Palliative and Supportive Care

This issue of ONCOLOGY Nurse Edition represents the full range of the cancer-management spectrum: Anna Schwartz and Laura Zitella, respectively, re-examine standard protocols and prevailing clinical assumptions in their review of evidence-based approaches toward relieving cancer-related fatigue and managing cancer patients' anemia. In contrast, Ellen Giarelli, in her cancer vaccine review, looks over the horizon at novel and promising approaches now under investigation for both treatment and prevention of cancer.

In May, the FDA issued a "Black Box" warning outlining new safety information about the use of erythropoiesis-stimulating agents (ESAs). In response, the Centers for Medicare & Medicaid Services (CMS) issued its own ruling that restricts coverage of ESAs in the cancer setting. Many oncologists feel that CMS restrictions go further than what is "reasonable and necessary." As we know, where Medicare goes, private insurance companies tend to follow. To shed light on this important discussion from the payer's side, Cancer Care & Economics (CC&E) spoke with Lee Newcomer, MD, senior vice president of oncology services at UnitedHealthcare, Minneapolis.

Dermatologic treatment of epidermal growth factor receptor inhibitor (EGFRI) skin toxicity is supportive and aims at maintaining quality of life while continuing EGFRI therapy. Despite the lack of randomized controlled trials or evidence-based guidelines, most cases of acneiform eruption are well controlled by topical metronidazole and oral minocycline 100 mg qd. For severe reactions, the minocycline dose is doubled and saline compresses are used. For superinfection with Staphylococcus aureus, oral cefuroxime axetil can be added for a short term. Emollients and topical steroids can be administered for skin dryness or eczema. Paronychia is the hardest to treat but antiseptic soaks and a corticosteroid paste can alleviate symptoms to some degree.

This review summarizes the pathophysiology and clinical presentation of the cutaneous toxicities associated with EGFR inhibition. Such effects include papulopustular reactions, xerosis, pruritus, fissures, nail changes, hair changes, telangiectasias, hyperpigmentation, and mucositis. Most management strategies for these toxicities have been based on anecdotal experience; clinical trials are needed to provide uniform characterization to allow for evidence-based treatment strategies.

All nursing personnel actively participate in the nursing process, with the registered nurse taking primary responsibility. Five steps in the nursing process include assessment, diagnosis, planning, implementation, and evaluation. Health-care professionals have more than 10 years of experience with EGFR inhibitors in the oncology setting. To date, the application of the nursing process to assist in patient management has not been previously published or thoroughly described in the literature. This article will apply the nursing process utilizing current recommendations regarding the assessment and management of dermatologic toxicities associated with EGFR inhibitors.

Dermatologic toxicities associated with EGFR inhibitors can have a profound impact on patients' health-related quality of life (HRQL) and may interfere with treatment adherence. We interviewed 20 patients and 12 expert clinicians to identify the most bothersome aspects of dermatologic toxicities to better understand the impact on patients' HRQL. Patients and expert clinicians reported that dermatologic toxicities have an impact on patients' physical, functional, emotional, and social well-being. Patients identified the physical discomfort as having the most impact on their HRQL, specifically the sensations of pain, burning, and skin sensitivity. Patients experienced worry, frustration, and depression because of their dermatologic symptoms and reported withdrawing from social activities. Cognitive behavioral strategies such as guided imagery and symptom reframing (eg, rash means treatment is working) may provide patients with valuable skills for the management of this physical discomfort. Cognitive behavioral strategies may also be useful in helping patients manage anxiety and depression associated with any changes in their social function caused by skin rash, as well as distress associated with having a cancer diagnosis.

Epidermal growth factor receptor inhibitors (EGFRIs) have demonstrated clinical activity in patients with non–small-cell lung cancer, pancreatic cancer, and colorectal cancer. EGFRIs are generally well tolerated, but reversible dermatologic toxicities are commonly associated with their use. Limited clinical evidence has characterized these adverse reactions as a class effect. For panitumumab (Vectibix), mild-to-moderate dermatologic toxicities are the most common associated adverse reactions. This report details the Japanese experience in the management of dermatologic toxicities associated with panitumumab use. Treatment selection for skin toxicity in Japan is also detailed, with a flowchart depicting strategies to treat various stages of dermatologic toxicities. Panitumumab was well tolerated in Japanese patients with advanced solid tumors, with a safety profile similar to that seen in non-Japanese patients.

This article describes agents used to treat the dermatologic toxicities commonly seen during therapy with epidermal growth factor receptor inhibitors. Therapeutic options include topical emollients, antibiotics, corticosteroids, and other agents for supportive care. While medical approaches to these adverse reactions are still in a "learning phase," continued experience will provide further insight into effective management strategies.

Management of dermatologic toxicities from epidermal growth-factor receptor inhibitors (EGFRIs) is best tailored to the type of skin lesions present, extent of body surface involvement, and anatomic location affected. Although few randomized trials have been undertaken to address treatment of skin, hair, or nail side effects to this class of drugs, some basic principles of therapy based on experience of referral centers can help mitigate these toxicities and ensure consistent EGFRI administration and maintenance of patient quality of life. Patient education as to the expected EGFRI side effects and early physician intervention when these side effects appear can improve outcomes. Two dermatologists who treat high numbers of patients affected by these EGFRI-induced cutaneous side effects submit their recommendations for management.

An acneiform-like skin toxicity is commonly observed in patients with solid tumors treated with epidermal growth factor receptor inhibitors (EGFRIs). This symptomatic rash is related to epidermal growth factor receptor (EGFR) inhibition in the skin. A positive relation between the presence and severity of treatment-related rash and survival has been consistently observed with all EGFRIs approved for clinical use. These findings suggest that rash may be a useful surrogate marker of successful EGFR inhibition and clinical benefit and therefore of possible use in identifying patients most likely to benefit from therapy, as well as to guide dose adjustments. Increasing drug dose until skin toxicity appears is being studied. Further studies are needed to thoroughly evaluate the value of skin toxicity as a surrogate marker for clinical benefit. Current treatments of the skin toxicity are empirical and oriented toward mitigating symptoms and not validated by well-controlled clinical trials. Rational treatments based on the biological mechanisms of the skin toxicity must be developed and tested in well-controlled clinical trials.

Fatigue is the most common side effect of cancer and its treatment, and it frequently goes unrecognized and untreated. While the exact etiology of fatigue is unclear, numerous contributing factors that worsen fatigue can be clinically addressed. Substantial research supports physical exercise as an intervention for fatigue.

In cancer patients, anemia is multifactorial, resulting from cancer treatment, anemia of malignancy, blood loss, impaired production of or response to erythropoietin, and dysregulation of iron metabolism (decreased dietary iron intake, absorption, and utilization). Clinical studies have found that erythropoietin stimulating agents (ESAs) increase hemoglobin (Hb) levels and reduce the need for blood transfusions by 40%, with ESA-treated patients receiving an average of 1 unit less of red blood cells (RBCs) than non-ESA-treated anemic cancer patients.

Vaccines have been exceptionally effective against diseases such as smallpox, measles, chickenpox, and polio. They are among the safest and most cost-effective agents for disease prevention. In recent years, vaccination has been considered for other diseases, including AIDS and cancer. Cancer vaccines can be categorized as preventive or therapeutic. Preventive vaccines, which are commercially available for cervical cancer and liver cancer, block infection with the causative agents of human papillomavirus and hepatitis B virus, respectively. The benefit of cancer treatment vaccines lies in their ability to "boost" the immune system response to cancer cells, which is generally low. Using vaccines in the treatment of cancer is relatively new, however, and chiefly experimental. Therapeutic vaccines for breast, lung, colon, skin, renal, prostate, and other cancers are now being investigated in clinical trials. Oncology nurses may play a significant role in reducing barriers to uptake of preventive vaccines among the general public and in increasing patients' acceptance of therapeutic cancer vaccines.

Oncologists have protested to the Centers for Medicare & Medicaid Services (CMS) that new rules restricting coverage of erythopoiesis-stimulating agents (ESAs) contradict Food and Drug Administration's approved labeling for the drugs and tie the hands of physicians treating cancer patients with chemotherapy-induced anemia.

Approximately 60% of cancer patients experience pain, and 25% to 30% have severe pain. With some cancers, opioids will be needed before chemotherapy begins and may be more frequently prescribed than chemotherapy. Given the frequency with which pain management is necessary in cancer patients, all oncologists should be familiar with opioid prescribing principles. This article reviews the World Health Organization recommendations for analgesic therapy in this setting, as well as guidelines for opioid therapy in patients with renal failure or hepatic failure, assessment of pain, dosing strategies in both acute and chronic pain, management of opioid overdose, pain associated with dose-limiting side effects, and pain in the actively dying.

In a 3-month extension study of the methylnaltrexone phase III MNTX-302 trial, the investigational agent continued to produce laxation in patients with advanced illness being treated with opioids for pain

The Moores UCSD Cancer Center has implemented the use of an innovative instrument for screening cancer patients at first visit to assist them with distress due to cancer-related problems. This 36-question screening instrument addresses physical, practical, social, psychological and spiritual problems. Patients are asked to rate the severity of each problem on a scale of 1 to 5, and to circle "Yes" if they would like staff assistance. Data from a prospective study of the first 2,071 patients to complete this questionnaire has been entered into a database and analyzed to identify common patient problems, demographics, and trends. The five most common causes of problem-related distress were fatigue, sleeping, finances, pain, and controlling my fear and worry about the future. The five most common problems for which patients circled "Yes" to ask for assistance were understanding my treatment options, fatigue, sleeping, pain, and finances. Compared to the entire population, patients who circled "Yes" on a particular problem, demonstrated a robust increase in problem-related distress.

A multiphase education plan can promote the use of evidence-based practice among oncology nursing staff

The National Cancer Institute (NCI) has initiated a 3-year pilot study for its National Community Cancer Center Program (NCCCP) to explore issues surrounding the effective delivery of cancer care at the local level.

42-year-old Caucasian female who was in her usual state of health when her first mammogram showed suspicious calcifications and a spiculated mass in the upper outer quadrant of the right breast. An ultrasound-guided biopsy showed an invasive ductal carcinoma. She underwent a lumpectomy, with the excised tumor measuring 1.2 cm. The tumor was estrogen and progesterone positive and HER2/neu negative.

Gina, age 9, and Rosemary, age 66. They had different cancers, but developed similar skin ulcers over their entire bodies. Gina's wounds were open to air for 4 weeks. Her pain was severe. Two weeks after starting wound care, Gina allowed us to take pictures of her wounds. We promised to teach doctors and nurses how to care for her wounds. Unfortunately, Gina died. The pictures were lost. A year later, Rosemary was admitted with a similar skin condition and allowed us to photograph the progression of her wound care. Our promise to Gina is now kept. Here we describe the wound care plan necessary to relieve the pain and discomfort of partial-thickness wounds from dermatological conditions in oncology patients.

Diabetes mellitus is a frequent comorbidity of cancer patients. The growing epidemic of diabetes is anticipated to have tremendous impact on health care. Diabetes may negatively impact both cancer risk and outcomes of treatment. Oncology nurses are ideally positioned to identify patients at risk for complications that arise from cancer treatment in the setting of pre-existing diabetes. Additionally, oncology nurses may be the first to identify underlying hyperglycemia/hidden diabetes in a patient undergoing cancer treatment. Strategies for assessment and treatment will be discussed, along with specific strategies for managing hyperglycemia, potential renal toxicity, and peripheral neuropathy. Guidelines for aggressive treatment of hyperglycemia to minimize risks of complications will be reviewed. The role of interdisciplinary care, utilizing current evidence, is crucial to supporting patients and their families as they manage the challenges of facing two life-limiting diseases. Whole-person assessment and individualized treatment plans are key to maximizing quality of life for patients with cancer and diabetes.

FDA-Approved Drugs: 5-HT3 receptor antagonists Zofran (ondansetron), Kytril (granisetron), Anzamet (dolasetron), Aloxi (palonosetron); NK-1 receptor antagonist: Aprepitant (Emend)

Chemotherapy-induced nausea and vomiting (CINV) remains an important and common toxicity of cancer treatment. Recent guideline revisions have classified chemotherapeutic agents into four categories of emesis risk without the use of preventive agents: high (> 90%), moderate (30%-90%), low (10%-30%), and minimal (< 10%). Currently available antiemetic agents, including corticosteroids, 5-hydroxytryptamine (HT)3 receptor antagonists, and neurokinin (NK)-1 antagonists are used alone or in combination depending on the level of emetogenic potential as prophylaxis against the development of CINV during the acute period (up to 24 hours after chemotherapy) and the delayed period (up to 5 days after treatment). Newer agents, including the second-generation 5-HT3 receptor antagonist palonosetron (Aloxi) and the NK-1 antagonist aprepitant (Emend), offer additional clinical benefit in highly and moderately emetogenic therapy. However, delayed nausea and vomiting continue to occur frequently in many patients and have an impact on quality of life. Other classes of agents including the benzodiazepines and cannabinoids offer the potential for additional protective benefit. Continued research with new drugs and combinations is necessary to meet this significant unmet need of cancer patients.

Prostatic acid phosphatase (PAP) emerged as the world's first clinically useful tumor marker in the 1940s and 1950s. With the introduction of the prostate-specific antigen (PSA) test in the 1980s, which performed significantly better than PAP in terms of screening and monitoring response to treatment, PAP fell into disfavor. An increasing number of recent studies have identified PAP as a significant prognostic factor for patients with intermediate- and high-risk prostate cancer. PAP appears to be particularly valuable in predicting distant failure in higher-risk patients for whom high levels of local control are achieved with aggressive initial local treatment. As prostate cancer care becomes increasingly focused on identifying the minority of patients who would benefit from aggressive systemic therapy, a reevaluation of the potential contribution of the prostatic acid phosphatase test seems timely.

The Food and Drug Administration (FDA) should require additional restrictions in product labeling and/or additional clinical trials before approving new erythropoiesis-stimulating agents (ESAs) or new indications for ESAs already on the market, the Oncologic Drugs Advisory Committee (ODAC) told the agency.

Merck & Co., Inc. announced that it has received an approvable letter from the US Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Emend (fosaprepitant dimeglumine) for Injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting.

The Centers for Medicare & Medicaid Services (CMS) has reacted to an FDA "Black Box Warning" for erythropoiesis-stimulating agents (ESAs), manufactured by Amgen (Ara-nesp and Epogen) and Johnson & Johnson (Procrit) by proposing a national coverage decision (NCD) that would put limits on the dose and duration of therapy in patients with cancer and related neoplastic conditions.

US Food and Drug Administration (FDA) has approved a new indication for dalteparin sodium injection (Fragmin), for the extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer.

FDA has approved a new indication for Pfizer and Eisai's Fragmin (dalteparin sodium injection), for the extended treatment of symptomatic venous thromboembolism (VTE)&#151;proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)&#151;to reduce the recurrence of VTE in patients with cancer.