bluuebunny/crossref_metadata_2025_split huggingface dataset:
Implementation of a standardized approach to borderline resectable pancreatic cancer in a community oncology program.
Authors: Bleeker Jonathan Scott , Sumey Christopher Joseph , Powell Steven Francis , Steen Preston D. , Keppen Michael D. , Lohr Michele , Thambi-Pillai Thavam C. , Kurniali Peter , Mazurczak Miroslaw , Gitau Mark Mutuota , Blanchard Miran Joel , Nowak Ryan Kenneth , McGraw Steven , Sticca Robert , Tuvin Daniel , Timmerman Gary 
Published: January 2019

493 Background: Treatment paradigms for borderline resectable pancreatic cancer (BRPC) continue to evolve with increasing use of neoadjuvant chemotherapy (NAC) and chemoradiation (NACR). Variations in the definition of BRPC and in neoadjuvant approaches have made standardization of care for BRPC difficult. We report an effort to standardize management of BRPC throughout Sanford Health, a largely rural community oncology (CO) network in the Upper Midwest. Methods: Starting in February 2014, cases of PC without evidence of metastatic disease were categorized as BRPC if they met one or more of the following criteria: 1) abutment of superior mesenteric, common hepatic or celiac arteries with < 180o involvement 2) venous involvement deemed potentially reconstructable and/or 3) biopsy proven regional lymph node involvement. Patients with BRPC were treated with NAC followed by reimaging and surgery if resectable; if disease remained BRPC, patients underwent NACR and surgical re-evaluation. NAC was administered at 5 CO sites in the Sanford network; NACR and surgery were performed at 2 high volume centers. Results: Forty-three patients from 2/2014-4/2017 were diagnosed with BRPC. Median age of patients was 64 (range 39-83); 56% were male. 42/43 patients received NAC as initial therapy, with 1 receiving NACR due to patient preference. 90% of patients receiving NAC received mFOLFIRINOX (38/42), with FOLFIRI (1) and gemcitabine/nab-paclitaxel (3) also utilized. 11/42 (26%) patients had resectable disease after NAC and underwent surgery; 23 (55%) proceeded to NACR. Overall, 26/43 (61%) went to surgery with 18 (42%) able to undergo resection. Of those, 12/18 (67%) attained R0 resection and 10/18 (56%) were pathologic N0. Primary tumor location (head v. body/tail), age, pretreatment CA19-9, change in CA19-9 with treatment and NACR were not associated with a higher likelihood of resection. Conclusions: This report demonstrates the feasibility of implementing a standardized approach to BRPC across multiple CO sites over a wide geographic area. Adherance to protocol therapies was good and surgical outcomes are similar to many reported series; survival data is maturing and will be presented at the meeting.
Initial and maintenance dose of sorafenib in female patients with advanced hepatocellular carcinoma should be modified to maximize therapeutic effect.
Authors: Tsuchiya Kaoru , Kubota Yohei , Takaura Kenta , Takada Hitomi , Tamaki Nobuharu , Yasui Yutaka , Nakanishi Hiroyuki , Itakura Jun , Kurosaki Masayuki , Izumi Namiki 
Published: January 2019

497 Background: Sorafenib is the only approved first-line agent in patients with advanced HCC and patients who showed progressive disease after sorafenib therapy have an opportunity to receive regorafeib as 2nd-line agent. Therefore, it is very important to maintain sorafenib therapy until sorafenib resistance occurs. We retrospectively analyzed initial and maintenance dose especially in female patients. Methods: A total of 232 patients with advanced HCC who received sorafenib in our institution from July, 2009 until May, 2017 were enrolled. Overall survival (OS), radiological response evaluated by modified RECIST criteria and dose of sorafenib were analyzed. Results: The 232 patients included 179 males and 53 females, with a mean age of 71 ± 9 years. The majority of patients (N = 131, 56.4%) were HCV Ab positive and HBs Ag was positive in 29 patients. Eighty-six patients had extrahepatic metastasis and 50 patients showed major portal invasion defined as VP3 or VP4 by Liver Cancer Study Group of Japan. The overall survival rates of the 232 patients at 6, 12 and 18 were 72.4%, 53.6% and 41.9%, and MST was 14 months. In all patients no existence of major portal invasion, serum Albumin level ≧3.5g/dl before administration of sorafenib, and post-sorafenib anticancer therapy were independently associated with OS. The mean age of female patients was 75 years and mean body weight was 49kg. In female patients only 5 patients (9.4%) showed over 60kg. The dose reduction of sorafenib was necessary in all female patients and 26 female patients could receive post-sorafenib anticancer therapy including regorafenib. The muscle mass calculated by direct segmental multifrequency bioelectrical impedance analysis method was associated with duration of sorafenib therapy, dose reduction of sorafenib and possibility of post-sorafenib anticancer therapy. Conclusions: The modification of sorafenib dose according to sex and muscle mass is clinically important to improve overall survival in patients with advanced HCC treated with sorafenib. It is associated with duration of sorafenib therapy and the possibility for induction of other therapies after sorafenib failure.
Effect of treatment center volume on outcomes in gastroenteropancreatic neuroendocrine tumor patients.
Authors: Baeg Kiwoon Joshua , Harris Cynthia , Lee Mi Ri , Martin Jacob Andrew , Rustgi Sheila , Mhango Grace , Wisnivesky Juan P. , Kim Michelle Kang 
Published: January 2019

502 Background: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are relatively rare tumors, where patients seek care at medical centers with varying levels of expertise. While treatment center volume is associated with better survival in multiple cancers, it remains unknown whether the same applies to GEP-NETs. The objective of this study was to assess the impact of center volume on GEP-NET treatment outcomes. Methods: We used the Surveillance, Epidemiology, and End Results (SEER) registry linked to Medicare claims data in this study. We included patients diagnosed between 1995-2010 who had no HMO coverage, participated in Medicare parts A and B, were older than 65 at diagnosis, had full tumor grade information, and had no secondary cancer. We used Medicare claims to identify the medical centers at which patients received GEP-NET treatment (surgery, chemotherapy, somatostatin analogues, or radiation therapy). Center volume was divided into tiers – low, medium, and high – based on the number of unique GEP-NET patients treated by a medical center over two years. Kaplan-Meier curves and Cox regression were used to assess the association between volume and disease-specific survival (DSS). Results: We identified 1025 GEP-NET patients, of whom 65%, 28%, and 7% received treatment at low, medium, and high volume centers, respectively. Surgery was the most common first treatment (84-90%). Comorbidity and tumor stage distribution were similar across tiers, but the distribution of patients with poorly-differentiated tumors differed significantly (p < 0.001). Median DSS for patients at low and medium centers were 3.7 years and 6.6 years, respectively, but was not reached for patients at high volume centers. After adjusting for confounders, patients treated at high volume centers had better survival than those treated in low volume centers (HR: 0.55, 95% CI: 0.30-0.99). However, no difference in survival was noted at medium volume centers (HR: 0.98, 95% CI: 0.78-1.22). Conclusions: Our results suggest that centers with expertise in GEP-NET treatment have better patient outcomes. Thus, centralization of care, particularly of more difficult cases, may lead to improved patient outcomes.
Final toxicity results from a phase II study of 5-fluorouracil, oxaliplatin, and dasatinib (FOLFOX-D) in previously untreated metastatic pancreatic adenocarcinoma.
Authors: George Thomas J. , Starr Jason Scott , Parekh Hiral D. , Ivey Alison Marguerite , Dang Long H. , Daily Karen Colleen , Allegra Carmen Joseph , DeRemer David L. , Hughes Steven J. , McEwan Margaret A. , Cioffi Jessica L , Trevino Jose Gilberto 
Published: January 2019

504 Background: Systemic chemotherapy for pancreatic adenocarcinoma (PCa) improves survival but most targeted agents have consistently failed to demonstrate clinical benefits. Src is overexpressed in PCa and promotes an aggressive cancer phenotype. Dasatinib (D) is an oral multi-tyrosine kinase inhibitor (TKI) affecting tumor proliferation through inhibition of Src, Bcr-Abl, CKit and other pathways. Inhibition of Src is associated with biologic modifications favorably modifying the PCa phenotype and has synergy with restoring inherent chemosensitivity. Src inhibition can also increase oxaliplatin activity and modulate Tcell responses. The addition of D to the well-established backbone of FOLFOX represents a multifaceted line of scientific investigation. Methods: This single arm phase II trial is to determine activity and toxicity of FOLFOX + D in previously untreated metastatic PCa. Pts must have at least 1 RECIST measurable target lesion, ECOG PS 0-2, normal QTc and adequate organ function. Treatment is standard q14d cycles of mFOLFOX6 with continuous D (150mg PO daily). Tumor assessments occur q8w. Endpoints are PFS (primary), objective and biochemical response rates, clinical benefit rate, freedom from metastases, overall survival (OS), toxicity, and quality of life. Exploratory tissue, circulating tumor cell and serum analyses to identify predictors of response are planned, particularly in those with durable disease control or exceptional response. Sample size is based on a 50% improved median PFS from 4 (historical) to 6 months. Results: Enrollment is now closed on this prospective phase II study with 42 of 42 evaluable pts. Baseline demographics are in Table 1. Toxicity and outcomes continue to be assessed. Conclusions: Final toxicity data will be presented at the meeting for this novel combination treatment in advanced PCa. Clinical trial information: NCT01652976. [Table: see text]
Advancing evidence-based decisions in the management of pancreatic cancer.
Authors: Herrmann Tara , Littman Gwen , Piatt Leah 
Published: January 2019

506 Background: As a result of updates to pancreatic cancer treatment guidelines, oncologists face a host of escalating treatment challenges that may hinder their abilities to select the most appropriate regimen for patients. A study was conducted to determine if simulation-based educational interventions could improve decisions of oncologists in the management of pancreatic cancer. Methods: A cohort of US-practicing oncologists who participated in a virtual patient simulation (VPS)-based education initiative was evaluated. The VPS consisted of 2 cases presented on a platform that allowed oncologists to assess each patient and make decisions limited only by an extensive database of treatment possibilities matching the scope and depth of actual practice. Clinical decisions made by participants were analyzed using a decision engine, and instantaneous clinical guidance (CG) employing current evidence-based and expert faculty recommendations was provided immediately after each decision. Oncologists were allowed a second chance at each decision point; decisions before and after CG were compared using a 2-tailed paired T-test. P values are shown as a measure of significance; P values < .05 are statistically significant. Results: 410 oncologists made clinical decisions within the VPS. Significant improvements were observed in: Selecting the most appropriate first-line regimen in a patient with a PS of 2 (29%, P< 0.001); Ordering an anti-emetic in patients who are receiving chemotherapy (24% , P< 0.001); Evidence-based treatment selection for individuals whose disease progressed on therapy (17%, P= .003); and Ordering adverse event education and counseling (11% and 16%, P= .001). In addition, this study revealed that up to 55% of oncologists would test patients for BRCA mutations while 52% would consider enrolling a patient in a clinical trial if they have progressed on therapy. Conclusions: This study showed improvements in evidence-based practices of oncologists in the management of advanced pancreatic cancer across the continuum of care, thus demonstrating that VPS-based instruction can result in an increase in evidence-based clinical decisions. Therefore, VPS may have a role in improving the quality of care and patient outcomes.
Treatment and survival rates of stage IV pancreatic cancer at VA hospitals: A nationwide study.
Authors: Azar Ibrahim , Virk Gurjiwan , Esfandiarifard Saghi , Wazir Ali , Khreis Tariq , Mehdi Syed 
Published: January 2019

507 Background: Metastatic Pancreatic Cancer (MPC) is associated with an extremely high mortality. Current NCCN guidelines recommend systemic therapy, as it is superior to best supportive care. Undertreatment of MPC continues to be an issue. Recent treatment and survival data of MPC in Veterans’ Affairs’ (VA) hospitals have not been published. The relationship between treatment and American College of Surgeons’ (ACS) Committee on Cancer (CoC) accreditation has not been studied. Methods: Nationwide data from the National Veterans Affairs Cancer Cube Registry was analyzes. 7,585 patients were diagnosed with MPC between 2000 and 2017. Systemic therapy was only looked at as it is the standard of treatment for MPC. CoC accreditation of each VA hospital was obtained using the ACS website. Local IRB approval was obtained. Results: MPC constitutes 52.44% of pancreatic cancer diagnosed (7,585 out of 14,464 cases). The near totality were men (97.43%). The 60-70 age group constitutes the most common age at diagnosis (38.7%). The anatomic site distribution was: head (38.2%), tail (18.77%) and body (12.25%) with the rest unspecified or overlapping sites. Treatment rate over the years has increased from 32.03% in 2000-2004 to 41.17% in 2010-2014. The use of oxaplatinin and nab-paclitaxel as part of combination drugs has increased over the years as NCCN guidelines changed. This has corresponded with an increase of 1-5 years survival of 7.84% in 2000-2004 to 14.87 % in 2010-2014. Treatment rates in CoC- accredited and non-CoC accredited VA hospitals were similar (38.94% and 38.12%, respectively). Survival rates in CoC- accredited and non-COC accredited VAs were similar with a 1-5years survival rate of 8.89% and 8.57%, respectively. Conclusions: Treatment and survival of MPC have risen significantly in the past decade at VA hospitals. CoC accreditation is not associated with a change in treatment or survival rates. [Table: see text]
The antidiarrheal efficacy of a proprietary amino acid mixture in gastroenteropancreatic neuroendocrine patients.
Authors: Chauhan Aman , Miller Rachel C , Yu Qian , Aslam Bilal , Weiss Heidi , Anthony Lowell Brian 
Published: January 2019

509 Background: Based on SEER database, gastroenteropancreatic neuroendocrine tumor incidence has increased 6 fold from 1 in 100,000 cases to about 6 in 100,000 cases over past 3 decades. North American Neuroendocrine Tumor Society estimates that over 100,000 GEPNET patients are currently living in the United States. One of the common quality of life limiting symptom seen in GEPNET patient is diarrhea. Diarrhea in these patients could be due to excessive serotonin production, secondary to post-operative short gut syndrome, steatorrhea from somatostatin analogs, bile acid colitis or intestinal bacterial overgrowth. A novel amino acid based oral rehydration solution (Enterade) is currently being evaluated in a Phase II clinical trial for antidiarrheal effects in post bone marrow transplant patients (NCT02919670). We conducted a pilot study of Enterade in neuroendocrine tumor patients with quality of life limiting diarrhea to evaluate its antidiarrheal efficacy. Methods: Medical records of all the GEPNET patients treated with Enterade for symptomatic diarrhea were evaluated. Patients were treated at Markey cancer center between May 2017-August 2017. Results: Total 8 patients were treated with Enterade. Five were small bowel NETs and 3 were pancreatic NETs. Five patients had prior bowel resections for removal of primary tumor; 5 patients were on somatostatin analogs at the time of initiation of Enterade. Five (62%) patients reported improvement in diarrhea within 6 days of initiating Enterade. The responders had 50 % reduction in their stool output. Mean stools dropped from 6 per day to 3 per day in responders. Conclusions: These pilot data suggest that Enterade may be an effective option in diarrhea control in NET patients. A prospective Phase II study of Enterade in gastroenteropancreatic neuroendocrine tumor patients with quality of life limiting diarrhea is planned.
Survival of chemotherapy (chemo) refractory gastric or gastroesophageal junction cancer (GC/GEJC) patients from Flatiron Health (FH): Matched clinical characteristics to ATTRACTION-2 and CHECKMATE-032.
Authors: Janjigian Yelena Yuriy , Le Dung T , Ott Patrick Alexander , Korytowsky Beata , Le Hannah , Le Trong Kim , Zhang Ying , Sanchez Teresa , Maglinte Gregory , Laurie Melissa , Patel Dhiren , Shangguan Tong , Chau Ian 
Published: January 2019

51 Background: Treatments for advanced/metastatic (adv/met) GC/GEJC after failure of second-line (2L) chemo are limited. Nivolumab (NIVO) demonstrated encouraging anti-tumor activity and long-term OS in adv/met GC/GEJC Asian patients (pts) in ATTRACTION-2 compared with placebo (12-month OS rate, 26% vs 11%; HR, 0.63; P < .0001) and in CHECKMATE-032 (CM-032) in Western pts (12-months OS rate, 45%). This study explored outcomes in US GC/GEJC pts by establishing real world (RW) standard of care (SOC) comparators, against placebo in Asian pts and NIVO in Western pts. Methods: Data were captured from FH electronic health record database. Median OS, estimated by Kaplan-Meier, was calculated from last treatment for adv/met GC/GEJC to death. To create a US RW SOC arm to the ATTRACTION-2 placebo pts, a 2-step matching process was applied: (1) similar inclusion/exclusion (I/E) criteria (2) frequency matching based on significant differences in baseline characteristics associated with survival, identified by univariate analysis. A similar approach was used to create a US RW SOC arm to NIVO treated pts in CM-032. Results: 742 adv/met GC/GEJC pts with ≥ 2 prior lines of therapy were identified in FH from Jan11-Apr17. Two-step matching resulted in 90 US RW SOC vs. 163 ATTRACTION-2 placebo pts, and 100 US RW SOC vs. 42 CM-032 pts. All pts had ECOG performance status (PS) of 0 or 1. Median OS of US RW SOC arm was similar to matched placebo in ATTRACTION-2. Comparison of RW SOC to NIVO-treated pts in CM-032 showed a favorable median OS with NIVO therapy (Table). Conclusions: These analyses highlight the grave outcomes in US adv/met GC/GEJC pts in FH and signal a need for more effective treatments. The data also suggest favorable outcomes with NIVO vs. SOC in both Asian and Western pts with 3L adv/met GC/GEJC. [Table: see text]
A phase I fixed-dose feasibility study of MK615 and gemcitabine in patients with advanced or metastatic pancreatic cancer.
Authors: Moriyama Ichiro , Ikejiri Fumiyoshi , Kawakami Koshi , Inoue Masaya , Kumanomido Satoshi , Shinichiro Matsuda , Takahashi Fumimasa , Ito Shunsuke , Okada Yusuke , Mochida Hiroshi , Shimazaki Yasumasa , Ugata Norimi , Okada Takahiro , Jo Yumi , Onishi Chie , Takahashi Tsutomu , Miyake Takaaki , Suzuki Ritsuro , Suzumiya Junji 
Published: January 2019

510 Background: The medical agent MK615 is produced from Japanese apricot and contains a number of cyclic triterpenes. Antitumor activity of MK615 and its additive effect when combined with gemcitabine in pancreatic cancer cell line. MIAPaCa-2 was previously reported by our group. The objective of this phase I trial was to evaluate safety and feasibility of combined MK615 and gemcitabine therapy in patients with advanced or metastatic pancreatic cancer. Methods: Patients with untreated pancreatic cancer or those who underwent chemotherapy without gemcitabine were enrolled. Gemcitabine was infused at 1000 mg/m2 over 30 minutes once weekly for 3 weeks of each 28-day treatment cycle. Three packets of MK615 were orally administered daily during each 28-day treatment cycle, until any discontinuation criteria were met. If severe toxicity occurred, dose was reduced. Results: All five patients enrolled were evaluable for toxicity and response. Median age was 72 (54-79) years. Three patients had performance status (PS) 0, one had PS 1, and one PS 2. Three of five patients had been treated with chemotherapy; two with FOLFIRINOX and one with S-1. One of five patients treated had grade 4 neutropenia and two were administered granulocyte-colony stimulating factor. No patient had febrile neutropenia or adverse event leading to death. Relative dose intensity was 96.6% and 69.8% for MK615 and gemcitabine, respectively. No patients had objective response (complete response + partial response), while 2 of 5 patients (40%) had disease control (objective response + stable disease). Conclusions: Combined MK615 and gemcitabine therapy was well-tolerated and showed antitumor activity in patients previously treated without gemcitabine or untreated patients with advanced or metastatic pancreatic cancer. Currently, we are planning phase II trials for elderly or frail people.
Evaluation of the positional differences between bone matching and fiducial marker matching in target localization of the expiratory breath-hold radiation therapy for pancreatic cancer.
Authors: Ashida Ryo , Goto Yoko , Akimoto Mami , Mukumoto Nobutaka , Kishi Takahiro , Sakanaka Katsuyuki , Nakamura Mitsuhiro , Yoshimura Michio , Mizowaki Takashi 
Published: January 2019

517 Background: In radiation therapy, the accuracy of target localization is very important to increase the agreement between the planned treatment and the actual dose delivered to the patient. Therefore, image-guided techniques, such as bone matching, soft-tissue matching, fiducial marker (FM) matching and so on, are used to improve the precision and effectiveness of radiation therapy. In this study, we evaluate the positional differences of the target localization between bone matching and FM matching in the expiratory breath-hold radiation therapy (BH-RT) for pancreatic cancer. Methods: We analyzed 15 patients who underwent BH-RT for pancreatic cancer using FM matching between July 2016 and August 2017 in our institution. The FMs were implanted in the pancreatic cancer using endoscopic ultrasound. Prior to each treatment session, bone matching using orthogonal kilovolt x-ray images and FM matching using cone beam computed tomography at end-exhalation (BH-CBCT) was performed. A total of 226 matching data from 15 patients was analyzed. The positional differences of these matching were evaluated in the left - right (LR), anterior - posterior (AP) and superior - inferior (SI) directions. Results: The systematic and random errors between bone matching and FM matching were 3.6 and 3.0 mm, 3.3 and 2.0 mm, and 3.7 and 3.5 mm in the LR, AP and SI directions, respectively. Absolute positional differences of > 5 mm were observed in 78 fractions (34.5%), 40 fractions (17.7%), and 69 fractions (30.5%), and those of even > 10 mm were observed in 14 fractions (6.2%), 2fractions (0.6%), and 11 fractions (4.9%) in each direction, respectively. There were no significant correlations between positional differences in SI and both LR and AP. Conclusions: In pancreatic irradiation using BH-RT, it was considered that bone matching alone was insufficient for accurate target localization and other target matching techniques, such as FM matching, were required to achieve effective treatment.