P013 Resolution of Infliximab Associated Infusion Hypersensitivity After Switching to Biosimilar Infliximab-dyyb.

CASE: Background: Administration of infliximab for the treatment of inflammatory bowel disease has a well-recognized risk of infusion-related (IR) adverse events. The recent introduction of the biosimilar infliximab-dyyb (Inflectra®) has been shown to have similar efficacy with comparable safety profile when compared to infliximab; however, although the active ingredients are similar, the inactive ingredients are different. We present a case of a 26-year-old female with ulcerative colitis who had resolution of her IR hypersensitivity when switched from infliximab to infliximab-dyyb. CASE DESCRIPTION: A 26-year-old female with a past medical history of ulcerative pancolitis presented to our clinic with the chief complaint of rash associated with her infliximab infusions. She described pruritic raised lesions which would occur on her upper and lower extremities during her infusions. She denied any shortness of breath or wheezing, and her symptoms were well controlled with methylprednisolone 40mg IV prior to her infusions. Previously, she had been treated for her UC with oral mesalamine, azathioprine and intermittent prednisone and did not have any adverse reactions to these medications. She has no known allergies to other medications and her peripheral eosinophil count was 1.6%. She was initially started on infliximab 5mg/kg every 8 weeks since 2013 and had achieved clinical as well as endoscopic remission with her most recent colonoscopy graded as Mayo 0. On account of her infusion reaction, drug antibodies were checked but were not detected. Infliximab level was 8.8 µg/ml. Due to insurance she was required to switch to infliximab-dyyb. After switching to the biosimilar, she has not had any infusion related reactions and no longer requires premedication with methylprednisolone with her infusions. DISCUSSION: Immediate IR reactions have been reported in 5-23% of IBD patients receiving infliximab and those who develop antibodies towards infliximab have a 2-fold risk of acute IR events. Side effects have been reported to be the primary reason for discontinuation of infliximab, and studies have shown that discontinuation can lead to an increased risk of relapse of inflammatory bowel disease. Although infliximab and infliximab-dyyb have analogous active ingredients, the inactive ingredients differ. Specifically, infliximab-dyyb lacks monobasic sodium phosphate and dibasic sodium phosphate, which acts as an emulsifier which we believe contributed to her IR with originator biologic infliximab. It is important to recognize these differences as IR hypersensitivities may be attributed to inactive ingredients; especially when antibodies are negative. Our case report suggests that a switch to biosimilar infliximab in patients may provide added benefit especially in those that have reactions occurring from inactive ingredients in the originator biologic.

Hypothyroidism after craniospinal irradiation with proton or photon therapy in patients with medulloblastoma.

BACKGROUND: Craniospinal irradiation (CSI) often results in endocrine deficiencies in children with medulloblastoma due to irradiation of the hypothalamic-pituitary axis (HPA) or the thyroid gland. CSI with Proton radiation therapy (PRT) has the potential to decrease the risk of hypothyroidism by reduction in radiation dose to these organs. This study compares the risk for hypothyroidism in patients with medulloblastoma treated with Photon radiation therapy (XRT) or PRT. METHODS: The records of patients with medulloblastoma diagnosed at a single institution between 1997 and 2014 who received CSI were, retrospectively, reviewed. Ninety-five patients (54 XRT and 41 PRT) who had baseline and yearly follow-up thyroid studies were included. We used interval censored Cox regression to calculate hazard ratios of developing any, primary, and central hypothyroidism. RESULTS: With a median time to last thyroid studies post radiation of 3.8 years in PRT and 9.6 years in XRT, 33/95 (34.7%) patients developed hypothyroidism (median time to hypothyroidism: 2.6 years). Hypothyroidism developed in 25/54 (46.3%) who received XRT vs. 8/41 (19%) in the PRT group (HR =1.85, p = .14). Primary hypothyroidism developed in 15/95 (15.8%) patients: 12/54 (22.2%) after XRT and 3/41 (7.3%) after PRT (HR =2.1, p = .27). Central hypothyroidism developed in 17/95 (18.0%) patients: 13/54 (24.0%) after XRT and 4/41 (9.8%) after PRT (HR =2.16, p = .18). CONCLUSIONS: The use of PRT in patients with medulloblastoma was associated with numerically lower but not significantly lower risk of hypothyroidism. Further studies including larger numbers and longer follow up must be performed to assess whether lower radiation doses achieved with PRT show statistically significant differences.

Predictors of Suboptimal Follow-up in Pediatric Cancer Survivors.

Attendance to follow-up care after completion of cancer treatment is an understudied area. We examined demographic, clinical, and socioeconomic predictors of follow-up by pediatric cancer patients at a large center in 442 newly diagnosed patients using multivariable logistic regression analyses. Patients who did not return to clinic for at least 1000 days were considered lost to follow-up. Two hundred forty-two (54.8%) patients were lost. In multivariable analyses, the following variables were independent predictors of being lost to follow-up: treatment with surgery alone (odds ratio [OR]=6.7; 95% confidence interval [CI], 3.1-14.9), older age at diagnosis (reference, 0 to 4; ages, 5 to 9: OR=1.8, 95% CI, 1.1-3; ages, 10 to 14: OR=3.3; CI, 1.8-6.1; and ages, 15 and above: OR=4.8; CI, 2.1-11.7), lack of history of stem cell transplantation (OR=2, 95% CI, 1.04-3.7) and lack of insurance (OR=3.4; CI, 1.2-9.2). Hispanic patients had the best follow-up rates (53.7%) compared to whites and blacks (P=0.03). Attendance to long-term follow-up care is suboptimal in childhood cancer survivors. Predictors that were associated with nonattendance can be used to design targeted interventions to improve follow-up care for survivors of pediatric cancer.

APHON/ASPHO Policy Statement for the Transition of Patients With Sickle Cell Disease From Pediatric to Adult Health Care.

With advances in medical care, the majority of children with sickle cell disease are surviving to adulthood. Patients, families, and providers now face the need for this growing population to move from pediatric- to adult-focused care. In order to facilitate a successful transfer to adult health care, and prepare young adults for greater independence, it is recommended that all pediatric patients with sickle cell disease receive transition preparation. ASSOCIATION POSITION: As the professional voice of pediatric hematology/oncology healthcare practice, the Association of Pediatric Hematology/Oncology Nurses (APHON) and the American Society of Pediatric Hematology Oncology (ASPHO) recommends that the discussion of transition begin early and is presented as part of the natural process of becoming an adult; that patients, providers, and families are all involved in creating a transition plan and assessing transition preparedness annually; and that transfer of care involve direct communication between the pediatric team and the accepting adult provider.

Enhancing pediatric oncology nursing care through research, quality improvement, and evidence-based practice.

Research, quality improvement (QI), and evidence-based practice (EBP) are knowledge-based methods used to enhance nursing practice. Nurses need to conduct studies to fill empirical gaps of knowledge (research), continually monitor health care practices and processes (QI), and systematically compile and review evidence (EBP). Research, QI, and EBP are valuable instruments within the health care setting as they can benefit the patient, families, health care team members, and the nursing profession, but it is important to understand when and how to use each method. This article will differentiate between and provide examples of research, QI, and EBP by focusing on the characteristics and purposes of each method. Clinical issues and concerns can transform practices based on evidence through the proper use of these methods. Nurses are highly motivated to create the best possible environment of healing for their patients. Therefore, it is essential that nurses use research, QI, and EBP so pediatric oncology knowledge can continue to evolve.

Human papillomavirus vaccination in female pediatric cancer survivors.

STUDY OBJECTIVE: Survivors of childhood malignancy may be at increased risk for HPV infection for biological and cognitive/behavioral reasons. HPV vaccination is currently recommended for females 11-12 years old with catch up vaccination up to age 26 years. The objective of this cross-sectional study was to determine the prevalence of HPV vaccination among female pediatric cancer survivors, age 11-18 years, at Texas Children's Hospital. STUDY DESIGN, SETTING, AND PARTICIPANTS: A 42-question survey was distributed to parents/guardians of 172 long-term cancer survivors from August-November of 2010. Data were analyzed using frequencies, t-tests, and chi-square analyses. MAIN OUTCOME MEASURES: Prevalence of HPV vaccination (intention and completion). RESULTS: Sixty-six persons (38%) responded. The median current age of survivors was 14 years. Most were white/non-Hispanic (48%) or white/Hispanic (37%). Seventy-one percent had discussed HPV vaccination with a healthcare provider. The overall rate of HPV vaccination (≥ 1 dose) was 32%, including 5% of those age 11-12 years (n = 1 of 21), 36% of those age 13-17 years (n = 13 of 36), and 78% of those age 18 years (n = 7 of 9). Of those whose children had not been immunized, 36% intended to do so in the future. Factors associated with HPV vaccination included age ≥13 years, report of sexual activity, and report of having discussed HPV vaccination with a healthcare provider. CONCLUSION: The rate of HPV vaccination among female pediatric cancer survivors is not appreciably different than that seen in the general population.

Nausea and vomiting perspectives among children receiving moderate to highly emetogenic chemotherapy treatment.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) are common adverse effects, but occurrences among pediatric oncology patients are not well documented. OBJECTIVE: The primary aim was to describe anticipatory, acute, and delayed CINV among children with cancer from the child's, caregiver's, and nurse's perspective. A secondary aim evaluates the correlation of CINV among the child's, caregiver's, and nurse's perspectives. METHODS: CINV perspectives were evaluated before, during, and after a single course of highly or moderately emetogenic chemotherapy. CINV were evaluated among 40 pediatric cancer patients using the Adapted Rhodes Index of Nausea and Vomiting for Pediatrics, among their caregivers using the Adapted Rhodes Index of Nausea and Vomiting for Parents, and among their nurses using the National Cancer Institute Nausea and Vomiting Grading Criteria. RESULTS: CINV were reported by the patient, caregiver, and nurse at all times, with the most frequent reports occurring in the delayed period. Patient's mean total nausea and vomiting scores increased significantly over time. Patient reports of anticipatory, acute, and delayed CINV correlated with caregiver and nurse reports except for anticipatory nausea between the nurse and patient. CONCLUSIONS: CINV occurred throughout the chemotherapy course, with delayed CINV occurring most frequently and with greater severity and distress. Caregiver CINV reports correlated closely with patient reports. IMPLICATIONS FOR PRACTICE: Nurses need to be aware of the frequency, severity, and distress of CINV throughout the chemotherapy regimen. CINV can occur before and after chemotherapy treatment and should be assessed so that appropriate interventions can be implemented.

Transition of chronically ill youth to adult health care: experience of youth with hemoglobinopathy.

INTRODUCTION: The purpose of this study was to describe the transition experience, expectations, and concerns of chronically ill youth with hemoglobinopathy (CIYH) (e.g., sickle cell disease) who have transitioned to adult health care. METHOD: A descriptive phenomenological study was used to explore the transition experience of CIYH through interviews. A purposive sample of 14 CIYH aged 19 to 25 years were recruited from a large southwestern medical center. The Colaizzi method was used to analyze the CIYH's meaning of the transition experience. RESULTS: Themes identified were: Reactions to adult care transition ("I don't want to go"), concerns about transition experience ("What's going to happen to me?"), pushed into transitioning to adult care ("Facing the music"), and transitioned to adult care ("Accepting that I had to leave"). DISCUSSION: The findings revealed CIYH's adjustment process, which may facilitate the design of effective interventions to provide uninterrupted medical care as the CIYH transitions to adult health care.

Transition of the chronically ill youth with hemoglobinopathy to adult health care: an integrative review of the literature.

With the advent of innovative technologies and medical advances, more than a half million chronically ill youth (CIY) cross the threshold into adulthood yearly. Successful transition of the CIY with hemoglobinopathy (e.g., sickle cell, thalassemia) from pediatrics to adult care continues to be an inconsistent process. The purpose of undertaking a comprehensive empirical review was to synthesize the transition literature focusing on CIY with hemoglobinopathy and clinical recommendations. Among 17 studies critically reviewed and summarized, five studies focused on the CIY with hemoglobinopathy, and the remainder on youth with other chronic conditions. Further research on transition, especially for CIY with hemoglobinopathy, is needed.

Asthma in the pediatric sickle cell patient with acute chest syndrome.

INTRODUCTION: Acute chest syndrome (ACS) is a potential life-threatening complication of sickle cell disease (SCD). The purpose of this study was to identify the frequency of asthma in children with SCD who were diagnosed with ACS. The objective was to determine if an increased frequency of asthma exists in children with SCD and ACS. METHOD: A retrospective descriptive chart review covering the period from June 1997 to June 2002 was conducted on 60 children ranging in age from 1.5 years to 17 years who had SCD and ACS. Cross-tabs analysis and student t tests were used to determine the significance of the occurrence of asthma in children in whom ACS developed. RESULTS: Of the 60 eligible children with SCD, 53% (32/60) had asthma and/or abnormal pulmonary function tests prior to the development of ACS. DISCUSSION: This is the first study to report a slight increase in the frequency of asthma prior to the initial ACS in children with SCD. The small convenience sample size from one center may have been a limitation in this study to detect significant differences between the variables.

Three instruments to assess fatigue in children with cancer: the child, parent and staff perspectives.

The purpose of this study was to develop and test three instruments to measure fatigue in children with cancer from the perspectives of the child, parents and staff. The study consisted of three phases: instrument development, content validation, and estimations of psychometric properties of the three fatigue instruments. One hundred forty-nine children between the ages of 7-12 years presently receiving chemotherapy for cancer, 147 parents and 124 staff participated in this study. The instruments demonstrated strong initial validity and reliability estimates. This study is the first to provide valid and reliable instruments to measure fatigue in children with cancer.

Managing side effects of childhood cancer treatment.

This article focuses on the nurse's role as a member of the supportive care team for the child diagnosed with cancer and the family. The most common side effects of the cancer treatment are discussed in depth in this article. The adequate management of the side effects experienced by the child receiving cancer therapy may greatly influence the child's quality of life.