bluuebunny/crossref_metadata_2025_split huggingface dataset:
Inclusion criteria for cancer cachexia clinical trials: CT-defined skeletal muscle loss versus body weight loss.
Authors: Roeland Eric , Nelson Sandahl H , Campillo Ashleigh , Heavey Sean , Ma Joseph D. , Revta Carolyn , Gallivan Andrea , Baracos Vickie E 
Published: February 2017

67 Background: Cancer cachexia is defined by skeletal muscle loss, with or without fat loss (Fearon et al 2011); however, inclusion criteria for cachexia clinical trials requires a defined weight loss over time rather than muscle loss. We hypothesized that cross sectional imaging may reveal the presence of cachexia otherwise obscured by fat mass changes. Methods: A retrospective analysis of longitudinal CT scans was performed in metastatic colorectal cancer (mCRC) patients screened for a cancer cachexia trial, which required ≥5% weight loss in the prior 6 mos. De-identified CT images were analyzed for total muscle, subcutaneous, and visceral fat cross-sectional areas (cm2) at the 3rd lumbar vertebra at baseline and up to 12 mos prior (Lieffers et al 2009). Logistic regression was used to test differences between patients with <5% vs ≥5% weight loss. Random intercept regression was used to evaluate significant trends in CT measures over time. Results: 42 mCRC patients were screened and 3(7%) enrolled. Patients were excluded for comorbidity/contraindication 14 (33%), excessive [>20%] weight loss 4 (9.5%), and insufficient [<5%] weight loss 19 (45%). For the <5% weight loss subset, there was a mean of 6.7 CT scans (SD=2.67) and of 9% (SD=5.4, min=0%, 25th percentile=4.9%) mean max muscle loss. Notably this group was simultaneously losing muscle (p=0.002) and gaining visceral adipose (p=0.007). For the ≥5% weight loss subset, there was a mean of 7.5 CT scans (SD=4.5) and 20% (SD=10.0, min=5.2%, 25th percentile =10.6) mean max muscle loss. Greater max muscle loss increased the odds of being in the ≥5% weight loss subset (OR=1.19, 95% CI: 1.06,1.33). This group also had a significant decrease in visceral adipose over time (p<0.001). Redefined inclusion criteria of ≥5% muscle loss would have included 14 of the 19 patients excluded because of <5% weight loss. Conclusions: Defining cancer cachexia as weight loss over time may be limited as it does not capture body composition changes and hinders trial accrual. Cross-sectional CT body composition analysis may improve early detection of muscle loss and improve trial accrual.
Occurrence, severity, and impact of cancer-related fatigue in Taiwanese patients with cancer: A national survey.
Authors: Hsieh Ruey Kuen , Shun Shiow-Ching , Rau Kun-Ming , Chiou Tzeon-Jye , Sung Yung-Chuan , Yeh Su-Peng 
Published: February 2017

77 Background: Cancer-related fatigue (CRF) is common symptom in cancer patients. However, there is no study related to occurrence, severity and impact of CRF in Taiwan. The aim of this study was to report the occurrence and severity of CRF, and its impact on quality of life in cancer inpatients and outpatients in Taiwan. Methods: A national survey with cross-sectional study design was used. Patients were recruited from 20 hospitals with inpatients unit (n = 574) and outpatients clinics (n = 633) in Taiwan. The structured questionnaire was used to assess patients’ demographic, clinical, and CRF characteristics among Taiwanese cancer patients. The CRF were assessed by International Classification of Diseases 10th Revision (ICD-10) and Brief Fatigue Inventory–Taiwan Form (BFI-T). Quality of life (QOL) was assessed by FACT-general. Descriptive statistics and bivariate correlations were used to compare the occurrence, severity, and impacts on quality of life of CRF between cancer inpatients and outpatients. Results: Overall, the occurrence was 23.36% based on ICD-10 CRF criteria and 31.9% and 15.6 for inpatients and outpatients, respectively. About94.4% of inpatients and 89.7% of outpatients experienced fatigue. Inpatients had significant higher fatigue severity (current fatigue, general fatigue, and worst fatigue) during the past 24 hours compared to the outpatients. Enjoyment of life was the most interfered by fatigue in both inpatients and outpatients. The mean levels of current fatigue, general fatigue and worst fatigue were moderate in inpatients, and they were mild to moderate in outpatients. The mean score of FACT-general was 17.57 in overall with the lowest level of functional well-being, and 15.68 and 19.29 in inpatients and outpatients. Conclusions: The occurrence based on the ICD-10 CRF criteria was relative low compared to self-report. Fatigue interfered patients’ enjoyment of life and the patients had the lowest level of quality of life in functional well-being. Healthcare providers should pay attention on how to decrease cancer patients’ fatigue in order to improve their QOL, especially in inpatients.
Comparison of prevalence of pain symptoms and completion rates using a patient-reported outcomes (PRO) tool of pain in palliative and curative patients.
Authors: Yeung Sabrina , Brown Catherine , Perez Cosio Andrea , Leung Yvonne , Liang Mindy , Gill Gursharan , Sarabia Samantha , Liu Aixin , Wong Lauren , Howell Doris , Liu Geoffrey 
Published: February 2017

78 Background: Regular self-reporting of symptoms using validated computerized assessment tools can improve individualized symptom management. Yet there are concerns that palliative patients who may benefit most from such self-reporting may be reluctant to adopt such approaches or have barriers to proper reporting. We compared actual prevalence and completion rates of a PRO-tool between patients being managed with a palliative (PAL) or curative intent (CUR). Methods: A pain PRO-tool was administered cross-sectionally using tablet technology across outpatient clinics in a comprehensive cancer centre. Questions were adapted from the Brief Pain Inventory (BPI) and Edmonton Symptom Assessment System (ESAS), recording responses on pain severity and interference in life. PRO-tool completion rates and prevalence of pain symptoms were compared between CUR and PAL. Results: Of 200 patients, 82 were PAL and 118 were CUR; median age was 60 (21-86) years; 48% were female. A greater proportion of PAL were found with gastrointestinal, gynecological and lung cancers than CUR (p = 0.04). Each question had greater than 95% completion rates for both groups, capturing a wide range of scores. 16% of PAL reported no pain as their worst pain in the last 24 hours as opposed to 31% of CUR (p = 0.02). 82% (PAL) and 68% (CUR) reported their average pain as being at least “some pain” (p = 0.03), and there were no differences in the proportion of patients reporting interference with their general activity between PAL and CUR (p > 0.05). Presence of current pain was equivocal when assessed via the ESAS adapted question (76% PAL vs 66% CUR, p = 0.16), but was significantly different when assessed using the BPI adapted question (72% PAL vs 56% CUR; p = 0.02). Conclusions: A Pain PRO-tool was completed with similarly high rates in PAL and CUR patients. As expected, prevalence of recent and current pain was high in both groups, and in some instances, higher in PAL than CUR patients. These results suggest that a Pain PRO-tool could be implemented with ease in the palliative setting, and would capture pain comprehensively.
Are palliative patients less accepting to self-report symptom measures for clinical management than curative patients?
Authors: Sarabia Samantha , Perez Cosio Andrea , Brown Catherine , Leung Yvonne , Gill Gursharan , Liang Mindy , Yeung Sabrina , Liu Aixin , Wong Lauren , Liu Geoffrey , Howell Doris 
Published: February 2017

79 Background: Patient reported outcome measures (PROMs) are a tool used for collecting patient symptom data in the clinic, prior to the patient’s appointment. Patients being treated with a palliative intent are often assumed to find completing PROM surveys more burdensome than patients being treated with a curative intent. We compared patient acceptability of palliative versus curative patients to complete PROM surveys. Methods: 202 cancer out-patients (120 curative and 82 palliative) at the Princess Margaret Cancer Centre completed a PROM survey using a touchscreen tablet regarding their symptoms of pain. Ten questions assessed patient acceptance of completing PROM surveys. Results: The median age was 60 (range 21-86) and 48% were female. There were no clinically relevant demographic differences between the palliative and curative patients; however there were a higher proportion of palliative patients than curative patients with gynecological (8.3% palliative, 16% curative), lung (5.8% palliative, 10% curative), and gastrointestinal (14% palliative, 28% curative) cancers. There were no significant differences in acceptability between palliative and curative patients (p>0.05, all 10 comparisons). Only 3.6% of palliative patients and 3.3% of curative patients reported that completing the survey made their clinic visit more difficult; 16% of palliative patients and 11% of curative patients found the survey to be time consuming; no palliative patients and only 0.83% of curative patients found the questions upsetting or distressful. 93% of palliative patients and 92% of curative patients were happy to complete the surveys on a touchscreen tablet. Overall 62% of patients surveyed were willing to complete surveys at every visit (56% palliative and 67% curative, p>0.05). Conclusions: Palliative and curative patients appear to have an equally high level of acceptance of PROM surveys, though a significant minority would have problems with completing them at every visit. Further research using mixed-methods analysis will be done to better understand the factors limiting the overall willingness of both palliative and curative patients to complete the survey on a regular basis.
Patient- versus physician-reported outcomes in patients enrolled in a prospective study involving stereotactic body radiation therapy in unresectable or recurrent pancreatic cancer.
Authors: Rosati Lauren M. , Cheng Zhi , Robertson Scott P. , Kummerlowe Megan N. , Hacker-Prietz Amy , Pawlik Timothy M. , Wolfgang Christopher Lee , Le Dung T , Zheng Lei , Laheru Dan , Herman Joseph M. 
Published: February 2017

84 Background: Prospective evaluation of correlations between patient- (PROs) and physician-reported outcomes (PhROs) was conducted among a group of patients receiving stereotactic body radiation therapy (SBRT) for recurrent or locally advanced pancreatic cancer (PCA). Methods: Forty-two patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Eight outcomes (performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea) were consistently evaluated by patients and providers prior to SBRT and 4-6 weeks post-SBRT. Patient-reported quality of life (QOL) metrics were assessed using the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE v4.0.A Pearson’s correlation was used to determine the relationship between PROs and PhROs. Results: Of the 42 enrolled patients, 36 had both PROs and PhROs collected before (median, 2.9 weeks) SBRT. Physician-reported pain, nausea, constipation, and diarrhea did not show a correlation with patient-reported overall health or QOL. Physician-reported fatigue showed a correlation with patient-reported pain (r > 0.5, p < 0.001) and QOL (r > -0.5, p < 0.001) but not fatigue (r < 0.3, p > 0.05). Nausea and constipation were the only PROs that did not correlate with their respective PhROs (nausea, r < 0.3, p > 0.05; constipation, r < 0.5, p = 0.07) or any of the other 7 PhROs. Only 24 had both PROs and PhROs collected 4-6 weeks after (median, 5.1 weeks) SBRT. Vomiting, constipation, and diarrhea were PhROs that demonstrated no correlation with patient-reported overall health or QOL. Physician-reported vomiting did not correlate with patient-reported vomiting (r < 0.3, p > 0.05) or any of the 7 other PROs. The correlation between patient- and physician-reported pain increased from pre- (r > 0.3, p = 0.03) to post- (r > 0.7, p < 0.0001) SBRT. Conclusions: Discrepancies among PROs and PhROs appear to exist in pancreatic-specific outcomes of interest such as constipation and diarrhea. Future health care teams may find it helpful to consider PROs to better manage symptoms and deliver more personalized care. Clinical trial information: NCT01781728.
Correlations between functional Interleukin-1 and changes in fatigue and quality of life in children and adolescents with cancer.
Authors: Bomfim Emiliana de Omena , Anatriello Elen , Nunes Michelle Darezzo Rodrigues , Moraes Jordana Carvalhes , Cintra Michel Marcossi , Lopes-Junior Luis Carlos , Miyauti Michele , Nascimento Lucila Castanheira , de Lima Regina Aparecida Garcia , Floria-Santos Milena 
Published: February 2017

95 Background: Several studies have explored the hypothesis of involvement of the immune system in the cancer-related fatigue (CRF) and quality of life in adults with cancer via release of cytokines. However, how the immune system may produce these outcomes remains a largely unanswered question. Furthermore, research on fatigue in children and adolescents with cancer has included primarily self-reports of this symptom, with scarce although increasing data exploring biologic variables related to this symptom. Methods: To comprehensively examine the influence of cytokines in the fatigue and health related quality of life (HRQOL) in children and adolescents with cancer, we investigated the plasma levels of pro and anti-inflamatory cytokines and its correlation with fatigue and HRQOL in children and adolescents with cancer. Plasma levels of 6 cytokines were measured via flow cytometry. Results: The final sample consisted of 33 hospitalized children and adolescents aged between 8 and 18 years. We found a correlation between general fatigue and IL-1β (r = –0.361, p = 0.039) and correlation with quality of life was noted with IL-1β (r = –0.382, p = 0.028). The results of this research indicate that there may be a relationship between cytokines and fatigue, and HRQOL in children and adolescents with cancer. When analyzed the correlation between fatigue and some confounding variables found the link between general fatigue and neutrophils (r = –0.360, p = 0.040). This correlation is a novel found in this population under cancer condition, implicating a possible interleukin-hematological pathway for CRF in oncology. Conclusions: Our study confirms the potential role of cytokines in developing cancer-related symptoms, thus supporting the utility of the neuroimmunological approach to the discovery of biomarkers linked to the clusters of cancer-related symptoms.
A cross-sectional analysis of symptom burden among adult cancer patients in a Filipino tertiary care cancer center.
Authors: Bacorro Warren Ramos , Que Jocelyn C , Sy Ortin Teresa Tan , Feeley Thomas W. , Reyes-Gibby Cielito C. 
Published: February 2017

98 Background: Palliative and supportive care has been shown to improve quality of life (QOL) and survival and reduce caregiver burden and costs, but remains poorly integrated into cancer care in the Philippines. Understanding symptom burden profile among patients will guide policy-making in a limited/moderate resource setting. Methods: This cross-sectional study was conducted among adult Filipino cancer patients. Demographic and clinical data were collected from medical records and patient interviews. Symptom severity and interference were assessed using the M.D. Anderson Symptom Inventory. Symptom prevalence and mean severity scores were determined. Pearson correlation analysis was used to examine relationships between symptom severity and interference. Results: Participants (n = 251)were aged 18-80 years; the majority were aged < 60, females, or with good performance status (PS). Breast, head-and-neck and gastrointestinal primaries were most common; 45% had advanced disease. Moderate and severe symptoms were prevalent across stages. Fatigue (65%), pain (62%), sadness (62%), and anxiety/distress (58%) were the most prevalent, most severe and most interfering. In metastatic disease, sadness was most prevalent, and fatigue, most serious; among those with poor PS, disturbed sleep was most prevalent and most serious. Pain was more disabling among females, and fatigue and sadness, among the elderly. Conclusions: This is the first study to describe symptom burden among adult Filipino cancer patients. The clinical impact of symptoms is determined by their concurrence and the patient’s demographic and clinical profile. Symptom burden is highest for fatigue, pain, sadness, and anxiety/distress. Comprehensive symptom evaluation and tailored approach to care is necessary for optimal management. While a clinical practice guideline (CPG) has been adopted for use at our institute, effective CPGs for the screening, assessment and management of fatigue, depression and anxiety/distress have yet to be identified and implemented.
Could methylated reprimo cell-free DNA serve as a novel tumor marker to assess response in locally advanced gastric cancer treated with preoperative chemotherapy?
Authors: Muller Bettina Gabriele , Alarcon Alejandra , Arancibia Jorge M , Alfaro Francisca , Sola Jose Antonio , Maturana Maria J. , Ascui Rodrigo Andres , Fernandez Wanda , Corvalan Alejandro 
Published: February 2017

101 Background: Gastric cancer (GC) is one of the leading causes of cancer death. Perioperative chemotherapy (CT) for locally advanced GC improves curative resection rates and survival compared to surgery alone. Response assessment is challenging and no tumor markers have been validated for this purpose. We conducted a pilot study to investigate the role of methylated Reprimo (RPRM) cell-free DNA (cfDNA) as tumor marker for assessment of response to preoperative CT in patients enrolled in the study GOCCHI 2009-01 (NCT01633203). Methods: Patients with locally advanced GC referred to receive preoperative CT with Epirubicin + Cisplatin + Capecitabine for 3 cycles were offered to enter the study. Patients had to have operable GC, with baseline CT showing a transmural tumor and/or regional lymphnode metastasis with no distant spread assessed by a multidisciplinary tumor board. After the approval of the amendment of the protocol to allow blood sampling for tumor marker measurement and only if informed consent had been given, blood samples were taken at day one of each cycle of preoperative CT. The status of methylated RPRM cfDNA was assessed by Methylight and the number of copies per mL was determined. Patients with at least 2 samples were analyzed. Results: Thirteen patients signed the informed consent form for this substudy, and 11 patients had blood samples available for analysis. Of these, 8 patients had detectable methylated RPRM cfDNA on Day 1 of the first cycle (i.e. baseline). Five patients showed decrease in methylated RPRM cfDNA, while 5 patients had increased levels of the tumor marker in subsequent measurements. In one patient, methylated RPRM cfDNA was not detected in either of two assessments. One patient with a marked increase in methylated RPRM cfDNA after two cycles of CT had metastatic disease at laparotomy. Correlation between pathological findings and changes in methylated RPRM cfDNA will be presented. Conclusions: Our findings suggest that methylated RPRM cfDNA could serve as a novel tumor marker to assess response in locally advanced GC treated with preoperative chemotherapy. Further validation of these preliminary results is warranted.
Perioperative chemotherapy with ECX +/- panitumumab in locally advanced gastroesophageal adenocarcinomas (GEA): A randomized study of the Arbeitsgemeinschaft Internistische Onkologie and the Chirurgische Arbeitsgemeinschaft Onkologie of the German Cancer Society.
Authors: Stahl Michael , Mihaljevic Andre L. , Moehler Markus , Kanzler Stephan , Hoehler Thomas , Thuss-Patience Peter C. , Moenig Stefan Paul , Kunzmann Volker , Schroll Sebastian , Lordick Florian , Meyer Hans-Joachim , Sandermann Andreas , Schumacher Christoph , Wilke Hansjochen 
Published: February 2017

104 Background: Perioperative chemotherapy represents the European standard of care in locally advanced GEA. Efficacy may be improved by combining chemotherapy and molecular targeted drugs. Due to overexpression of epidermal growth factor receptor (EGFR) in most GEA EGFR-inhibitors may be candidates for such improvement. Methods: To evaluate the role of EGFR-antibodies in the perioperative treatment we performed a multicenter randomized phase II study. Patients with locally advanced (cT3-4 N0-3 M0) adenocarcinomas of the stomach or gastro-esophageal junction (GEJ) were eligible. Patients were treated with ECX with (arm 1 ) or without (arm 2) panitumumab (P, 9 mg/kg body weight iv, q 3 weeks). Three cycles were planned prior to and after surgery. The primary endpoint was to prove a reduction in ypT3-4 categories by adding P to ECX. Results: From 11/2010 to 7/2013 a total of 171 pts. were randomized, and 163 pts. (83 arm 1, 80 arm 2) were eligible. Prior to therapy 29% of the pts. in both arms had T4 tumors (CT scan and EUS) and 82% vs. 78% showed lymph node involvement. In 42% vs. 45% the primary tumour was located in the GEJ. 68 pts. (82%) vs. 68 pts. (85%) completed 3 preoperative cycles. The mean total dose of preoperative chemotherapy related to the planned dose reached 90% for panitumumab (arm 1 only), 91% vs. 92% for cisplatin, and 81% vs. 85% for capecitabine. R0-resection was achieved in 90% vs. 89% of the patients. The rate of pts. without downstaging (ypT3-4 at surgery) was statistically not significant higher in the experimental arm (73% vs. 66%, p=0.23), as was the overall treatment failure in the ITT analysis (odds ratio 1.37 (0.65-2.86)). The PCR-rate (ypT0N0) was comparable (3% vs. 5%, p=0.43). One toxic death was observed during chemotherapy (arm 2) and 1 pt. of both arms died due to complications after surgery. Conclusions: The study failed to reach its primary endpoint. The addition of P to ECX was not able to improve downstaging of locally advanced GEA. Survival data and results of translational research will be available during the course of 2015. Clinical trial information: NCT01234324.