bluuebunny/crossref_metadata_2025 huggingface dataset:
Changes in the sleep-wake rhythm, sleep quality, mood, and quality of life of patients receiving treatment for lung cancer: A longitudinal study.
Authors: Lin Chia-Chin , Chang Wen-Pei
Published: September 2018

e21657

Background: Studies on the diurnal sleep–wake rhythm of patients with lung cancer have mostly examined patients cross-sectionally, whereas the effects of lung cancer treatment over time have rarely been considered. Through long-term longitudinal tracking of patients with lung cancer, this study examined changes in their sleep–wake rhythm, sleep quality, anxiety, depressive symptoms, fatigue, and quality of life (QoL) at various treatment stages. In addition, factors affecting their QoL were explored. Methods: Hierarchical linear modelling was adopted to analyze a convenience sample of 82 patients with lung cancer. The changes in their sleep–wake rhythm, sleep, mood (anxiety, depressive symptoms, and fatigue), and QoL were observed at five time points: prior to treatment and at weeks 6, 12, 24, and 48 after the start of the treatment. The effects of sex, age, cancer stage, treatment type, comorbidities, and time were controlled to determine the predictors of patients’ QoL. Results: The results showed that patients’ sleep–wake rhythms were poor before treatments. Compared with baseline, the sleep–wake rhythms of the patients significantly improved at week 48, and anxiety significantly improved at weeks 6, 12, 24, and 48. By contrast, their fatigue became exacerbated at weeks 8 and 48. Moreover, QoL improved significantly from week 6 until the end of the treatment period. QoL was negatively affected by poor sleep quality ( β = −0.69, p = 0.00) and depressive symptoms ( β = −2.59, p < 0.001) and positively affected by regular sleep–wake rhythms ( β = 0.23, p = 0.001). Conclusions: Therefore, clinical healthcare professionals should focus more attention to the fatigue levels of patients with lung cancer before, during, and after treatment. Healthcare professionals may also need to provide such patients with health education regarding sleep hygiene and with emotional support to assist them in maintaining regular sleep–wake rhythms in order to improve their QoL.
The reasons and timing of the oral transmucosal fentanyl administration in Japan.
Authors: Kajiura Shinya , Kashii Tatsuhiko , Takaki Akiyoshi , Chikaoka Shingo , Hayashi Naomi , Matsushita Takako , Kadota Ayaka , Fukai Sakie , Nakaya Rumi , Tachida Natsumi , Yamamoto Keiko , Nakajima Kazunori , Horikawa Hideyo , Takemura Yoshinori , Shima Tomoko , Furuichi Astushi , Ando Takayuki , Miwa Toshiro , Murakami Nozomu
Published: September 2018

e21665

Background: The oral transmucosal fentanyl disintegrating tablet, Abstral, is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid onset analgesia, and which may be effective for breakthrough cancer pain. It can be administered for the patients who cannot take the oral medicine. It has been marketed since 2014 in Japan. Methods: We selected patients who were administered Abstral for breakthrough cancer pain between 2014 and 2016 at Toyama University Hospital in Japan. We retrospectively investigated administration reasons based on medical record of those patients. Results: There were 111 patients who were administered Abstral. Primary lesions of lung/Gastrointestin/others were 43/52/16, respectively. ECOG PS 0-2/3-4 were 27/84, respectively. The median age was 66 y.o. (range 35-91 y.o.). Regularly using opioid were fentanyl patch prescribed for all patients. Median dose of fentanyl patch was 25mcg/hr (range 12.5-250mcg/hr). 90 patients (81%) had difficulties in the administration of oral medicine, which was the main reason of Abstral administration. Four patients (4%) were to reduce constipation and vomiting as side effects of oxycodone. Seven patients (6%) were to start a fentanyl patch. Three patients (3%) were assessed poor effect for short-acting opioid. Only seven patients (6%) were expected of rapid onset of analgesia effect. Abstral was administered in 27 patients (24%) during aggressive treatment such as chemotherapy administration and in 84 patients (76%) after aggressive treatment. Conclusions: The oral transmucosal fentanyl was administered for the patients who cannot take the oral medicine in Japan while it is expected to be administered to those who want to relieve breakthrough pain fast. Affirming a common understanding of the efficacy of the oral transmucosal fentanyl and breakthrough cancer pain is necessary in Japan.
Patient reported outcomes following palliative gastric RadiOtherapy for symptomatic advanced gastric cancer (PROG): Results from a phase 2 trial.
Authors: Tey Jeremy Chee Seong , Zheng Huili , Soon Yu Yang , Koh Wee Yao , Leong Cheng Nang , Lim Keith Hsiu Chin , Tham Ivan Weng Keong , Lu Jiade J.
Published: September 2018

e21667

Background: To determine the effect of gastric radiotherapy (RT) on patient reported outcomes (PROs; secondary endpoint) in the PROG trial. Methods: Patients with symptomatic locally advanced or metastatic gastric carcinoma with at least one index symptom of bleeding, pain or obstruction were treated with palliative gastric radiotherapy to a dose of 36Gy in 12 fractions (at 3Gy daily fractions). PROs were assessed using the European Organisation for Research and Treatment of Cancer Qualify of Life Questionanaire-C30 and stomach module STO22. The primary PRO hypothesis was that at least 30% of patients will achieve a > 10 point absolute improvement (considered significant) in the fatigue, nausea/vomiting and pain subscales in the C30, and dysphagia and pain subscales in the STO22 at 12 fractions and one month after radiotherapy. Assessments were performed at baseline, 12 fractions and one month post radiotherapy. Paired T test was used to compare the mean scores from baseline, and at 12 fractions and one month post completion of RT Results: Questionnaires were available from 49 of 50 patients (98%) at baseline, 36 of 45 patients (80%) at 12 fractions and 16 of 38 patients (42%) at one-month post RT. At 12 fractions, 50%, 28% and 44% of patients achieved a significant improvement in fatigue, nausea/vomiting and pain subscales in the C30 respectively. 42% and 28% of patients achieved a significant improvement in dysphagia and pain subscale in the STO22. The observed mean difference was 11 points and 4 points for pain subscale in the C30 and STO22 (P < 0.02). At one-month post RT, 63%, 31% and 50% of patients achieved a significant improvement in fatigue, nausea/vomiting and pain subscales in the C30 respectively. 44% and 19% of patients achieved a significant improvement in dysphagia and pain subscale in the STO22. There were no significant differences in the mean scores in the subscales of interest. Conclusions: Palliative gastric radiotherapy resulted in improvements in fatigue, dysphagia and pain at 12 fractions and at 1-month post radiotherapy in a significant proportion of patients. A phase III trial comparing the effects of different fractionation regimens on PROs is warranted. Clinical trial information: NCT01341756.
Assessment of dysgeusia and taste identification in patients undergoing chemotherapy for breast cancer.
Authors: Kuba Sayaka , Fujiyama Rie , Yamanouchi Kosho , Sakimura Chika , Hatachi Toshiko , Matsumoto Megumi , Yano Hiroshi , Kobayashi Kazuma , Takatsuki Mitsuhisa , Hayashida Naomi , Nagayasu Takeshi , Eguchi Susumu
Published: September 2018

e21668

Background: Dysgeusia is a common side effect of chemotherapy (CT) and often impacts negatively on QOL. This study analyzed the prevalence of gustatory test abnormalities in breast cancer (BC) patients undergoing CT. Methods: We enrolled 33 BC patients who were undergoing CT (26 adjuvant CT and 7 CT for advanced BC) and conducted 2 gustatory tests on CT day. In the test of sensitivity using the instillation method (IM), 4 basic taste stimuli (sweet, salty, sour, and bitter) at 5 concentrations were applied to the entire oral cavity. For the electrogustometry method (EM), we measured the amount of current for perception of metallic tastes, examining the front two thirds of the tongue (cranial nerve VII) and the back third of the tongue (cranial nerve IX). We compared awareness of dysgeusia with results of the 2 gustatory tests. Results: Median CT duration was 83 days (12–1,353). Fifteen (45%) patients had awareness of dysgeusia (Grade 1: 11, Grade 2: 4). IM revealed 8 (24%) patients with abnormalities, 7 in a single taste species and 1 in 3 taste species. EM revealed 20 (61%) patients withabnormalities, 7 in the cranial nerve VII and 20 in the cranial nerve IX innervation area. All patients with abnormalities in the cranial nerve VII innervation area also had abnormalities in the cranial nerve IX innervation area. Among 15 patients with awareness of dysgeusia, there were 5 (33%) IM abnormalities and 12 (80%) EM abnormalities (4 in the cranial nerve VII and 12 in the cranial nerve IX innervation area). Among 18 patients without awareness of dysgeusia, there were 3 (16%) IM abnormalities and 8 (44%) EM abnormalities (3 in the cranial nerve VII and 8 in the cranial nerve IX nerve innervation area). Patients with IM abnormalities had a higher frequency of abnormalities in the cranial nerve VII innervation area than the normal range (50% and 12%, respectively; p = 0.04); there was no significant difference in the cranial nerve IX innervation area. Conclusions: Nearly half of the patients reporteddysgeusia, but most of these could correctly identify the four basic tastes. Further studies to clarify the discrepancy between subjective and objective observations could lead to effective prevention and treatment of dysgeusia.
Online education needs and preferences of patients with cancer and their caregivers.
Authors: Herrmann Tara , Peters Pamela M. , Van Laar Emily Sherene
Published: September 2018

e21669

Background: Patients and caregivers have many questions upon receiving a diagnosis of cancer. One way to help alleviate this burden, and enable participation in care is through education. Patient education correlates with higher levels of satisfaction and improved clinical outcomes. However, little is known about how patients and caregivers define their education needs. Methods: We surveyed patients with cancer and caregivers to assess their perceived education needs and resources. Results:2327 individuals representing 9 malignancies participated in the survey. Participants were predominantly patients (72%), with a majority (51%) having received their initial diagnosis of cancer within the past 2 years. Less than a quarter (22%) of respondents felt their educational needs were being completely met by available resources. Respondents were most likely to seek out information at the time of diagnosis (24%) and to increase understanding of treatment options (24%). Conversely, individuals were least likely to seek education upon disease progression (7%). In all malignancies examined, the 2 topics considered most important were treatment options (70%-89%) and understanding test results (74%-87%) while information about how to take medication as prescribed was deemed least important (46%-67%). Conclusions: Our study identified a lack of educational materials available and designed to meet cancer patients’ needs on the internet. Given that few patients and caregivers reported that their educational needs are being met, efforts may be needed to ensure that those patients who want to receive education to become informed patients can find what they need, when they need it.
Improving distress screening completion rates: Does virtual robot animation make a difference?
Authors: Dvorak Tomas , Robinson Diane , Ross Emily , Milliard Sharlin , Metcalf David , Hajdenberg Julio
Published: September 2018

e21672

Background: Distress screening is an important part of cancer patients’ care. Programs accredited by Commission on Cancer must implement distress screening programs, based on improved doctor-patient relationships and clinical outcomes. We are interested in evaluating the use of an anthropomorphic robotic interface to improve survey completion rates and the patient experience. Methods: A validated distress screening survey was scheduled for 74 patients in 2016 in an IRB-exempt survey study. Patients were randomly assigned to fill out the survey on iPAD (N = 33), or on iPAD with a virtual robot animation (“Betty”) introducing the survey (N = 41). Patients were then asked to fill out a validated 10 question Technology Acceptance Model questionnaire (TAM) asking about ease of iPAD use. A five point Likert scale was used. Finally, two yes/no questions were asked: 1) “Were you more interested in filling out the distress screening survey because of the “Betty” animation?”, and 2) “Did the animation make filling out the distress screening survey more enjoyable?” Results: The survey completion rate was 24/33 = 73% for control and 26/41 = 63% for intervention groups (p = 0.86). Forty five patients completed the TAM questionnaire, with completion rate 92% and 88%, respectively. Average iPAD TAM score was 4.3 in the control group and 4.0 in the intervention group (p = 0.12), and none of the 10 questions showed statistically significant difference in ease of use. The last two questions evaluating “Betty” directly were answered by 17/23 and 15/23 patients, respectively. 8/17 felt they were more interested in filling out the distress screening because of “Betty”, and 7/15 felt “Betty” made the distress screening more enjoyable. Conclusions: The presence of “Betty” as part of the survey process did not negatively impact the completion rates. There was no significant difference between the groups in perceived ease of use of the iPAD on which the survey was administered. Approximately half of the patients taking the distress survey with the “Betty” animation felt they were more interested in filling out the survey and the process was more enjoyable. We are currently evaluating whether a true robot may improve completion rates and patient experience.
Oral vitamin B12 to improve aromatase inhibitors (AI)-associated musculoskeletal symptoms (AIMSS).
Authors: Campbell Aleli , Nahleh Zeina A. , Heydarian Rosalinda , Ochoa Cecilia , Dwivedi Alok
Published: September 2018

e21679

Background: Breast cancer patients undergoing Aromatase Inhibitor (AI) therapy often experience many side effects, which include musculoskeletal and joint pain. Vitamin B12 has often been used as a naturopathic supplement to relieve joint pain that is caused by arthritis. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal pain and arthralgias induced by aromatase inhibitors (AI) therapy. Methods: After approval by Institutional Review Board (IRB), we enrolled consecutive patients treated at the Texas Tech Breast Care Center who had a diagnosis of invasive breast cancer, Stages I-III, and were taking an AI and experiencing significant musculoskeletal symptoms assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. Participants received 2500 mcg of sublingual vitamin B12 daily for 90 days. Assessments included improvement in BPI-SF pain scores at 3 months, the impact on quality of life determined by the Functional Assessment of Cancer Therapy–Endocrine Symptoms, FACT-ES and correlative serum markers. Results: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. Analysis of the data collected indicate a 34% average pain improvement (P-value = 0.0001) as reported by patients at baseline and at the end of treatment in the BPI-SF questionnaire. Additionally, a 23 % worst pain improvement (P-value = 0.0003) was obtained for worst pain scores evaluated similarly, at baseline and at the end of treatment. Analysis of the results for the FACT-ES scoring showed improvement on all scales. No significant adverse events were observed. Additionally, decrease in pain score was correlated with increased serum B12 levels. A paired t-test was used to assess the mean difference between baseline and endpoint. Conclusions: This study suggests that vitamin B12 reduces pain and improves quality of life for patients taking AIs who experienced AI-related musculoskeletal symptoms. If confirmed in large randomized prospective trials, Vitamin B12 would be a safe and cost effective option for the treatment of AI -related musculoskeletal symptoms.
Feasibility and acceptability of a best supportive care (BSC) checklist among clinicians.
Authors: Boucher Nathan Adam , Nicolla Jonathan , Ogunseitan Adeboye , Kessler Elizabeth Riley , Ritchie Christine , Zafar Yousuf
Published: September 2018

e21682

Background: Some clinical trials for advanced cancer compare experimental therapy to BSC. Usually BSC is not standardized across sites, consistent with best available evidence in palliative care practice, or described in sufficient detail. We developed a consensus-based checklist to document BSC delivery, including symptom management, decision making, and care planning. We hypothesized that BSC can be feasibly documented with this checklist consistent with Consolidated Standards Of Reporting Trials (CONSORT) statements. Methods: Clinicians at 4 academic centers were asked to complete the BSC checklist at each encounter with eligible cancer patients. Enrolled physicians completed a survey regarding use of the checklist during clinic appointments. Descriptive statistics and frequencies were generated. Results: 15 clinicians completed the checklist survey, 9 of whom were advanced practice providers. Mean age was 41 (SD = 7.9). Mean number of years in practice since fellowship for physicians was 7.2 (SD = 4.5). Represented were medical oncology (n = 8), gynecologic oncology (n = 4), palliative care (n = 2), and other (n = 1). For “overall impact on your delivery of supportive/palliative care,” 40% noted improved impact with the checklist. For “overall impact on your documentation of supportive/palliative care,” 46% noted improvement. Impact on “frequency of comprehensive symptom assessment” was 33% “increased.” Impact on “frequency with which you assessed for referral to support services” was 26% “increased.” Impact on “frequency with which you educated patients regarding goals of therapy” was 20% “increased.” No one noted decreased frequency or worsening impact. Regarding feasibility of integrating BSC in workflow, 73% agreed or strongly agreed that the BSC checklist could be easily integrated; 73% saw value in integration; and 80% found it easy to use. Conclusions: Clinicians viewed the BSC checklist favorably. While a small sample, this illustrates proof of concept, minor impact on provider workflow, and potential benefit to patients for use in a future randomized trial.
Assessing the clinical feasibility of implementing a novel assessment of frailty: The electronic Rapid Fitness Assessment in diverse thoracic surgery clinics.
Authors: Downey Robert J. , Korc-Grodzicki Beatriz , Weber Ryan , Vickers Andrew J. , Jones David Randolph , Bains Manjit S. , Shahrokni Armin
Published: September 2018

e21687

Background: The American College of Surgeons and American Geriatrics Society recommend a geriatric/frailty assessment (GA) in the preoperative evaluation. We previously reported the development and implementation of the electronic Rapid Fitness Assessment (eRFA) in geriatric clinics. The eRFA captures data on multiple GA domains, including functional activity, social support, emotional well-being, weight loss, polypharmacy, and cognitive function. We now report the feasibility of clinical implementation of the eRFA in diverse thoracic surgery outpatient settings. Methods: Over 5 months, the eRFA was implemented until used by 5 surgeons in 2 outpatient clinics. All patients presenting for initial consultation were to complete the self-reported components of the eRFA by themselves or with the help of caregivers using a tablet or desktop computer, before coming to the clinic or in the clinic. A nurse performed the timed “get up and go” test and MiniCog test. A summary report was prepared for the clinician by the time of the encounter, and the data were stored in a database and as part of the electronic medical record. Time to complete the eRFA was recorded. Results: Since initiation in 9/2016, 78% of patients (65/83; median age, 71 [range, 20-88]; 31F:34M) completed the eRFA at initial consultation with a thoracic surgeon. Median time to complete was 9 min (range, 2-50); 75% of surveys were completed by the patient alone, 23% with a caregiver, and 3% by a caregiver alone. A large number of geriatric syndromes were uncovered: 26% of patients (17/65) had abnormalities in word recall, clock drawing, and/or timed “get up and go”; 41% (27/65) needed assistance with activities of daily living; 9% needed a cane or other support to ambulate; and 26% had at least 1 fall in the last year. Conclusions: Administration of the eRFA, an electronic assessment of patient frailty, is feasible in the initial evaluation of thoracic surgery patients. Future steps include characterization of functional reserve of patients considered for surgery, creation of prognostic models, and development of clinical trials to assess means of improving outcomes in this population of patients at risk.
Correlating wearable activity monitor data with PROMIS detected distress and physical functioning in advanced cancer patients.
Authors: Shinde Arvind Manohar , Gresham Gillian K. , Hendifar Andrew Eugene , Li Quanlin , Spiegel Brennan , Rimel Bj , Walsh Christine S. , Tuli Richard , Piantadosi Steven , Figlin Robert A.
Published: September 2018

e21689

Background: Patients with advanced cancer experience significant distress. Timely identification and treatment of distress can improve outcomes and quality of life. Domains of distress (i.e. pain, fatigue, physical function) can be assessed using patient reported outcome (PRO) questionnaires. However, PROs can be burdensome to patients, particularly when performed serially. Given the relationship between physical activity and sleep with domains of distress, wearable activity monitors may assist in the real-time detection of distress in advanced cancer patients. Methods: We conducted a prospective, observational study at Cedars-Sinai Medical Center and enrolled patients with measurable stage 3+ cancer, ≥18yr, English speaking, ambulatory, with a smartphone, and prognosis of > 3 months. Patients wore a Fitbit Charge HR continuously through 3 consecutive clinic visits, and completed NIH PROMIS tools (Physical Function, Pain, Sleep, Fatigue, and Emotional Distress) during visits. Fitbits recorded average daily step counts, stairs climbed, and sleep time. We conducted regression analyses that adjusted for baseline confounding variables and accounted for correlated responses. Results: 35 patients (Mean age 62; 53% males; 82% GI cancers) were evaluated. Patients had ECOG PS of 0 (20%), 1 (40%), 2 (23%), and 3(17%). The table below displays regression coefficients for steps, floors, and sleep in each PROMIS distress domain. Conclusions: There is a significant association between steps and floors climbed with multiple domains of distress and physical functioning. The lack of association between total sleep time and these PROs, may suggest that other metrics of sleep quality (i.e. awakenings), may be more relevant. These findings support further exploration of wearable data as a continuously monitored PRO surrogate in advanced cancer patients; wearable data should be further validated for use in both clinical and therapeutic trial settings. Clinical trial information: NCT02659358. [Table: see text]
Safety profile of EP2006 biosimilar filgrastim: A combined analysis of two independent phase III studies.
Authors: Harbeck Nadia , Gascon Pedro , Krendyukov Andriy , Hoebel Nadja , Gattu Sreekanth , Blackwell Kimberly
Published: September 2018

e21701

Background: The biosimilar filgrastim Zarzio (EP2006) was approved in Europe in 2009 and in 2015 became the first biosimilar approved by the FDA for use in the USA, marketed as Zarxio. Two phase III registration studies were performed to confirm the efficacy and safety of biosimilar filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Methods: Data were combined from the studies to evaluate safety. Study 1 (US registration trial) was a randomized, double-blind comparative study of biosimilar and reference filgrastim (Neupogen, Amgen) in women ≥18 years with breast cancer receiving (neo)adjuvant treatment for 6 consecutive cycles with TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2). Study 2 (EU registration trial) was a single-arm, open-label study of biosimilar filgrastim in women ≥18 years with breast cancer receiving doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 for 4 consecutive cycles. In/exclusion criteria and statistical definitions used for both studies were similar. Data of the patients treated with biosimilar filgrastim only were combined for Cycles 1-4. Results: A total of 277 patients (mean±SD age: 51.1±10.8 years) received biosimilar filgrastim (5 μg/kg bw/day sc). Treatment-emergent adverse events (TEAEs) were consistent with the known safety profile of filgrastim. The most frequently reported filgrastim-related TEAEs were musculoskeletal/connective tissue disorders (9.4%), including bone pain (5.8%) (Cycle 1). No neutralizing anti-filgrastim antibodies were detected. Mean±SD duration of severe neutropenia was 1.04±1.51 days in Cycle 1. Mean±SD depth of absolute neutrophil count nadir in Cycle 1 was 0.94±1.40 x 109/L. Conclusions: Safety data for biosimilar filgrastim EP2006 is consistent with reference filgrastim in women with breast cancer undergoing myelotoxic chemotherapy. Clinical trial information: NCT01519700. [Table: see text]
Unmet spiritual needs and its correlation with fatigue in early and advanced stage cancer patients in Indonesia.
Authors: Martina Diah , Putranto Rudi , Rachman Andhika , Shatri Hamzah
Published: September 2018

e21709

Background: Spirituality is a powerful coping mechanism during life-threatening illness trajectories. The unmet spiritual needs have been associated with increasing pain, depression, and anxiety. However, its relation to fatigue as one of the most prevalent and distressing symptoms in cancer patients has remained understudied in either early or advanced stage. Methods: This study was a cross-sectional study with consecutive sampling in the national referral hospital of Indonesia, between September 2015 and January 2016. This study interviewed adult cancer patients undergoing treatment in outpatient and inpatient settings and excluded those with cognitive and/or affective disorders and weak general condition which did not allow the filling of questionnaire. We used validated Problems and Needs in Palliative Care (PNPC)-short version questionnaire (Bahasa version) to assess unmet spiritual and fatigue needs. In addition to finding both prevalences, this study applied Mann-Whitney tests to analyze the relationship between unmet spiritual and fatigue needs in the early and late stage. Results: By the end of the study 329 (97.6%) subjects completed the questionnaire, 45.3% of which was among advanced stage. The prevalences of spiritual problem and fatigue were 39% and 63% while the unmet needs of both aspects, respectively, were up to 78% and 42%. Experiencing unmet needs on one or more of spiritual aspects was significantly related to the emergence of unmet fatigue needs, particularly in the advanced stage of cancer (p = 0.024). In the early stage, unmet needs of fatigue were prominent among those who remained to experience difficulties to be engaged usefully (p = 0.006). In advance stage, the unmet needs of fatigue were significantly correlated with difficulties concerning the meaning of death (p = 0.038). Conclusions: Most cancer patients remained to suffer from unmet spiritual needs, and it was significantly correlated with the occurrence of fatigue. Although it escalated in the latest stage of cancer, both were also found and related at the earliest stage. It underlined the importance of addressing spiritual needs and fatigue adequately since the diagnosis of cancer was made.
Sexual function and satisfaction in Mexican young women undergoing breast cancer treatment.
Authors: Villarreal-Garza Cynthia Mayte , Platas Alejandra , Castro-Sanchez Andrea , Miaja Melina , Fonseca Alan , Vega Yoatzin , Barragan-Carrillo Regina , Bukowski Alexandra , Chapman Judy-Anne Williams , Bargallo-Rocha Enrique , Goss Paul E. , St. Louis Jessica , Mohar Alejandro
Published: September 2018

e21714

Background: Compared to other regions, the burden of breast cancer (BC) in Mexico is disproportionately borne by younger women. Yet, their particular needs and concerns have remained understudied, including treatment-related sexual adverse effects. We aim to assess the sexual function and satisfaction in Mexican young women with BC undergoing treatment. Methods: This is a prospective sexual assessment study in BC patients of the pilot phase of the Joven y Fuerte Mexican cohort (N=96). Sexual health was assessed using the Female Sexual Function Index (FSFI) and the Sexual Satisfaction Inventory (SSI) at two points in time: baseline (BL) and 6-months follow-up (6-FU). FSFI and SSI scores lower than 26.55 and 111, respectively, were defined as sexual morbidity. Differences between proportions of BL and 6-FU were examined with Pearson chi-square test. Matched t-tests were used to test for differences in the domains of the FSFI and in the SSI total score. Results: 70 women completed the FSFI at both time points and 69 the SSI. Our results showed a high percentage of sexual dysfunction among Mexican women at BL and 6-FU (61.4% and 74.3%, respectively, p<0.001), as well as an elevated proportion of sexual low satisfaction at both time lines (40.6% and 43.5%, p=0.004). Most 6-FU FSFI domain scores were significantly worse than those at BL (Table 1). There were no significant differences in the SSI total score (102.31 [BL] vs 96.11 [6-FU], p=0.16). Conclusions: Mexican young patients with BC report significant sexual morbidity at BL, which even worsens after the first short follow-up. Reasons for the low sexual performance among Mexican women remain understudied and should be actively sought. In this prospective study, data will be annually collected for five years. This information will provide valuable information in an often-neglected matter of BC patients’ care. [Table: see text]
Effect of nationwide palliative care education program on lung cancer specialists.
Authors: Inoue Akira , Yamaguchi Takuhiro , Tanaka Keiko , Sakashita Akihiro , Aoe Keisuke , Eguchi Kenji
Published: September 2018

e21715

Background: Although palliative care has owed an essential part of cancer treatment, palliative care specialists are still insufficient. Thus in Japan, the Palliative care Emphasis program on symptom management and Assessment for Continuous Medical Education (PEACE) was launched in 2008 to provide primary palliative care education for all physicians engaged in cancer treatment. However, the effect of PEACE program on participants was uncertain. Methods: We conducted web-based surveys for physicians belonging to the Japan Lung Cancer Society and assessed outcomes of the PEACE program across three domains: knowledge, practices, and difficulties regarding palliative care by using the palliative care knowledge questionnaire for PEACE (PEACE-Q), Palliative Care self-reported Practice Scale (PCPS), and the Palliative Care Difficulties Scale (PCDS), respectively. All of these instruments were already validated in previous studies. Results: In February 2015, the survey was distributed to 5300 physicians and 923 of those surveyed including 455 respiratory physicians, 345 pulmonary surgeons, and 35 medical oncologist responded to all questionnaires. The result of PEACE-Q, PCPS, and PCDS (low score is better) were significantly superior in physicians who had participated in the PEACE program (n = 519) compared with non-participants (n = 404) (28.0 vs. 24.5, 71.8 vs. 67.1, and 34.4 vs. 36.9, respectively). The PEACE participants made significantly better scores than non-participants in all domains of PEACE-Q (philosophy of palliative care, cancer pain, side effects of opioids, dyspnea, nausea and vomiting, psychological distress, delirium, communication, and community-based palliative care) and PCPS (pain, dyspnea, delirium, dying-phase care, communication, and patient- and family-centered care), and 3 domains of PCDS (alleviation of symptoms, expert support, and communication with the patient and family). Conclusions: The PEACE program improved knowledge and practice of palliative care in lung cancer specialists in Japan.
QoL of pediatric-inspired compared to hyper-CVAD regimens for newly diagnosed AYA patients with Ph-ALL: A modeling analysis.
Authors: Hooper Ellen , Hu Xingdi , Lin Peggy L , DeAngelo Daniel J.
Published: September 2018

e22002

Background: The treatment of acute lymphoblastic leukemia (ALL) requires 2+ years of intensive multi-agent chemotherapy, with significant impact on quality of life (QoL). While treatment protocols exist for adolescent / young adult (AYA) patients, there is limited evidence on the QoL impact for patients treated with pediatric-inspired protocols, which include asparaginase, versus regimens such as Hyper-CVAD. Objective: To compare the QoL impact of pediatric-inspired vs Hyper-CVAD regimens in the 1st-line treatment of AYA patients with Ph- ALL using disease simulation. Methods: A 6-state Markov model was developed to simulate total life-years and quality-adjusted life-years (QALYs) for AYA ALL patients receiving 1st line pediatric-inspired or Hyper-CVAD regimens. Modeled health states were: no first complete remission (no treatment/non-response to 1st line), first complete remission, first relapse, second complete remission, second relapse, and death. Model inputs for CR, EFS, OS, AEs, and health utility were obtained from literature. Weibull function was fitted to extrapolate survival and QALY over time. Results: Compared with Hyper-CVAD, the pediatric-inspired protocol resulted in increased life-years and QALYs at years 5, 10 and through a lifetime horizon. Benefits were mainly driven by more favorable progression-free survival and OS of patients in pediatric-inspired protocols compared to hyper-CVAD. Conclusions: This disease simulation model suggests that pediatric-inspired protocols for newly diagnosed AYA patients with Ph- ALL may increase QoL, as measured by QALYs, compared to Hyper-CVAD. Future long-term follow-up studies are needed to confirm these findings. [Table: see text]
Single institution experience of posterior reversible encephalopathy syndrome (PRES) associated with high risk pediatric ALL induction therapy: Is there a role of pharmaco-ethnicity.
Authors: Mittal Nupur , Nagarajan Murali , Heydemann Peter
Published: September 2018

e22005

Background: PRES, a rare complication of childhood leukemia treatment occurs in up to 5% patients in small series and < 1% of patients on the current COG high risk leukemia protocol. Hypertension, chemotherapy and cortical spreading depression have been implicated in the pathophysiology. It is important to recognize the characteristic radiologic findings, manage appropriately and reintroduce chemotherapy since delays can be unfavorable for high risk ALL patients. Pharmaco-ethnicity may determine variation in drug responsiveness and neurotoxicity in children with ALL. Ethnic Differences in occurrence of PRES in pediatric ALL have not been reported. Methods: 12 children (1-20 yrs) diagnosed with ALL between 2011-2016 were retrospectively reviewed for the occurrence of PRES, demographics, chemo-therapy received, clinical features, radiology and management. All literature on PRES in pediatric leukemia on Pubmed was reviewed. Results: 5/12 (42%) children (avg 8.5 yrs) developed PRES during days 10-29 of induction. 80% of the patients that developed and 45% of those that did not develop PRES were Hispanic. All the patients that developed and 3/7 that did not develop PRES were high risk ALL. All patients received vincristine, 4/5 daunorubicin and intrathecal methotrexate and 1/5 peg asparaginase in the 1 week before the event. MRI findings confirmed the diagnosis of PRES in all patients. All patients were in remission based on MRD and spinal fluid cytology. 3/5 patients had clinical and electroencephalographic seizures and hypertension at the time of the event. All patients had complete neurologic recovery. Conclusions: Hispanic ethnicity, high risk ALL and exposure to vincristine ,daunomycin and intrathecal methotrexate during induction were associated with PRES in our cohort . Ethnicity emerged as a new association possibly contributing to the increased incidence of PRES in our cohort compared to historical cohorts. Larger studies to understand the importance of pharmcoethnicity in PRES will help in individualization of chemotherapy with the goal of improving the tolerability and effectiveness of chemotherapy.
Association of immune contexture, age, and tumor stage in peripheral neuroblastic tumors (PNT).
Authors: Renne Salvatore Lorenzo , Camisaschi Chiara , Spagnuolo Rosalin Dolores , Podda Marta Giorgia , Barisella Marta , Castelli Chiara , Luksch Roberto , Collini Paola
Published: September 2018

e22006

Background: PNTs, a family of tumors arising in the embryonal remnants of the sympathetic nervous system, account for 7-10% of all tumors in children. NMYC status, stage, and age are the most important prognostic factors. The association of patient age and prognosis could be influenced by the maturity of immune system. The aims of this study were to describe the immune contexture in PNTs and to investigate its relationships with patient age and tumor stage. Methods: A cohort of 45 consecutive children with PNT diagnosed and treated at a single centre (2008-2014) with available primary tumor specimen at disease diagnosis and no prior chemotherapy was investigated. Immunohistochemistry for CD45, CD3, CD20, CD14, CD163, CD68, PDL1(P142), and FOXP3 was performed. Presence and status of immune infiltration were scored as follow: the presence of aggregates was assessed at 2.5X scanning magnification and recorded as "high" if present or "low" if no aggregates were visible. Patient age was categorized according to London WB et al (2005) using a 460 days cut-off and INSS tumor stage was considered. Results: Patient age ranged between 8 days and 14 years. Tumor infiltrating CD45 and CD3 scores were lower in INSS tumor stage 4 compared to other INSS tumor stages (CD45: OR=12.37, 95%CI 1.38 -171.00, P=0.01; CD3: OR=9.86, 95%CI 1.52-114.13; P<0.01). Similarly, the monocytes and macrophages markers CD163 and CD14 were associated with tumor INSS stage. The expression of these markers was significantly higher in patient older than 460 days (CD163: OR=4.41, 95%CI 0.77-32.12, P=0.03; CD14: OR=6.94, 95%CI 0.79-335.33, P<0.01). Interestingly, PD-L1 was detected only on immune cells but not on neuroblastic cells. Finally, Treg(FOXP3+) score was low in all but one case. Conclusions: Immune contexture in PNT significantly varies across patient age and tumor stage suggesting a role for maturity of immune system in these patients. [Table: see text]
The rates of ABO, Rh, and Kell antigens in children with cancer.
Authors: Maslov Andrey A. , Guskova Nailya , Guskova Ekaterina , Avanesova Kristina , Belgova Svetlana V. , Gornostaeva Ekaterina , Tselishcheva Irina V. , Zakharchenko Viktoria , Torpudzhyan Izabella , Donskaya Aliya K. , Gusareva Marina A. , Abakumova Svetlana V. , Golomeeva Nadezhda , Nozdricheva Anastasia
Published: September 2018

e22007

Background: The purpose of the study was to analyze phenotypic characteristics of red blood cells by the AVBO, Rh and Kell systems in children with cancer. Methods: ABO and Rh blood groups were determined and erythrocyte antigens (D, С, с, Сw, Е, е, К, k) were typed (AutoVue Innova, USA) in blood samples of 114 children with solid tumors. Results: ABO blood groups distribution was as follows: A(II) > O(I) > B(III) > AB(IV) with A(II) prevalence. Rh(D)-positive phenotype was observed in 82 (71.9%) patients of 114: 47 (57.3%) boys and 35 (42.6%) girls. 32 (28.1%) patients of 114 were Rh(D)-negative: 15 (46.8%) boys and 17 (53.1%) girls. Only 8 (7%) children were Kell-positive, which was similar to the antigen prevalence in European population. 4 erythrocyte phenotypes were the most frequent in Rh(D)-positive patients: СсDееK− (34.1%), ССDееK− (22.0%), ccDEeK− (13.4%) and СсDЕеK− (11.0%). I.e., more than a half of children with oncopathologies (56.1%) had Kell-negative phenotypes, СсDееK− and ССDееK−. 86.4% of Rh(D)-positive patients had homozygous combinations of Rhesus antigens causing transfusion reactions - СС, сc, ЕЕ and ее. 18 (22.0%) of Rh(D)-positive patients were homozygous for the C antigen and 64 (78.0%), i.e. every third patient, had the c antigen. Children with the C antigen may be sensitized to the c antigen through blood transfusion with subsequent development of hemolytic complications. The K (Cellano) antigen was found in all children, and 93% of them had kk phenotype and 7% - Kk. The Сw (Willis) antigen was revealed only in 5 (6.0%) Rh(D)-positive patients with rare phenotypes - CwCceeK-, CwccEeK-, CwCcEEK-, CwCcEeK-. Matching a donor for patients with one of these phenotypes could pose a problem. Conclusions: Studying phenotypic characteristics of red blood cells is necessary for providing a successful blood transfusion, especially in children Kell-positive for the K antigen, in children homozygous for the C antigen with ССDееК- phenotype and in children with the Сw antigen and СwСсееК-, СwссЕеК-, СwСсЕЕК- and СwСсЕеК- phenotypes.
Efficiency and toxicity of mifamurtid in childhood osteosarcoma.
Authors: Tacyildiz Nurdan , incesoy Ozdemir Sonay , Unal Emel Cabi , Dincaslan Handan , Yavuz Gulsan , Asarcikli Fikret , Tanyildiz Gulsah , Yildiz Yusuf
Published: September 2018

e22010

Background: There are only few data concerning efficiency and toxicity of mifamurtide in children with osteosarcoma (OS). The aim of this study was to evaluate efficiency and side effects of mifamurtide in childhood OS. Methods: We retrospectively analyzed the data of 18 patients with OS and who received mifamurtide between January 2012 and December 2016. Four hundred seventy seven doses of 2 mg/m2intravenous mifamurtide, along with paracetamol premedication were given in 15 patients with primary non-metastatic OS after complete surgical resection and 3 patients with progressive OS. Results: There were 11 males and 7 females, and the median age was 14 years (ranged, 9-18). The median follow-up time was 20 months (ranged, 7-51). The metaphyseal plates around the knee was the most frequent disease location with 94.4%. The median necrosis percentage was 94 (range, 35-100). All patients received Euromos protocol. The most common side effects were chills and fever (17/18). These reactions were observed in 4 patients during every administration, in only one patient at last administration and in the remaining 12 patients during first or first two administration. Headache, myalgia and arthralgia were observed in 2 patients during every infusion. In another one case, headache was observed during only first two infusions and he also hearing loss was developed (could be related CisPlatin) Back pain was observed in two patient during first infusion but one them suffered with severe back pain after few doses and stoped Mifamurtid. . Grade 3-4 neutropenia, trombocytopenia, abnormal liver enzymes and abnormal BUN and creatinin levels were not observed in patients who received mifamurtide alone after completion of chemotherapy. Of the 15 patients with primary non-metastatic OS treated with the addition of mifamurtide to chemotherapy, 13 showed complet remission for median 24 months (ranged,16-36) and 2 patients are still under treatment with complet remission. Of the 3 patients with progressive disease, 2 died and 1 had progressive disease for 51 months. Conclusions: Mifamurtide therapy is safe and well tolerated in childhood OS. Chills and fever were the major side effects, These events were transient and often no longer observed in subsequent administrations.
Safety and efficacy of fosaprepitant in pediatric patients for prevention of chemotherapy induced nausea and vomiting.
Authors: Kusick Karissa N , Waldron Madeline , Zembillas Anthony , Wai Maya , Hanna Rabi , Anderson Peter Meade
Published: September 2018

e22023

Background: Aprepitant is an antiemetic that antagonizes the substance P neurokinin-1 receptor. Fosaprepitant is an intravenous prodrug of aprepitant and is FDA-approved for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. Although the FDA extended approval of oral aprepitant to children and adolescents for CINV, pediatric patients have challenges obtaining aprepitant due to insurance or have difficulty taking oral medications during chemotherapy. Fosaprepitant is a logical alternative but data are lacking for safe and effective dosing in children. In 2015, fosaprepitant was added to our hospital formulary for pediatric patients receiving moderate to highly emetogenic chemotherapy. The fosaprepitant dose established was 150mg for weight ≥30kg or 3mg/kg/dose for < 30kg. There is also potential for overall cost savings to our institution. Fosaprepitant is about half the cost of aprepitant using equivalent adult doses. Methods: This retrospective chart review was considered exempt from IRB.All pediatric patients who received fosaprepitant between April 2015 and October 2016 while inpatient were included.Patients undergoing bone marrow transplant were excluded from the study.The primary objective was to determine safety of fosaprepitant. To evaluate safety, incidence of infusion related reactions related to fosaprepitant administration were assessed. Secondary objectives include efficacy of fosaprepitant in pediatric patients and evaluation of cost savings. To evaluate efficacy, the use of breakthrough antiemetics, documented emesis, and Adapted Rhodes Index for Nausea and Vomiting score were collected. Descriptive statistics were used for all data analyses on a per cycle basis. Results: A preliminary safety evaluation of 20 patients ages 9 months through 16 years received 87 doses of fosaprepitant for CINV prophylaxis.Six patients < 30kg received weight-based dosing; the other 14 patients received a dose of 150mg.One patient experienced an infusion related reaction from fosaprepitant but symptoms resolved after the infusion was stopped. Conclusions: Fosaprepitant appears to be safe and cost-effective to prevent CINV in children.