bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinicopathologic characteristics of patients who underwent additional gastrectomy after incomplete endoscopic resection for early gastric cancer.
Authors: Hwang Jae Jin , Lee Dong Ho , Lee Ae-Ra , Yoon Hyuk , Shin Cheol Min , Park Young Soo , Kim Nayoung 
Published: February 2017

39 Background: Endoscopic resection (ER) is widely accepted as standard treatment for early gastric cancer (EGC) without lymph node metastasis. However, surgery is sometimes needed after endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) due to incomplete resection. We analyzed the clinicopathological characteristics of patients who underwent additional gastrectomy after incomplete EMR/ESD. Methods: From 2003 to 2013, 80 patients received additional gastrectomy after EMR/ESD due to incomplete resection. The patients were grouped according to the presence of histologic residual tumor in specimens obtained by gastrectomy as residual tumor (RT, n = 47) or non-residual tumor (NRT, n = 33). We analyzed reasons for gastrectomy, tumor characteristics of RT and NRT group, risk factors associated with residual tumor, retrospectively from medical records. Results: After the gastrectomy, the positive residual tumor rate and lymph node metastasis rate were 58.7% (47/80) and 7.5% (6/80). RT group showed significantly higher rate of lateral and vertical margin involvement compared to NRT group (59.5 vs. 15.1%).Multivariate analysis demonstrated that endoscopic piecemeal resection, H. pylori infection, depressed or mixed type, large tumor size (> 2cm), histologic diagnosis (signet ring cell carcinoma or mixed carcinoma) were significantly independent predictive factors associated with positive residual tumor of patients who underwent additional gastrectomy after incomplete EMR/ESD (p < 0.05). Conclusions: For complete and curative ER, endoscopists should try to determine the depth of invasion, histologic diagnosis accurately and to eradicate the H. pylori infection before ER. During ER, wide marking and En bloc resection could be considered to avoid the risk of incomplete resection.
Early surgical bypass versus endoscopic stent placement in pancreatic cancer.
Authors: Bliss Lindsay A. , Kent Tara , Watkins Ammara , Eskander Mariam , deGeus Susanna , Ng Sing Chau , Callery Mark , Moser James , Tseng Jennifer F. 
Published: February 2017

391 Background: Biliary obstruction frequently occurs in locally advanced or metastatic pancreatic cancer and is often managed by surgical biliary bypass or endoscopic stenting. We compared readmissions/reinterventions among pancreatic cancer patients undergoing bypass vs. stenting. Methods: Retrospective analysis of unresected pancreatic cancer patients in the Healthcare Cost and Utilization Project (HCUP) Florida State Inpatient Database and Florida State Ambulatory Surgery Database 2007-2011 using revisit variables. Patients with early surgical or endoscopic approach analyzed. Subsequent admissions and surgical, endoscopic or percutaneous interventions identified. Propensity score matching by approach. Univariate analysis of patient characteristics and outcomes before and after matching. Multivariate analysis of readmission and reintervention performed by logistic regression. Results: 1,823 and 342 underwent endoscopic treatment vs. early surgical bypass, respectively. After propensity score matching, 684 patients analyzed (table). 64.0% (219) of endoscopic and 70.5% (241) of surgical patients readmitted (p=0.07) and 15.2% (57) and 9.1% (31) underwent reintervention (p=0.01). Endoscopic patients had lower index median length of stay (6 vs 11 days, p<0.01) and admission costs ($11,549 vs $23,215, p<0.01). In multivariate analysis, surgical biliary bypass was predictive of readmission (OR 1.50; 95% CI 1.03-2.18), but initial procedure was not predictive of reintervention (p=0.20). Conclusions: Surgical biliary bypass is less commonly performed than endoscopic stenting. Among propensity score-matched patients, readmission rates are similar, though endoscopic patients require more subsequent interventions. Candidates for both techniques may experience fewer invasive procedures if offered initial surgical biliary bypass. [Table: see text]
Enhanced recovery after surgery protocols as a management strategy following major pancreatic surgery.
Authors: Palani Velu Lavanniya Kumar , Chandrabalan Vishnuvardhan , Carter Ross , McKay Colin , Jamieson Nigel B , Dickson Euan 
Published: February 2017

396 Background: Enhanced Recovery After Surgery (ERAS) protocols have been shown to have positive effects on lengths of stay (LOHS) and resource utilisation without a rise in readmission and post-operative morbidity rates in colorectal, hepatic and oesophago-gastric surgery. This study aimed to investigate the effects of an ERAS protocol on postoperative morbidity and readmission rates following pancreatic surgery in a tertiary referral centre. Methods: The perioperative care of patients undergoing pancreatic surgery was guided by a locally developed ERAS protocol incorporating pre-operative counselling and carbohydrate loading. Intra-thecal opiate and Patient Controlled Analgesia devices were utilised for postoperative analgesia. Supplemental intravenous fluid prescription was protocolised. Oral intake was restarted from post-operative day (PoD) 1 and escalated on an on-demand basis. Patients were mobilised from PoD 1 and escalated daily. Drain removal and step down care decisions were guided by serum markers and clinical progress. Results: 212 consecutive patients from 2010 to 2014 were included (conventional, N = 108, ERAS protocol, N = 104). 134 (63.2%) patients underwent pancreaticoduodenectomy, 41 (19.3%) patients underwent distal pancreatectomy, 11 (5.2%) patients underwent total pancreatectomy and the rest underwent palliative bypass or other procedures. There was a statistically significant reduction in the volume of supplemental intravenous fluids received with no significant renal impairment noted. Median LOHS was reduced to 10 days (Inter-quartile range [IQR] 7 – 19) from 16 days (IQR 12 – 26) (P < 0.001). Median critical care stay was reduced from 7 days (IQR 5 – 10) to 6 (IQR 4 -7) (P = 0.020). There was a statistically significant reduction in clinically significant wound complications (P = 0.019). There were no statistically significant increases in readmission rates, pancreas-specific or other generic post-operative morbidity rates. Conclusions: ERAS protocols are a viable peri-operative management strategy after major pancreatic surgery, and data suggests that LOHS can be reduced without an associated increase in readmission or post-operative morbidity rates.
Population pharmacokinetic (PK) analysis of lanreotide autogel/depot in the treatment of gastroenteropancreatic (GEP) neuroendocrine tumors (NETs): Pooled analysis of four clinical trials.
Authors: Buil-Bruna Nuria , Garrido Maria Jesus , Dehez Marion , Manon Amandine , Nguyen Thi Xuan Quyen , Gomez-Panzani Edda L. , Troconiz Inaki F 
Published: February 2017

397 Background: Lanreotide Autogel (Depot in US) has been shown in clinical trials to have antitumor effects and control symptoms associated with hormone hypersecretion in GEP NET patients. Objectives: To describe the PK of Lanreotide 60, 90, or 120 mg SC injections every 4 weeks in GEP NET patients, to quantify inter-patient variability (IPV) and to identify PK impacting patient characteristics. Methods: 1,541 serum concentrations were obtained from 290 patients and analysed simultaneously using the population approach with the software NONMEM version 7.2. The covariates evaluated included demographics, renal and hepatic function markers, and disease related information. Results: Serum profiles were described with a one-compartment disposition model and with an absorption process characterized by two parallel absorption pathways following first and zero order kinetics. The estimated apparent volume of distribution was 18.3 L. The estimated apparent total serum clearance for a typical 74 kg patient was 513 L/day. No covariate tested showed a statistically significant effect on the PK profile except body weight, which showed a moderate effect on clearance (clearance increased by 25% as weight increased by 30%). However, when comparing a subject with low weight (51 kg) to a subject with high weight (104 kg), their PK profiles were similar with a great degree of overlapping. Therefore, this weight effect on clearance was not considered clinically relevant. The magnitude of IPV was low for clearance (27%) and moderate for absorption constant (61%). However due to the lack of PK timepoints around the Cmax, a higher IPV was observed for volume of distribution (150%). Mean (SD) derived parameters AUC and Cmaxat steady-state were respectively 239 (64.8) ng.day/mL and 13.9 (7.44) ng/mL, showing moderate IPV in the PK profile. Conclusions: The PK of lanreotide Autogel/Depot was well characterized in GEP NET patients using two mechanisms of absorption. The IPVof the PK of lanreotide was moderate. Among all the patients characteristics tested, none were found clinically relevant to a potential dose adjustment in clinical practice.
Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon α-2b for advanced hepatocellular carcinoma.
Authors: Kasai Kazuhiro 
Published: February 2017

400 Background: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined hepatic arterial infusion chemotherapy of 5-fluorouracil (5-FU) and systemic pegylated interferon (PEG-IFN) α-2b in patients with advanced HCC. Methods: Subjects comprised 59 HCC patients with PVTT treated using subcutaneous administration of PEG-IFNα-2b (50-100 mg on day 1 of every week, for 4 weeks) and intra-arterial infusion of 5-FU (250 mg/day for 5 h on days 1-5 of every week, for 4 weeks). One treatment cycle lasted 4 weeks. Response to treatment was evaluated according to the Response Evaluation Criteria in Solid Tumors. The current therapy was discontinued in patients with progressive disease (PD). For responses other than PD, treatment was repeated for ³1 cycle. The primary efficacy endpoint was the objective early response rate. Secondary efficacy endpoints were progression-free survival (PFS) and overall survival (OS). Results: Objective early response rate was 73.0%. Cumulative PFS rates were 67.4% at 6 months, 30.2% at 12 months, 25.9% at 18 months and 20.7% at 24 months. Median PFS was 9.7 months. Cumulative survival rates were 82.4% at 6 months, 73.6% at 12 months, 52.8% at 24 months, and 44.0% at 36 months. Median survival time was 29.9 months. Prognostic factors affecting patient survival were analyzed by examining 21 potential parameters. Univariate analysis revealed two significant prognostic factors related to survival: PVTT grade (P=0.038); and therapeutic effect (P<0.001). All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment-related deaths were not observed. Conclusions: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-FU and PEG-IFNα-2b, this new combination therapy may be useful for patients with advanced HCC.
Defining the optimal timing of adjuvant therapy for resected pancreatic cancer: A statewide cancer registry analysis.
Authors: Saeed Hayder M. , Hnoosh Dima , Huang Bin , Durbin Eric B , McGrath Patrick , Maynard Erin , Kudrimoti Mahesh R. , Anthony Lowell Brian , Hosein Peter Joel , DeSimone Philip A. , Tzeng Ching-Wei David 
Published: February 2017

406 Background: Recent long-term results from the ESPAC-3 trial suggest that while completing adjuvant therapy (AT) is necessary after resection of pancreatic adenocarcinoma (PDAC), early initiation of AT before 8 weeks may not be associated with improved overall survival (OS). The primary aim of this study was to evaluate the impact of early vs. late AT initiation on OS in a statewide population-based analysis. Methods: Among all patients with stage I-III PDAC in the Surveillance Epidemiology and End Results (SEER) - Kentucky Cancer Registry (KCR) from 2004-2012, those undergoing pancreatectomy were stratified by postoperative chemotherapy/radiotherapy delivery and timing. Patients with preoperative therapy, no AT, or postoperative therapy beyond 16 weeks, were excluded. Remaining patients were stratified into 2 groups defined as “early” (<8 weeks) and “late” AT (8-16 weeks). A Cox regression model was created to analyze the impact of AT timing, adjusting for clinicopathologic variables. Results: Of the 4,882 total patients with PDAC, 1,193 (24%) underwent pancreatectomy. Of these, only 364 (30%) received AT within 16 weeks. With median age 65 years (range 20-101), 86% patients were stage II and 76% were node-positive. Median time to AT initiation was 52 days (range 5-111). Timing of AT did not affect OS (median OS: early AT, 19.5 vs. 19.7 mo, late AT, p=0.63). Median OS for stages I, II, and III were 46.1, 19.3, and 8.6 mo, respectively (p<0.001). Poorly/undifferentiated tumors were associated with worse median OS 17.6 vs. 21.3 mo for well/moderately differentiated tumors (p<0.001). Lymph node positivity was associated with worse median OS 18.1 vs. 25.8 mo for node negativity (p<0.001). On multivariate analysis, factors that affected OS included stage (II, HR 2.54, p=0.022; III, HR 5.16, p<0.001), node positivity (HR 1.57, p=0.008), poorly/undifferentiated grade (HR 1.50; p=0.002), but not AT timing. Conclusions: In this SEER-KCR analysis, there was no difference in OS between early and late AT initiation. Despite its proven value, the ideal window for AT initiation remains unknown as tumor biology continues to trump current treatment regimens.
Survival benefit of TACE plus iodine-125 seed implantation in unresectable hepatitis b-related hepatocellular carcinoma with PVTT.
Authors: Huang Mingsheng , Lin Qu , Wang HaoFan , Wang Long , Bai Mingjun , Zhu Kangshun , Shan Hong 
Published: February 2017

408 Background: The aim of this study is to investigate the survival benefit of transarterial chemoembolization (TACE) plus Iodine-125 seed implantation on Hepatitis B-related hepatocellular carcinoma (HB-HCC) patients complicated with PVTT and the underlying prognostic factors. Methods: A retrospective matched cohort study was done on unresectable HB-HCC patients with PVTT at our hospitals between January,2011 and June, 2014. The treatment group enrolled 70patients receiving TACE plus Iodine-125 seed implantation. The control group included 140 case-matched HB-HCC patients receiving TACE. The factors that might affect the overall survival (OS) were examined. Results: There was no significant difference in the baseline demographic characteristics between the two groups (p>0.05). Median survival time of the two groups was 11.0months and 7.5 months, respectively (P<0.001). The OS at 6, 12, 24, and 36 months was 85% vs 55%, 50% vs 25%, 14.5% vs 9%, and 14.5% vs 5% in the treatment group and control group, respectively (all P<0.001). The OS rate for type I+II PVTT patients, type III PVTT patients, patients complicated with arterial-portal-shunt (APS) or patients with mass/nodules in the treatment group was significantly higher than that in the control group (P=0.006, P<0.001, P<0.001,and P<0.001, respectively). Multivariate analysis showed that type III PVTT [Hazard ratio (HR)=0.274; 95% confidence interval (CI): 0.187~0.400; P<0.001], ECOG performance status 1~2 (HR=0.647; 95% CI: 0.428~0.979; P=0.039), diffusely infiltrating tumor subtype (HR=0.596; 95% CI: 0.417~0.852; P=0.005), and the presence of APS (HR=2.387; 95%CI: 1.594~3.574; P<0.001) were independent predictors of poor prognosis. Treatment modality of TACE plus Iodine-125 seed implantation (HR=0.291; 95% CI: 0.185~0.456; P<0.001) was independently associated with better survival. Conclusions: TACE plus Iodine-125 seed implantation can improve OS of unresectable HB-HCC patients with PVTT. Treatment modality, ECOG, PVTT type, presence of APS, and subtype of tumor were independent factors for predicting prognosis.
Chemotherapy toxicity predicted by baseline nutrition assessment in gastrointestinal (GI) malignancies: A multicenter analysis.
Authors: Klute Kelsey , Brouwer Julianna , Jhawer Minaxi , Sacks Hayley , Gangadin Anatasia , Ocean Allyson J. , Popa Elizabeta C. , Dai Tong , Wu Guojiao , Christos Paul J. , Shah Manish A. 
Published: February 2017

410 Background: Malnutrition is prevalent in GI malignancies and is associated with decreased survival, frequent hospitalizations and increased healthcare costs. Outside the perioperative setting, malnutrition rarely impacts treatment decisions. The subjective global assessment (SGA) is a validated tool that stratifies patients by nutritional status. We hypothesized that malnutrition independently predicts chemotherapy-related toxicity in patients with GI malignancies. Methods: All patients enrolled in the GI Cancer Registry which collects baseline demographic data, comorbid conditions and baseline nutrition status. In patients treated with chemotherapy, we reviewed dosing, schedule and toxicities over the first two months of treatment and compared results between well-nourished (SGA-A) and malnourished (SGA B/C) patients. Two-sample t-test or chi-square tests were used for comparisons as appropriate. Multivariable logistic regression analysis was used to estimate the independent effect of SGA status after controlling for demographic/prognostic factors. Results: We enrolled 184 patients between 5/2012 – 5/2013. The overall rate of malnutrition was 31.0%: 40.4% upper GI, 13.6% lower GI, 50.0% hepatobiliary. Malnourished patients received less chemotherapy (mean 63.9±23.8% vs. 81.4±18.8% of standard dose, p<0.0001) due to toxicity-related dose-reductions, even when stratified by tumor type or treatment type (based on toxicity risk). After controlling for age, gender, ECOG (≥1 vs. 0) and albumin in a multivariable logistic regression model, malnutrition was an independent predictor of receiving less than 80% of the standard dose (adjusted odds ratio = 2.30; 95% confidence interval = 1.07, 4.95, P=0.03). Malnourished patients had a slightly higher rate of hospitalization, not statistically significant (29.8% vs. 22.0%, p=0.26). Conclusions: In patients receiving chemotherapy for GI malignancies, malnutrition (defined by SGA B/C) is an independent predictor of toxicity-related chemotherapy dose-reductions. Prospective studies should evaluate whether nutrition interventions in malnourished patients decrease chemotherapy-related toxicities.
Analysis of prognostic factors in advanced pancreatic cancer (APDAC) patients (pts) undergoing to first-line nab-paclitaxel (Nab-P) and gemcitabine (G) treatment.
Authors: Giordano Guido , Vaccaro Vanja , Lucchini Eleonora , Bertocchi Paola , Bergamo Francesca , Musettini Gianna , Santoni Matteo , Lo Re Giovanni , Giommoni Elisa , Russano Marco , Campidoglio Serena , Santini Daniele , Vasile Enrico , Cascinu Stefano , Zagonel Vittorina , Zaniboni Alberto , Melisi Davide , Milella Michele , Febbraro Antonio 
Published: February 2017

412 Background: Nab-P + G combination represents an optimal first line therapeutic option in APDAC. Actually we have no parameters to predict prognosis in pts receiving this regimen. Here we present data of a multicentre retrospective analysis evaluating prognostic impact of clinical or biological factors in a cohort of APDAC pts treated with Nab-P + G first line CT. Methods: Clinical records of 118 APDAC pts receiving first line Nab-P + G were retrospectively reviewed. Overall survival (OS) and progression free survival (PFS) were evaluated with Kaplan Meier method with 95% CI and curves were compared with log-rank test. Cox-regression model was applied to the data with univariate and multivariate approach. Variables included in analysis were age, gender, ECOG PS, primary tumor site, liver metastases, multiple metastatic sites, baseline CA19-9, bilirubin levels, neutrophil/lymphocyte ratio (NLR), CA19-9 decrease > 50%, biliary stent and symptomatic disease. Results: Median age was 66 (37 - 83), M/F:65/53, ECOG PS 0/1/2: 51/46/21 respectively. 4 complete and 27 partial responses were observed with 26% response rate (RR). Median OS and PFS were 11 months (95% CI 9.58 – 12.41) and 7 months ( 95% CI 5.96 – 8.03) respectively. When considered at univariate analysis primary tumor location to the head, ECOG PS of 2, bilirubin levels higher than median and NLR ≥ 5 had a bad prognostic impact both on PFS and OS. Differently, CA19-9 decrease > 50% was considered a positive prognostic factor for PFS and OS. Multivariate analysis confirmed the negative role of NLR ≥ 5 respect of PFS (HR 3.21; 95%CI 1.61 – 5.68, p = 0.002) and OS (HR 3.38; 95%CI 1.88 – 5.79, p = 0.001) and positive impact of CA19-9 decrease > 50% on PFS (HR 0.37; 95% CI 0.11 – 0.68, p=0.006) and OS (HR 0.53; 95% CI 0.15 – 0.97, p=0.005), as independent prognostic factors. Conclusions: This analysis suggest that in APDAC pts receiving first line Nab-P + G, high NLR value (≥5) could be considered an easy detectable, independent parameter to predict poor outcomes in terms of PFS and OS. Furthermore CA19-9 reduction > 50% from baseline may be, in absence of other clinical and molecular parameters, an early marker of good prognosis.
Gemcitabine (Gem) and nab-paclitaxel (nab-P) in patients (pts) with refractory advanced pancreatic cancer.
Authors: Palacio Sofia , Akunyili Ikechukwu Immanuel , Ernani Vinicius , Macintyre Jessica , Merchan Jaime R. , Pollack Terri , Reis Isildinha , Restrepo Maria H. , Rocha Lima Caio Max S. , Hosein Peter Joel 
Published: February 2017

413 Background: The combination of nab-P and Gem improves survival compared to Gem alone in first-line therapy of metastatic pancreatic cancer. Efficacy data with this doublet in previously treated pts are scant. Our group presented preliminary results on 10 pts treated with this two-drug combination in the second and third line setting and herein present updated data on 59 pts. Methods: This IRB approved analysis identified all pts diagnosed with advanced refractory pancreatic cancer, treated with second-line Gem and nab-P at University of Miami and Sylvester Comprehensive Cancer Center between September 2010 and June 2014. Response by RECIST, CA19-9, and symptomatic improvement were assessed. Progression-free survival (PFS) and overall survival (OS) were calculated from the start of Gem + nab-P and were analyzed using the Kaplan-Meier method. Clinical benefit was defined as the percentage of patients with a partial response (PR) or stable disease (SD). Results: Data from59 pts were analyzed. The median age was 60; 55% were male; 54% received Gem + nab-P as second line therapy and 46% received it as third-line or beyond. Five (10%) pts had confirmed PR, 23 (47%) SD and 21 (43%) progressed. Among the 31 (52%) pts who received prior Gem, 18 (58%) had clinical benefit, 3 PR and 15 SD. The median OS was 3.9 months. The median PFS was 3 months. Toxicity appears similar to what has been reported on the MPACT trial with the combination. Conclusions: The clinical benefit seen withGem and nab-P in this group of pretreated pancreatic cancer pts suggests that it can be considered as an option. Additionally, prior Gem treatment appears not to decrease Gem and nab-P benefit in this population. Since nab-P monotherapy has modest activity in pre-treated pancreatic cancer pts, our data suggests a positive interaction between Gem and nab-P that may overcome resistance to Gem. [Table: see text]