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Objectives: Advances in science and technology have meant there are numerous treatment options available for people with advanced breast cancer (ABC). However, each therapeutic approach can cause side effects or adverse events, which can significantly affect the person's quality of life, overall well-being, and, in some instances, safety. This report presents an overview of the common side effects of systemic anticancer therapy and ways to manage them., Data Sources: Data sources include peer-reviewed articles sourced in electronic databases and national and international best practice guidelines (ESMO, ASCO, and MASCC guidelines)., Conclusion: Systemic anticancer therapies have side effects that healthcare professionals need to know about to monitor and manage them in early stages. Nurses play an important role in patient education, early identification, monitoring, and management of treatment side effects., Implications for Nursing Practice: People with ABC face many challenges during their treatment journey. Oncology nurses, specialist nurses, and nurse practitioners can be of support by providing preventive measures and side effects management at an early stage. Nurses need to have a good understanding of toxicity management but also advanced tumor-specific cancer knowledge of the different subtypes of ABC and holistic assessment skills. They are also key to providing support and enhancing self-management and early recognition of side effects., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Celia Diez de los Rios and Theresa Wiseman were Guest Editors for the Metastatic Breast Cancer Special Issue of Seminars in Oncology Nursing. As an author of this article, they did not participate in any editorial process or decision-making, which was handled by another editor., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Purpose: Evidence-based guidelines on how to prevent or treat cetuximab-related skin reactions are lacking and multiple care and management strategies are used. The main purpose of the present study is to gain information about the different skincare products being used against skin reactions in metastatic colorectal cancer (mCRC) and recurrent/metastatic (R/M) or locally advanced (LA) squamous cell cancer of the head and neck (SCCHN) patients treated with cetuximab., Methods: An open-label, prospective observational study conducted in the Netherlands. The occurrence of skin reactions and the care and management options taken were documented for 16 weeks, starting from the first administration of cetuximab., Results: A total of 103 patients were included in 7 hospitals. 38 patients (37%) developed a grade ≥ 2 skin reaction. Eighty-six patients could be analysed for the primary endpoint (73.3% males, mean age 62.4 years, n = 44 LA SCCHN, n = 16 R/M SCCHN, n = 26 mCRC). The most frequently used skin products at some point during the observation period were moisturizing products (70%), systemic antibiotics (64%), topical antibiotics (58%), lipid-regenerating (28%) and other topical products (28%). The overall use of products gradually increased from baseline to week 6-10, reducing by week 16. Hospital protocols were the primary reason (> 50%) for choice of the skincare products and medications., Conclusion: A variety of skin care products and antibiotics were commonly used. Only few patients developed severe cutaneous reactions. For patients, the occurrence of skin reactions did not influence their willingness to continue cetuximab therapy.

Targeted cancer therapies have fundamentally transformed the treatment of many types of cancers over the past decade, including breast, colorectal, lung, and pancreatic cancers, as well as lymphoma, leukemia, and multiple myeloma. The unique mechanisms of action of these agents have resulted in many patients experiencing enhanced tumor response together with a reduced adverse event profile as well. Toxicities do continue to occur, however, and in selected cases can be clinically challenging to manage. Of particular importance in the context of this monograph is that the pathobiology for oral mucosal lesions caused by targeted cancer therapies has only been preliminarily investigated. There is distinct need for novel basic, translational, and clinical research strategies to enhance design of preventive and therapeutic approaches for patients at risk for development of these lesions. The research modeling can be conceptually enhanced by extrapolating "lessons learned" from selected oral mucosal conditions in patients without cancer as well. This approach may permit determination of the extent to which pathobiology and clinical management are either similar to or uniquely distinct from oral mucosal lesions caused by targeted cancer therapies. Modeling associated with oral mucosal disease in non-oncology patients is thus presented in this context as well. This article addresses this emerging paradigm, with emphasis on current mechanistic modeling and clinical treatment. This approach is in turn designed to foster delineation of new research strategies, with the goal of enhancing cancer patient treatment in the future., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: The objective of this sub-analysis of the BeCet study (NCT01136005) was to examine health-related quality of life (HRQoL) of patients experiencing dermatological adverse events (AEs) during the first 6 weeks of epidermal growth factor receptor inhibitor (EGFRI) treatment., Methods: Patients (n = 85) treated with EGFRI completed five questionnaires during the first 6 weeks of treatment. 77 patients provided enough data for the sub-analysis. Experienced AEs were reported in the Dermatological Reactions Targeted Therapy-Patients (DERETT-P), a symptom experience diary for patients treated with targeted therapy. The impact of EGFRI-associated dermatological adverse events on HRQoL was examined using four HRQoL questionnaires; the Functional Assessment of Cancer Therapy-EGFRI (FACT-EGFRI-18), the Functional Assessment of Cancer Therapy-General (FACT-G), the 36-Item Short Form Health Survey (SF-36), and the Skindex-16., Results: During the first 6 weeks of EGFRI treatment, physical discomfort was the most significantly affected domain. In the entire study population, xerosis (dry skin) (22.3 %) and pruritus (itchy skin) (16.9 %) were reported as the most impactful AEs. For patients experiencing a papulopustular eruption (acneiform rash) pruritus (24.2 %), xerosis (18.9 %), and papulopustular eruption (6.3 %) were reported as the most impactful AEs. Papulopustular eruption, xerosis, and pruritus all showed a significant negative effect on HRQoL, displayed in FACT-EGFRI-18 scores., Conclusions: In addition to papulopustular eruption, xerosis and pruritus are major EGFRI-associated dermatological AEs with an impact on HRQoL, which warrant more attention in clinical practice and research.

Background and Purpose: Cancer patients treated with targeted therapies (e.g., epidermal growth factor receptor inhibitors) are susceptible to dermatologic adverse events (AEs) including secondary skin infections. Whereas infections such as paronychia and cellulitis have been reported, nasal vestibulitis (NV) has not been described with the use of these agents. The aim of our study was to characterize NV in cancer patients treated with targeted therapies., Methods: We utilized a retrospective chart review of cancer patients who had been referred to dermatology and were diagnosed with NV. We recorded data including demographics, referral reason, underlying malignancy, targeted anticancer regimen, NV treatment, and nasal bacterial culture results., Results: One Hundred Fifteen patients were included in the analysis, of which 13 % experienced multiple NV episodes. Skin rash was the most common reason (90 %) for a dermatology referral. The most common underlying malignancies were lung (43 %), breast (19 %), and colorectal (10 %) cancer. Sixty-eight percent of patients had been treated with an EGFRI-based regimen. Nasal cultures were obtained in 60 % of episodes, of which 94 % were positive for one or more organisms. Staphylococcus aureus was the most commonly isolated organism [methicillin-sensitive S. aureus 43 %; methicillin-resistant S. aureus 3 %]., Conclusions: We report the incidence and characteristics of an unreported, yet frequent dermatologic condition in cancer patients treated with targeted therapies. These findings provide the basis for additional studies to describe the incidence, treatment, and consequences of this event. A better understanding of NV would mitigate its impact on patients' quality of life and risk for additional dermatologic AEs.

Purpose: Dermatologic adverse events (dAEs) in cancer treatment are frequent with the use of targeted therapies. These dAEs have been shown to have significant impact on health-related quality of life (HRQoL). While standardized assessment tools have been developed for physicians to assess severity of dAEs, there is a discord between objective and subjective measures. The identification of patient-reported outcome (PRO) instruments useful in the context of targeted cancer therapies is therefore important in both the clinical and research settings for the overall evaluation of dAEs and their impact on HRQoL., Methods: A comprehensive, systematic literature search of published articles was conducted by two independent reviewers in order to identify PRO instruments previously utilized in patient populations with dAEs from targeted cancer therapies. The identified PRO instruments were studied to determine which HRQoL issues relevant to dAEs were addressed, as well as the process of development and validation of these instruments., Results: Thirteen articles identifying six PRO instruments met the inclusion criteria. Four instruments were general dermatology (Skindex-16©, Skindex-29©, Dermatology Life Quality Index (DLQI), and DIELH-24) and two were symptom-specific (functional assessment of cancer therapy-epidermal growth factor receptor inhibitor-18 (FACT-EGFRI-18) and hand-foot syndrome 14 (HFS-14))., Conclusions: While there are several PRO instruments that have been tested in the context of targeted cancer therapy, additional work is needed to develop new instruments and to further validate the instruments identified in this study in patients receiving targeted therapies., Competing Interests: AND SOURCES OF FUNDING There were no sources of funding used in this study. The authors have full control of the primary data, which is available to the journal at their request for review. Dr. Roeland has a consultant role with Cellulitix. Dr. Choi has received remuneration from Onyx Pharmaceuticals and has a consultant role with Biotest AG. Dr. Bryce has a consultant role with AstraZeneca and Roche. Dr. Gerber has a consultant role with Galderma International. He is also receiving research funding from Hoffman La Roche. Dr. Lacouture has a consultant role with AstraZeneca, Roche, Bayer, Janssen, Exelixis, Advancell, BMS, Amgen, and Genentech. He is also receiving research funding from Berg, Roche and BMS.

Objectives: To provide background information and management strategies for non-rash dermatological adverse events., Data Sources: Peer-reviewed journal articles, professional manuals, online sources., Conclusion: During the last decade, many dermatological adverse events of targeted therapy have been reported, including xerosis, skin fissures, pruritus, photosensitivity, pigmentation changes, hair and nail changes, hand-foot skin reaction, squamoproliferative lesions, Stevens-Johnsons syndrome, and toxic epidermal necrolysis. Although evidenced-based treatment options are scarce, many recommendations have been described in the literature that should be considered to apply in daily practice., Implications for Nursing Practice: Nursing practice will be enhanced by education, assessment, and management recommendations., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Regorafenib is an oral multikinase inhibitor that has shown antitumor activity in a range of solid tumors. Based on data from phase III clinical trials, regorafenib is indicated for the treatment of adult patients with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other available therapies, and in patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other appropriate treatments. A panel of oncology nurses, research coordinators, and other medical oncology experts, experienced in the care of patients treated with regorafenib, met to discuss the best practice for the management of regorafenib-associated adverse events (AEs). The panel agreed that, in clinical trials and daily practice with regorafenib, AEs are common but mostly manageable. The most common and/or important AEs associated with regorafenib were considered to be hand-foot skin reaction, rash or desquamation, stomatitis, diarrhea, hypertension, liver abnormalities, and fatigue. This manuscript describes the experience and recommendations of the panel for managing these AEs in everyday clinical practice. Appropriate education, monitoring, and management are considered essential for reducing the incidence, duration, and severity of regorafenib-associated AEs.

Purpose: The Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on patients. The FACT-EGFR-18 was translated into Dutch and evaluated in order to document that the translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population., Method: Translation of the FACT-EGFRI-18 from English to Dutch was accomplished by employing the Functional Assessment of Chronic Illness Therapy (FACIT) multilingual translation methodology. Ten native-speaking residents of the target country who reported EGFRI associated dermatological adverse events (dAEs) were asked to review the translation of the harmonized FACT-EGFRI-18., Results: Participants generally found the Dutch FACT-EGFRI-18 easy to understand and complete. In addition, the translation retained the original meaning of the FACT-EGFRI-18 items and instructions. Based on the results of the cognitive debriefing interviews, no changes to improve clarity and comprehension of translations were identified., Conclusions: The Dutch FACT-EGFRI-18 demonstrates content validity and linguistic validity, and was found conceptually equivalent to its English source, thus confirming linguistic validation. The results suggest that the Dutch FACT-EGFRI-18 can be applied to measure dAE related health related quality of life in Dutch-speaking patients undergoing EGFRI therapy. Formal validation of the Dutch FACT-EGFRI-18 is ongoing., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

With the recent introduction of inhibitors of mammalian target of rapamycin (mTOR) in oncology, distinct cutaneous and oral adverse events have been identified. In fact, stomatitis and rash are documented as the most frequent and potentially dose-limiting side effects. Clinically, mTOR inhibitor-associated stomatitis (mIAS) more closely resembles aphthous stomatitis than oral mucositis due to conventional anticancer therapies. While most cases of mIAS are mild to moderate and self-limiting, more severe and persistent mIAS can become a dose-limiting toxicity. Small ulcerations may cause significant pain and mucosal sensitivity may occur in the absence of clinical changes. Use of clinical assessment tools that are primarily driven by ulceration size may underestimate mIAS, and assessment should include patient-reported outcomes. This article provides an up-to-date review of the clinical presentation, terminology, pathogenesis, assessment and management of mIAS and other mTOR inhibitor-associated oral adverse events. In addition, areas of future research are considered.

Purpose: The purpose of this study was to estimate the risk and severity of oral and gastrointestinal mucosal toxicities associated with selected targeted agents., Methods: We searched the English-language literature in February 2011 for reports of randomized clinical trials comparing a FDA-approved targeted agent to a standard of care regimens. Long-term follow-up and secondary reports of trials were excluded, leaving 85 studies for analysis. Using meta-analytic methods, we calculated the relative risks of oral and gastrointestinal toxicities, adjusting for sample size using the inverse variance technique. For each targeted agent and each side effect, we calculated the number needed to harm, the number of patients that, if treated with the more toxic regimen, would produce one additional episode of the toxicity., Results: Oral mucositis was significantly more frequent among patients treated with bevacizumab, erlotinib, sorafenib, or sunitinib, although this difference was confined to low-grade mucositis. The clinical significance of these findings is unclear given its low incidence and mild severity. In contrast, diarrhea was significantly more frequent with most of the targeted agents studied, with adjusted relative risks between 1.5 and 4.5. An additional patient with diarrhea will be observed for every three to five patients treated with these targeted agents, compared with conventional regimens., Conclusions: Oral mucosal toxicities occasionally complicate treatment with these targeted agents, but the clinical significance of this finding is not clear. Diarrhea is a hallmark of treatment with these targeted agents; this side effect should be carefully ascertained to permit early intervention and control.

Radiation dermatitis (RD) results from radiotherapy and often occurs within the first 4 weeks of treatment, although late effects also occur. While RD may resolve over time, it can have a profound effect on patients' quality of life and lead to dose modifications. A study group of international, interdisciplinary experts convened to develop RD prevention and treatment guidelines based on evidence from randomized, controlled trials. Evidence-based recommendations were developed after an extensive literature review. Randomized, controlled trials with standardized measurement of outcomes were considered the best evidence, and a majority of the recommendations were formulated from this literature. The adoption of washing with water, with or without a mild soap, and allowing the use of antiperspirants is supported by randomized trials. Use of topical prophylactic corticosteroids (mometasone) is recommended to reduce discomfort and itching. There is some evidence that silver sulfadiazine cream can reduce dermatitis score. There is insufficient evidence to support, and therefore the panel recommends against the use of trolamine, topical sulcrate, hyaluronic acid, ascorbic acid, silver leaf dressing, light-emitting diode lasers, Theta cream, dexpanthenol, calendula, proteolytic enzymes, sulcralfate, oral zinc, and pentoxifylline. Moreover, there is no evidence to support the superiority for any specific intervention in a reactive fashion. For patients with established radiation-induced telangiectasia and fibrosis, the panel suggests the use of pulse dye laser for visual appearance, and the use of pentoxifylline and vitamin E for the reduction of fibrosis.

Purpose: The functional assessment of cancer therapy epidermal growth factor receptor inhibitor 18 (FACT-EGFRI-18) is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on health-related quality of life (HRQoL)., Methods: Ten native-speaking residents of The Netherlands who reported EGFRI-associated mucocutaneous adverse events (mcAEs) were administered the questionnaire. Patients were subsequently asked a standardized series of questions about the items' personal relevance., Results: Responses reflected a major negative impact of mcAEs due to EGFRI on physical, social/emotional, and functional domains. In some cases, especially in the social/emotional domain, the responses to the qualitative interview indicated a greater impact on HRQoL than the numerical ratings previously selected for the Dutch FACT-EGFRI-18 questions., Conclusions: Based on these interviews, we identified that the physical items associated with mcAEs interfere most with HRQoL. The results suggest that the FACT-EGFRI-18 can be applied to measure mcAE-related HRQoL in cancer patients undergoing EGFRI therapy. In addition, patients feel the need to rate their symptom burden, too, and we recommend additional adverse event items to be incorporated into the questionnaire.

Background: Oral adverse events (OAEs) associated with multitargeted tyrosine kinase inhibitors (TKIs) and mammalian target of rapamycin inhibitors (mTORIs) are underestimated but frequent and novel presentations of mucosal manifestations. Because optimal antitumor activity requires maintaining the optimal dose, it is essential to avoid unintended treatment delays or interruptions., Methods: We review the reported prevalence and appearance of OAEs with TKIs and mTORIs and the current oral assessment tools commonly used in clinical trials. We discuss the correlations between OAEs and hand-foot skin reaction (HFSR) and rash., Results: The reported prevalence of oral mucositis/stomatitis of any grade is 4% for pazopanib, 28% for sorafenib, 38% for sunitinib, 41% for temsirolimus, and 44% for everolimus. Oral lesions associated with these agents have been reported to more closely resemble aphthous stomatitis than OM caused by conventional agents. In addition, these agents may result in symptoms such as oral mucosal pain, dysgeusia, and dysphagia, in the absence of clinical lesions. Because of these factors, OAEs secondary to targeted agents may be underreported. In addition, a correlation between OAEs and HFSR was identified., Conclusions: OAEs caused by TKIs and mTORIs may represent dose-limiting toxicities, especially considering the fact that even low grades of OAEs may be troubling to the patient. We discuss how these novel AEs can be assessed because current mucositis assessment tools have limitations. Prospective studies investigating the pathogenesis, risk factors, and management of OAEs are needed in order to minimize the impact on patient's health-related quality of life.

The last decade in oncology has been highlighted by the emergence of novel, highly specific anti-cancer agents, targeting a variety of molecular structures and able to inhibit aberrantly activated oncogenic pathways. Epidermal growth factor receptor inhibitors (EGFRIs) represent one type of such "targeted" agents. Their use made treatment more tolerable and resulted in significant reduction of systemic adverse effects. However, EGFRIs are associated with toxicities affecting the skin and adnexal structures, and mucosal surfaces that affect the majority of treated patients. Significant dermatologic toxicities have changed the role and involvement of dermatologists in their care. It is essential to be familiar with these adverse effects, potential complications, long-term sequelae, and available effective treatment strategies in order to appropriately manage these patients. This review will describe the clinical presentation, histopathology, underlying mechanisms, and management options, emphasizing evidence-based approaches., (© 2011 The International Society of Dermatology.)