bluuebunny/crossref_metadata_2025_split huggingface dataset:
Perioperative decrement of factor XIII as a predictor of anastomotic leakage after esophagectomy in patients with esophageal cancer.
Authors: Takeuchi Hiroya , Inoue Masazumi , Matsuda Satoru , Fukuda Kazumasa , Nakamura Rieko , Takahashi Tsunehiro , Wada Norihito , Kawakubo Hirofumi , Kitagawa Yuko 
Published: February 2017

32 Background: Factor XIII(F13), or fibrin stabilizing factor, is involved in the last stage of blood coagulation. Although F13 is also known to be activated in wound healing after surgery, the association between F13 levels and postoperative complications after surgery remains unknown. In this study, we hypothesized that the F13 levels during perioperative periods may be related to the postoperative complications after esophagectomy in patients with esophageal cancer. Methods: A prospective study has been conducted for patients with esophageal cancer at our institution (UMIN000011658). Preoperative and postoperative (1st, 3rd, 5th, and 7th postoperative days) F13 levels were examined in 73 patients with primary esophageal cancer who underwent transthoracic esophagectomy. We investigated the association of F13 levels with clinicopathological background factors and the postoperative complications after esophagectomy. Results: The average age of the patients who underwent esophagectomy was 64.8 years, and 66 patients (90%) were males. Major postoperative complications included anastomotic leakage (C-D grade ≥ I: 19%), and pneumonia (C-D grade ≥ I: 34%). F13 level in preoperative esophageal cancer patients ranged from 36 to 155% (median 102%). In general, F13 levels markedly decreased after esophagectomy and gradually recovered after the 5th postoperative day. Preoperative and postoperative F13 levels at each point did not correlate with occurrence of any postoperative complications. However, the patients with 35% or more reduction of F13 level in the 1st postoperative day compared to the preoperative F13 level significantly correlated with higher incidence of anastomotic leakage. The incidence of anastomotic leakage of the patients with F13 change≥35% was 27% while that of the patients with F13 change<35% was only 4% (p = 0.013). Conclusions: This study revealed that perioperative decrement of factor XIII may be a promising predictor of anastomotic leakage after esophagectomy in patients with esophageal cancer.
Stereotactic body radiotherapy for unresectable hepatocellular carcinoma: A population based analysis of tumors up to 15 cm.
Authors: Yeung Rosanna , Rackley Thomas , Weber Britta , Lee Richard , Camborde Marie-Laure , Pearson Moira , Duzenli Cheryl , Loewen Shaun , Liu Mitchell , Ma Roy , Schellenberg Devin 
Published: February 2017

322 Background: Stereotactic body radiotherapy (SBRT) has an emerging role for patients with hepatocellular (HCC). The purpose of this study is to describe the efficacy of HCC SBRT at a population level without any tumor size restriction. Methods: A retrospective study of the first 49 HCC patients treated with SBRT between March 2011-July 2015 at the British Columbia Cancer Agency was conducted. All patients were either ineligible for or failed standard local therapies (partial hepatectomy, radiofrequency ablation, percutaneous ethanol injection, transarterial chemoembolization, or radioembolization) and discussed in a multidisciplinary rounds setting. Local control (LC), progression free survival (PFS) (defined as freedom from failure elsewhere in the liver) and overall survival (OS) were analyzed at 1 and 2 years. Changes to Child’s Pugh (CP) score at 3 months post-SBRT were also analyzed. Results: Median follow-up was 14 months with 35 patients (71%) alive at last follow-up. Fifty-two separate HCC lesions were treated with a median size of 4.2 cm (range: 1.3-15.6 cm) and a planning treatment volume (PTV) of 114 cm3 (range: 22-1776 cm3). Over half of the lesions (55%) were ≥ 4cm. Thirty-six patients (74%) had previous local therapies. Prior to SBRT, 57% of patients were CP A5, 33% were CP B6, 8% were CP B7, and 1 patient (2%) was CP B8. At 3 months post-SBRT, 35% of patients had an increased CP score, with a mean increase of 1.8 points. The most common dose and fractionation was 45Gy in 3 or 5 fractions. Median V90 (dose to 90% of the PTV) was 99.8% (range: 74.1-100%). LC for all patients was 96% at 1 and 2 years. LC was comparable between moderate to large tumors ( ≥ 4cm) and those < 4cm (1 and 2 year LC: 96% for ≥ 4cm vs 95% for < 4cm). OS for all patients at 1 year was 67% and 62% at 2 years. PFS was 53% and 38% at 1 and 2 years respectively. The median PFS was 13.7 months with 13 patients (27%) undergoing further local treatment due to regional progression including 4 patients who had liver transplants. Conclusions: SBRT provides high local control for patients with HCC of even moderate to large size. Regional progression is prominent in HCC patients and SBRT does not appear to preclude further local treatments.
A phase II study of Chinese patients (pts) treated with nab-paclitaxel (nab-P) plus gemcitabine (Gem) for metastatic pancreatic cancer (MPC).
Authors: Shen Lin , Yu Xianjun , Hao Jihui , Wang Liwei , Pan Hongming , Han Guohong , Xu Jian-Ming , Zhang Yanqiao , Yang Shujun , Chen Jia , Ying Jieer , Dai Guanghai , Li Mingyu , Begic Damir , Lu Brian D. , Xu Ruihua 
Published: February 2017

327 Background: nab-P + Gem demonstrated significantly better overall survival (OS; median: 8.7 vs 6.6 mo; HR 0.72; P < 0.001) than Gem alone as first-line treatment for pts with MPC in the MPACT study. This phase II bridging study evaluated efficacy and safety of nab-P + Gem in Chinese pts with MPC. Methods: Efficacy and safety of nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 every 4 weeks was evaluated in a 3-part sequential study. In part 1, safety was examined. In part 2, efficacy was evaluated by the Simon optimal 2-stage design. If there were > 2 responses in 28 pts in stage 1 of part 2, an additional 54 pts would be treated in stage 2. The study would be completed if > 9 responses were observed. If there was an insufficient number of responses in either stage of part 2, part 3 would be triggered to compare nab-P + Gem vs Gem alone. The primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), OS, and safety. Correlation of OS and baseline neutrophil-to-lymphocyte ratio (NLR) was also analyzed. Results: Eighty-three pts were treated. Median age was 57.0 y; 19% were aged > 65 y; baseline Karnofsky performance status was 90 - 100 in 70% of pts and 70 - 80 in 30%. Combining results for stages 1 and 2, ORR was 35% by independent assessment, median DOR was 8.9 mo (95% CI, 6.01 - 8.94), median OS and PFS were 9.2 mo (95% CI, 7.60 - 11.10) and 5.5 mo (95% CI, 5.29 - 7.16), respectively (Table). Baseline NLR ≤ 5 was associated with a nonsignificant trend toward longer OS vs NLR > 5 (median, 10.0 vs 8.3 mo; HR 0.62; P= 0.148). The most common grade ≥ 3 adverse events included neutropenia (37%), leukopenia (31%), and fatigue (14%). Grade ≥ 3 peripheral neuropathy occurred in 7% of pts. Part 3 was not triggered per study design. Conclusions: nab-P + Gem demonstrated efficacy in Chinese pts with MPC. The OS and ORR were numerically better than those of the phase III MPACT trial (Table). A trend toward longer OS in pts with baseline NLR ≤ 5 vs > 5 confirmed previous findings from the MPACT study. No new safety signals were identified. Clinical trial information: NCT02135822. [Table: see text]
Gallbladder cancer presenting with jaundice: Uniformly fatal or still potentially curable?
Authors: Tran Thuy , Ethun Cecilia Grace , Pawlik Timothy M. , Buettner Stefan , Idrees Kamran , Isom Chelsea A , Fields Ryan C. , Krasnick Bradley , Weber Sharon M. , Salem Ahmed I. , Martin Robert C. G. , Scoggins Charles R. , Shen Perry , Mogal Harveshp , Schmidt Carl Richard , Beal Eliza W , Hatzaras Ioannis , Shenoy Rivfka , Maithel Shishir Kumar , Poultsides George A. 
Published: February 2017

336 Background: The prognosis of patients with gallbladder cancer (GBC) who present with jaundice has historically been considered dismal, however recent Eastern literature has demonstrated that surgical resection can be associated with long-term survival. The objective of this study was to utilize a contemporary, Western, multi-institutional dataset to examine the prognostic significance of preoperative jaundice on short- and long-term outcomes after GBC resection. Methods: Patients with GBC managed surgically from 2000 to 2015 in 10 academic institutions participating in the U.S. Extrahepatic Biliary Malignancy Consortium were stratified based on the presence of preoperative jaundice (bilirubin > 3 mg/ml or requiring preoperative biliary drainage). Postoperative morbidity, mortality, and overall survival were compared. Results: Of 449 patients with GBC evaluated for resection, 301 (67%) eventually underwent curative-intent resection. Resectability for cure was much lower in patients with preoperative jaundice (48% vs. 79%, p < 0.001). Of 273 patients who underwent curative-intent resection and had available preoperative bilirubin levels, 53 (19%) had preoperative jaundice and were noted to have tumors of T3/4 stage (63% vs 42%, P = 0.008), with lymph node metastasis (63% vs. 41%; p = 0.014), lymphovascular invasion (68% vs 39%; p = 0.003), and R1 margins (37 vs. 9%; p < 0.001). Patients with jaundice more commonly required CBD (55% vs 32%, P = 0.004), major liver (25% vs. 7%; p < 0.001) and portal vein resection (8% vs. 0.5%; p = 0.006), as well as intraoperative blood transfusion (29 % vs. 11%; p = 0.002). Overall morbidity (57% vs. 38%; p = 0.031) and in-hospital mortality (7.5% vs. 1.4%; p = 0.029) rates were higher in patients with jaundice. Overall survival after curative-intent resection was worse in patients with jaundice (median 12 vs 33 months; p < 0.001). Conclusions: Half of GBC patients presenting with jaundice are not resectable for cure and when they are, their 5-year survival is 12%. These patients should not be excluded from multidisciplinary treatment strategies that include surgery, however expectations should be clearly set and selection should be cautious.
Survival of pancreaticoduodenectomies with venous reconstruction using a population-based database.
Authors: Goldner Bryan S. , Tozzi Federrico , Melstrom Laleh , Warner Susanne , Singh Gagandeep 
Published: February 2017

340 Background: Locally advanced disease requiring pancreaticoduodenectomy (PD) with venous reconstruction is a controversial topic that is often determined by careful patient selection. There are numerous published single institution, but sparse multicenter studies, demonstrating the safety and efficacy of PD with venous reconstruction. The goal of this study is to evaluate survival outcomes in patients who underwent a PD with our without venous reconstruction utilizing a large statewide database. Methods: The California Cancer Registry (CCR) was used to obtain data on all PD performed from 2000-2011. This data was merged with Office of Statewide Planning and Development data to obtain inpatient hospitalization data. ICD-09 codes were used to identify all PD with or without venous reconstruction. Data was obtained on demographics, disease process, surgery, hospitalization statistics, and survival. Venous reconstruction was divided into venous segmental resection with reconstruction (VSR) and primary repair of the vein with a patch (PR). Survival was analyzed using Kaplan-Meier Survival analysis (KM). Results: Data were obtained on 5,228 patients who underwent PD, 3.7% (161) underwent venous reconstruction (148; 2.8% VSR and 43; 0.8% PR). A significant overall survival difference between PD and all vascular reconstruction was observed (23 months vs 17 months respectively, p < 0.001). Further analysis revealed no significant difference in survival between standard PD and PD with PR (median 21 months; p = 0.2). However, there was a significant survival advantage of PD compared to PD with VSR (21 vs 16 months respectively, p < 0.001). Evaluation of length of stay and complications revealed no statistical difference (p = 0.07 and p = 0.8). Conclusions: Venous reconstruction in PD is associated with worse survival compared to PD alone. Interestingly, patients who had a PR had a better survival than VSR alone. Overall survival for all comers of vascular reconstruction remains inferior which reinforces the biology of disease as an important predictor of outcomes as well as shorter segment portal vein involvement conferring improved survival.
Comprehensive analysis of radiographic, clinical, and inflammatory markers demonstrating changes in lean muscle correlate with outcome in patients (pts) with metastatic pancreatic adenocarcinoma (mPDAC) who undergo taxane-based chemotherapy (CT).
Authors: Ahn Daniel H. , Ahn Chul , Nagar Veena , Noonan Anne M. , Farren Matthew , Lesinski Gregory B. , Knopp Michael V. , Bekaii-Saab Tanios S. 
Published: February 2017

349 Background: MPDAC is associated with a poor prognosis. The mechanisms of carcinogenesis are complex; involve multiple signaling pathways and inflammatory cytokines that may promote cachexia, a major cause of morbidity and mortality in mPDAC. The purpose of this study is to understand factors related to skeletal muscle changes, and its effect on outcomes in pts with mPDAC. Methods: Pt and clinical data were obtained from a recent prospective clinical trial in mPDAC where all pts received first-line taxane-based CT. We examined changes in modified Glasgow prognostic score, neutrophil lymphocyte ratio, a 32-cytokine panel, weight, and skeletal muscle area (SMA), determined by validated methodology with computed tomography, at baseline and cycle 3. We defined > 6cm2 in SMA, correlating to 1kg of skeletal muscle gain (SMG), as significant. Univariate and multivariate Cox regression models were used to determine the association between laboratory, radiographic and clinical findings with progression free survival (PFS) and overall survival (OS). Results: 66 evaluable pts were included. Independent of clinical response, an OS advantage was seen in pts who experienced significant SMG (p = 0.023) and in patients with nominal SMG (p = 0.012). A numerical benefit in PFS was observed with SMG. Decreases in IFN-a (p = 0.024), IFN-g (p = 0.001) and IL-6 (p = 0.042) were inversely associated with SMG. A comprehensive analysis incorporating all relevant laboratory, radiographic and clinical assessments demonstrated a 4.62-month OS advantage in pts with favorable characteristics vs. those with poor prognostic factors (11.47 versus 6.84 mos., p = 0.0029). Conclusions: SMG, or the reversal of cachexia confers an OS advantage in pts with mPDAC treated with taxane-based CT regardless of clinical response. A comprehensive assessment of muscle change is a precise measurement that can identify pts at greatest risk for muscle loss, which could predict for trmt response and pt outcomes. This merits further investigation as a tool and in trials directed at reversing the process of cachexia.
A phase II study of biweekly gemcitabine at fixed dose rate infusion plus S1 as first-line chemotherapy in patients with locally advanced or metastatic pancreatic cancer.
Authors: Xiang Xj , Zhang L , Li Jh , Zhan Zy , Feng M , Chen J , Xiong JP 
Published: February 2017

357 Background: The combination regimen of gemcitabine plus S1 (GS) as first-line chemotherapy has shown good efficacy in advanced pancreatic cancer. However, it is inconvenient to deliver gemcitabine on days 1 and 8 within one treatment cycle. In addition, previous studies have demonstrated that the gemcitabine administration by fixed dose rate infusion of 10 mg/m2/min should maximize the rate of intracellular accumulation of gemcitabine triphosphate and might improve clinical efficacy. The aim of this study was to evaluate the efficacy and safety of biweekly gemcitabine at fixed dose rate infusion combined with S1 (FGS) in chemonaive patients with locally advanced or metastatic pancreatic cancer. Methods: Forty-three eligible patients with locally advanced or metastatic pancreatic cancer received gemcitabine at a fixed dose of 10 mg/m2/min intravenously over a 2-h period on day 1, together with oral S1 40mg/m2twice daily on days 1 to 10, every 2 weeks. Tumor assessment was performed for every 3 cycles of chemotherapy. Results: All patients were evaluable for toxicity and 42 patients for efficacy. The overall response rate was 35.7% with 1 complete response, 14 partial responses, 17 stable diseases, and 10 progressions. Median time to progression was 5.9 months and median overall survival was 9.6 months. The main grade 3/4 toxicities included neutropenia (30.2%), thrombocytopenia (6.9%), anemia (2.3%), nausea (4.6%), diarrhea (2.3%). Conclusions: The biweekly FGS regimen is active, well tolerated and conveniently delivered as first-line chemotherapy for patients with locally advanced or metastatic pancreatic cancer.
Stereotactic body radiotherapy (SBRT) with or without surgery for primary and metastatic liver tumors.
Authors: Kirichenko Alexander V. , Parda David S. , Sanguino Angela , Gayou Olivier , Raj Moses S. , Monga Dulabh K. , Thai Ngoc 
Published: February 2017

360 Background: We report on the outcome and toxicity of liver SBRT alone or in combination with surgery for inoperable primary and metastatic liver tumors. Methods: Patients with up to four isolated hepatic metastases (sum of tumor diameters ≤ 8cm) and individual tumor diameter ≤ 9 cm received SBRT at 46.8Gy ± 3.7 in 4-6 fractions. In patients with hepatic cirrhosis, liver dose constraints were imposed exclusively on residual functional liver volume defined on SPECT during SBRT treatment planning. The primary end point was local control with at least 6 months of radiographic followup, and secondary end points were toxicity and survival. Results: Between 2007-2014, 120 lesions in 91 patients with either unresectable primary (n = 43) or metastatic liver cancer (n = 48) completed liver SBRT to 36-60 Gy delivered in 4 to 6 treatment fractions, with a mean BED of 197 Gy3 (range 108 – 300 Gy3). Median followup was 20.3 months (range 1.9 - 64.1). Fourteen patients underwent liver transplant with SBRT as a bridging therapy or for tumor downsizing. Eight patients completed hepatic resections in combination with planned SBRT for unresectable tumors. Two-year local control was 96% for hepatoma and 93.8% for metastases; it was 100% for lesions ≤ 4cm. Ten of 14 transplanted patients developed complete pathological response with median time to transplant of 5.7 months (range 1.7 – 23.3). No incidence of grade > 2 treatment toxicity was observed. There was no accelerated Child-Pugh class migration from A to B or from B to C. There were no operative or perioperative complications in patients who received SBRT prior to liver transplant or in combination with planned hepatectomy. Two-year overall survival was 82.3% (hepatoma) and 64.3% (metastases). Conclusions: In this retrospective analysis we demonstrate that liver SBRT alone or in combination with surgery is safe and effective for the treatment of isolated inoperable hepatic malignancies and provides excellent local control rates with minimal toxicity.
Defining radiation induced liver toxicity in the treatment of hepatocellular carcinoma: Which metric is most predictive for survival?
Authors: Chapman Tobias Robert , Bowen Stephen R. , Nyflot Matthew J. , Apisarnthanarax Smith 
Published: February 2017

361 Background: Radiation induced liver disease (RILD) is of critical concern in the treatment of hepatocellular carcinoma (HCC) with radiation therapy (RT). Variability exists in metrics used to define RILD with no consensus on which best predict for overall survival (OS) and RILD-specific survival (RILDSS). We examined the correlation between toxicity metrics and clinical outcomes in a heavily pre-treated population that received RT. Methods: The charts of 37 HCC patients treated from 2013 - 2015 were reviewed retrospectively. At baseline, 62% were Child-Pugh (CP)-A, 32% CP-B and 5% CP-C. The majority (59%) had prior liver-directed therapy (LDT), 43% received stereotactic body RT and 49% proton RT. Pre-treatment, toxicity ( ≤ 6 months from treatment) and outcomes data were collected. Deaths from RILD were scored. Pre-treatment factors and toxicity outcomes were assessed by univariate Cox models for association with OS and RILDSS. Statistically significant predictors formed the basis for stepwise multivariate Cox regression to retain independent predictors of survival. Results: At a median follow-up of 8 months, 14 patients had an increase in CP score ( ≥ 2, n = 7) and 3 had ≥ G3 RTOG transaminitis. There were 11 deaths, 5 from RILD. On univariate analysis (UA), tumor size, pre-treatment liver function, prior LDT and 5 toxicity metrics (CP score increases and transaminitis) were significantly associated with OS. An increase of ≥ 1 CP score (HR 22.7, p = 0.005), pre-treatment ALBI grade (HR 6.0, p = 0.02) and tumor size (HR 1.2, p = 0.01) were independent predictors of OS on multivariate analysis (MVA). Similar factors were associated with RILDSS on UA, including ≥ 2 CP score increase and ≥ G3 ALT elevation; however, only pre-treatment CP score (HR 4.0, p = 0.01) and tumor size (HR 1.5, p = 0.03) were independently predictive on MVA. Conclusions: Pre-treatment liver functional status and tumor size were highly predictive of OS and RILDSS, suggesting that baseline functional hepatic reserve is the primary determinant in developing fatal RILD rather than post-RT changes in liver function. Further work is needed to define dosimetric parameters and pre-treatment factors that predict RILD toxicity.
Using the ALBI grade as a prognostic marker for radioembolization of hepatocellular carcinoma.
Authors: Mohammadi Homan , Abuodeh Yazan , Jin Will , Frakes Jessica M. , Friedman Mark , Biebel Benjamin , Choi Junsung , El-Haddad Ghassan , Kis Bela , Sweeney Jennifer , Kim Richard D. , Pimiento Jose Mario , Malafa Mokenge Peter , Anaya Daniel A. , Hoffe Sarah E. 
Published: February 2017

366 Background: The Childs-Pugh class (C-P) is a commonly used scoring system to measure liver function in patients with hepatocellular carcinoma (HCC). While originally developed for patients undergoing esophageal resection for varices in the setting of cirrhosis and portal hypertension, it is now a widely accepted measure of liver function. The Albumin-Bilirubin (ALBI) grading system is a model developed in 2015 to assess liver function that has eliminated the subjective measures present in C-P. We correlate the ALBI grading system and C-P classes to overall survival in our HCC patients receiving radioembolization. Methods: With IRB approval, we retrospectively evaluated patients who received radioembolization for HCC between 2009-2014. We evaluated the albumin and bilirubin levels in our patients prior to receiving their first radioembolization (n = 121). The ALBI grades were calculated from these data with the formula (log10 bilirubin x 0.66) + (albumin x -0.085) and separated into grades based on the thresholds set in the original manuscript. These grades were then correlated to outcomes using Mantel-Cox Log analysis. The statistical comparisons were duplicated with C-P classes. Results: Median survival for C-P class A and B were 13.1 and 8.4 months (p < 0.0005), respectively while median survival for ALBI grades 1 and 2 were 20.9 and 11.0 months (p < 0.0005), respectively. Our C-P class A patient group was re-stratified using the ALBI formula and found to have two cohorts of patients with statistically significant differences in survival. The median survival between ALBI grades 1 and 2 within this patient group was 20.9 and 11.0 months (p = 0.002), respectively. Too few C-P class C or ALBI grade 3 patients were within our dataset for statistically significant results. Conclusions: We demonstrated that the ALBI grading system is a more sensitive marker of liver function than the C-P classes in the setting of mild to moderate dysfunction. Using the ALBI grade, we identified a subset of patients that have significantly better outcomes from radioembolization for HCC within C-P class A.