth can also be affected by encorafenib, potentially resulting in liver-related side effects. 4 10

  • Increased liver function tests

Other Side Effects

Besides the side effects mentioned above, encorafenib can also cause various other side effects. 4 10

  • Fever
  • Fatigue
  • Loss of appetite
  • Weight loss
  • Muscle pain
  • Joint pain
  • Headache
  • Dizziness
  • Shortness of breath
  • Cough
  • Nosebleed
  • Gum bleeding
  • Anemia
  • Leukopenia
  • Thrombocytopenia

Side Effect Management

Skin Side Effects

To minimize skin side effects, using sunscreen and wearing protective clothing is advised. 12

Gastrointestinal Side Effects

Managing gastrointestinal side effects often involves dietary changes and medications. 4 10

Eye Side Effects

Regular eye examinations by an ophthalmologist are essential to manage eye side effects. 4 10 7 5

Heart Side Effects

Regular electrocardiograms play a crucial role in managing heart-related side effects. 4 10

Liver Side Effects

Regular liver function tests are essential for managing liver side effects. 4 10

Comparison Between Studies

Commonalities Between Studies

Encorafenib has been shown to be effective in treating advanced melanoma with BRAF mutations, both as a monotherapy and in combination with binimetinib. Skin, gastrointestinal, and eye side effects have been reported across all studies.

Differences Between Studies

The frequency of skin side effects was observed to differ between encorafenib monotherapy and the combination therapy with binimetinib. 12 Moreover, encorafenib and binimetinib used together have shown promising results in terms of safety and efficacy compared to other BRAF inhibitor/MEK inhibitor combinations. 3

Considerations for Real-World Application

Although encorafenib has proven to be effective in treating advanced melanoma with BRAF mutations, it's crucial to understand that side effects are a potential risk. Before starting encorafenib treatment, it's essential to have a thorough discussion with your doctor, ensuring you fully comprehend the risks and benefits involved. Regular follow-up appointments with your doctor are crucial while on encorafenib therapy.

Limitations of Current Research

Research on the side effects of encorafenib is still limited. More studies are necessary to gain a more comprehensive understanding of its effects.

Future Research Directions

Further research is essential to delve deeper into the side effects of encorafenib. In particular, long-term side effects associated with the combination therapy of encorafenib and binimetinib require thorough investigation.

Conclusion

Encorafenib is a valuable treatment option for advanced melanoma with BRAF mutations, but it's essential to be aware of the associated side effects. Consulting with your doctor to understand the risks and benefits before starting treatment is vital. Regular follow-up appointments are crucial while taking encorafenib.

Literature analysis of 14 papers
Positive Content
14
Neutral Content
0
Negative Content
0
Article Type
2
0
0
5
14
1.

A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section.

Author: MunishankarB, FettesP, MooreC, McLeodG A

Pain relief

A combination of diclofenac and paracetamol was found to be more effective in reducing morphine use after elective caesarean section than paracetamol alone.

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

2.

Effects of Pipemidic Acid, Phenazopyridine HCL and Sodium Diclofenac on Pain Perception Following Endoscopic Urological Surgery: Double-blinded Randomized-Controlled Trial.

Author: YuriPrahara, AliZulfikar, RasyidNur, BirowoPonco

Pain relief
Endoscopic urological surgery

Oral analgesics, including pipemidic acid, phenazopyridine, and sodium diclofenac, were effective in reducing pain after endoscopic urological surgery in 80 patients. Pipemidic acid demonstrated a superior analgesic effect compared to the other two drugs.

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

3.

COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.

Author: DummerReinhard, FlahertyKeith T, RobertCaroline, AranceAna, B de GrootJan Willem, GarbeClaus, GogasHelen J, GutzmerRalf, KrajsováIvana, LiszkayGabriella, LoquaiCarmen, MandalàMario, SchadendorfDirk, YamazakiNaoya, PietroAlessandra di, Cantey-KiserJean, EdwardsMichelle, AsciertoPaolo A

Improved survival
Reduced tumor growth

This summary presents the 5-year results of the COLUMBUS clinical study, evaluating the combination treatment of encorafenib plus binimetinib for advanced or metastatic BRAF V600-mutant melanoma. The study compared the combination therapy with encorafenib alone and vemurafenib alone.

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.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

5.

Visual symptoms in a patient treated with MEK inhibitors.

Author: TibaldiTommaso, RoccuzzoGabriele, FazioAlessandra, CattaniIlaria, NuzziRaffaele, QuaglinoPietro, ReibaldiMichele

SRF resolution
Blurry vision
Colored halos
Macular changes

A patient experiencing visual symptoms associated with subretinal fluid induced by Binimetinib, a component of Encorafenib/Binimetinib, demonstrated intermittent visual symptoms both with and without detectable subretinal fluid.

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

Language : English

6.

Options of Therapeutics and Novel Delivery Systems of Drugs for the Treatment of Melanoma.

Author: WangHongbin, TranTuan T, DuongKatherine T, NguyenTrieu, LeUyen M

Melanoma treatment
Side effects

Melanoma treatment using FDA-approved drugs has limitations due to side effects and patient non-compliance. Novel drug delivery systems, such as nanoparticles and liposomes, have been developed to improve drug delivery, targeting, and bioavailability, potentially reducing toxicity and enhancing treatment effectiveness.

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

8.

Encorafenib plus binimetinib in patients with <i>BRAF</i><sup>V600</sup>-mutant non-small&#160;cell lung cancer: phase II PHAROS study design.

Author: RielyGregory J, AhnMyung-Ju, FelipEnriqueta, RamalingamSuresh S, SmitEgbert F, TsaoAnne S, AlcasidAnn, UsariTiziana, WisselPaul S, WilnerKeith D, JohnsonBruce E

NSCLC treatment

PHAROS, a phase II trial evaluating encorafenib plus binimetinib for metastatic <i>BRAF</i><sup>V600</sup>-mutant NSCLC, aims to assess the antitumor activity and safety of this combination therapy.

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.

Language : English

9.

A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with <i>BRAF<sup>V600E/K</sup></i> -mutant Solid Tumors.

Author: SullivanRyan J, WeberJeffrey, PatelSapna, DummerReinhard, CarlinoMatteo S, TanDaniel S W, LebbéCeleste, SienaSalvatore, ElezElena, WollenbergLance, PickardMichael D, SandorVictor, AsciertoPaolo A

Encouraging activity
Tolerable combination

The combination of encorafenib (450 mg) plus binimetinib (45 mg) showed acceptable tolerability and encouraging activity in patients with BRAF V600E-mutant melanoma.

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

Language : English

10.

Tolerability of BRAF/MEK inhibitor combinations: adverse event evaluation and management.

Author: HeinzerlingLucie, EigentlerThomas K, FluckMichael, HasselJessica C, Heller-SchenckDaniela, LeipeJan, PauschingerMatthias, VogelArndt, ZimmerLisa, GutzmerRalf

BRAFi+MEKi therapy
Well-tolerated
Anaemia
Cardiac events
Cutaneous events
Facial paresis
Fever
Gastrointestinal events
Increased liver function tests
Musculoskeletal events
Neutropenia
Ocular events
Photosensitivity
QTc prolongation
Skin rash

Combining BRAF and MEK inhibitors has become a standard treatment for melanoma patients with BRAF mutations. This review examines the safety profiles of three BRAF/MEK inhibitor combinations, focusing on common side effects like skin rashes, gastrointestinal problems, and heart-related issues.

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.

Targeting the ERK Signaling Pathway in Melanoma.

Author: SavoiaPaola, FavaPaolo, CasoniFilippo, CremonaOttavio

Melanoma treatment
Drug resistance

Vemurafenib, dabrafenib, and encorafenib are BRAF inhibitors for treating melanoma. While effective, drug resistance often develops. Combination therapy with MEK inhibitors can circumvent resistance and reduce side effects. Ongoing research is focused on developing RAS and ERK inhibitors to further improve treatment 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.

Language : English

12.

A comparative study of the cutaneous side effects between BRAF monotherapy and BRAF/MEK inhibitor combination therapy in patients with advanced melanoma: a single-centre experience.

Author: RussoIrene, ZorzettoLudovica, FrigoAnna Chiara, Chiarion SileniVanna, AlaibacMauro

Improved survival
Cutaneous side effects
Drug resistance

BRAF inhibitors are effective in treating advanced melanoma, but they can cause significant skin side effects. This study found that the combination therapy with BRAF and MEK inhibitors is associated with a different pattern of skin side effects compared to BRAF inhibitor monotherapy.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

13.

Management of Treatment-Related Adverse Events with Agents Targeting the MAPK Pathway in Patients with Metastatic Melanoma.

Author: DaudAdil, TsaiKaty

Improved survival
Prolonged survival
Drug-related adverse events
Toxicity

This review discusses the toxicity profiles of BRAF and MEK inhibitors used to treat advanced-stage BRAF V600-mutant melanoma. It provides practical guidance for managing key drug-related 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

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