bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.