bluuebunny/crossref_metadata_2025_split huggingface dataset:
FOLFIRINOX for advanced pancreatic cancer: The Princess Margaret experience.
Authors: Chllamma Muralidharan , Cook Natalie , Giby Kazim , Dodd Anna , Wang Lisa , Dhani Neesha C. , Hedley David W. , Moore Malcolm J. 
Published: February 2017

417 Background: The FOLFIRINOX regimen has been shown to significantly increase both overall (OS) and progression free (PFS) survival in metastatic pancreas cancer (MPC), albeit with an increase in adverse events (AEs). It is not known whether initial dose reductions compromise FOLFIRINOX efficacy and there are limited data regarding treatment of locally advanced pancreatic cancer (LAPC). Methods: We conducted a retrospective review of patients (pts) treated with FOLFIRINOX for MPC or LAPC at Princess Margaret Cancer Centre, and began treatment between Dec 2011 and April 2014. The primary objective was to evaluate the efficacy and safety of FOLFIRINOX when used with dose modifications. Results: 102 pts were identified; 66 MPC and 36 LAPC. Median age was 65 years. 72% of pts had pancreatic head tumors. At baseline 95% of pts had an ECOG performance status of 0 or 1; 95% had bilirubin < 1.5 ULN and 45% had a biliary stent. 68% of pts initiated treatment with a dose reduction (93% reduction or omission of bolus 5FU, 88% reduction in Irinotecan, 68% reduction in Oxaliplatin and 66% reduction in infusional 5FU). Median number of cycles was 6 (1-31); 25% of pts received <4 cycles. Median OS in metastatic pts was 12.9 months (mo) and 23 mo in LAPC; Median PFS was 8.7 mo (metastatic) and 11.1 mo in LAPC. There was no significant difference in PFS (10.9 vs. 10.3 mo; p=0.60) or OS (11.1 vs. 14.0 mo; p=0.19) between the full starting dose and reduced starting dose groups respectively. Partial response or stable disease was achieved in 57% of pts; 11% of the LAPC pts had a surgical resection. Grade 3/4 hematologic AEs were observed in 43% of pts (febrile neutropenia in 6%). Only 13% of pts received G-CSF support. Grade 3/4 non-hematologic AEs were observed in 28% of pts, including vomiting (19%), nausea (16%) and diarrhea (16%). 18% of pts had a treatment related hospitalization (5% neutropenic sepsis, 13% GI toxicity/dehydration.) There was one treatment related death. Pt wellbeing (scored on a validated questionnaire) significantly improved from baseline to cycle 4 (p=0.002). Conclusions: Modest dose reductions do not appear to compromise efficacy of FOLFIRINOX. Our median PFS, OS and AEs are comparable to other studies using FOLFIRINOX in both LAPC and metastatic disease.
Preoperative risk assessment of pancreatic surgery for pancreatic cancer by the surgical Apgar score.
Authors: Aoyama Toru , Katayama Yusuke , Murakawa Masaaki , Asari Masahiro , Yamaoku Koichiro , Kanazawa Amane , Higuchi Akio , Shiozawa Manabu , Ueno Makoto , Morimoto Manabu , Akaike Makoto , Yamamoto Naoto , Oshima Takashi , Rino Yasushi , Masuda Munetaka , Morinaga Soichiro 
Published: February 2017

419 Background: Postoperative morbidity is high after pancreatic surgery. Numerous studies have evaluated factors to predict the patients at risk. Recently, a simple and easy-to-use surgical complication prediction system, the surgical Apgar score (SAS) calculated using three intraoperative parameters (estimated blood loss, lowest mean arterial pressure and lowest heart rate) has been proposed for general surgery. In this study, we evaluated the predictability of the SAS for severe complications after pancreatic surgery for pancreatic cancer. Methods: We investigated 189 patients who underwent pancreatic surgery at Kanagawa Cancer Center between 2005 and 2014. Clinicopathological data, including the intraoperative parameters, were collected retrospectively. In this study, the patients with postoperative morbidities classified as Clavien-Dindo grade II or more were classified as having severe complications. Uni- and multivariate logistic regression analyses were performed to identify the risk factors for morbidity. Results: Postoperative complications were identified in 73 patients, and the overall morbidity rate was 38.6%. The results of both univariate and multivariate analyses of various factors for overall operative morbidity showed that a SAS of 0-4 points and a body mass index > 25 kg/m2 were significant independent risk factors for overall morbidity (P=0.024 and P=0.014, respectively). The rate of abdominal abscess formation was significantly higher in the patients with a SAS of 0-4 points, while the occurrence of a pancreatic fistula was significantly higher in the patients with a body mass index > 25 kg/m2. Conclusions: The SAS was a significant risk factor for surgical complications after pancreatic surgery for pancreatic cancer. Careful attention is required for these patients in order to help prevent complications and treat them as soon as they develop.
Gastric cancer prevention and early detection program for an at-risk population: A prospective study of the Korean American community.
Authors: Woo Yanghee , Trapp Garrick , Hyun Jae Geun , Hyun Chul Soo , Katherine Lu Zen , Gonda Tamas , Oberstein Paul Eliezer , Chabot John A. , Wang Timothy C. 
Published: February 2017

42 Background: Gastric cancer development is multifactorial with varying incidence rates. People of Korean heritage have the highest rate of gastric cancer in the world and among Americans. While this gastric cancer disparity is well known, an evaluation of the population-specific risk factors and the effectiveness of selective screening in the Korean American communities have not been studied. Methods: Korean Americans living in Northern New Jersey over 40 years of age without a known history of gastric cancer were eligible to participate in this prospective study. Each participant received a 30-minute one-to-one consultation with a gastric cancer surgeon, given a 44-item questionnaire, and underwent an upper endoscopy with biopsies. The consultation included assessment for the presence of relevant history, symptoms, and signs. The questionnaire addressed patient-specific demographic, epidemiologic, and cultural information. Two gastroenterologists blinded to the consultation and questionnaire results performed the upper endoscopies. Results: Between September 2013 and September 2014, one hundred participants enrolled in our study. All participants denied the presence of alarm symptoms, such as acute weight loss, melena or persistent vomiting. Risk factors, including prior H. pylori infection (25%), family history of gastric cancer (15%), cigarette smoking (16%), and daily intake of salty and pickled foods (87%) were present. On upper endoscopy, 18% of the participants were found to have “moderate to severe H. pylori associated chronic active gastritis." Other endoscopic findings were mild gastritis (61%), severe erosive gastritis (4%), polyps (4%), and metaplasia (21%). Only 4 patients had normal mucosal pathology. Gastric dysplasia or cancer has not yet been identified. Conclusions: Korean Americans have high rates of modifiable risk factors for developing gastric cancer. Novel population-specific gastric cancer prevention and early detection strategies should be designed to eliminate gastric cancer from the Korean American Community.
Clinical outcomes of patients with gastrointestinal malignancies participating in phase I clinical trials.
Authors: Mahipal Amit , Burke Nancy , Wapinsky Georgine , Bertels Barbara , Juan TzuHua , Lee Jae K , Lush Richard , Sullivan Daniel , Denson Aaron 
Published: February 2017

428 Background: Early phase clinical trials play a pivotal role in drug development. However, limited data is available on the clinical outcomes of patients with gastrointestinal (GI) malignancies enrolled in phase 1 clinical trials. The aim of this study is to evaluate the clinical characteristics and survival of patients with GI cancers participating in phase 1 clinical trials. Methods: All consecutive patients with advanced GI tumors who participated in phase 1 clinical trials from 1/2007 to 12/2013 at Moffitt Cancer Center were included. Data for individual patients were extracted from the OnCore database and clinical charts. Only patients who received at least one dose of the study drug were included. Cox regression model was used to estimate multivariable adjusted hazard ratios and 95% CI. Results: 243 pts with GI malignancies who participated in phase 1 clinical trials were included. Median age was 62 years (26-82 years) with 55% of the patients aged >60 years. Patients had the following disease types: pancreas (42%), colorectal (34%), gastro-esophageal (10%), hepatobiliary (13%) and others (2%). The distribution of patients for baseline variables are: male (55%), DVT/PE (12%), ECOG ≥1 (72%), prior systemic therapies ≥2 (59%), no. of metastatic sites > 2 (31%), lung metastases (40%) and liver metastases (77%). Pts received treatment with chemotherapy only (14%), targeted therapy (41%), chemotherapy + targeted therapy (42%) and others (2%). The response rate was 4% with 38% achieving stable disease; 42% of pts had progressive disease. The median OS was 5.8 months (0.2-52.4). ECOG score of 0, prior systemic therapies < 2 and absence of liver metastases were associated with better OS on multivariate analysis. Conclusions: This is the largest study to assess clinical outcomes in this patient population. Phase 1 clinical trials provide clinical benefit to patients with advanced GI malignancies and should be recommended as a treatment option in appropriate patients. [Table: see text]
Pretreatment lab values to predict overall survival in patients with primary unresectable pancreatic adenocarcinoma treated with SBRT.
Authors: Alagappan Muthuraman , Pollom Erqi L. , von Eyben Rie , Kunz Pamela L. , Fisher George A. , Ford James M. , Poultsides George A. , Visser Brendan C. , Norton Jeffrey A. , Kamaya Aya , Columbo Laurie Ann , Koong Albert , Chang Daniel Tandel 
Published: February 2017

433 Background: This study investigates which pre-treatment hematologic and tumor marker values can predict for overall survival (OS) in patients with unresectable pancreatic adenocarcinoma treated with stereotactic body radiotherapy (SBRT) using data from the past 11 years from a single institution. Methods: Clinical data from 196 patients with primary unresectable pancreatic adenocarcinoma treated with SBRT at our institution from 2002 to 2013 was collected. Of these, 161 (82.1%) had locally advanced disease, 12 (6.1%) had borderline resectable disease, 21 (10.7%) were medically inoperable, and 2 (1.0%) had resectable disease but refused surgery. Prior to the start of treatment, lab values were collected for 191 of these patients including: hemoglobin, platelets, albumin, red blood cell (RBC) count, white blood cell (WBC) count, absolute lymphocyte count, absolute neutrophil count, and neutrophil to lymphocyte ratio (NLR). Additionally, tumor markers CA 19-9 and CEA were collected. Background clinical and demographic data was also available for the entire cohort. Results: The median follow-up for the entire cohort following SBRT was 7.7 months. Median OS from the start of treatment was 7.88 months (IQR 4.96-12.72). Prior radiation therapy (p = 0.0462), lower RBC (p = 0.0307), higher pre-treatment CEA (p = 0.0166), and higher NL ratio (p < 0.0001) correlated with worse OS on univariate analysis. WBC, platelet counts, and CA 19-9 did not predict for OS on univariate analysis. On multivariate analysis, higher NL ratio (p = 0.0455) and higher CEA (p = 0.0148) were both correlated with decreased OS, while RBC and prior radiation therapy had no association. Conclusions: Review of pre-treatment hematologic and tumor marker values serves as a valuable predictor of overall survival in patients with unresectable pancreatic adenocarcinoma treated with SBRT. Higher pre-treatment NL ratio and CEA values are associated with poorer OS, which may help to stratify patients into different risk categories.
A retrospective analysis assessing effects of cytotoxic versus cytostatic agents on body mass, nutritional parameters, and performance status in patients with exocrine pancreas cancer enrolled in phase I and II trials.
Authors: Schwerkoske John Philip , Borazanci Erkut , Schroeder Katy , Zhang Lei , Jameson Gayle S. , Schaffer Joyce Rosemarie , Nieves Jeffery A. , Von Hoff Daniel D. 
Published: February 2017

438 Background: The 5-year survival for pancreatic adenocarcinoma is poor, and patients increasingly turn to experimental agents after conventional treatments have failed. Novel chemotherapeutic agents undergo rigorous phase I and II trials to confirm efficacy, safety, tolerability, and optimal dose for entry into late phase trials. Cytostatic therapies are theorized to have an improved tolerability compared to traditional cytotoxic therapies. Methods: This retrospective study compared the tolerability of cytostatic vs cytotoxic therapies in patients with advanced pancreatic cancer who participated in phase I or II trials at a single institution. Nutrition parameters of weight and albumin, performance status, tumor marker CA 19-9 level, and mean tumor dimension defined by RECIST criteria were obtained for patients within four weeks of trial start date and conclusion. Results: 117 patient trials were assessed in final analysis. No statistically significant difference was observed between patients receiving cytostatic and cytotoxic agents with regards to mean weight loss (1.01 vs 1.30 kg; p =.733), decrease in albumin (0.36 vs 0.29 g/dL; p =.397), and percent change in CA 19-9 (-72% vs -76%; p =.882). Results of change in performance status were similar, with mean increase in ECOG (0.63 vs 0.61; p =.948) and decrease in Karnofsky (13 vs 12, p =.709). There was a statistically significant difference in tumor dimension with cytostatic vs cytotoxic agents (18% vs -3%, p =.043). There were no differences in trends between patients enrolled in one trial compared to those enrolled in multiple trials. Conclusions: This study did not show a significant difference between cytostatic and cytotoxic agents in patients with advanced pancreatic adenocarcinoma in early phase trials with regards to nutritional parameters, performance status, or change in CA 19-9. However, there was a statistically significant change in tumor dimension. Thus, cytotoxic agents have similar tolerability to cytostatic agents and may have additional benefit on tumor burden in patients with advanced pancreatic adenocarcinoma.
Phase III study of nab-paclitaxel (nab-P) plus gemcitabine (Gem) versus Gem alone in patients (pts) with metastatic pancreatic adenocarcinoma (mPC): Subgroup analysis of Canadian pts from the MPACT trial.
Authors: Tehfe Mustapha Ali , Dowden Scot D. , Kennecke Hagen F. , El-Maraghi Robert Hassan , Lesperance Bernard , Couture Felix , Letourneau Richard , Penenberg Darryl Neil , Romano Alfredo , Von Hoff Daniel D. 
Published: February 2017

439 Background: Weekly nab-P + Gem is a new option for first-line treatment (Tx) of mPC. In the MPACT trial, nab-P/Gem demonstrated superior overall survival (OS; primary endpoint) vs Gem alone as first-line Tx of mPC (Table). Here we report a subgroup analyses evaluating the efficacy and safety outcomes with nab-P + Gem vs Gem alone from the Canadian cohort of the MPACT trial. Methods: Previously untreated pts (N = 861) with mPC were randomized 1:1 (stratified by Karnofsky Performance Status [KPS], region, and the presence of liver metastases) to receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle or Gem 1000 mg/m2 weekly for 7 weeks followed by 1 week of rest (cycle 1) and then days 1, 8, and 15 of each 28-day cycle (cycle ≥ 2). Results: 63 pts from Canada enrolled in the MPACT trial. Baseline pt characteristics were well balanced. Median age was 61 years and KPS was similar for both groups and comparable to the intent-to-treat (ITT) populations. Primary lesion in the pancreatic head was more common among pts in the nab-P + Gem vs Gem arm (55% vs 30%); use of biliary stent was similar (33% nab-P + Gem; 27% Gem). Median OS and progression-free survival (PFS) were longer with nab-P + Gem vs Gem (Table). Median Tx duration was 4.2 mo with nab-P + Gem vs 3.2 mo with Gem. Use of subsequent therapy was 30% in the nab-P + Gem arm vs 43% in the Gem arm. The median relative dose intensity for Gem was similar in each arm (81% nab-P + Gem vs 85% Gem). The most common grade ≥ 3 AEs for nab-P + Gem vs Gem were neutropenia (22% vs 10%), fatigue (34% vs 33%), and neuropathy (25% vs 0%). Conclusions: Canadian pts participating in MPACT were similar to the ITT population and nab-P + Gem was well tolerated and showed improved median OS, PFS, and ORR vs Gem alone, although not statistically significant (likely due to the small number of pts). Clinical trial information: NCT00844649. [Table: see text]
Interim analysis of fluorodeoxyglucose uptake in patients with metastatic or recurrent gastric cancer treated with fluoropyrimidine based chemotherapy.
Authors: Lee Suk-young , Uh Jaeseon , Oh Sang Cheul 
Published: February 2017

44 Background: The role of 18F-FDG PET/CT scanning in advanced gastric cancer (AGC) is still under investigation. We evaluated its prognostic role in patients with recurrent or metastatic AGC who received fluoropyrimidine based chemotherapy. Methods: Forty-six patients with metastatic or recurrent AGC who had the baseline and interim PET/CT scanning during the palliative chemotherapy were analyzed. The lesion with the highest SUVmax value among target lesions was determined to be a main target (SUVmax1), and interim SUVmax of the target lesion was measured after several cycles (4-12 cycles) of chemotherapy (SUVmax2). The formula calculating metabolic change follows: ΔSUVmax2-SUVmax1 (%) = (SUVmax2-SUVmax1)/SUVmax1 * 100 Results: Patients with SUVmax1 value > 6 had a significantly higher response rate than those with the lower SUVmax1 (73.9% vs. 26.1%, p=0.036). SUVmax2 < 5 was significantly associated with better overall survival (OS) (p=0.035) with univariate analysis. ΔSUVmax2- SUVmax1 > -20% or appearance of new lesions with 18F-FDG PET/CT scanning at interim analysis was significantly associated with worse OS (p=0.027). ΔSUVmax2- SUVmax1 > -20% or new lesions (p=0.03) was the only factor significantly independently associated with OS using multivariate analysis (Table). Female (p=0.028), SUVmax2 > 5 (p=0.002), and ΔSUVmax2-SUVmax1 value > -20% (p=0.004) were significantly associated factors with worse progression free survival (PFS) using univariate analysis. Both SUVmax2 (p=0.028) and ΔSUVmax2-SUVmax1 value (p=0.043) were the significant factors associated with PFS using multivariate analysis. Conclusions: Analysis ofmetabolic change by interim PET/CT scanning is useful in predicting prognosis in patients with recurrent or metastatic AGC undergoing fluoropyrimidine based chemotherapy. [Table: see text]
Use of sorafenib in recurrent hepatocellular carcinoma (HCC) after liver transplantation.
Authors: Chiu Joanne Wing-Yan , Yau Thomas Cheung , Cheung Tan To , Chan Albert , Chok Siu-Ho , Dai Wing-Chiu , Leung Roland Ching-Yu , Chan See-Ching , Lo Chung-Mau 
Published: February 2017

440 Background: Sorafenib (Sor) is the only approved systemic therapy for advanced HCC yet the safety and efficacy for its use in patients (pts) who developed recurrence after liver transplantation (LT) has not been established. There is an unmet need for treatment option in this group of pts. Methods: This is a retrospective analysis of pts treated with Sor for recurrent HCC post-LT in Queen Mary Hospital, Hong Kong. Results: During year Jan 2008 to Feb 2014, 25 post-LT pts with HCC recurrence were treated with Sor. Tacrolimus and sirolimus were the immunosuppressant of choice during the same treatment period in 76% (19/25) and 40% (10/25) pts respectively. All pts had Child-Pugh A liver function and ECOG performance status 0-1. Majority of pts were chronic hepatitis B carriers (88%) and male (88%). Median time to recurrence was 13.2 months (range 3.4-71.1). Intrahepatic recurrence and extrahepatic recurrence were found in 52% and 80% of pts respectively. Up to 68% of pts received the standard dose of 800 mg/day. The most common adverse events (AEs) were hand-foot syndrome (44%) and diarrhea (28%). G3 transaminase elevation was found in 4 pts (16%), in which 2 had histological evidence of acute graft rejection. Both cases were associated with tailing down of tacrolimus upon tumor progression, and the liver function recovered after adjustment of immunosuppressant. Nine pts (36%) required dose adjustment. The median maintenance dose was 400 mg/day. The median duration of treatment was 4.44 months (95% CI 2.53-6.44). Median time to progression was 6.21 months (95% CI 2.83-9.63). Median overall survival was 13.6 months (95% CI 7.69-19.61). Ten (40%) pts also received other subsequent systemic therapy. Conclusions: Sor given in combination with tacrolimus and sirolimus did not lead to unexpected graft rejection. The drug is in general tolerated in this population and toxicities appeared to be similar to non-transplant pts. Further study is required to evaluate for drug interaction and efficacy.
A retrospective review of the University Health Network (UHN) multimodal treatment experience with extended resection of pancreatic ductal adenocarcinoma (PDAC) in patients with arterial involvement.
Authors: Tremblay St-Germain Amélie , Fox Adrian , Segedi Maja , Serrano Aybar Pablo Emilio , Scholtz Paul , O'Malley Martin , Borgida Ayelet , Bianco Teresa , Dodd Anna , Krzyzanowska Monika K. , Moore Malcolm , Kim Joon-Hyung J. , Wei Alice Chia-chi , Gallinger Steven , Dhani Neesha C. , McGilvray Ian M 
Published: February 2017

447 Background: Involvement of a major artery with PDAC is a criteria of unresectability. Although major vein resection/reconstruction is now accepted in PDAC resection, the feasibility of arterial resection requires investigation. The response to neoadjuvant therapy (NAT) may be a useful tool for identifying appropriate candidates for extended resection. Methods: We retrospectively reviewed the UHN experience of multimodality therapy in patients (pts) with histologically confirmed PDAC and single vessel arterial involvement (superior mesenteric, celiac or hepatic artery) on CT from Jan 2009 to Dec 2013. These pts received NAT prior to being re-assessed for surgery; pts whose disease was either stable or improved were considered for surgery. Baseline imaging was reviewed independently. Postoperative complications were assessed and oncologic outcomes were analysed with Kaplan-Meier method. Results: We identified a cohort of 57 pts of whom 56 received NAT. On reassessment, 26 (46%) had no evidence of disease progression and were considered operable, while 31 had local or distant progression and were deemed inoperable. Of 26 pts proceeding to surgery, 21 (81%) underwent resection and 5 had a palliative procedure. In the resection group, 10 pts required arterial resection/reconstruction to achieve R0. The post-operative mortality at 90-days was 0% and morbidity was 86% with 33% major complications (Clavien-Dindo III-IV). With a median follow-up of 12,1 months, the median survival for the resection group was 18.7 months (95% CI: 11.2-NA) vs. 13.6 months (95% CI: 11.9-18.1) for the non-resection group, P=0.0246. Conclusions: Our results suggest that a multimodal approach including NAT +/- segmental arterial resection/reconstruction, can be considered but with high post-operative morbidity. The encouraging survival rates of pts after extended resection must be balanced with the morbidity of this surgery. Given the poor prognosis of pts with locally advanced PDAC, there is a rationale for prospective evaluation of this approach to identify pts who are most likely to benefit from this aggressive strategy.