Safety > Side Effects. PDF: Managing common side effects from EGFR final October 2019 v2.pdf [pdf] 232KB. These telangiectasias vanish with time, but often leave some degree of hyperpigmentation.4,12. The present study describes, for the first time, HFS induced by high-dose icotinib in a 65- … As bleaching creams have not been shown to be effective, p… Other skin and hair side effects of EGFR inhibitors are mild to moderate alopecia, paronychias, conjunctivitis, hypertrichosis, skin fissures, and generalized pruritus. Histopathological analysis showed a neutrophilic suppurative infiltrate in the dermis, particularly involving the follicular infundibula. Scope A, Agero AL, Dusza SW, et al. Side effects of TKI EGFR are observed in the majority of patients (Table 6); however, unlike the toxicity of chemotherapy they are rarely life threatening. Rationale of a new concept. Although these eruptions are considered a class effect from EGFR inhibition, antibody-induced eruptions tend to be more severe than TK1 induced skin changes.4, The pathogenesis of acneiform eruptions caused by EGFR is not yet fully understood. Appearance of more severe rash has been correlated with better treatment outcomes. As the use of EGFR inhibitors increases, a growing number of cutaneous side-effects will be treated by dermatologists. Some patients may also experience dryness of vaginal and perineal regions. Treatment of acne vulgaris with tetracycline hydrochloride: a double-blind trial with 51 patients. The management of skin reactions in cancer patients receiving epidermal growth factor receptor targeted therapies. The development of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) has dramatically improved the prognosis of patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Patients in the cetuximab arm showed a 2-month improvement in overall survival. Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community online and in print. GIOTRIF ® (afatinib) has a well-characterised side effects profile 1-5. These findings are likely due to AZD9291 being relatively sparing and selective against wild-type EGFR while having better potent activity against mutant EGFR , including T790M mutations. Role of tyrosine kinase inhibitors in cancer therapy. Trichomegaly, with or without additional hypertrichosis, may develop after 2 to 5 months of continuous anti-EGFR treatment. All of the TKIs list keratitis (irritation to the cornea) as a side effect. Hu JC, Sadeghi P, Pinter-Brown LC, et al. Potthoff K, Hofheinz R, Hassel JC, et al. Xerosis (dryness of the skin) is a common side effect caused by EGFRI therapy, occurring in up to 35% of individuals . Many EGFR inhibitors are given orally and present new challenges for oncology nurses, pharmacists, and physicians. 30 patients, acneiform eruptions were reduced significantly by the topical use of a cream containing urea and 0.1% K1 vitamin (Reconval K1®).26, Oral tetracyclines have been used for the treatment of acne vulgaris for more than 50 years27 because of their anti- inflammatory and immunomodulatory properties.28-30 These broad-spectrum polyketide antibiotics reduce neutrophilic chemotaxis and inhibit the production of proinflammatory cytokines and matrix metalloproteinase 9.29 Some recent studies investigated the benefit of prophylactic tetracycline for EGFR- induced acneiform eruptions.31-32 Tetracycline-treated patients reported less itching, burning, stinging, and other subjective symptoms compared with placebo. Topical therapy with nadifloxacin cream and prednicarbate cream improves acneiform eruptions caused by the EGFR-inhibitor cetuximab – A report of 29 patients. J Clin Oncol 26(suppl):abstract 20750 (2008). Other less common GI side effects can be nausea and vomiting, anorexia, and stomatitis. If you wish to read unlimited content, please log in or register below. Perifollicular xanthomas associated with epidermal growth factor receptor inhibitor therapy. Saltz LB, Meropol NJ, Loehrer PJ, Sr., et al. - And More, Close more info about Managing EGFR inhibitor side effects in lung cancer patients, Prevention and management of hand-foot syndromes. Register for free and gain unlimited access to: - Clinical Updates The higher expression of EGFR in the outer root sheath of the hair follicles may be causative for this infrequent but characteristic side-effect.4,8,12 Hyperpigmentation may appear after several months of EGFR inhibitor therapy. Cancer 113(4):847-53 (2008 Aug 15). You may report side effects to FDA at 1-800-FDA-1088. PDF of CE 0810HOW TO TAKE THE POST-TEST: To obtain CE credit, please click here after reading the article to take the post-test on myCME.com. In addition to the pivotal role of EGFR in the development and progression of malignant tumors, EGFR is also important for proliferation and differentiation of the human epidermis and hair follicles. Xerosis typically presents as dry, scaly, itchy skin that can be found on any part of the human body. Registration is free. Use favorite eye drops as much as possible. Painful aphthae and larger erosions may appear on the oral mucosa, lips, and nose, as well as on the anal and genital mucosa. Cetuximab-induced acne. ... inhibitors, albeit at the cost of greater toxicity causing side effects including high-grade diarrhea, Cunningham D, Humblet Y, Siena S, et al. J Eur Acad Dermatol Venereol 24(8):958-60 (2010 Aug). Periungual abscesses and pyogenic granuloma may develop in some cases.4,8,15 A recent study showed that a wide variety of Gram-positive and Gram- negative bacteria, as well as Candida albicans, may be cultured from the nail lesions.15, Initial stages of paronychia should be treated with topical antiseptic measures and application of antiseptic or antibiotic ointments. Fingernail involvement may lead to significant functional impairment. Table 1 provides information on incidence and severity. Webster G, Del Rosso JQ. Skin toxicity is generally manageable with standard topical or systemic antibiotics and anti-inflammatory agents. Nadifloxacin downmodulates antigen- presenting functions of epidermal Langerhans cells and keratinocytes. URL: https: ... the most notable side effect being a maculopapular, acneiform rash in patients who respond (108). You’ve viewed {{metering-count}} of {{metering-total}} articles this month. receiving EGFR TKI therapy rarely demonstrate T790M resistance mutations, which is consistent with a pharmacological rather than biological mechanism [44,45]. The higher expression of EGFR in the outer root sheath of the hair follicles may be causative for this infrequent but characteristic side-effect.4,8,12, Hyperpigmentation may appear after several months of EGFR inhibitor therapy. Hautarzt 57(6):509-13 (2006 Jun). It is given once daily at a recommended dose of 150 mg. Based on the results of a large, randomized, phase III clinical trial showing improved response rates and overall survival in patients taking erlotinib versus placebo, erlotinib was FDA approved for second- or third-line treatment of locally advanced or metastatic NSCLC after failure of a prior chemotherapy regimen.2 The most common side effects experienced by patients in the study were rash and diarrhea. J Dermatol Sci 42(2):91-9 (2006 May). Our first choice for severe acneiform eruptions is early treatment with a combination of low dose oral retinoid, topical nadifloxacin, and topical prednicarbate.21-22 We limit the use of this highly effective “triple therapy” to the first 2-3 months of EGFR- inhibitor treatment.21 Some authors have raised the issue of increased xerosis or reduced anticancer properties of the EGFR- inhibitors, 5,10,11 whereas others see a potential synergistic effect of this combinatorial approach.11, Management of acneiform skin eruptions is influenced by the level of dermatological background of the treating physician.33 EGFR inhibitors very likely develop cutaneous side effects. Switching EGFR-TKIs because of adverse events provided a clinical benefit for patients with EGFR mutation-positive NSCLC. Cutaneous side-effects in cancer patients treated with the antiepidermal growth factor receptor antibody C225. 4,8, Painful fissures on the tips of fingers and toes, on the nailfolds, and especially over the interphalangeal joints may develop as a consequence of excessively dry skin. To determine whether the EGFR tyrosine kinase inhibitor, erlotinib may cause hypomagnesemia, inflammation and cardiac stress, erlotinib was administered to rats (10 mg/kg/day) for 9 weeks. This is a common side-effect of TKI medications. Ann Oncol 16(9):1425-33 (2005 Sep). Interdisciplinary management of EGFR- inhibitor-induced skin reactions: a German expert opinion. Patients frequently present with involvement of the great toenails. N Engl J Med 351(4):337-45 (2004 Jul 22). Our Tagrisso (osimertinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Eames T, Kroth J, Flaig MJ, et al. The small molecule kinase inhibitors often block multiple enzymes meaning means there is some cross over in the actions and side effects of these drugs. [Cutaneous side effects of EGF-receptor inhibition and their management]. Enjoying our content? Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Br J Dermatol 144(6):1169-76 (2001 Jun). It provides a clinical score with five grades of severity.4 The dermatological skin score (WoMoScore) is a sensitive dermatologic scoring system for the long-term assessment of acneiform skin rashes that has been used in our department since 2006.22 The final WoMoScore is calculated from body involvement, facial involvement, and clinical grading of erythema, papulation, postulation, scaling, and crusts, providing a clinical score ranging from 0 to 100.22 Mild skin changes score up to 20, moderate cases range between 20 and 40, whereas severe acneiform eruptions exceed a WoMoScore of 40.20, Treatment of mild acneiform eruptions mostly involves Clin Colorectal Cancer 5(Suppl 1):S19-27 (2005 Apr). Daily online exclusives cover late breaking oncology news, safe handling and administration of chemotherapy drugs, side effect management, and new developments in specific cancers. Hand-foot syndrome (HFS) induced by EGFR-TKI is rare. Cetuximab is a monoclonal antibody that attaches to the EGFR receptor on the cell surface (large molecule), thus preventing binding of the EGF ligand to the receptor. Severe cases of pulpitis sicca (dry skin on the tips of the fingers and toes) with painful rhagades have also been described.4,8, First-line treatment of xerosis is the liberal use of emollients, which should be started within the first days of initiating EGFR inhibitor treatment. Here, we demonstrate the first report of dual EGFR and ABL TKI treatment in a patient with concomitant EGFR-mutated lung adenocarcinoma and BCR-ABL1-positive chronic myeloid leukemia (CML). - Evidence-Based Guidance Ocvirk J, Rebersek M. Managing cutaneous side effects with K1 vitamin creme reduces cutaneous toxicities induced by cetuximab. Key Words: Klein E, Tietze J, Wollenberg A. Unerwünschte kutane arzneimittelwirkungen von EGF-rezeptor-antagonisten und deren behandlung. In studies of gefitinib, ILD occurred in 0.3% to 1% of the US population and in about 2% of Japanese patients.5 ILD rates in the BR.21 erlotinib trial were less than 1%.2, From the August 01, 2010 Issue of Oncology Nurse Advisor, Already have an account? Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); ... or interrupted and reduced in patients experiencing side effects. Rash is one of the most common toxicities in patients treated with EGFR inhibitors. Other skin and hair side effects of EGFR inhibitors are mild to moderate alopecia, paronychias, conjunctivitis, hypertrichosis, skin fissures, and generalized pruritus. Eames T, Grabein B, Kroth J, et al. The EGFR is physiologically expressed in epithelial tissues and hair follicles, where it contributes to epidermal proliferation, differentiation, and hair growth. The most common localisation of the skin side ef-fects of the TKI EGFR therapy is the head and trunk area. EGFR inhibitors can often shrink tumors for several months or more. Rash, diarrhoea and mucositis are very common toxicities with EGFR TKIs. [Cutaneous side effects of EGFR inhibitors– appearance and management]. This side effect can be very bothersome, given the resultant itching, fissuring with associated pain, or even bacterial or rarely herpes simplex virus super infection . The incidence may be as high as 75% to 100% of cases.2,4,8,14,16-19 Evidence suggests that severity of the skin rash might be a surrogate marker determining clinical outcome of patients receiving EGFR inhibitor treatment.1,19-21 The eruption usually occurs after 1 week of treatment. Drug Saf 14(6):375-85 (1996 Jun). Wollenberg A, Moosmann N, Klein E, et al. 18. Modest increases in plasma substance P (SP) occurred at 3 (+27%) and 9 (+25%) weeks. The most commonly seen toxicity from EGFR inhibitors is a papulopustular rash that erupts most often on the face but can also be seen on the chest, back, trunk, and limbs (Figure 1). Epidermal growth factor receptor as a target for chemotherapy. Fissures are less common late phase reactions from therapy with EGFR inhibitors. Calculated antibiotic treatment of paronychia is recommended with oral cephalosporines, but oral fluoroquinolones may also be used, especially if Gram-negative infection is suspected. These drugs target receptors either on the outside of cancer cells or at an intracellular domain to inhibit cell survival, metastases, angiogenesis, and inhibition of apoptosis. Consequently, the prophylactic use of sunscreens is highly recommended to prevent these solar-induced reactions. However, the median progression-free survival (PFS) of NSCLC patients treated with EGFR-TKI is only 10–12 months, so the problem of drug resistance in treatment needs to be urgently solved. It is available as an intravenous drug. CTRL + SPACE for auto-complete. For this reason, consequent treatment and psycho-dermatological support are very important. Dtsch Med Wochenschr 135(4):149-54 (2010 Jan). J Clin Oncol 23(9):1803-10 (2005 Mar 20). All rights reserved. [Therapy of severe cetuximab-induced acneiform eruptions with oral retinoid, topical antibiotic and topical corticosteroid]. Erlotinib is a small molecule. Different strategies for EGFR inhibition have been described,3 two of which entered routine clinical use: EGFR-targeting monoclonal antibodies (MoAbs) bind specifically to the extracellular domain of the receptor and competitively inhibit ligand binding,1 and tyrosine kinase inhibitors suppress EGFR signaling at the intracellular domain of the receptor.1 Experimental data exist for EGFR ligand toxin and EGFR immunotoxin conjugates. The rash commonly manifests in the first 1 to 2 weeks of treatment. Anti-inflammatory activity of tetracyclines. This disease manifests as acute-onset dyspnea, usually occurring over a 24- to 48-hour period. Xerosis may progress to chronic asteatotic eczema and become infected with Staphylococcus aureus or herpes simplex virus. This trial demonstrated an efficacy benefit with a more amenable side effect profile (AURA; NCT01802632). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities Supportive Care in Cancer, Volume 19, Number 8, 1079-1095, DOI: 10.1007/s00520-011-1197-6. The FDA approved it based on phase II data showing promising response rates; however, in 2005, the labeling was revised as a result of failure of the phase III trial data to show a benefit over placebo.4 Gefitinib is an oral tablet dosed at 250 mg daily and is a small molecule TKI. Don’t miss out on today’s top content on Oncology Nurse Advisor. Call your doctor for medical advice about side effects. Laura Maximiliane Ehmann, MD, Thomas Ruzicka, MD and Andreas Wollenberg, MD Erlotinib (Tarceva) is an EGFR-tyrosine kinase inhibitor (TKI), meaning that it inhibits EGFR by gaining entrance into the cell and blocking the downstream signaling at the tyrosine kinase domain. Sign in Clinical studies have shown that metformin and EGFR-TKI have synergistic effects in … These novel drugs are composed of an EGFR ligand or EGFR-binding antibody and a cytotoxic agent. The skin toxicity appears as early as two weeks into treatment with TKI EGFR … Br Med J 2(5649):76-9 (1969 Apr 12). Xerosis and fissures are complications appearing in later treatment phases. Eur J Dermatol 20(1):82-4 (2010 Jan-Feb). Cetuximab (Erbitux) is another EGFR inhibitor. Certain antibiotics and antifungal medication and grapefruit products may increase the levels of TKIs in the blood to high, unsafe levels.TKIs can have serious or even deadly interactions with other prescription … Osimertinib (Tagrisso) TKI EGFR inhibitor ... (CML) and the cardiovascular side effects have been extensively reviewed by Moslehi et al. Bierhoff E, Seifert HW, Dirschka T. [Cutaneous lesions due to inhibition of epidermal growth factor receptor]. 2 and 6 weeks of therapy.22 Both drugs were selected because nadifloxacin has antimicrobial as well as immunomodulatory effects on the antigen-presenting function of Langerhans cells and keratinocytes,23 and prednicarbate is a well established anti-inflammatory topical corticosteroid with an improved risk- benefit ratio.24, Preclinical data suggest that topical application of the potent phosphatase inhibitor menadione (vitamin K3) might rescue the inhibition of EGFR and downstream signaling molecules in the skin of mice receiving systemic EGFR inhibitors erlotinib (Tarceva®) or cetuximab.25 In a non-randomized study with Chung KY, Shia J, Kemeny NE, et al. side-effects from EGFR Tyrosine Kinase Inhibitors in Lung Cancer Derriford Hospital Derriford Road Plymouth PL6 8DH Tel: 01752 202082 www.plymouthhospitals.nhs.uk . Cutaneous side effects of epidermal growth factor receptor inhibitors: clinical presentation, pathogenesis, and management. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. Epidermal growth factor receptor (EGFR) inhibitors are an increasingly important treatment option for metastasized cancer in patients. However, prophylactic tetracyclines did not lower the total incidence of the rash.31-32, Tetracyclines are clearly effective, but they may lead to unwanted systemic effects that are not encountered with topical treatment. However, this exanthema and other cuta-neous side effects can impair the quality of life of the patient and might limit the therapy with the EGFR inhibitor. Vallbohmer D, Lenz HJ. J Dtsch Dermatol Ges 3(8):599-606 (2005 Aug). Almost all side-effects are temporary and will resolve several weeks after discontinuation of EGFR inhibitor therapy. Gefitinib (Iressa) was the first EGFR inhibitor to become available in the United States. Katzer K, Tietze J, Klein E, et al. Erlotinib is orally available, which can aid or cause challenges in adherence. Understand EGFR TKI Side Effects: To compare Tarceva with chemotherapy for the initial treatment of advanced NSCLC that tests positive for an EGFR mutation, researchers conducted a study among 165 patients with Stage IIIB or Stage IV NSCLC. Segaert S, Tabernero J, Chosidow O, et al. View chapter Purchase book. The most frequent side-effects of icotinib include rash and diarrhea. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Allergo J 15:559-65 (2006). Silver nitrate solution, creams containing urea under plastic occlusion, and topical antibiotics can be used. Patients treated with EGFR inhibitors very likely develop cutaneous side effects. Treatment of epidermal growth factor receptor antagonist-induced skin rash: results of a survey among German oncologists. tyrosine kinase inhibitors (TKI) (eg, erlotinib, gefitinib): these bind to the tyrosine kinase domain in the epidermal growth factor receptor and stop the activity of the EGFR monoclonal antibodies (eg, cetuximab, necitumumab): these bind to the extracellular component of the EGFR and prevent epidermal growth factor from binding to its own receptor, therefore preventing cell division. Exp Dermatol 17(9):790-2 (2008 Sep). Nonspecific … Jatoi A, Rowland K, Sloan JA, et al. J Clin Oncol 22(7):1201-8 (2004 Apr 1). This is not a complete list of side effects and others may occur. Burris HA, 3rd, Taylor CW, Jones SF, et al. here. It tends to be associated with dry skin and at times can be diffuse and very disruptive to activities of daily living. The major side effects of cetuximab, as for other EGFR inhibitors, were rash and diarrhea, with grade 3/4 rash affecting 10% of patients and grade 3/4 diarrhea affecting 5% of patients.3 Cetuximab is currently awaiting FDA approval for stage IIIB/IV NSCLC. CT of the chest is often diagnostic and shows an inflammatory process within the lungs. Osimertinib (Tagrisso) is an EGFR inhibitor that works against cells with the T790M mutation. Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB). Febrile neutropenia was more significant in the cetuximab-containing arm of the FLEX trial (cetuximab, 22%; chemotherapy only, 15%; P =.0086), although the grade 3/4 neutropenia rates were exactly the same.3, In the EGFR-TKIs, rare but statistically significant occurrences of interstitial lung disease (ILD) have been reported. At the start of your treatment your doctor will ask about your normal Hautarzt 58(7):615-8 (2007 Jul). Icotinib is a new oral epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI). Dermatol Clin 25(2):133-5 (2007 Apr). - Full-Length Features The purpose of this study is to investigate the clinical outcome with or without EGFR-TKI resistance before WBRT and the sequence between EGFT-TKIs and whole brain radiotherapy (WBRT) of EGFR … They occur in about 25% of patients and are characterized by pain, severe tenderness, and poor healing tendency.4,8 Fissures are challenging to treat. Certain drugs, herbal supplements and even foods can affect the way TKIs work in the body. - Drug Monographs Lung cancer is the leading cause of cancer deaths in the United States, resulting in more deaths per year than breast, colon, prostate, and pancreatic cancers combined.1 In the past 5 to 10 years, significant advances in treatment have emerged, which have improved overall survival as well as response rates for metastatic non-small cell lung cancer (NSCLC). Patients must be warned to stay out of the sun, because photosensitivit y is increased during therapy with EGFR inhibitors and quite severe acneiform reactions can be triggered by UV exposure. Finally, antisense oligonucleotides specific for the EGFR or EGFR ligand messenger ribonucleic acids (RNAs) may decrease EGFR expression, thus resulting in inhibition of proliferation and induction of apoptosis. 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Busam KJ, Capodieci P, Motzer R, et al. It gained Medicare approval for use as a result of a large, randomized, phase III clinical trial commonly known as the FLEX trial.3 This predominantly European trial randomized chemotherapy-naive patients with stage IIIB/IV lung cancer to receive first-line cisplatin and vinorelbine (CV) or CV plus cetuximab. Gutzmer R, Werfel T, Kapp A, et al. It can be seen at any time during treatment with EGFR inhibitors. The follicles are frequently enlarged and sometimes obstructed by excess keratinocytes. Paronychia and alterations in hair growth are less common and generally seen after a longer period of treatment. Clin Cancer Res 15(21):6702-8 (2009 Nov 1). J Clin Oncol 25(34):5390-6 (2007 Dec 1). Ann Oncol [Epub ahead of print] (2010 Aug 13). The development of a papulopustular, follicular exanthema during the first weeks of therapy correlates with therapeutic benefit. It is not yet FDA approved for NSCLC, but it does have a Medicare compendia approval and clinical trial data to support its use in metastatic NSCLC. TCM combining EGFR-TKI administration illustrated no additional side effects for NSCLC patients According to the statistical analysis data of adverse effects in the Experimental group and Control group, there were no significant differences in rashes, diarrhea, ALT/AST increase, dental ulcer, or onychia lateralis between the 2 groups ( Table 2 , all p >0.05). The development of a papulopustular, follicular exanthema during the first weeks of therapy correlates with therapeutic benefit. Nicotinamide: An Update and Review of Safety & Differences from Niacin, Update on Drugs & Devices: November – December 2020, The Therapeutic Potential of Cannabinoids in Dermatology, Vitamin B Derivative (Nicotinamide) Appears to Reduce Skin Cancer Risk, Imiquimod 5% Cream (Aldara®) in the Treatment of Basal Cell Carcinoma, Sirolimus: A Therapeutic Advance for Dermatologic Disease, Non-Invasive Gene Expression Testing to Rule Out Melanoma, Management of Non-melanoma Skin Cancers in Canada. The side effects are generally less than with chemotherapy. Results for the adverse event profile in the LUX-LUNG 3 study that resulted in the approval of afatinib in non-small-cell lung cancer (NSCLC) showed that 89% of patients treated with the agent developed rash, with 16% having rash that was grade 3 or higher (JCO 2013, 31:3327–… ABSTRACT We present an overview of the various cutaneous side-effects associated with EGFR inhibition and discuss their respective therapeutic options. The rates of grade 3/4 hematologic side effects were generally similar in patients receiving chemotherapy alone and those also receiving cetuximab,3 and hematologic side effects are generally not significant with EGFR inhibitors. Adverse effects reported previously with TKI use, include fatigue, ... "If we identify longer-term side effects with TKIs then we might want to think about ... mean eGFR … The rate of grade 3/4 infusion reactions with cetuximab was about 4% in the lung cancer trial.3 Some electrolyte imbalances, such as hypomagnesemia and hypokalemia, have been more common in patients taking cetuximab and are often exacerbated by diarrhea. J Pharmacol Exp Ther 315(3):971-9 (2005 Dec). Hassel JC, Kripp M, Al-Batran S, et al. What Are Side Effects of Gilotrif? EGFR inhibitor-induced urticarial and anaphylactoid reactions are frequently seen in the US, but these are rarely encountered in Europe.9-10 Here, we review the diagnostic procedures and current treatment options for the more common side-effects of EGFR inhibitors.4,8,11-16, Acneiform eruptions are the earliest and most characteristic side-effect of EGFR inhibition. One such mutation is known as T790M. enrolled EGFR mutation-positive NSCLC patients with acquired resistance to EGFR-TKI therapy. Thus, concurrent use of an EGFR TKI with chemotherapy in the first-line setting remains investigational. - Conference Coverage Under current labeling, it is available only to patients who were taking the drug before its use was restricted who have proven continued radiographic response to the drug. Contact your ophthalmologist if irritation lasts longer than a couple of days. We hope you’re enjoying the latest clinical news, full-length features, case studies, and more. Liquid cyanoacrylate glue may be tried for recurrent cases.4,8, Trichomegaly, with or without additional hypertrichosis, may develop after 2 to 5 months of continuous anti-EGFR treatment. While there is a general effect on symptom control and survival in some studies, limited subgroups of patients particularly benefit from this treatment. Download this brochure for patients suffering with EGFRI side effects. The oncological classification, National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0, allows for a quick severity estimation of skin toxicity reactions. Appropriate judgment regarding switching from one EGFR-TKI to another may improve the performance status and prognosis of patients with EGFR mutation-positive NSCLC. Topical glucocorticoids with improved risk-benefit ratio. 10. Pathologe 27(1):53-6 (2006 Feb). The characteristic distribution pattern is similar to that of acne vulgaris, but there are no comedones present. The EGF receptor family as targets for cancer therapy. Drugs of this type have a different structure and work at different places in the cell than large molecule drugs; they are typically able to diffuse into cells and can act on targets that are found inside the cell. Mendelsohn J, Baselga J. Evidence-based practice for the unique side effects associated with EGFR inhibitors is still evolving. Segaert S, Van Cutsem E. Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Arora A, Scholar EM. Molinari E, De Quatrebarbes J, Andre T, et al. Common side effects of Gilotrif include: diarrhea, rash, blisters or other skin lesions or reactions, inflammation of the mouth and lips, chapped lips, mouth sores, infection of the skin around fingernails or toenails, dry skin, acne, … 1 st line EGFR M+ ... EGFR M+ TKI Sequence Effectiveness: Final Analysis Dose Modification & Effectiveness Uncommon EGFR pooled analysis Resources ... India; Home > Safety > Side Effects. PDF: Managing common side effects from EGFR final October 2019 v2.pdf [pdf] 232KB. These telangiectasias vanish with time, but often leave some degree of hyperpigmentation.4,12. The present study describes, for the first time, HFS induced by high-dose icotinib in a 65- … As bleaching creams have not been shown to be effective, p… Other skin and hair side effects of EGFR inhibitors are mild to moderate alopecia, paronychias, conjunctivitis, hypertrichosis, skin fissures, and generalized pruritus. Histopathological analysis showed a neutrophilic suppurative infiltrate in the dermis, particularly involving the follicular infundibula. Scope A, Agero AL, Dusza SW, et al. Side effects of TKI EGFR are observed in the majority of patients (Table 6); however, unlike the toxicity of chemotherapy they are rarely life threatening. Rationale of a new concept. Although these eruptions are considered a class effect from EGFR inhibition, antibody-induced eruptions tend to be more severe than TK1 induced skin changes.4, The pathogenesis of acneiform eruptions caused by EGFR is not yet fully understood. Appearance of more severe rash has been correlated with better treatment outcomes. As the use of EGFR inhibitors increases, a growing number of cutaneous side-effects will be treated by dermatologists. Some patients may also experience dryness of vaginal and perineal regions. Treatment of acne vulgaris with tetracycline hydrochloride: a double-blind trial with 51 patients. The management of skin reactions in cancer patients receiving epidermal growth factor receptor targeted therapies. The development of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) has dramatically improved the prognosis of patients with EGFR-mutant non-small-cell lung cancer (NSCLC). Patients in the cetuximab arm showed a 2-month improvement in overall survival. Oncology Nurse Advisor offers clinical updates and evidence-based guidance to the oncology nurse community online and in print. GIOTRIF ® (afatinib) has a well-characterised side effects profile 1-5. These findings are likely due to AZD9291 being relatively sparing and selective against wild-type EGFR while having better potent activity against mutant EGFR , including T790M mutations. Role of tyrosine kinase inhibitors in cancer therapy. Trichomegaly, with or without additional hypertrichosis, may develop after 2 to 5 months of continuous anti-EGFR treatment. All of the TKIs list keratitis (irritation to the cornea) as a side effect. Hu JC, Sadeghi P, Pinter-Brown LC, et al. Potthoff K, Hofheinz R, Hassel JC, et al. Xerosis (dryness of the skin) is a common side effect caused by EGFRI therapy, occurring in up to 35% of individuals . Many EGFR inhibitors are given orally and present new challenges for oncology nurses, pharmacists, and physicians. 30 patients, acneiform eruptions were reduced significantly by the topical use of a cream containing urea and 0.1% K1 vitamin (Reconval K1®).26, Oral tetracyclines have been used for the treatment of acne vulgaris for more than 50 years27 because of their anti- inflammatory and immunomodulatory properties.28-30 These broad-spectrum polyketide antibiotics reduce neutrophilic chemotaxis and inhibit the production of proinflammatory cytokines and matrix metalloproteinase 9.29 Some recent studies investigated the benefit of prophylactic tetracycline for EGFR- induced acneiform eruptions.31-32 Tetracycline-treated patients reported less itching, burning, stinging, and other subjective symptoms compared with placebo. Topical therapy with nadifloxacin cream and prednicarbate cream improves acneiform eruptions caused by the EGFR-inhibitor cetuximab – A report of 29 patients. J Clin Oncol 26(suppl):abstract 20750 (2008). Other less common GI side effects can be nausea and vomiting, anorexia, and stomatitis. If you wish to read unlimited content, please log in or register below. Perifollicular xanthomas associated with epidermal growth factor receptor inhibitor therapy. Saltz LB, Meropol NJ, Loehrer PJ, Sr., et al. - And More, Close more info about Managing EGFR inhibitor side effects in lung cancer patients, Prevention and management of hand-foot syndromes. Register for free and gain unlimited access to: - Clinical Updates The higher expression of EGFR in the outer root sheath of the hair follicles may be causative for this infrequent but characteristic side-effect.4,8,12 Hyperpigmentation may appear after several months of EGFR inhibitor therapy. Cancer 113(4):847-53 (2008 Aug 15). You may report side effects to FDA at 1-800-FDA-1088. PDF of CE 0810HOW TO TAKE THE POST-TEST: To obtain CE credit, please click here after reading the article to take the post-test on myCME.com. In addition to the pivotal role of EGFR in the development and progression of malignant tumors, EGFR is also important for proliferation and differentiation of the human epidermis and hair follicles. Xerosis typically presents as dry, scaly, itchy skin that can be found on any part of the human body. Registration is free. Use favorite eye drops as much as possible. Painful aphthae and larger erosions may appear on the oral mucosa, lips, and nose, as well as on the anal and genital mucosa. Cetuximab-induced acne. ... inhibitors, albeit at the cost of greater toxicity causing side effects including high-grade diarrhea, Cunningham D, Humblet Y, Siena S, et al. J Eur Acad Dermatol Venereol 24(8):958-60 (2010 Aug). Periungual abscesses and pyogenic granuloma may develop in some cases.4,8,15 A recent study showed that a wide variety of Gram-positive and Gram- negative bacteria, as well as Candida albicans, may be cultured from the nail lesions.15, Initial stages of paronychia should be treated with topical antiseptic measures and application of antiseptic or antibiotic ointments. Fingernail involvement may lead to significant functional impairment. Table 1 provides information on incidence and severity. Webster G, Del Rosso JQ. Skin toxicity is generally manageable with standard topical or systemic antibiotics and anti-inflammatory agents. Nadifloxacin downmodulates antigen- presenting functions of epidermal Langerhans cells and keratinocytes. URL: https: ... the most notable side effect being a maculopapular, acneiform rash in patients who respond (108). You’ve viewed {{metering-count}} of {{metering-total}} articles this month. receiving EGFR TKI therapy rarely demonstrate T790M resistance mutations, which is consistent with a pharmacological rather than biological mechanism [44,45]. The higher expression of EGFR in the outer root sheath of the hair follicles may be causative for this infrequent but characteristic side-effect.4,8,12, Hyperpigmentation may appear after several months of EGFR inhibitor therapy. Hautarzt 57(6):509-13 (2006 Jun). It is given once daily at a recommended dose of 150 mg. Based on the results of a large, randomized, phase III clinical trial showing improved response rates and overall survival in patients taking erlotinib versus placebo, erlotinib was FDA approved for second- or third-line treatment of locally advanced or metastatic NSCLC after failure of a prior chemotherapy regimen.2 The most common side effects experienced by patients in the study were rash and diarrhea. J Dermatol Sci 42(2):91-9 (2006 May). Our first choice for severe acneiform eruptions is early treatment with a combination of low dose oral retinoid, topical nadifloxacin, and topical prednicarbate.21-22 We limit the use of this highly effective “triple therapy” to the first 2-3 months of EGFR- inhibitor treatment.21 Some authors have raised the issue of increased xerosis or reduced anticancer properties of the EGFR- inhibitors, 5,10,11 whereas others see a potential synergistic effect of this combinatorial approach.11, Management of acneiform skin eruptions is influenced by the level of dermatological background of the treating physician.33 EGFR inhibitors very likely develop cutaneous side effects. Switching EGFR-TKIs because of adverse events provided a clinical benefit for patients with EGFR mutation-positive NSCLC. Cutaneous side-effects in cancer patients treated with the antiepidermal growth factor receptor antibody C225. 4,8, Painful fissures on the tips of fingers and toes, on the nailfolds, and especially over the interphalangeal joints may develop as a consequence of excessively dry skin. To determine whether the EGFR tyrosine kinase inhibitor, erlotinib may cause hypomagnesemia, inflammation and cardiac stress, erlotinib was administered to rats (10 mg/kg/day) for 9 weeks. This is a common side-effect of TKI medications. Ann Oncol 16(9):1425-33 (2005 Sep). Interdisciplinary management of EGFR- inhibitor-induced skin reactions: a German expert opinion. Patients frequently present with involvement of the great toenails. N Engl J Med 351(4):337-45 (2004 Jul 22). Our Tagrisso (osimertinib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Eames T, Kroth J, Flaig MJ, et al. The small molecule kinase inhibitors often block multiple enzymes meaning means there is some cross over in the actions and side effects of these drugs. [Cutaneous side effects of EGF-receptor inhibition and their management]. Enjoying our content? Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Br J Dermatol 144(6):1169-76 (2001 Jun). It provides a clinical score with five grades of severity.4 The dermatological skin score (WoMoScore) is a sensitive dermatologic scoring system for the long-term assessment of acneiform skin rashes that has been used in our department since 2006.22 The final WoMoScore is calculated from body involvement, facial involvement, and clinical grading of erythema, papulation, postulation, scaling, and crusts, providing a clinical score ranging from 0 to 100.22 Mild skin changes score up to 20, moderate cases range between 20 and 40, whereas severe acneiform eruptions exceed a WoMoScore of 40.20, Treatment of mild acneiform eruptions mostly involves Clin Colorectal Cancer 5(Suppl 1):S19-27 (2005 Apr). Daily online exclusives cover late breaking oncology news, safe handling and administration of chemotherapy drugs, side effect management, and new developments in specific cancers. Hand-foot syndrome (HFS) induced by EGFR-TKI is rare. Cetuximab is a monoclonal antibody that attaches to the EGFR receptor on the cell surface (large molecule), thus preventing binding of the EGF ligand to the receptor. Severe cases of pulpitis sicca (dry skin on the tips of the fingers and toes) with painful rhagades have also been described.4,8, First-line treatment of xerosis is the liberal use of emollients, which should be started within the first days of initiating EGFR inhibitor treatment. Here, we demonstrate the first report of dual EGFR and ABL TKI treatment in a patient with concomitant EGFR-mutated lung adenocarcinoma and BCR-ABL1-positive chronic myeloid leukemia (CML). - Evidence-Based Guidance Ocvirk J, Rebersek M. Managing cutaneous side effects with K1 vitamin creme reduces cutaneous toxicities induced by cetuximab. Key Words: Klein E, Tietze J, Wollenberg A. Unerwünschte kutane arzneimittelwirkungen von EGF-rezeptor-antagonisten und deren behandlung. In studies of gefitinib, ILD occurred in 0.3% to 1% of the US population and in about 2% of Japanese patients.5 ILD rates in the BR.21 erlotinib trial were less than 1%.2, From the August 01, 2010 Issue of Oncology Nurse Advisor, Already have an account? Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); ... or interrupted and reduced in patients experiencing side effects. Rash is one of the most common toxicities in patients treated with EGFR inhibitors. Other skin and hair side effects of EGFR inhibitors are mild to moderate alopecia, paronychias, conjunctivitis, hypertrichosis, skin fissures, and generalized pruritus. Eames T, Grabein B, Kroth J, et al. The EGFR is physiologically expressed in epithelial tissues and hair follicles, where it contributes to epidermal proliferation, differentiation, and hair growth. The most common localisation of the skin side ef-fects of the TKI EGFR therapy is the head and trunk area. EGFR inhibitors can often shrink tumors for several months or more. Rash, diarrhoea and mucositis are very common toxicities with EGFR TKIs. [Cutaneous side effects of EGFR inhibitors– appearance and management]. This side effect can be very bothersome, given the resultant itching, fissuring with associated pain, or even bacterial or rarely herpes simplex virus super infection . The incidence may be as high as 75% to 100% of cases.2,4,8,14,16-19 Evidence suggests that severity of the skin rash might be a surrogate marker determining clinical outcome of patients receiving EGFR inhibitor treatment.1,19-21 The eruption usually occurs after 1 week of treatment. Drug Saf 14(6):375-85 (1996 Jun). Wollenberg A, Moosmann N, Klein E, et al. 18. Modest increases in plasma substance P (SP) occurred at 3 (+27%) and 9 (+25%) weeks. The most commonly seen toxicity from EGFR inhibitors is a papulopustular rash that erupts most often on the face but can also be seen on the chest, back, trunk, and limbs (Figure 1). Epidermal growth factor receptor as a target for chemotherapy. Fissures are less common late phase reactions from therapy with EGFR inhibitors. Calculated antibiotic treatment of paronychia is recommended with oral cephalosporines, but oral fluoroquinolones may also be used, especially if Gram-negative infection is suspected. These drugs target receptors either on the outside of cancer cells or at an intracellular domain to inhibit cell survival, metastases, angiogenesis, and inhibition of apoptosis. Consequently, the prophylactic use of sunscreens is highly recommended to prevent these solar-induced reactions. However, the median progression-free survival (PFS) of NSCLC patients treated with EGFR-TKI is only 10–12 months, so the problem of drug resistance in treatment needs to be urgently solved. It is available as an intravenous drug. CTRL + SPACE for auto-complete. For this reason, consequent treatment and psycho-dermatological support are very important. Dtsch Med Wochenschr 135(4):149-54 (2010 Jan). J Clin Oncol 23(9):1803-10 (2005 Mar 20). All rights reserved. [Therapy of severe cetuximab-induced acneiform eruptions with oral retinoid, topical antibiotic and topical corticosteroid]. Erlotinib is a small molecule. Different strategies for EGFR inhibition have been described,3 two of which entered routine clinical use: EGFR-targeting monoclonal antibodies (MoAbs) bind specifically to the extracellular domain of the receptor and competitively inhibit ligand binding,1 and tyrosine kinase inhibitors suppress EGFR signaling at the intracellular domain of the receptor.1 Experimental data exist for EGFR ligand toxin and EGFR immunotoxin conjugates. The rash commonly manifests in the first 1 to 2 weeks of treatment. Anti-inflammatory activity of tetracyclines. This disease manifests as acute-onset dyspnea, usually occurring over a 24- to 48-hour period. Xerosis may progress to chronic asteatotic eczema and become infected with Staphylococcus aureus or herpes simplex virus. This trial demonstrated an efficacy benefit with a more amenable side effect profile (AURA; NCT01802632). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities Supportive Care in Cancer, Volume 19, Number 8, 1079-1095, DOI: 10.1007/s00520-011-1197-6. The FDA approved it based on phase II data showing promising response rates; however, in 2005, the labeling was revised as a result of failure of the phase III trial data to show a benefit over placebo.4 Gefitinib is an oral tablet dosed at 250 mg daily and is a small molecule TKI. Don’t miss out on today’s top content on Oncology Nurse Advisor. Call your doctor for medical advice about side effects. Laura Maximiliane Ehmann, MD, Thomas Ruzicka, MD and Andreas Wollenberg, MD Erlotinib (Tarceva) is an EGFR-tyrosine kinase inhibitor (TKI), meaning that it inhibits EGFR by gaining entrance into the cell and blocking the downstream signaling at the tyrosine kinase domain. Sign in Clinical studies have shown that metformin and EGFR-TKI have synergistic effects in … These novel drugs are composed of an EGFR ligand or EGFR-binding antibody and a cytotoxic agent. The skin toxicity appears as early as two weeks into treatment with TKI EGFR … Br Med J 2(5649):76-9 (1969 Apr 12). Xerosis and fissures are complications appearing in later treatment phases. Eur J Dermatol 20(1):82-4 (2010 Jan-Feb). Cetuximab (Erbitux) is another EGFR inhibitor. Certain antibiotics and antifungal medication and grapefruit products may increase the levels of TKIs in the blood to high, unsafe levels.TKIs can have serious or even deadly interactions with other prescription … Osimertinib (Tagrisso) TKI EGFR inhibitor ... (CML) and the cardiovascular side effects have been extensively reviewed by Moslehi et al. Bierhoff E, Seifert HW, Dirschka T. [Cutaneous lesions due to inhibition of epidermal growth factor receptor]. 2 and 6 weeks of therapy.22 Both drugs were selected because nadifloxacin has antimicrobial as well as immunomodulatory effects on the antigen-presenting function of Langerhans cells and keratinocytes,23 and prednicarbate is a well established anti-inflammatory topical corticosteroid with an improved risk- benefit ratio.24, Preclinical data suggest that topical application of the potent phosphatase inhibitor menadione (vitamin K3) might rescue the inhibition of EGFR and downstream signaling molecules in the skin of mice receiving systemic EGFR inhibitors erlotinib (Tarceva®) or cetuximab.25 In a non-randomized study with Chung KY, Shia J, Kemeny NE, et al. side-effects from EGFR Tyrosine Kinase Inhibitors in Lung Cancer Derriford Hospital Derriford Road Plymouth PL6 8DH Tel: 01752 202082 www.plymouthhospitals.nhs.uk . Cutaneous side effects of epidermal growth factor receptor inhibitors: clinical presentation, pathogenesis, and management. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. Epidermal growth factor receptor (EGFR) inhibitors are an increasingly important treatment option for metastasized cancer in patients. However, prophylactic tetracyclines did not lower the total incidence of the rash.31-32, Tetracyclines are clearly effective, but they may lead to unwanted systemic effects that are not encountered with topical treatment. However, this exanthema and other cuta-neous side effects can impair the quality of life of the patient and might limit the therapy with the EGFR inhibitor. Vallbohmer D, Lenz HJ. J Dtsch Dermatol Ges 3(8):599-606 (2005 Aug). Almost all side-effects are temporary and will resolve several weeks after discontinuation of EGFR inhibitor therapy. Gefitinib (Iressa) was the first EGFR inhibitor to become available in the United States. Katzer K, Tietze J, Klein E, et al. Erlotinib is orally available, which can aid or cause challenges in adherence. Understand EGFR TKI Side Effects: To compare Tarceva with chemotherapy for the initial treatment of advanced NSCLC that tests positive for an EGFR mutation, researchers conducted a study among 165 patients with Stage IIIB or Stage IV NSCLC. Segaert S, Tabernero J, Chosidow O, et al. View chapter Purchase book. The most frequent side-effects of icotinib include rash and diarrhea. This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization. Allergo J 15:559-65 (2006). Silver nitrate solution, creams containing urea under plastic occlusion, and topical antibiotics can be used. Patients treated with EGFR inhibitors very likely develop cutaneous side effects. Treatment of epidermal growth factor receptor antagonist-induced skin rash: results of a survey among German oncologists. tyrosine kinase inhibitors (TKI) (eg, erlotinib, gefitinib): these bind to the tyrosine kinase domain in the epidermal growth factor receptor and stop the activity of the EGFR monoclonal antibodies (eg, cetuximab, necitumumab): these bind to the extracellular component of the EGFR and prevent epidermal growth factor from binding to its own receptor, therefore preventing cell division. Exp Dermatol 17(9):790-2 (2008 Sep). Nonspecific … Jatoi A, Rowland K, Sloan JA, et al. J Clin Oncol 22(7):1201-8 (2004 Apr 1). This is not a complete list of side effects and others may occur. Burris HA, 3rd, Taylor CW, Jones SF, et al. here. It tends to be associated with dry skin and at times can be diffuse and very disruptive to activities of daily living. The major side effects of cetuximab, as for other EGFR inhibitors, were rash and diarrhea, with grade 3/4 rash affecting 10% of patients and grade 3/4 diarrhea affecting 5% of patients.3 Cetuximab is currently awaiting FDA approval for stage IIIB/IV NSCLC. CT of the chest is often diagnostic and shows an inflammatory process within the lungs. Osimertinib (Tagrisso) is an EGFR inhibitor that works against cells with the T790M mutation. Tetracycline to prevent epidermal growth factor receptor inhibitor-induced skin rashes: results of a placebo-controlled trial from the North Central Cancer Treatment Group (N03CB). Febrile neutropenia was more significant in the cetuximab-containing arm of the FLEX trial (cetuximab, 22%; chemotherapy only, 15%; P =.0086), although the grade 3/4 neutropenia rates were exactly the same.3, In the EGFR-TKIs, rare but statistically significant occurrences of interstitial lung disease (ILD) have been reported. At the start of your treatment your doctor will ask about your normal Hautarzt 58(7):615-8 (2007 Jul). Icotinib is a new oral epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI). Dermatol Clin 25(2):133-5 (2007 Apr). - Full-Length Features The purpose of this study is to investigate the clinical outcome with or without EGFR-TKI resistance before WBRT and the sequence between EGFT-TKIs and whole brain radiotherapy (WBRT) of EGFR … They occur in about 25% of patients and are characterized by pain, severe tenderness, and poor healing tendency.4,8 Fissures are challenging to treat. Certain drugs, herbal supplements and even foods can affect the way TKIs work in the body. - Drug Monographs Lung cancer is the leading cause of cancer deaths in the United States, resulting in more deaths per year than breast, colon, prostate, and pancreatic cancers combined.1 In the past 5 to 10 years, significant advances in treatment have emerged, which have improved overall survival as well as response rates for metastatic non-small cell lung cancer (NSCLC). Patients must be warned to stay out of the sun, because photosensitivit y is increased during therapy with EGFR inhibitors and quite severe acneiform reactions can be triggered by UV exposure. Finally, antisense oligonucleotides specific for the EGFR or EGFR ligand messenger ribonucleic acids (RNAs) may decrease EGFR expression, thus resulting in inhibition of proliferation and induction of apoptosis.

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