bluuebunny/crossref_metadata_2025_split huggingface dataset:
Utility of a multidisciplinary tumor board in the management of pancreatic diseases.
Authors: Brauer David G. , Strand Matthew S. , Sanford Dominic E. , Doyle Maria Majella , Murad Faris , Mullady Daniel , Kushnir Vladimir M. , Ruzinova Marianna , Olsen Jeffrey R. , Parikh Parag J. , Lim Kian-Huat , Tan Benjamin R. , Edmundowicz Steven Alphonse , Wang-Gillam Andrea , Hawkins William G. , Chapman William C. , Strasberg Steven M. , Fields Ryan C. 
Published: February 2017

319 Background: Multidisciplinary Tumor Boards (MTBs) are a requirement for comprehensive cancer centers and are routinely used to coordinate multidisciplinary care in oncology. Despite their widespread use, the impact of MTBs is not well characterized. We studied the outcomes of all patients presented at our pancreas MTB, with the goal of evaluating our current practices and resource utilization. Methods: Data were prospectively collected for all patients presented at a weekly pancreas-specific MTB over the 12-month period at a single-institution NCI-designated cancer center. The conference is attended by surgical, medical, and radiation oncologists, interventional gastroenterologists, pathologists, and radiologists (diagnostic and interventional). Retrospective chart review was performed at the end of the 12-month period under an IRB-approved protocol. Results: A total of 470 patient presentations were made over a 12-month period. Average age at time of presentation was 61.5 years (range 17 – 89) with 51% males. 61.7% of cases were presented by surgical oncologists and 26% by medical oncologists. 174 cases were the result of new diagnoses or referrals. 78 patients were presented more than once (average of 2.3 times). Pancreatic adenocarcinoma was the most common diagnosis (37%), followed by uncharacterized pancreatic mass (16%), and pancreatic cyst (7%). The treatment plan proposed by the presenting clinician was known or could be evaluated prior to conference in 402 cases. Presentation of a case at MTB changed the plan of management 25% (n = 100) of the time, including MTB recommendation against a planned resection in 46 cases. When the initial plan changed as a result of MTB discussion, the most common new plan was to obtain further diagnostic testing such as biopsy and/or endoscopy (n = 24). Conclusions: MTBs are required and resource-intensive but offer the opportunity to discuss a wide array of pathologies and influence management decisions in a sizable proportion of cases. Additional investigations evaluating adherence rates to MTB decisions and to published guidelines (i.e. National Comprehensive Cancer Network) will further enhance the assessment and utility of MTBs.
Adjuvant therapy in pancreatic adenocarcinoma: A systemic review and meta-analysis.
Authors: Nahar Kazi Jannatun , Chan David , Mittal Anubhav , Samra Jaswinder S. , Hugh Thomas , Diakos Connie Irene , Clarke Stephen John , Pavlakis Nick 
Published: February 2017

330 Background: The “optimal” adjuvant treatment in pancreatic cancer remains undetermined. Chemotherapy (chemo) such as gemcitabine (Gem), 5-fluorouracil (5-FU) and chemo-radiotherapy (chemoRT) with either Gem or 5-FU have been investigated in trials. We performed a systematic review and meta-analysis to determine the overall efficacy of adjuvant treatment. Methods: We searched databases (PubMed, Medline, Cochrane database) and major conference proceedings up until August 2015 for randomized trials comparing chemo or chemoRT versus (vs) observation, two different chemo regimens and chemoRT vs chemo. Primary end point was overall survival (OS); secondary end points were relapse free survival (RFS), grade 3/4 toxic effects and quality of life (QoL). We performed meta-analysis as per the PRISMA guidelines; hazard ratios (HR) for OS and RFS were pooled with random-effects modelling. Results: Fifteen trials were identified evaluating 4348 patients. For trials comparing chemo to observation (7 trials, n = 1383) the OS HR was 0.77 (95% CI 0.67-0.89, p = 0.001) and PFS HR 0.73 (95% CI 0.53-1.01, p = 0.06) both favouring chemo. For trials investigating Gem (2 trials, n = 472), OS was improved with HR 0.76 (95% CI 0.63 -0.92, p = 0.006) as was RFS (HR 0.56, 95% CI 0.46-0.68, p < 0.00001). For trials investigating agents other than Gem (5 trials, n = 911), OS was improved with HR 0.79 (95% CI 0.63-0.99, p = 0.04), but RFS was not (2 trials only, HR 1.00, 95% CI 0.73-1.37, p = 0.99). Five trials (n = 1832) compared different chemo regimens to Gem in each case; pooled OS HR was 0.90 (95% CI 0.65-1.25, p = 0.54) and RFS HR 0.88 (95% CI 0.67-1.15, p = 0.35). Insufficient data was available to pool grade 3/4 toxicity for chemo vs observation trials; no significant difference was found in incidence of overall grade 3/4 toxicity for trials comparing two chemo regimens (OR 0.98, 95% CI 0.39-2.47, p = 0.96). QoL data was available in 3 trials (ESPAC-1, ESPAC-3, CapRi) with no significant differences noted. Conclusions: Adjuvant chemo vs no chemo for resected pancreatic adenocarcinoma improves OS and RFS. Adjuvant ChemoRT vs no treatment is not beneficial. Overall, novel chemo regimens have not been shown to be superior to Gem. Reporting of QoL is inadequate to make any conclusion.
Treatment patterns and clinical outcomes of patients with metastatic gastroenteropancreatic neuroendocrine tumors (mGEP-NETs).
Authors: Jiao Xiaolong , Pulgar Sonia J. , Boyd Marley , Braiteh Fadi S. , Lowenthal Susan Pitman , Cox David , Fox Patricia S. , Paulson Andrew Scott 
Published: February 2017

331 Background: mGEP-NETs are rare and heterogeneous tumors. Limited data has been published on real world clinical management of these tumors. This study was conducted to understand the treatment patterns and clinical outcomes of patients with mGEP-NETs treated in the community oncology setting. Methods: A retrospective study was conducted using US Oncology’s (USON) iKnowMed electronic health record (EHR) database with supplemental chart review. The first diagnostic record of mGEP-NET in the EHR system was defined as the date of diagnosis of mGEP-NET. Inclusion criteria: ≥ 18 years of age at diagnosis; diagnosis of mGEP-NET between 1/1/2008 to 12/31/2012. Patients in clinical trials or with poorly differentiated tumors were excluded. Results: 229 patients were included with a median age of 64.0 years. Primary tumor site included small bowel (47.6%), pancreas (31.4%), and other (21.0%). Tumor grade was available for 134/229 (58.5%) patients, and the majority was reported as well-differentiated (52.8%). Chromogranin A (CgA) and urinary 5-HIAA were reported for 34.9%, and 32.8% of patients respectively. 37 (16.2%) of patients were under observation only. For those receiving systemic treatment, median time to first systemic treatment after diagnosis was 2.7 weeks, with 75% of patients starting therapy by 9.4 weeks. 120 (52.4%) patients received only somatostatin analogs (SSAs) during the study period, and 72 (31.4%) patients received chemotherapy, and/or targeted therapy. In the 1st line setting (n = 192), 148 (77%) patients received SSAs, 23 (12%) chemotherapy, and 21 (10.9%) targeted therapy. The most common AEs for SSAs were diarrhea (18.2%), abdominal pain (16.9%), and fatigue (13.5%). The median OS from diagnosis was 84.2 months [95%CI 70.9, 108.0 months] for the overall cohort. OS was longer in small bowel NETs than in pancreatic or other NETs (median OS 108.0 vs 69.9 vs 84.2 months, p = 0.017). Conclusions: Most of the patients with mGEP-NETs received systemic treatment soon after diagnosis and referral to USON. The OS and AEs were consistent with other studies. Low reporting of CgA, 5-HIAA, and tumor grade reflected variability of clinical practice in the community setting.
Outcome of second-line treatment (2L Tx) following nab-paclitaxel (nab-P) + gemcitabine (G) or G alone for metastatic pancreatic cancer (MPC).
Authors: Goldstein David , Chiorean E. Gabriela , Tabernero Josep , El-Maraghi Robert Hassan , Ma Wen Wee , Reni Michele , Harris Marion , Whorf Robert C. , Coughlin Susan , Li Jack , Manax Victoria G. , Lu Brian D. , Romano Alfredo , Von Hoff Daniel D. 
Published: February 2017

333 Background: The impact of 2L Tx in MPC is not well described. The phase III MPACT trial (N = 861) demonstrated superior efficacy for nab-P + G vs G alone for 1L Tx of MPC. This post hoc analysis examined 2L Tx use in pts in MPACT. Methods: OS was estimated by the Kaplan-Meier method, using the most updated information from MPACT. Data were summarized by type of 2L Tx. Results: 347 pts received 2L Tx. Baseline characteristics (at start of 1L) of those pts were balanced between arms and representative of the ITT population: median age, 61-62 years; 12% had > 3 metastatic sites, and ≈ 30% had Karnofsky PS 70-80 in each arm. 26% and 14% of pts in the nab-P + G and G arms, respectively, discontinued 1L Tx for adverse events. OS in the 347 pts was significantly longer for nab-P + G vs G (Table). The median time from the end of 1L Tx to death for pts receiving no 2L Tx was 2.5 and 1.6 mo in the nab-P + G and G arms, respectively (HR, 0.67; P < 0.001), less than half for those who received any 2L Tx (5.3 and 4.5 mo). 78% and 76% of pts received a 5FU/capecitabine (cape)–containing regimen as 2L Tx after nab-P + G and G and achieved 13.5 and 9.5 mo of median OS, respectively. Conclusions: 2L Tx after nab-P + G or G alone in MPC is feasible and may potentially improve pt outcomes. Clinical trial information: NCT00844649. [Table: see text]
Preoperative accuracy of gastric cancer staging in patient selection for neoadjuvant therapy.
Authors: Ikoma Naruhiko , Elimova Elena , Blum Mariela A. , Ajani Jaffer A. , Chiang Y. Sabrina , Fournier Keith F. , Mansfield Paul F. , Badgwell Brian D. 
Published: February 2017

34 Background: Because gastric cancers stage ≥ T2 or ≥ N1 are considered for neoadjuvant treatment, accuracy of preoperative staging is critical. The purpose of this study was to identify preoperative staging accuracies of computed tomography scan (CT) and endoscopic ultrasound (EUS) in gastric cancer and their utilities in selecting patients for neoadjuvant therapy. Methods: Medical records of 8,260 patients with gastric or gastroesophageal adenocarcinoma (presented 1995-2013) were reviewed to identify those who underwent gastrectomy but not neoadjuvant treatment. We reviewed preoperative EUS reports and CT images to identify detailed T stage (based on AJCC 7thedition) and lymph node positivity (short axis diameter ≥ 6mm). T stage and N status were compared with those from the surgical pathology report. Clinicopathologic variables associated with incorrect preoperative staging were also examined. Results: We identified 187 patients who underwent preoperative staging by EUS (n = 145) and/or CT (n = 134) for gastrectomy. The accuracy, sensitivity, and specificity of EUS in distinguishing T1 from more advanced tumors were 82%, 78%, and 85%, respectively. In univariate analysis, tumor location and lymphovascular invasion were associated with incorrect EUS T staging. In multivariate analysis, variables associated with underestimation of EUS T stage was lymphovascular invasion (OR 7.51, 95% CI 1.91-29.5, p < 0.01) and Caucasian race (OR 3.75, 95% CI 1.31-10.75, p = 0.01). The accuracies, sensitivities, and specificities for N status were, respectively, 65%, 49%, and 79% with CT and 66%, 29%, and 95% with EUS. In univariate analysis, poor differentiation and lymphovascular invasion were associated with incorrect diagnosis of CT N status. In multivariate analysis, lymphovascular invasion was associated with false-negative (OR 3.79, 95% CI 1.34-10.7, p = 0.01), and differentiated histology was associated with false-positive CT N status (OR 7.14, 95% CI 2.00-25.44, p < 0.01). Conclusions: EUS has reasonable accuracy in T stage, while both CT and EUS have low sensitivities and high specificities in N status. These accuracies should be considered when selecting patients for neoadjuvant treatment.
An institutional analysis of gemcitabine and capecitabine for advanced biliary cancer.
Authors: Gandhi Shipra , Gabriel Emmanuel M. , Attwood Kristopher , Ma Wen Wee , Kuvshinoff Boris W. , Hochwald Steven N. , Iyer Renuka V. 
Published: February 2017

342 Background: The results of ABC-2 trial established gemcitabine and cisplatin (gem-cis) as a standard regimen for advanced biliary cancer. Although no randomized trial has been performed with gemcitabine and capecitabine (gem-cap), this regimen has reported benefits and has been a standard treatment at our institution. We report our experience with outcomes and toxicity. Methods: This is a single institution, retrospective study from 2005-2015 of patients with advanced biliary cancer, including intra and extrahepatic cholangiocarcinoma (IHCC/EHCC) and gallbladder carcinoma (GBC). Overall survival (OS) and progression-free survival (PFS) on gem-cap were reported using standard Kaplan-Meier methods. Comparisons were made using log-rank test. Results: A total of 372 patients were identified. Of these, 227 (61.0%) had chemotherapy data at our institution. A total of 153 patients (41.1%) received gem-cap, 133/153 (86.9%) received it in first line. The majority of patients (67.4%) had metastatic disease. Twenty-seven patients (17.6%) received it as adjuvant therapy, of which 16 (10.5%) also received adjuvant radiation. Forty-four patients (33.1%) received second line of chemotherapy and 12 (9.0%) received third line. Disease sites included 48.9% IHCC, 24.0% EHCC and 27.1% GBC. Median follow-up was 45.1 months (mo). The median OS and PFS for the entire cohort were 13.0 mo (95% CI 10.7-17.4) and 8.0 mo (6.0-9.3), respectively. Patients with metastatic disease had poorer OS and PFS compared to locally advanced disease: median OS – 11.4 vs 16.3 mo (p = 0.01); median PFS – 6.9 vs 10.4 mo (p < 0.001). There was no statistically significant differences in OS/PFS by disease site. Overall, 69 patients (55.6%) experienced grade 3/4 toxicity. The most common (35.7%) was hematologic toxicity (neutropenia/thrombocytopenia). Other adverse events included elevated LFT’s (9.3%) and non-hematologic events (22.5%), including fatigue (6.8%) and hand-foot syndrome (6.0%). Conclusions: Gem-cap provides a similar PFS to gem-cis based on historical comparison with ABC-2 trial. Gem-cap may offer the advantage of fewer adverse events (55.6%) compared to the 70.7% reported in ABC-2. Prospective comparison of these two regimens is warranted.
Intrahepatic cholangiocarcinoma: Ambitious operations and outcomes.
Authors: Raoof Mustafa , Dumitra Sinziana , Ituarte Philip HG , Melstrom Laleh , Warner Susanne , Fong Yuman , Singh Gagandeep 
Published: February 2017

345 Background: Data from specialized institutions suggests that resection for large ( > 7cm) and mutifocal intrahepatic cholangiocarcinoma (ICC) is safe and feasible. We aim to study this hypothesis using a population-based dataset. Methods: This is a study of a contemporary cohort from California Cancer Registry database (2004-2011) that was merged with Office of Statewide Health Planning and Development inpatient database. All patients with ICC that underwent resection or ablation were included. Tumors were classified into two groups; intrahepatic, small ( < 7cm) & solitary (ISS) vs. extrahepatic extension, large or multifocal (ELM). Mortality was recorded at 90 days. Overall survival (OS) analysis was performed using the Kaplan-Meier and Cox-proportional hazard model. Results: Of the total 275 patients that met the inclusion criteria, 55% were female, 52% were white and median age was 65 years (IQR 55-72). Majority of patients had > 3 segment resection 59% (Ablation 10%, 1-3 segments 30%). Portal lymphadenectomy was performed in 45% of patients. Vascular Invasion was found in 22% of patients, 14% were bilobar and 20% were node positive. Median follow up was 23 months (IQR 13-40). Number of ISS tumors (139, 50.5%) and ELM tumors (136, 49.5%) was similar. The two groups were comparable in regards to age, sex, race, comorbidities, extent of surgery, portal lymphadenectomy, node positivity. ELM tumors were more likely to have vessel invasion (27% vs. 17%, p = 0.048) and be bilobar (26% vs. 2%, p < 0.001). There was no significant difference in overall complication rate (ISS 34%, ELM 27%, p = 0.19) and mortality rate (both groups < 1%, p = 0.32). A multivariate Cox-proportional hazard model demonstrated that age > 60 years, > 1 comorbidity, high grade tumors, ELM tumors (HR 1.63: 95%CI 1.11-2.40; p = 0.013) and LN positivity (HR 2.30: 95%CI 1.49-3.54; p < 0.001) are independently associated with worse OS. Conclusions: Surgical resection of tumors > 7cm, multifocal lesions involving contiguous extrahepatic organs is safe with acceptable morbidity and mortality. Age > 60 years, grade, comorbidity, ELM tumors and LN positivity are independent predictors of worse OS.
Role of adjuvant chemoradiotherapy for duodenal cancer: An update of the experience at a single institution.
Authors: Park Hae Jin , Kim Kyubo , Chie Eui Kyu , Jang Jin-Young , Kim Sun Whe , Oh Do-Youn , Bang Yung-Jue 
Published: February 2017

370 Background: The patterns of failure after resection for duodenal cancer are very limited, and the benefit of adjuvant chemoradiotherapy has not been proven. We compared the treatment outcomes of surgery alone to those of surgery followed by adjuvant chemoradiotherapy (CRT) for duodenal cancer. Methods: Forty-seven patients with duodenal cancer underwent pancreaticoduodenectomy between January 1991 and February 2013. There were 33 males and 14 females, and their median age was 62 years (range, 31-80). Twenty-two patients (47%) received adjuvant CRT, and 25 (53%) did not. Postoperative radiotherapy was delivered to tumor bed and regional lymphatics (dose range = 40-55.4 Gy). All the patients underwent CRT concurrently with 5-fluorouracil. Median follow-up period was 31 months (range, 6-286). Results: Nodal stage and stage group were more advanced in CRT(+) group (p = 0.003 and 0.002, respectively). Locoregional recurrence (LRR) occurred in 11 patients; 8 out of 25 in CRT(-) and 3 out of 22 in CRT(+) group. Distant metastasis (DM) occurred in 19 patients; 7 out of 25 in CRT(-) and 12 out of 22 in CRT(+) group. Five patients experienced LRR and DM, and 3 of them were synchronous. Five-year overall survival rates of CRT(-) and CRT (+) group were 50% and 47%, respectively (p = 0.794). Five-year locoregional relapse-free survival rates of CRT(-) and CRT(+) group were 68% and 80%, respectively (p = 0.267). On multivariate analysis, the addition of CRT after curative resection was the only prognostic factor predicting superior locoregional relapse-free survival (p = 0.049). No patient suffered from grade 3 or higher toxicity during or after CRT. Conclusions: The addition of CRT after pancreaticoduodenectomy was associated with improvement of local control in duodenal cancer. Given the high LRR in surgery alone group, adjuvant CRT should be considered.
Effect of metformin on survival in pancreatic ductal adenocarcinoma.
Authors: Amin Sunil , Mhango Grace , Lin Jenny J , Aronson Anne , Boffetta Paolo , Wisnivesky Juan P. , Lucas Aimee 
Published: February 2017

383 Background: Pancreatic ductal adenocarcinoma (PDAC) remains highly lethal. Diabetes mellitus (DM) is both a risk factor for and a sequela of PDAC. Metformin, a commonly prescribed biguanide oral hypoglycemic used for the treatment of type II DM, has been found to have a chemo-protective role in PDAC in some in-vitro and human-based studies; conflicting literature exists regarding its potential role as a therapeutic agent. We investigated whether metformin use prior to PDAC diagnosis is associated with improved survival of patients with DM. Methods: We used the Surveillance, Epidemiology, and End-Results (SEER) linked Medicare database to identify diabetic patients with PDAC diagnosed between 2007-2011. Information regarding use of anti-hyperglycemic drugs prior to cancer diagnosis was extracted from Part D claims. The diabetic severity comorbidity index (DCSI) was used to control for DM severity. Logistic regression was used to calculate propensity scores for metformin use based on each patient’s sociodemographic characteristics, diabetic severity, and co-morbidity status. Inverse propensity weighted Cox Proportional-Hazard Models were subsequently used to assess the association between metformin use and overall survival adjusting for measured confounders. Results: We identified 1916 patients with PDAC and a diagnosis of DM on hypoglycemic medications at least one year prior to cancer diagnosis. Of these, 1098 (57.3%) were treated with metformin and 818 (42.7%) with other DM medications. Mean survival for those on metformin was 5.5 months compared with 4.2 months for those not on metformin (p < 0.01). After adjusting for confounders, patients on metformin had a 12% decreased risk of mortality compared to patients on other medications (hazard ratio [HR]: 0.88, 95% confidence interval [CI]: 0.81-0.96, P <.01). In stratified analysis, differences persisted for those with Charlson score 0-1 vs > 2, DCSI 0-1 vs > 2, and for those treated with insulin vs other hypoglycemic medications (p < 0.01 for all). Conclusions: Metformin is associated with increased survival among diabetics with PDAC. If confirmed in prospective study, these results suggest a possible role for metformin use in diabetics with PDAC.
JASPAC 06: Observational study of FOLFIRINOX therapy for unresectable and recurrent pancreatic cancer—Preliminary report on serious adverse events.
Authors: Ozaka Masato , Todaka Akiko , Mori Keita , Boku Narikazu , Mizuno Nobumasa , Ueno Hideki , Kobayashi Satoshi , Uesugi Kazuhiro , Kobayashi Noritoshi , Hayashi Hideyuki , Sudo Kentaro , Okano Naohiro , Horita Yosuke , Kamei Keiko , Yukisawa Seigo , Nakamori Shoji , Yachi Yutaka , Henmi Toshiyuki , Kobayashi Marina , Fukutomi Akira 
Published: February 2017

407 Background: In Japan, indication of FOLFIRINOX for unresectable and recurrent pancreatic cancer was approved in 2013. Because clinical data of FOLFIRINOX in Japanese patients based on only one exploratory trial is limited, this observational study was conducted to survey practical use of FOLFIRINOX and to evaluate incidences of adverse events in Japanese patients. Methods: The subjects were patients with unresectable or recurrent pancreatic cancer who received FOLFIRINOX therapy during one year from Dec. 20, 2013 (approval date of this study). All the subjects were registered and their clinical data were sent to the data center. In this preliminary report, we analyzed patients’ characteristics related to serious adverse event (SAE). This study was approved by the IRB in each institution. Results: Four hundred patients (pts) were registered from 27 institutions in Japan. Median age was 63 years (range 27-80). Sixty-four percent (n = 254) had no prior treatment and 254 pts (60%) had distant metastatic lesions. The UGT1A1 genotype was wild-type in 56.8% of the subjects, heterozygous (*1/*6, *1/*28) in 39.3%, and homozygous (*6/*6, *6/*28, *28/*28) in 3.9%. One hundred forty-one SAEs in 115 pts (28.8％) were reported until Aug. 10, 2015. Most common SAEs were febrile neutropenia (n = 26), neutrophil count decreased (n = 26), anorexia (n = 21) and biliary tract infection (n = 18). Of these 141 events, five events were results in death. The proportion of patients who met the inclusion criteria (as follows: ECOG PS of 0 or 1; age 20-75 years; adequate hematological, liver and renal functions) used in the phase II trial of FOLFIRINOX for Japanese patients was significantly lower in the subjects with SAEs than those without SAE (60.5% vs. 72.4%, p = 0.023). Four of the 5 pts who resulted in death did not fulfill the inclusion criteria; C-reactive protein in 4, platelet count in 1 and hemoglobin in 1. Conclusions: This is a first report to evaluate the safety profile of FOLFIRINOX in Japanese pancreatic cancer patients. These data highlight the importance of patient selection for FOLFIRINOX. The final safety and efficacy results of this study will be reported at the coming meeting. Clinical trial information: UMIN000014658.