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White Paper Managing Skin Toxicities Skin toxicities from chemotherapy and radiation in patients with cancer A survey by CancerCare, a leading source for treatment-related patient information,1 confirmed that although only two in five people with cancer were concerned about experiencing skin-related toxicities when they started treatment, almost 80% were troubled by the actual skin effects they experienced during and after treatment. The survey, conducted in early 2008, involved 345 patients who participated in a CancerCare Telephone Education Workshop. Survey respondents reported having either breast, ovarian, lung, colon/rectal, prostate, bladder, or kidney cancer and were undergoing or had completed various treatment regimens. Survey results showed that 63% of respondents agreed with the statement: “The effect or impact on my skin was worse than I thought.” Further, one in three respondents said the skinrelated side effects had negatively affected their lives. Oncology nurses must be prepared to help their patients manage skin toxicities, and an important starting point is knowing what types of treatment cause skin-adverse events. In recent years, perhaps the greatest attention has been focused on the skin effects of targeted therapies, including epidermal growth factor receptor (EGFR) inhibitors, vascular endothelial growth factor inhibitors (VEGFR), and mammalian target of rapamycin (mTOR) inhibitors. Agents in these categories can be either tyrosine kinase inhibitors or monoclonal antibodies. Rash in response to EGFR inhibitor. Photo provided by Pamela Hallquist Viale, RN, MS, ANP, AOCNP ®. Hand foot skin reaction, patient on capecitabine for 10 weeks. Lucid Smog, photo in public domain. 1 Managing Skin Toxicities with Lindi Skin Products • April 2014 Table 1. Selected Targeted Agents That May Cause Skin Effects Agent Axitinib2 Cabozantinib2 Cetuximab Skin Effect(s) Type Target TKI VEGFR 1,2,3; PDGFR, c-kit HFSR TKI VEGFR2, c-Met HFSR MoAB EGFR Rash TKI EGFR Rash Everolimus4 TKI mTORcomplex-1 Rash Lapatinib TKI EGFR Rash EGFR Rash 3 Erlotinib3 3 Panitumumab3 MoAB 2,5 Pazopanib TKI VEGFR, PDGFR, and c-kit tyrosine kinases HFSR Regorafinib2 TKI Stromal and oncogenic receptor tyrosine kinase (RTK) HFSR Sorafenib2 TKI ATP-competitive multitargeted kinase inhibitor (MKI); Raf kinase, VEGFR 2-3, PGDFR-β, c-kit, Fms-like tyrosine kinase 3 (Flt-3), and Ret HFSR VEGFR 1-3, PDGF α and β, stem cell factor receptor c-kit, Flt-3, colony-stimulating factor receptor type 1, and Ret HFSR Sunitinib2 TKI Chemotherapy of a variety of types may also cause skin-adverse events. For example, macular-papular rashes of varying severity have been observed in patients receiving high-dose chemotherapy as induction, consolidation, or conditioning therapy prior to stem cell or bone marrow transplant.8 In one study, the primary offender was cytarabine,8 but other agents such as docetaxel, doxorubicin, fluorouracil, cyclophosphamide, and vincristine can also cause hyperpigmentation, photosensitivity, onycholysis (shedding of nails), alopecia, hand foot skin reaction (HFSR), dry skin and itching, and radiation recall and enhancement.9 Table 2. Selected Chemotherapy Agents That May Cause Skin Effects9 Agent Type Skin Effect(s) Polypeptide antibiotic Rash Azathioprine Antimetabolite Eccrine squamous metaplasia Bleomycin Glycopeptide antibiotic neutrophilic eccrine hidradenitis, Hyperpigmentation, itching Capecitabine Antimetabolite Eccrine squamous metaplasia Chlorambucil Nitrogen mustard Eccrine squamous metaplasia Cyclophosphamide Nitrogen mustard HSFR, eccrine squamous metaplasia Cytarabine Nucleoside Metabolic Inhibitor HSFR, neutrophilic eccrine hidradenitis Actinomycin D Temsirolimus4 TKI mTORcomplex-1 Rash Dacarbazine Alkylating agent Photosensitivity Vandetinib TKI EGFR Rash Daunorubicin TKI V600E mutated BRAF HFSR Anthracycline Topoisomerase Inhibitor HSFR, hyperpigmentation Taxane HSFR, alopecia, recall reaction, nail changes Doxorubicin Anthracycline HSFR, alopecia, recall reaction, eccrine squamous metaplasia, nail changes Epirubicin Anthracycline Alopecia, eccrine squamous metaplasia, nail changes Etoposide Topoisomerase inhibitor HSFR, recall reaction Fluorouracil Antimetabolite HSFR, photosensitivity, eccrine squamous metaplasia Gemcitabine Nucleoside Metabolic Inhibitor Recall reaction Hydroxyurea Antineoplastic Nail changes 3 Vemurafinib 2 HFSR=Hand foot skin reaction causes redness, swelling, and pain on the hands and/or the soles of the feet, sometimes with blisters. It can occur on other areas of the skin, such as the knees and the elbows. It can cause discomfort, pain on grasping or using hands, and difficulty walking.2 TKI=tyrosine kinase inhibitor; MoAB=monoclonal antibody; VGFR=vascular endothelial growth factor receptor; PDGFR=plateletderived growth factor receptor; c-kit=gene for transmembrane kinase related to colony-stimulating factor type 1 and PDGFR; Raf=serine/ threonine-specific protein kinase related to retroviral oncogenes; Flt3=receptor tyrosine kinase with important roles in hematopoietic stem/ progenitor cell survival and proliferation; V600E mutated BRAF= determinant of sensitivity to proteasome inhibitors; mTOR= mammalian target of rapamycin; EGFR=epidermal growth factor receptor. The rash most commonly seen with EGFR inhibitors has been variously described as macular-papular or acneiform, and it usually affects the head and neck, face, upper chest, and upper back. It can vary widely in severity, but severity has been associated with drug efficacy for several agents.6 It can be potentially disfiguring and painful, and it may lead to dose reduction or interruption. No uniform method of assessing the EGFR-related rash has been created, nor has a uniform technique of assessing the psychological impact of the rash on patients. It is widely recognized that the rash can have a profound psychological effect; some patients may refuse to leave their homes or to participate in social activities because of it.7 Docetaxel 2 Managing Skin Toxicities with Lindi Skin Products • April 2014 Table 2. Selected Chemotherapy Agents That May Cause Skin Effects9 (cont.) Agent Type Skin Effect(s) Idarubicin Anthracycline Alopecia, eccrine squamous metaplasia, nail changes Melphalan Nitrogen mustard Eccrine squamous metaplasia Thiopurine HSFR Methotrexate Antimetabolite HSFR, photosensitivity, recall reaction, eccrine squamous metaplasia Mitoxantrone Anthracycline Alopecia Taxane Alopecia, nail changes Mercaptopurine Paclitaxel Vinblastine Vinca alkaloid HSFR Vincristine Vinca alkaloid HSFR Vinorelbine Vinca alkaloid Hyperpigmentation Neutrophilic eccrine hidradenitis=fever and skin eruptions. Recall reaction= recu r rence of sy mptoms af ter sunbu r n or radiation. Photosensitivity=increased reactivity to sun exposure. Alopecia=hair loss. Eccrine squamous metaplasia=noninflammatory metaplasia of the cuboidal epithelial cells of the eccrine sweat ducts. Hyperpigmentation=increase in and darkening of skin color.10 Finally, among the most frequently seen skin effects are the toxic results of radiation therapy. Schnur, Ouellette, DiLorenzo, et al. found that radiation dermatitis affects multiple dimensions of quality of life. It can cause physical discomfort, body image disturbance, emotional distress, and impair both day-to-day functioning and satisfaction with radiation treatment in women with breast cancer.11 In fact, up to 90% of patients with breast cancer or head and neck cancer who are treated with radiation may experience radiation dermatitis.12 How can oncology nurses help their patients manage these effects in order to maximize outcomes? Experts have developed recommendations for the management of skin reactions, especially those related to EGFR inhibitors. Dr. Mario Lacouture and others published clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic reactions in 2011.13 In addition, the Multinational Association for Supportive Care in Cancer (MASCC) issued a patient guide based on one developed at Memorial Sloan Kettering Cancer Center.14 These two statements have important commonalities. They identify the most frequent skin effects as rash, itching, dry skin, and nail and hair changes. For rash, they suggest antibiotics (topical and systemic) and hydrocortizone with moisturizers and sun screen and discourage acne medications. For dry skin, they recommend moisturizers and sun screen. For itching, they suggest gentle skin care, antihistamines, topical steroids, and creams with menthol. For hair loss, if scarring, they suggest the same treatment as for rash; if not scarring, minoxidyl may help. For paronychia, they call for diluted bleach or vinegar soaks, mild skin care, and corticosteroids – antibiotics may be needed in case of infection. The one thread that runs through all the recommendations is skin hygiene and care that includes mild cleansing agents, moisturizers, and sun screen. Similar suggestions are made for HSFR, including moisturizers and avoidance of harsh chemical products, by Cancer.Net.2 Lindi Skin products Fortunately for patients with cancer and their caregivers, a line of skin care products has been specially created for them. It was developed with the counsel of leading dermatologists and oncologists for those suffering the skin side effects of specific cancer therapies. This extensive collection of mild and luxurious serums, lotions, and balms is the only full line of skincare products developed to improve the lives of individuals undergoing chemotherapy and radiation therapy. They are formulated to be non-irritating and hypo-allergenic, and they have been laboratory tested. In addition, an advisory panel of leading medical and scientific experts that includes prominent oncologists helps to insure that Lindi Skin products are safe and effective. Oncology nurses asked Lindi Skin for evidence of the products’ effectiveness.15 The company initiated a clinical trial, conducted at Northwestern University, in which 99 patients with cancer who were receiving systemic anticancer therapies and/or radiation therapy were evaluated for skin reactions. The National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0) and the Skindex-16 self-reported quality of life instrument were used. Each participant received three test products and was instructed to use them once daily for four weeks. The products included a skin moisturizer, face moisturizer, and face wash. All were formulated based on surveys of patients with cancer for their skin product preferences. At four weeks, the remaining patients (n=77) were reassessed and tolerability questionnaires were administered for each product used. Dry skin, HFST, and rash decreased significantly from baseline to follow-up. Participants had a significantly lower mean overall Skindex-16 score compared to baseline (16.19 vs. 25.05; p=0.0003). Most patients rated their overall experience with the products as good or very good. Most found the products to be better tolerated than others previously tried and to be more soothing. Satisfaction with the products did not vary by skin type. These findings suggested that quality of life improved with product use, and three critical forms of skin toxicity were decreased with the use of the products within four weeks.16 “We started using your face serum [Lindi Skin] on our daughter ’s face (she’s a 2-yearBEFORE AFTER old with Acute Lymphoblastic Leukemia) at the end of January. We had tried numerous other things that hadn’t helped clear up her rash. Within the first 2 weeks of using the face serum, we watched the rash fade and nearly disappear. She has gone from screaming and trying to hide with other products to asking if it is time for her ‘cream that makes my face feel better.’ It is nothing short of a miracle.” February 2014 3 Managing Skin Toxicities with Lindi Skin Products • April 2014 Lindi Skin now offers eleven products for use with sensitive or compromised skin: 1. Cooler roll – non-adhesive dressing for post-radiation relief 2. Lavender face serum, including proprietary LSA ® complex 3. Citrus face serum 4. Body wash 5. Soothing balm – useable on body, but particularly for dry, cracked hands and feet 6. Face moisturizer 7. Lip balm 8. Eye hydrator gel 9. Reusable cooler pad 10. Body lotion 11. Face wash Patients can also purchase sets of products in sample sizes or to comprise regimens designed for radiation therapy, chemotherapy, and combined therapy. As word of the effectiveness and tolerability of Lindi Skin products has spread, they have been made available in at least 100 cancer centers across the county. Genentech, GlaxoSmithKline, and Merck included them in starter packs and as aids for patients receiving their agents that cause skin effects. Lindi Skin products can be ordered directly from the Lindi Skin website, and now they are widely available in pharmacies. In 2014, CVS joined the growing list of distributors. For more information or to place an order, go to: www.Lindi Skin.com. To find a store near you and your patients, go to: www.linkiskin.com/retail-locator. Note: T his White Paper was prepared by ONS:Edge in collaboration with Lindi Skin. References Retrieved March 31, 2014, from www.cancercare.org. Hand-Foot Syndrome or Palmar-Plantar Erythrodysesthesia. Cancer. Net. Retrieved April 1, 2014, from http://www.cancer.net/navigatingcancer-care/side-effects/hand-foot-syndrome-or-palmar-plantarerythrodysesthesia. 3 EGFR Inhibitors. Drugs.com. Retrieved April 1, 2014, from http://www. drugs.com/drug-class/egfr-inhibitors.html. 4 Balagula Y, Rosen A, Tan BH, et al. Clinical and histopathologic characteristics of rash in cancer patients treated with mammalian target of rapamycin inhibitors. Cancer. 2012;118:5078–83. 5 Balagula Y, Wu W, Su X, et al. The risk of hand foot skin reaction to pazopanib, a novel multikinase inhibitor: a systematic review of literature and meta-analysis. Invest New Drugs. 2012; 30:1773–1781. 6 Ortega-Parra C, Donath E, Garcia SR, Jacobson RJ. Correlation between development of rash and efficacy of EGFR inhibitors: a meta-regression analysis. J Clin Oncol. 2013;31 (suppl; abstr e13539). 7 White KJ, Roydhouse JK, Scott K. Psychosocial impact of cutaneous toxicities associated with epidermal growth factor receptor-inhibitor treatment. Clin J Oncol Nurs. 2001;15:88-96. 8 Wright LG. Maculopapular skin rashes associated with high-dose chemotherapy: Prevalence and risk factors. ONF. 2007;33:1095-1103. 9 Skin Toxicity of Chemotherapy Drugs. Derm Net NZ. Retrieved March 31, 2014, from http://dermnetnz.org/reactions/chemotherapy-toxicity.html. 10 Kufe DW, RE, Pollock RE Weichselbaum RR, et al., eds. Holland-Frei Cancer Medicine. 2003: Hamilton, ON: BC Decker. 11 Schnur JB, Ouellette SC, DiLorenzo TA, et al. A qualitative analysis of acute skin toxicity among breast cancer radiotherapy patients. Psychooncology. 2011;20:260-268. 12 Balagula Y, Hensley JR, Gerami P, Lacouture ME. Acneiform rash as a reaction to radiotherapy in a breast cancer patient. JSCO. 2010; 8: 268-271. 13 Lacouture ME, Anadkat MJ, Bensadoun R-J, et al., for the MASCC Skin Toxicity Study Group. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 201;19:1079–1095. 14 Multinational Association of Supportive Care in Cancer (MASCC). Caring for Your Skin, Hair and Nails when on “Targeted Therapies.” Retrieved March 31, 2014, from http://www.mascc.org. 15 ONS:Edge Advisory Board, 2008. 16 Haley AC, Calahan C, Gandhi M, et al. Skin care management in cancer patients: an evaluation of quality of life and tolerability. Support Care Cancer. March 25, 2010: published online. 1 2 4 Managing Skin Toxicities with Lindi Skin Products • April 2014