bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Esophageal Online Patient Reported Outcomes (EsO-PRO) Questionnaire: Formal implementation and assessment of a combined clinical and research data collection tool.
Authors: Jiang Shirley Xue , Shah Shubhangi , Smith Elliot Charles , Baek Justine , Liang Mindy , Brown M. Catherine , Mayo Allyson , Liu Geoffrey , Yeung Jonathan , Wong Rebecca , Elimova Elena , Darling Gail Elizabeth 
Published: January 2019

37 Background: Systematic symptom monitoring improves quality of life, and possibly overall survival in cancer outpatients receiving chemotherapy. To reduce patient, staff, and resource burden, combining research surveys with electronic PRO assessments in a multidisciplinary academic esophageal cancer clinic may allow dual clinical-research goals to be met. Methods: EsO-PRO is a data collection tool directed at esophageal cancer outpatients created through expert feedback. Using the Canadian Institutes of Health research (CIHR) Knowledge-to-Action (KTA) framework, clinic flow and stakeholder maps were constructed. Facilitators and barriers were then identified, and responses were generated to address implementation barriers. Multiple iterations of the questionnaire were implemented; patient and clinic staff feedback was collected through key informant interviews, and major themes were described. Results: Creation of EsO-PRO included multiple validated tools: the FACT-E, modified Cancer Research UK esophageal cancer risk questionnaire, EQ5D-5L, PRO-CTCAE for common esophageal symptoms, and baseline clinico-demographic data. Four iterations of the KTA cycle for pilot implementation identified specific key facilitators (clinician champions, staff engagement, resource-integration, and clinician-researcher synergy) and barriers (familiarity with technology, survey length, and communication barriers). Qualitative assessment also identified perceived importance of questions as key to patient completion, and role delegation, staff burden, clinic flow interruption as critical issues to address. Splitting EsO-PRO into two separate visits for completion, allowing completion at home, and changing fill-in-the-blanks to check-off boxes were identified as potential solutions. Conclusions: The CIHR-KTA framework identified concrete methods for improved integration of a combined clinical-research survey tool for routine use in a multidisciplinary esophageal cancer outpatient clinic. Our process serves as an effective model for integration of innovations in multidisciplinary esophageal cancer clinics.
Impact of neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT) on R0 resection rate for borderline resectable and locally advanced pancreas cancer.
Authors: Zakem Sara Jean , Mueller Adam Christopher , Meguid Cheryl Lauren , Torphy Robert J. , Schefter Tracey E. , Davis S. Lindsey , Leal Alexis Diane , Leong Stephen , Lieu Christopher Hanyoung , Messersmith Wells A. , Purcell William T. , Ahrendt Steven Arthur , McCarter Martin , Del Chiaro Marco , Schulick Richard D. , Goodman Karyn A. 
Published: January 2019

370 Background: Management for borderline resectable pancreas cancer (BRPC) and locally advanced pancreas cancer (LAPC) is controversial. Multiagent chemotherapy (CT) followed by SBRT may allow for tumor downstaging and the ability to perform an R0 resection. Methods: We retrospectively evaluated BRPC and LAPC patients (pts) treated on our multidisciplinary treatment pathway. Pts underwent 2-3 months of CT. Pts without systemic progression received five fractions of SBRT, delivered every other day, to a dose of 30-33 Gy. After restaging, pts underwent surgery if resectable. Overall survival (OS), distant metastasis free survival (DMFS) and local progression free survival (LPFS) were estimated and compared by Kaplan-Meier and log-rank methods. Results: We identified 80 pts with BRPC (65) or LAPC (15) treated with neoadjuvant CT + SBRT between 2011-2017. Median follow up was 20 months. CT primarily included FOLFIRINOX (65%) and gemcitabine/nab-paclitaxel (30%). Of pts completing CT + SBRT, 67 (84%) went to surgery and 53 (79%) of those pts underwent definitive surgery including seven LAPC patients. The remaining 14 pts underwent palliative or exploratory surgery due to intraoperative metastases (43%) or vascular involvement (57%). Of pts undergoing definitive surgery, 51 had R0 resection (96%) and 5 (9%) had a complete pathologic response (PR) to CT + SBRT. The R0 resection rate of the cohort was 64%. OS was 24.5 months. Pts with a complete or marked (14%) PR had significantly better OS than those with a moderate (40%) PR (41.3 vs 30 months, p = 0.04) and pts unable to undergo definitive surgery (18.2 months, p < 0.001). Zero of 11 pts who had a marked or complete PR had local progression, significant compared to those with moderate PR (p = 0.012). DMFS between these two groups was not statistically significantly different. Conclusions: Neoadjuvant CT + SBRT are associated with favorable PR rates and R0 resection rates. Marked or complete PR was associated with improved LPFS and OS compared to moderate PR and pts who did not undergo definitive surgery. DMFS was not significantly different between complete and marked PR compared to those with moderate PR.
Interaction of race and pathology for neuroendocrine tumors: Epidemiology, natural history, or racial disparity?
Authors: Lee Rachel M , DePalo Danielle K , Lopez-Aguiar Alexandra G , Zaidi Mohammad Yahya , Rocha Flavio G. , Kanji Zaheer S. , Poultsides George A. , Makris Eleftherios , Dillhoff Mary , Beal Eliza W , Fields Ryan , Panni Roheena Z. , Idrees Kamran , Marincola Smith Paula , Nathan Hari , Beems Megan , Abbott Daniel , Rendell Victoria , Maithel Shishir K. , Russell Maria C. 
Published: January 2019

376 Background: The prognostic value of pathologic variables is not consistent for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). We previously demonstrated a limited prognostic role of lymph node (LN) positivity in small bowel NETs (SBNET) compared to pancreatic NETs (panNET). Although minority race is often associated with worse cancer outcomes, the interaction of race with pathologic and oncologic outcomes of pts with GEP-NETS is not known. Methods: Pts with GEP-NETs who underwent curative intent resection at eight institutions of the US NET Study Group from 2000-16 were included. Given few pts of other races, only Black and White race pts were analyzed. Results: Of 2,182 pts, 1,143 met inclusion criteria. Median age was 58 yrs, median follow up was 3 yrs, 48% were male, 14% (n = 157) were Black, and 86% (n = 986) were White. Black pts were more likely uninsured (7 vs 2%, p = 0.005), had symptomatic bleeding (13 vs 7%, p = 0.006), required emergency surgery (7 vs 3%, p = 0.003), and had LN positive disease (47 vs 36%, p = 0.016). Despite this, Black pts had improved 5 yr recurrence free survival (RFS) compared to White pts (90 vs 80%, p = 0.008). The quality of care received was comparable between both groups, demonstrated by similar LN yield at surgery, neg margin resection rate, post-op complications, and need for reoperation or readmission (all p > 0.05). Black pts were more likely to have SBNET (22 vs 13%) and less likely to have panNET (43 vs 68%) compared to White pts (p < 0.001). Consistent with prior data, pts with LN pos panNET had decreased 5yr RFS (67 vs 83%, p = 0.001); however, for SBNET, LN involvement was not prognostic (77 vs 96%, p = 0.08). The prognostic value of LN pos disease was similar between Black and White pts in both SBNET (p = 0.34) and panNET (p = 0.95). Conclusions: Black pts with GEP-NET present with more advanced disease, including higher LN positivity. Despite this, Black pts have improved RFS compared to White pts. Although there may be delays in seeking or reaching care, Black pts received similar quality of care compared to White pts. The improved RFS seen in Black pts may be attributed to the epidemiologic differences in the site of presentation of GEP-NETs and variable prognostic value of LN pos disease.
Comparison of concurrent chemoradiation with stereotactic body radiation therapy versus conventionally fractionated radiation therapy following induction chemotherapy for unresected locally advanced pancreatic cancer.
Authors: Ma Sung Jun , Iovoli Austin J , Prezzano Kavitha M , Hermann Gregory , Serra Lucas M , Singh Anurag K 
Published: January 2019

378 Background: Induction chemotherapy (iC) followed by concurrent chemoradiation has been shown to improve overall survival (OS) for locally advanced pancreatic cancer (LAPC). A recent National Cancer Data Base (NCDB) analysis has also shown improved OS with the use of stereotactic body radiation therapy (SBRT) versus conventionally fractionated radiation therapy (CFRT). This NCDB analysis evaluated outcomes of concurrent chemoradiation with SBRT compared to CFRT, following iC. Methods: The NCDB was queried for primary stage III, cT4N0-1M0 unresected pancreatic adenocarcinoma treated with concurrent chemoradiation following iC (2004-2015). CFRT was defined as 1.8-2.5 Gy per fraction up to a total dose of 45-70 Gy, whereas SBRT was defined as > 4.0 Gy per fraction up to a total dose of 20-60 Gy. Baseline patient, tumor, and treatment characteristics were examined. The primary endpoint was overall survival (OS). Kaplan-Meier analysis, Cox proportional hazards method, logistic regression, and propensity score matching were used. Results: Among 872 patients, 738 patients underwent CFRT and 134 patients received SBRT. Median follow-up was 24.3 months and 22.9 months for the CFRT and SBRT cohorts, respectively. The use of SBRT showed improved survival in the multivariable analysis compared to CFRT (HR 0.78, p = 0.025). Using 1:1 propensity score matching, a total of 240 patients were matched, with 120 patients in each cohort. The receipt of SBRT remained statistically significant for improved OS, including median OS (18.1 months vs 15.9 months) and 2-year OS (37.3% vs 25.5%) compared to the CFRT (p = 0.0040). Conclusions: This NCDB analysis shows a significant survival benefit with the use of SBRT versus CFRT, in the setting of definitive management for LAPC following iC. Further prospective studies evaluating the use of SBRT in the definitive treatment of this challenging population are warranted.
Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy.
Authors: Shin Sung Kwan , Park Jun Chul , Kim Eun Hye , Lee Sang Kil , Lee Yong Chan 
Published: January 2019

38 Background: Adequate tissue acquisition is important in making treatment decisions for patients with upper gastrointestinal subepithelial tumors (SETs). This study aimed to compare the outcomes of endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) with those of the unroofing biopsy technique. Methods: This study was a single-center, prospective comparative study conducted at Severance Hospital, Yonsei University College of Medicine. A total of 39 patients with SETs ≥15 mm were enrolled between January 2016 and August 2017. Results: Of the 39 patients, 28 underwent biopsy with both techniques (4 underwent only unroofing and 7 underwent only EUS-FNB). The mean tumor size was 21.0 mm (median, 19.0 mm; 15.0–45.0 mm). Histological diagnosis was made with EUS-FNB in 64.3% and with unroofing biopsy in 78.6% (p = 0.344), and immunohistochemical diagnosis was made with EUS-FNB in 46.4% and unroofing biopsy in 67.9% (p = 0.180). In the subgroup analysis (28 patients), there was no significant difference in diagnostic yield between the 2 methods. The mean procedural time with EUS-FNB was shorter than that with unroofing biopsy (p < 0.001). The larger SET (≥ 20 mm) (p = 0.035) and satisfaction of procedure (p = 0.019) were positively associated with successful histological diagnosis by EUS-FNB. No complications were reported with both methods. Conclusions: There was no significant difference in the histological diagnostic yield for SETs between the EUS-FNB and unroofing biopsy techniques. Further study is needed to confirm the efficacy of EUS-FNB and unroofing biopsy in a larger study population. Clinical trial information: NCT02646241.
Efficacy of liposomal-irinotecan (nal-IRI) plus 5-fluorouracil/folinic acid (5-FU/LV) versus oxaliplatin plus fluoropyrimidines in previous gemcitabine treated pancreatic adenocarcinoma (PAC) patients (pts).
Authors: Kieler Markus , Unseld Matthias , Bianconi Daniela , Scheithauer Werner , Prager Gerald W. 
Published: January 2019

383 Background: The chemotherapy regimens nal-IRI plus 5-FU/LV as well as oxaliplatin plus fluoropyrimidines are used after previous gemcitabine based chemotherapy in the 2nd line treatment of metastatic PAC. We aimed to compare the clinical efficacy of these two treatment options. Methods: In this single institutional retrospective cohort analysis all pts with advanced PAC that were treated between 01/2012-08/2018 with nal-IRI plus 5-FU/LV or oxaliplatin plus fluoropyrimidines after previous 1st line gemcitabine based chemotherapy were analysed for clinical parameters, median progression free survival (mPFS) and overall survival (mOS). Survival analyses were performed by Kaplan-Meier method. Results: Characteristics of pts were well matched (Table). mPFS in pts (n=30) that received nal-IRI plus 5-FU/LV in the 2nd line treatment after gemcitabine based chemotherapy was 4.49 months while treatment with oxaliplatin plus fluoropyrimidines (n=31) resulted in a mPFS of 3.44 months (p=0.007, HR 0.47, 95% CI 0.27-0.81). Furthermore, pts with a CA 19-9 level >1000 kU/l at the beginning of 2nd line treatment had a significantly improved mPFS and mOS, when treated with nal-IRI plus 5-FU/LV compared to oxaliplatin plus fluoropyrimidines (mPFS 4.94 months versus 3.44 months, p=0.0186, HR 0.42, 95% CI 0.18-0.98; mOS 9.31 months versus 6.16 months, p=0.0386, HR 0.43, 95% CI 0.18-1.02). Conclusions: The efficacy of nal-IRI plus 5-FU/LV in our study is encouraging and outperforms oxaliplatin-based chemotherapy in the 2nd line treatment setting for PAC pts pretreated with gemcitabine. Prospective randomized trials are urged to validate our observation. [Table: see text]
Symptom burden of patients with advanced pancreas cancer (APC): A provincial cancer institute observational study.
Authors: Ward Julie , Kim Christina , Lambert Pascal J 
Published: January 2019

384 Background: Patients (pts) with advanced pancreatic cancer (APC) experience many disease-related symptoms. The Edmonton Symptom Assessment System (ESAS) measures the severity of 9 separate domains, and is completed by pts at each visit at our provincial cancer institute. The aim of this study was to describe symptom burden at baseline and over time for chemotherapy (CT) treated pts with APC, using ESAS. Methods: Pts diagnosed with APC between 2012-2016 and treated with at least 1 cycle of CT were identified. ESAS scores were extracted from the electronic medical record. Descriptive statistics were used to report the most common symptoms of pts with APC. A joint model was used to describe the trajectory of ESAS during follow-up while controlling for death. Multivariable Cox regression was used to identify independent predictors of death. Results: Of 123 pts identified, 61% had metastatic disease, 82.1% had a baseline ECOG of 0-1, with an average age of 64.8. 1608 clinic visits had an ESAS score documented and 87% of pts completed ≥ 2 ESAS assessments. Median overall survival was 10.2 months. Median progression free survival was 6.7 months. At baseline, the 10th percentile, median and 90th percentile for total symptom distress (TSD) score were 6.2, 24 and 53 respectively. 86% of pts had at least one ESAS score of ≥ 4 at baseline, with the most common being: fatigue, nausea, anxiety, and shortness of breath. Using a joint model, average TSD scores for the cohort improved for the first 4 to 5 months after starting CT and started to rise after 6 months. Average TSD scores at 15 to 18 months were similar to scores at baseline. Controlling for metastatic disease and CT type, for every increase of 10 in baseline TSD score, there was a 5% increased risk of death. Conclusions: The ESAS tool reflects the heavy burden of cancer-associated symptoms in APC. Symptoms improve months after starting CT and eventually worsen. The impact of early intervention to address symptom management is an important area of investigation in APC.
Pooled safety analysis of high-specific-activity I-131 MIBG in iobenguane scan positive cancer patients.
Authors: Jimenez Camilo , Grewal Ravinder K. , Ravizzini Gregory , Chin Bennett B , Pampaloni Miguel H , Matthay Katherine K. , Jensen Jessica Donato , Lin Tess , Apfel Stuart , White Theresa , Stambler Nancy , DiPippo Vincent A. , Mahmood Syed , Wong Vivien , Pryma Daniel 
Published: January 2019

388 Background: Iobenguane scan positive cancers include pheochromocytoma and paraganglioma (PPGL), neuroblastoma, and gastroenteropancreatic neuroendocrine tumors. A pooled analysis was conducted to assess the safety profile of high-specific-activity I-131 metaiodobenzylguanidine (HSA I-131 MIBG [AZEDRA]) in PPGL and neuroblastoma. Methods: Safety data were pooled from four clinical studies with 118 subjects who received HSA I-131 MIBG. Adverse events (AEs) were described by age, gender, race, number of HSA I-131 MIBG doses, temporal association of AEs within 12 weeks after therapeutic dose 1, vital signs, laboratory values, hematological events of Grade 3/4 or serious AEs, and changes in mean hematology values over a period of 12 months. Results: Out of 118 subjects, mean age was 47.0 ± 18.9 years (range 3-76); 57.6% were males and 74.6% were white. A total of 102 (86.4%) subjects had at least one AE assessed as treatment-related. The incidences of most AEs were similar among both genders and all racial groups. The most common toxicities associated with HSA I-131 MIBG were gastrointestinal disorders, with nausea the most prevalent. The incidences of nausea and salivary gland pain showed decreasing trends with age while dyspnea, asthenia, and peripheral edema showed increasing trends. The second most common toxicities were hematologic. Following each therapeutic dose, mean hemoglobin, leukocytes, neutrophils, and platelets decreased. Most hematological AEs resolved within 12 weeks, and recovery to pre-therapeutic dose values was apparent 6 months after each therapeutic dose. After therapeutic dose 1, higher percentages of subjects experienced AEs in the first 2 weeks, and the incidence decreased beyond 6 weeks. No notable changes were observed in clinical chemistry tests. The incidence of Grade 3/4 AEs was similar following each therapeutic dose. Conclusions: HSA I-131 MIBG was safe and well-tolerated among subjects with iobenguane scan positive cancers. No trends were discerned between baseline characteristics and AEs. Hematology results reflected toxicity profile expected in a population of subjects administered a radiopharmaceutical. Clinical trial information: Pooled Safety.
Combination chemotherapy for pancreatic cancer in older adults: Efficacy and safety analysis of patients at a majority-Hispanic NCI-designated cancer center.
Authors: Henkel Emily , Hernandez Brian , Michalek Joel , Mahalingam Devalingam , Arora Sukeshi Patel 
Published: January 2019

389 Background: Pancreatic cancer (PCa) is more frequent in older adults, but older patients are underrepresented in large clinical trials. There is limited data on efficacy and safety of regimens such as FOLFIRINOX or nab-paclitaxel/gemcitabine (nab-gem) in older adults, especially Hispanics. Therefore, we compared the efficacy and safety of first-line PCa regimens in older adults. Methods: Retrospective analysis of stage IV PCa at our Hispanic-majority NCI-designated cancer center from 2000-2017. mPFS and mOS estimated from KM curves and groups were statistically compared with the log-rank test. The magnitude of association between dichotomous factors and survival was estimated with the hazard ratio (HR). Results: Forty-eight pts, mean age 71.7 years, median 69.2 (range 65-90). 31% Hispanic; 50% Male. First-line treatment: FOLFIRINOX (n=9), nab-gem (n=11), gem (n=11), other (n=9), supportive care (n=2). Baseline ECOG 0-1: 100%, 94%, 45%, 100%, 1% (p=0.004). Baseline albumin: 3.4, 3.4, 3.1, 3.5, 2.25 (p=0.06). mOS 7.1 months (95% CI 5.9-10.1). mPFS 5.6 months (95% CI: 5.3-NR). mOS by group: 8.6 mo, 7.1 mo, 3.2 mo, 2.9 mo, not available (p=0.95). Most patients had grade 0-2 toxicities (See table). Grade 3-4: fatigue n=2, neutropenia n=1, neuropathy n=1, mucositis n=1. Conclusions: Combination systemic chemotherapy are tolerated in older adults with PCa; however, in our cohort, survival was lower than historic phase 3 clinical trials with these regimens. Patients receive 2+ drugs had higher ECOG and albumin at baseline. Prospective studies with geriatric assessments are needed to determine patients who benefit from combination chemotherapy. [Table: see text]
Preoperative factors predictive of pathologic upstaging in clinical stage I gastric cancer patients.
Authors: Thuppal Hayavadhan , Friedmann Patricia , McAuliffe John Christopher , Muscarella Peter , In Haejin 
Published: January 2019

39 Background: In patients with stage 1 gastric cancer, surgical resection without neoadjuvant therapy is offered as the first line treatment. However, some of these patients are found to have higher stage after resection and miss the opportunity for neoadjuvant therapy. Preoperative patient and tumor characteristics may be predictive of the likelihood of pathological upstaging in stage 1 gastric cancer patients who have not received neo-adjuvant therapy. Methods: The National Cancer Database was queried for patients diagnosed from 2004-2015 with clinical stage 1 gastric adenocarcinoma who had undergone surgical resection without neoadjuvant therapy. Univariate analysis and multivariable logistic regression were conducted to determine pre-operative factors associated with pathological upstaging. Candidate variables examined included age, sex, race, tumor size, histology, grade, tumor location, days to surgery, and lymphovascular invasion. Results: Analysis was conducted on 8,015 clinical stage 1 patients. Overall 1,981 (25%) patients were upstaged. On multivariable logistic regression analysis, significant predictors of upstaging included increasing tumor size [ref : size < 1 cm, 1-2 cm aOR=3.8 (95% CI 2.3-6.1); 2-4 cm aOR=12.4 (7.9-19.5); > = 4cm aOR=25.9 (22.9-56.4)], younger age [ref: > = 75, < 50 aOR=1.7 (1.4-2.1), 50-65 aOR=1.4 (1.2-1.6), 65-75 aOR=1.2 (1.1-1.5)], male gender [aOR=1.16 (1.0-1.3)], presence of diffuse type gastric cancer [aOR=2.3 (1.7-3.2)], mucinous type [aOR=1.7 (1.1-2.5)], or signet ring cell histology [aOR=1.6 (1.3-2.0)] compared to intestinal histology, presence of lymphovascular invasion [aOR=6.0 (5.0-7.1)], and increasing grade [ref: grade 1, grade 2 aOR=2.30 (1.7-3.5); grade 3 aOR=4.9 (3.6- 6.7)]. Conclusions: A quarter of all patients thought to have stage 1 gastric cancer prior to surgery had higher pathologic stage at time of resection. Patients with the above risk factors may be understaged with currently available diagnostic tools. The addition of neoadjuvant therapy should be considered when the above risk factors are present in clinical stage 1 patients.