bluuebunny/crossref_metadata_2025_split huggingface dataset:
Overall survival with preoperative biliary drainage in patients with resectable pancreatic cancer.
Authors: Strom Tobin Joel Crill , Hoffe Sarah E. , Vignesh Shivakumar , Klapman Jason , Harris Cynthia L. , Choi Jungsun , Springett Gregory M. , Meredith Kenneth L. , Hodul Pamela Joy , Malafa Mokenge Peter , Shridhar Ravi 
Published: February 2017

314 Background: Resectable pancreatic cancer patients often present with obstructive jaundice necessitating the placement of biliary stents or percutaneouse drainage catheters. We sought to evaluate whether preoperative biliary drainage affects recurrence and survival. Methods: An IRB-approved study was conducted on our institutional tumor registry to identify pancreatic cancer patients who were treated with upfront surgery between 2000 and 2012. Patients were then stratified by preoperative use of endoscopically placed stents (ERCP), percutaneous catheters (PTC), or no biliary drainage (NBD). The primary endpoint was overall survival (OS). Survival curves were calculated using the Kaplan-Meier method and the log-rank test. Multivariate analysis (MVA) was performed with a Cox regression model. Results: We identified 202 patients for the study (21 PTC; 89 ERCP; 92 NBD). Key differences between the 3 groups were mean pathologic tumor size (p=0.005), pathologic T3/4 (p =0.01), and pathologic N1 (p=0.007) status, with more aggressive pathologic features in PTC patients. PTC patients had a non-significant increase in rate of hepatic recurrences compared with ERCP and NBD patients (47.4% vs. 26.6% vs. 28.7%, respectively; p=0.20). PTC patients also had worse median and 3 year survival (21 months and 16%) compared to ERCP (23.3 months and 39%) and NBD patients (29 months and 45%, p=0.02). MVA revealed that PTC was an independent predictor of worse overall survival (HR 2.3[95% CI 1.3-4.0], p=0.005), along with pathologic tumor size (HR 1.1[1.0-1.3], p=0.008), nodes positive (HR 1.1[1.1-1.2], p=0.001), and post-operative CA19-9 >90 (HR 2.6[1.5-4.4], p=0.001). Conclusions: Patients with resectable pancreatic cancer who require a pre-operative PTC drain had a non-significant increase in hepatic recurrence rate and worse overall survival than patients who either had an ERCP stent placed or no biliary decompression prior to surgery. Given their worse prognosis, patients who require PTC placement might also benefit from neoadjuvant treatment with restaging prior to surgery.
Outcomes and toxicity of SBRT for patients with unresectable pancreatic adenocarcinoma.
Authors: Pollom Erqi L. , Alagappan Muthuraman , Chan Cato , Shultz David , Kunz Pamela L. , Koong Albert , Chang Daniel Tandel 
Published: February 2017

317 Background: To report updated outcomes and toxicity of stereotactic body radiotherapy (SBRT) for patients with unresectable pancreatic adenocarcinoma treated over the past 11 years from a single institution. Methods: One hundred and ninety-nine patients with primary, unresectable pancreatic adenocarcinoma were treated with SBRT at our institution from 2002 to 2013. One hundred and sixty-four had locally advanced disease, 12 had borderline resectable disease, 21 were medically inoperable, and 2 had resectable disease but refused surgery. Fifteen patients had metastases at the time of SBRT. Forty-six patients were treated with prior RT, 16 of whom were enrolled on a combined IMRT/SBRT trial. Most common treatment regimens were 25 Gy x 1 (51.3%), 6.6 Gy x 5 (25.6%), 6 Gy x 5 (15.0%). Fifty-seven patients had no prior/current chemo while 142 patients had prior/current chemo (134 had gemcitabine-based chemo). BED10 and BED3 were defined using the linear quadratic equation assuming an α/β of 10 and 3, respectively. Results: Median follow-up was 7.1 months (0.13-63.58). The 6- and 12-month cumulative incidence of local recurrence (CIR) were 7.93% (4.07-11.80%, 95% CI) and 12.48% (7.68-17.28%, 95% CI), respectively. Three patients converted to resection after SBRT. BED10 (median 87.5, range 19.5-97.5), prior RT, prior/current chemo, and tumor location did not predict for CIR. OS rates at 6 months and 12 months were 71.23% (65.02-78.0%, 95% CI) and 36.23% (29.54-44.4%, 95% CI), respectively. Median OS from date of diagnosis was 14.27 months (13.25-16.90 95% CI). Patients who received prior/current chemo had better OS (p=0.0035). There were 26 (13%) recorded GI ulcers/strictures/bleed (5 acute, 21 late) after treatment. BED3 (median 233.3, 30-233.3) predicted for these toxicities (OR 1.01, 1.00-1.01 95% CI, p=0.022), while age, prior RT, prior/current chemo, tumor location did not. Conclusions: SBRT for pancreatic adenocarcinoma is effective for local control with associated risk of toxicity. The risk of GI toxicity is correlated with BED3. Survival is associated with the use of chemotherapy. SBRT may be advantageous due to its good local control with shortened treatment duration that minimizes interruption in chemotherapy.
Second-line FOLFOX chemotherapy in patients with metastatic gallbladder cancer and cholangiocarcinoma.
Authors: Leal Jose Luis , Roa Juan Carlos , Jarufe Nicolas , Madrid Jorge , Ibanez Carolina , Herrera Maria Elisa , Garrido Marcelo , Nervi Bruno 
Published: February 2017

322 Background: After first-line treatment with gemcitabine-based regimen, there is not standard second-line chemotherapy for patients with metastatic gallbladder cancer (GB) and cholangiocarcinoma (CC). The aim of this study was to evaluate the activity, progression free survival (PFS), and overall survival (OS) of the FOLFOX4 regimen as second-line chemotherapy. Methods: We performed a retrospective analysis of all metastatic GB and CC that were treated with gemcitabine (Gem) based first-line chemotherapy, and second-line FOLFOX4 chemotherapy (oxaliplatin 85 mg/m2, day 1; leucovorin 200 mg/m intravenously, days 1 and 2; 5-fluorouracil 400 mg/m intravenous bolus, days 1 and 2; and 600 mg/m in 22 h intravenously, continuous infusion days 1 and 2; every 14 days) in our Institution since 2003. The response rate was evaluated every 2 to 4 months according to the RECIST criteria, and PFS/OS were calculated according to the Kaplan-Meier method. Results: Eighty patients (n=40 GB; n=40 CC) received Gem based first-line treatment (42 Gem alone; 38 Gem + platinum). There was no survival difference between Gem or Gem+platinum treatment (161 versus 254 days; p=0.09). Response rate (complete and partial response) was 16% and stable disease was 31%. Ca19-9 at presentation was predictive for OS: <100U/ml =403 days versus >100 U/ml =223 days (p=0.025). Eighteen patients (22%; n=10 GB and n=8 CC) were treated with second-line FOLFOX4. In the second-line group, stable disease was achieved in 4 patients (22%), and 11 patients progressed (66%). The median DFS and OS were 96 and 138 days respectively. The median OS for patients that received one versus both lines of chemotherapy were 161 versus 400 days (p=0.009). Conclusions: FOLFOX4 has activity in second line chemotherapy for patients with metastatic GB and CC. A prospective study is warranted to confirm this observation.
Economic burden of advanced hepatocellular carcinoma (HCC) in Spain among patients discontinuing first-line sorafenib.
Authors: Liepa Astra M. , Candrilli Sean D. , D'yachkova Yulia , Taipale Kaisa , Kaye James A. 
Published: February 2017

324 Background: No treatments (Txs) are currently recommended after discontinuation (DC) of sorafenib (SOR) for advanced HCC and there are limited reports of Tx patterns. This study assessed Tx patterns, resource use, and associated costs for a select cohort of patients (pts) from Spain. Methods: Via an internet-based chart review, 50 physicians provided clinical and resource use data for 5 de-identified pts each. Medical records were eligible if the pt was ≥18 years old, was diagnosed with advanced HCC, initiated first-line SOR after 2008, subsequently discontinued SOR, survived ≥2 months post-SOR DC, and had ≥6 months of follow-up data (or had died). Unit costs for healthcare resources were obtained from publicly-available sources and applied to the number of each resource type to obtain cost estimates. All analyses were descriptive in nature. Results: From September to October 2012, physicians provided data for 250 pts. Mean pt age was 61 years and 73% were male. At SOR initiation, 35% were Barcelona Cancer Liver Clinic stage B and 63% C. From SOR initiation to DC, 43% declined in Child-Pugh status. Following SOR DC, inpatient hospitalization was reported for 45% and emergency room visits for 49%. For those reported as having received supportive care (n=209), 73% received pain interventions, 42% nutritional support, 33% antiemetics, and 17% transfusions. 28% received anti-cancer Tx (chemotherapy, procedures). For all pts, hospitalization represented about half of total costs. For pts who received further anti-cancer Tx, chemotherapy and procedures represented about one-third of costs and hospitalization less than one-third. Total costs per pt are summarized (Table). Conclusions: Following sorafenib DC, most advanced HCC pts who we studied did not receive further anti-cancer Tx. Those who received further anti-cancer Tx had greater total healthcare costs, but these costs accrued over a longer period of time. [Table: see text]
First report of a prospective trial of proton therapy and concomittant capecitabine for patients with nonmetastatic unresectable pancreatic adenocarcinoma.
Authors: Nichols Romaine Charles , Morris Christopher G. , George Thomas J. , Zaiden Robert Anthony , Johnson Elizabeth , Ahmed Bestoun H. , Ho Meng Wei , Huh Soon N. , Mendenhall Nancy P. , Hoppe Bradford S. 
Published: February 2017

326 Background: Review initial outcomes for patients enrolled on the University of Florida Proton Therapy Institute PC01 protocol for patients with unresectable pancreatic cancer. Methods: The protocol received Institutional Review Board (IRB) approval in 7/2007. The first patient was enrolled in 4/2010. The accrual target was 66 patients to test if the Serious Adverse Event (SAE) ratecould be reduced from 15% (expected) to less than 5%. Protocol therapy consisted of proton therapy to a planning target volume (PTV) dose of 59.4 Cobalt Gray Equivalent (CGE) at 1.8CGE per fraction with concomitant oral Capecitabine (1000mg PO BID 5 days/week on radiation treatment days). Only gross disease was targeted. Results: 12 patients were enrolled. 1 patient died of a gunshot wound 5 days after starting treatment so only 11 patients are reported. Median follow up from start of treatment: 13 months (range 2 to 21 months). Median age: 68 (range 51 to 86) years. Gender: Males 5, Females 6. Race/Ethnicity: 9 White, 2 Hispanic. Overall survival: 90% at 6 months and 60% at 12 months. Freedom from progression: 80% at 6 months and 53% at one year. Local control: 100% at 6 months and 86% at 12 months. Freedom from metastasis: 80% at 6 months and 67% at 12 months.No patient experienced any grade 3 or greater toxicity during treatment or the follow up period. Grade 2 toxicity was limited to a single patient experiencing grade 2 fatigue. Median weight loss over the course of treatment was 1.7 (range: loss of 5.7 to gain of 4.9) Kg. 4 patients were deemed to have had an adequate radiographic response to radiotherapy so as to justify surgical exploration. Conclusions: Proton therapy to 59.4 CGE with concomitant Capecitabine was well tolerated with no grade 2 or greater gastrointestinal toxicities. 4 of 11 patients achieved a radiographic response allowing for attempted surgical resection. The study was closed to accrual on 9/1/2013 due to recognition that slow accrual made achievement of the primary study endpoint unlikely. At the same time, the lack of any meaningful gastrointestinal toxicity suggests significant opportunities for treatment intensification when proton therapy is used in this setting. Clinical trial information: NCT00685763.
Influence of obstructive jaundice on chemotherapy in patients with unresectable biliary tract cancer.
Authors: Shimizu Satoshi , Mitsunaga Shuichi , Ohno Izumi , Takahashi Hideaki , Okuyama Hiroyuki , Kuwahara Akiko , Okusaka Takuji , Ikeda Masafumi 
Published: February 2017

336 Background: The aim of this study was to investigate the influences of obstructive jaundice (OJ) in unresectable biliary tract cancer (BTC) patients. Methods: Data of a total of 200 patients who were newly diagnosed as having unresectable BTC and received chemotherapy between July 2006 and December 2012 were retrospectively reviewed. Patients were divided into two groups according to whether or not they presented with OJ as the incipient chief complaint (Group 1, patients with OJ; Group 2, patients without OJ). Results: There were 81 patients in Group 1 and 119 patients in Group 2. In regard to the primary site (Group 1/Group 2), 29 had perihilar (27/2), 7 had distal (7/0), 68 had intrahepatic (15/53), 92 had gallbladder (31/61) and 4 had ampulla of vater (1/3) (p<0.01). The rate of distant metastasis was 60% in Group 1 and 76% in Group 2 (p=0.02). The performance status was good (0 or 1) in 96% of cases of both the groups. There were no significant differences in the median survival time between Group 1 and Group 2 (9.0 months vs. 9.0 months, p=0.42) or in the progression free survival of 1st line chemotherapy between the two groups (4.1 months vs. 3.7 months, p=0.08). The rate of development of biliary obstruction in Group 1 was significantly high during the first line chemotherapy (56% vs. 10%, p<0.01). Discontinuation of 1st line chemotherapy was necessitated due to biliary obstruction in 9 patients (10%) of Group 1 and none of the patients (0%) of Group 2. Multivariate analysis showed that absence of metastasis and use of a doublet chemotherapy regimen were significantly correlated with the overall survival, but not the presence of OJ as the incipient chief complaint (HR, 0.772; 95% CI, 0.532-1.119). Conclusions: Patients with OJ as the incipient chief complaint showed high rate of recurrent biliary obstruction and discontinuation chemotherapy due to biliary obstruction. However, OJ may not disadvantage for overall survival in BTC.
Effect of neoadjuvant therapy in patients with resected pancreatic adenocarcinoma.
Authors: LoConte Noelle K. , Mohammed Tabraiz Aijaz , Winslow Emily , Neuman Heather B. , Smith Maureen , Allen Glenn , Schmacher Jessica 
Published: February 2017

338 Background: Retrospective data suggest that neoadjuvant therapy in patients with resectable pancreatic cancer may improve the R0 resection rate and potentially survival. We examined the impact of neoadjuvant therapy on survival rates at a population level for patients with resected pancreatic adenocarcinoma. Methods: Treatment and outcome data were obtained from the Surveillance, Epidemiology and End Results (SEER) Medicare database for patients with pancreatic adenocarcinoma, who underwent a curative intent pancreatectomy from 2001-2007. Patients were stratified by treatment (neoadjuvant vs no neoadjuvant therapy). Kaplan Meier curves were constructed to analyze survival. Cox proportional hazards regression models with and without propensity score weighting were performed to determine the effect of neoadjuvant therapy and race on mortality while adjusting for age, gender, race, marital status, SEER site, urban/rural location, income, education, year of diagnosis, and Charlson Comorbidity Score. Results: 2608 patients were included. 58.4% (n=1523) were between age 66-75 and 41.6% (n=1085) were age 76 or older. 94% (n=2459) did not receive neoadjuvant therapy and 6% (n=162) received neoadjuvant therapy. Patients undergoing neoadjuvant therapy were 28% less likely to experience death at one year (HR 0.72; 95% CI, 0.53-0.97; p=0.03). There was also a trend towards a lower risk of death in this group at 2 years (HR 0.82; 95% CI, 0.66-1.01; p=0.07). Conclusions: Patients with pancreatic adenocarcinoma who underwent neoadjuvant therapy followed by resection had an improved one-year survival relative to patients who did not receive neoadjuvant therapy in this cohort. This effect may partially reflect the role of neoadjuvant chemotherapy in allowing for better selection of patients likely to benefit from surgery. To our knowledge this is the first population-based study that suggests an improved survival in patients with pancreas cancer undergoing neoadjuvant therapy prior to resection. [Table: see text]
A qualitative study of patient and clinician attitudes regarding surveillance following resection of pancreatic and periampullary cancer.
Authors: Deobald Raymond Gilbert , Cheng Eva , Ko Yoo-Joung , Wright Frances Catriona , Karanicolas Paul Jack 
Published: February 2017

339 Background: Pancreatic carcinoma is the fourth leading cause of cancer death in North America. Following surgical resection, most patients will develop recurrence within two years. Intense follow-up is often recommended; however, the impact on survival is unknown. We sought to qualitatively assess patient and clinician attitudes towards follow-up and the perceived benefits and challenges. Methods: The research team developed a semi-structured interview guide. Purposive sampling identified patients who had undergone curative attempt resection and were in active surveillance or had developed recurrence. Clinicians involved in patient care were also interviewed.Themes were derived using standard qualitative methods. Results: Fifteen patients and seven clinicians were interviewed. Patient themes included (1) Limited understanding of disease prognosis; (2) Desire for reassurance through follow-up; (3) Desire to know if and when recurrence occurred; (4) Challenging treatments; (5) Minimal difficulties with the follow-up protocol; and (6) Limited role of family doctors in pancreatic cancer follow-up. Clinician themes included (1) Expectation that patients are aware of recurrence risk; (2) Desire to provide reassurance to patients; (3) Support for intense follow-up protocol despite lack of supporting evidence; (4) Secondary goals for surveillance; (5) Perceived patient challenges in follow-up; (6) Openness to family doctors doing follow-up. Overall, the dominant theme was one of disconnect between patients and clinicians in the understanding of the disease and its prognosis. Conclusions: Patients with pancreatic or periampullary cancer have an intense need for reassurance and obtain this through the follow-up process. Consequently they express few difficulties with follow-up despite the intensity of testing. Oncologists recognize this desire for reassurance and provide it through follow-up despite the lack of evidence to show benefit. There appears to be a disconnect between patients and clinicians in the understanding of the disease and its prognosis suggesting further work is needed to improve patient-physician communication.
CD44-overexpressed gastric cancer imaging by near IR using HA-based supramolecular hydrogels.
Authors: Park Jungmin 
Published: February 2017

34 Background: To establish NIR optical probe based on the HA-based supramolecular hydrogels (HASHs) conjugated with Cy5.5 for CD44-overexpressed gastric cancer imaging. Methods: To establish HASHs, Cy5.5 NHS ester was conjugated with polyethyleneimine (PEI, 25k Da) and mixed with hyaluronic acid (HA, 1M Da) by an electric interaction. The optimazed ideal molar ratio of PEI to HA was confirmed by DLS and gel electrophoresis. The CD44-expression level for various gastric cancer cell lInes (MKN1, MKN28, MKN45, MKN72, AGS, and N87 cells) was evaluated by FACS analysis. For establishment of the gastric cancer xenograft model, CD44-overexpressed gastric cancer cells were implanted into the BALB/c nude mouse's proximal thigh region. For in vitro targeting study, the cellular affinity of HASHs for CD44-low expressed gastric cancer cell line and CD44-overexpressed gastric cancer cell line was verified by confocal microscopy and IHC staing. For in vivo NIR imaging, HASHs were injected into established xenograft mouse via tail vein and NIR optical imaging was conducted time-dependently. Results: The colloidal size of HASHs was 1.4 micrometer and their morphology was confirmed by electron microscopy. CD44-expression level of MKN45 cells was 92.53% that was higher than MKN28 cells (2.66%). After the treatment of HASHs, the endocytosis into the cytosol was examined for MKN45 cells, but not observed in MKN28 cells due to the deficiency of CD44. 30 days after the transplantion of MKN45 cells, for in vivo imaging study, the prepared HASHs were intraveneously injected into tumor-bearing mouse model. By NIR optical imaging, the optical intensity at tumor site was enhanced upto 3 hours and the maximum intensity was 350 times larger than normal tissue. Conclusions: HASHs was established using supramolecular HA and Cy5.5-conjugated PEI for the targeted imaging of CD44-overexpressed gastric cancer cells. In vitro and in vivo studies demonstrated that SHAHs can visualize the individualized CD44-overexpressed gastric cancer cells by non-invasive optical imaging.
Second-line gemcitabine plus nab-paclitaxel (G+A) for advanced pancreatic cancer (APC) after first-line FOLFIRINOX: Single institution retrospective review of efficacy and toxicity.
Authors: Zhang Yue , Hochster Howard S. , Stein Stacey , Lacy Jill 
Published: February 2017

344 Background: Gemcitabine (G) plus paclitaxel protein-bound particles for injectable suspension (Abraxane, A) is an active first line regimen for APC based on improved efficacy compared to G (Van Hoff, DD et al. J Clin Oncol 31, 2013 [suppl;abstr 4005]). However, there is a paucity of data regarding efficacy of G+A in pts who received prior FOLFIRINOX. To assess efficacy and tolerability of 2nd line G+A, we reviewed our single institution experience with G+A in APC pts who received 1st line FOLFIRINOX. Methods: We conducted a retrospective review of dose, toxicity, efficacy of second line G+A in FOLFIRINOX-treated APC pts treated at Yale Cancer Center between 12/2011 and 08/2013. Pts were treated until progression, unacceptable toxicity, or pt preference. Doses were at treating physician’sdiscretion. Dose densities were compared to full doses (A 125 mg/m2 + G 1000 mg/m2 days 1, 8,15 q 4 wks). Response rate, med time to treatment failure (TTF), med overall survival (OS) were calculated. Results: 23 pts were treated with G+A after 1st line FOLFIRINOX. Pts characteristics: metastatic, 18; locally advanced, 5; med age, 61 (range 50-74);male, 9; ECOG PS ≤1, 22; med # FOLFIRINOX cycles, 12 (range 5-46). Med interval from FOLFIRINOX to G+A was 5 wks (range 1.7-40.3). Responses by RECIST were: PR, 2 (8.7%); SD for ≥7 wks, 8 (34.8%); PD, 10 (43.4%); ineval, 3 (13.1%). 9 (39%) and 8 (34%) pts had >30% decrease in CA 19-9 and CEA, respectively. 13 pts died, 6 pts stopped G+A, 4 pts are still receiving G+A. Med TTF was 11 wks (range 1-35). Med OS was >17.9 wks (range 2.1-69.6). All pts had initial dose reductions of G or A; 7 and 12 pts required further dose reductions with A and G, respectively. Dose densities were 56.9% and 63.5% for A and G, respectively. Grade ≥3 hematologic toxicities included neutropenia 17%, anemia 26%, thrombopenia 26%. Conclusions: In this single institution pt population, G+A has limited activity after FOLFIRINOX. Most of our pts received FOLFIRINOX for >6 months and were still able to receive a 2nd line doublet. Most required dose reductions for cytopenias, but this sequence was tolerable. In this setting, an additional 11 wks med TTF is about half of the TTF in 1st line G+A and may be clinically valuable.