bluuebunny/crossref_metadata_2025_split huggingface dataset:
Provider perspective: The clinical value of a novel digital medicine program in gastrointestinal oncology.
Authors: Greeno Edward , Morales Paul , Beiswenger Daniel , Wang Xue , Travis Ellen , Plowman R. Scooter 
Published: February 2020

76 Background: The differences in colorectal cancer (CRC) treatment between infusion and oral chemotherapy have challenged clinical teams to maintain clinical quality and patient communications with self-administered therapies. The complexity of many regimens, such as capecitabine, creates challenges with dosing and adverse event (AE) management. The first novel Digital Medicine Program (DMP), aimed at providing support to patients and providers, was integrated into CRC treatment at Fairview Health Services and University of Minnesota Health. The DMP consists of DigiMeds (medications co-encapsulated with ingestible sensors), a wearable patch, and a mobile app to facilitate passive collection of actual medication ingestion data and biometrics over time. Methods: Beginning in September 2018, patients with CRC were offered the DMP to augment standard of care. Clinical pharmacists monitored medication adherence and biometrics in near real-time through a secure web portal. This data was used to address barriers to adherence and adjust therapy when appropriate. Qualitative data regarding provider experiences with the DMP and their interactions with patients were collected via a 5-question survey. Results: Eleven patients used the DMP (age: 66.9 ± 9.9 years (mean ± SD); patch wear: 89.9 ± 11.6%; average adherence: 91.0 ± 5.6%) for 140 ± 137 days. Providers reported that the DMP enabled data-driven decision-making by helping identify non-adherence, prompted timely dose modification for AE management, and allowed personalized care and targeted counseling. Integration of the DMP data into the Electronic Medical Record system improved utility, but providers called the DMP a “time-saver”, creating a “proactive rather than reactive” care process in “ways no other technology can do”. Providers stated patients felt more ownership of their care, and that DMP revealed newly “quantifiable positive changes” in their cancer care. Conclusions: Use of the DMP in this small cohort enabled proactive decision-making and facilitated patient-focused and efficient care. Future pragmatic, large real-world studies are underway to assess the impact of DMP on adherence, AE management, and clinical and economic outcomes.
An assessment of the total cost of pancreatic cancer using real-world evidence.
Authors: Picozzi Vincent J. , Manax Victoria G. , Feehan Kelly , Wintrob Zachary , Korfin Michele , Del Priore Giuseppe , Goldberg Robert 
Published: February 2020

773 Background: The aggregate health economic implications of pancreatic cancer are poorly understood, especially from the patient perspective. As a preliminary effort, we sought to better understand changes in type and quantity of medical expenditures over time, along with quality of life related costs, from this perspective. This preliminary research is part of a larger effort to understand how the introduction of new treatments affect both the outcome and costs of pancreatic cancer associated with care, patients, survivors, their families, and their communities. Methods: We analyzed patient-level data from the Medical Expenditure Panel Survey (MEPS, 1996- 2017). All analyses were performed using R version 3.6.1 on Ubuntu 19.04. Averages were computed for the total health care costs, including prescription drug costs. Average individual annual cost estimates for the second year excluded individuals that were identified as having died prior to the first round of data collection in the second year. The individual patient level ratios of prescription drug cost to other medical expenses was also computed. All expenditures are adjusted for inflation using 2017 US dollars. Included subjects, N= 80 had a diagnosis of pancreatic cancer and available prescription data. Individual age and employment status were accounted for as covariates. Results: Between 1997 and 2017 inflation adjusted first and second year non-medication spending on pancreatic cancer care averaged $66,999.96 and $105,308.60 respectively. However, inflation-adjusted first and second year charges for hospitalizations and emergency visits fell between 2007-2017. Prescription drug as a proportion of total spending prescription drugs increased during the same time period. Lost work/school days declined between 2007 and 2017. Conclusions: Total inflation adjusted pancreatic cancer care expenses declined over the past decade even as drug costs increased. Quality of life costs declined as well. Further analysis is needed to evaluate the relationship between drug spending, total cost of care and quality of life.
Does aberrant hepatic arterial anatomy impact the complication rate or survival following resection of pancreatic adenocarcinoma?
Authors: Handy Nicketti M , Crown Angelena , Bertens Kimberly A. , Clanton Jesse , Alseidi Adnan , Biehl Thomas , Helton William Scott , Rocha Flavio G. 
Published: February 2020

775 Background: Patients with aberrant hepatic arterial anatomy (AHAA) are susceptible to tumor invasion and/or ligation during resection of the pancreatic head. The purpose of this study is to determine if AHAA negatively impacts perioperative outcomes or survival. Methods: All patients who underwent either pancreaticoduodenectomy or total pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) between 2005 and 2014 at our center were retrospectively reviewed. Univariate logistic regression was used to compare outcomes between patients with conventional hepatic arterial anatomy to those with AHAA. Survival analysis was performed by Kaplan-Meier method with log rank test. Results: During the study period, 330 patients underwent resection for PDAC, 69 (20.9%) with aberrant hepatic arterial anatomy. The presence of AHAA does not significantly increase operative time (p= 0.110) or length of stay (p=0.518). The overall frequency of complications (49.3% vs 37.9%, p=0.088) was higher in the AHAA group, but not significantly so. Certain postoperative complications are more common in the AHAA group, namely superficial surgical site infection (18.8% vs. 8.8%, p=0.018) and pancreatic fistula (18.8% vs. 10.0%, p=0.042). However, deep SSI, need for blood transfusion, respiratory failure, DGE, bleed from GDA/pseudoaneurysm, biliary fistula, chyle leak, PV thrombus, fascial dehiscence, and reoperation are not statistically different between the two groups. There is a trend for reduced overall survival in the AHAA group that is not statistically significant (p=0.11). Conclusions: Aberrant hepatic arterial anatomy is encountered in greater than 20% of pancreatic surgery patients, and its presence may increase the rate of certain postoperative complications such as superficial surgical site infection and pancreatic fistula.
Retrospective analysis of institutional outcomes with FOLFIRINOX versus nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer.
Authors: Singh Amisha , Shroff Rachna T. , McBride Ali 
Published: February 2020

776 Background: With an estimated six percent five-year survival, metastatic pancreatic adenocarcinoma is one of the most lethal cancers in the United States. Previously, treatments with FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (G+A) have demonstrated improved overall survival versus gemcitabine alone. The purpose of this study is to compare institutional outcomes for the two regimens, FFX vs. G+A in metastatic pancreatic cancer. Methods: We conducted a retrospective review of medical records of all metastatic pancreatic cancer patients from 2010 to 2018 who received first line treatment with FFX or G+A at University of Arizona Cancer Center. Results: Thirty-five patients received combination treatment with G+A and 29 patients received FFX. Patient demographics: median age was 66 years in FFX vs 70 years in the G+A group; baseline CA-19-9 was 791 in FFX vs 738 in the G+A group. Median ECOG score was 1 for both groups. Median overall survival was 11.5 months in the FFX group (range 0-39 mos) vs 5 months in the G+A group (range 0-37 mos). Overall survival at 6 months was 75.9% vs 51.4% in FFX vs G+A groups respectively. Median progression-free survival was 6 months with FFX (range 0-25 mos) and 3 months with G+A (range 0-24 mos). Twenty-one of 29 patients in the FFX group pursued second line treatment, compared to 12 of 35 patients in the G+A group. Time to next treatment was 6 months in the FFX group vs 5 months in the G+A group. More adverse effects were noted with FFX, the most common being neuropathy and neutropenia, leading to treatment discontinuation due to adverse effects in 31% of patients, compared to 3% of patients in the G+A group. FFX patients required a higher median no. of office visits (35 visits vs 18 visits in the G+A group). Conclusions: FFX showed improved progression-free survival vs G+A; however, this could be due to more patients pursuing second line treatment in the FFX group. Compared to G+A, FFX patients had higher rates of treatment discontinuation due to adverse effects. FFX patients also required more office visits and further analysis is necessary to assess whether this resulted in poorer quality of life and increased total cost of care for patients treated with FFX.
Racial and socioeconomic disparities in overall survival in colorectal cancer (CRC) at West Cancer Center (WCC), Memphis, TN.
Authors: Wookey Vanessa , Bufalino Gabriella , Vidal Gregory A. , Somer Bradley G. , Schwartzberg Lee S. , Grothey Axel 
Published: February 2020

80 Background: WCC, a comprehensive regional community oncology center in Memphis, Tennessee and the Mid-South region, serves a racially, geographically and socioeconomically diverse patient cohort. We sought to evaluate disparity of outcomes in survival by race and socioeconomic status, in addition to patient and tumor characteristics. Methods: All consecutive patients referred to and treated at WCC with colorectal adenocarcinoma from 2007-2013 were included. Individual chart review was performed to verify diagnosis, stage, and date and cause of death. Kaplan-Meier Overall Survival curves were generated for the entire cohort and by race, sex, tumor location and income derived from zip code. WCC survival data were compared to SEER data. Results: From 2007-2013, 1,176 patients were included in the analysis: 405 blacks, 757 whites, 14 others. Median age at diagnosis: Blacks 58 yrs, whites 61 yrs. Stage distribution at diagnosis: stage 1: 100, stage 2: 275, stage 3: 425, stage 4: 376. All stages combined, blacks trended towards shorter OS vs whites (5-year OS: 52.8% vs 58.3%; median survival 71.0 mos vs 98.6 mos; p= 0.095). Blacks presented at later stages (71.4% at stage 3 or 4 vs 66.3% for whites) but no statistically significant OS differences were seen when compared by stage. Patients at or below the median income of $39,590 for WCC had worse 5-year OS (51.6% vs. 61.1%; p= 0.006), as did patients without private insurance (5-year OS: uninsured: 48.0%, Medicare/Medicaid: 50.0%, private: 62.0%; p< 0.001). Adjusted for stage, 5-year OS was statistically significant for stage 4 (private: 18.0%, Medicare/Medicaid: 9.4%, uninsured: 8.3%; p= 0.020). A higher proportion of blacks were below the median income (69% vs 39%) but no statistically significant OS differences were seen when adjusted by race. Overall, cancer survival outcomes were similar to SEER results. Conclusions: At WCC, black patients with CRC presented at a later stage than whites, however, adjusted for stage, no significant racial difference in OS was found. Income and insurance status affected survival outcomes. Overall, our results reveal racial and socioeconomic disparities in colorectal cancer in a diverse US population.
The alarming rise in gastric and colorectal cancers in young adult patients: Analysis of large databases.
Authors: Khan Amir Ali , Ituarte Philip HG , Paz Isaac Benjamin , Goel Ajay , Lai Lily L. , Fong Yuman , Woo Yanghee 
Published: February 2020

805 Background: The alarming rise in the incidence of gastric (GC) and colorectal (CRC) adenocarcinomas in young adults (YA) over the past three decades is not well understood. How YA populations differ from older patients with the same gastrointestinal malignancies warrants further investigation. Methods: We retrospectively analyzed the California Cancer Registry and the Office of Statewide Health Planning and Development data for all GC and CRC cases from 2000 to 2012. Pearson’s Chi-square analysis was used to analyze differences in demographic, clinical and histopathologic features and log-rank test to compare survival between young (≤ 40 years old) and older adults (40-90 years old) with GC or CRC. Results: Of the GC (n = 19,368) and CRC (n = 117,415) patients included in the study, YA accounted for 4.5% (n = 883) of GC and 3.2% (n = 3723) of CRC. Hispanic ethnicity was more common in YA for both cancers compared to older patients (50.9% vs 26.8% GC, 29.6% vs. 15.7% CRC, p < 0.0001). YA were more likely to have poorly differentiated (74.6% vs. 59.8% GC, 22.5% vs 17.5% CRC, p < 0.0001), higher grade (77.0% vs 61.6% GC, 23.9% vs 18.6 CRC, p < 0.0001), and signet ring features (44.6% vs 21.0% GC, 3.2% vs 1.1% CRC, p < 0.0001) compared to older patients. Synchronous peritoneal metastases were more common in YA compared to older patients (32.1% vs. 14.1% GC, 8.8% vs 5.4% CRC, p < 0.0001). YA with GC or CRC had a greater 5-year survival compared with older patients with the same stage of malignancy. Subgroup analysis of Stage I GC demonstrated lower survival in YA compared with adults aged 41-49 and 50-64 years (65.1% vs. 70.7% and 69.1%, 95% CI 49.7-76.9%, 62.5-77.3%, 65.2-72.7% respectively). Conclusions: GC and CRC in young adults have distinctly worse clinical and histopathologic features compared to older patients with the same malignancy. Ethnic disparity exists in the YA patients. This study contributes to improving the understanding of younger versus older GI cancer patients.
The impact of precision medicine on real-world clinical care: A single institution retrospective study.
Authors: Patel Rajvi , Quinn Ryann , Zhu Xinhua 
Published: February 2020

806 Background: In Oncology, precision medicine (PM) utilizes next generation sequencing (NGS) to analyze actionable mutations (AMs) in tumors. It is commonly done for patients (pts) with advanced cancer resistant to standard treatment. FoundationOne-CDx (F1CDx) is the only FDA approved test that utilizes NGS for genomic profiling of tumors. It is necessary to report the real-world data and its impact on clinical care. Our aim was to identify pts at our institution with AMs on F1CDx testing who received non-FDA approved targeted treatments (TT) and assess objective response rate (ORR), progression free survival (PFS), and overall survival (OS). Methods: Retrospective study of pts at our institution from 2012 and 2018 that received non-FDA approved TT based on F1CDx testing. Descriptive statistics were used to describe the demographic and clinical characteristics. ORR based on interval scans at 3 (ORR1), 6 (ORR2), and 12 (ORR3) months (mos) were estimated using standard methods for proportions. Kaplan-Meier method was used to estimate PFS and OS. Results: Of 1000 pts, 652 had tumors harboring AMs, however, only 38 pts met study criteria of receiving non-FDA approved TT with sufficient follow up time. Median age was 57.7 years and 92% of pts received at least one prior line of therapy. Majority of the pts (58%) had gastrointestinal tumors. PDL-1, microsatellite instability, and tumor mutational burden constituted 50% of AMs and 45% of pts received TT with immunotherapy. 14/38 pts had ORR1, 12/13 pts had ORR2, and 6/7 pts had ORR3. PFS was estimated to be 2.73 mos (95% CI: 2.33 to 5.39) and OS was 9.93 mos (95% CI: 4.47 to 33.68). Conclusions: The majority of pts had progression within 3 mos of initiating TT indicating a PM approach with non-FDA approved TT may not be an effective strategy. However, a minority of pts (4 with colorectal and 1 with pancreatic cancer), derived significant benefit in achieving sustained partial response and one pt with complete response at 3 years. Although genomic profiling of tumors may be a step in the right direction, we need better and more cost effective strategies to identify pts who will truly benefit from a PM approach. More PM trials are needed to establish the standard of care to guide real-world practice.
Risk factors for cancer-associated thrombosis in advanced cancer patients with chemotherapy or palliative treatment (retrospective study).
Authors: Uehara Koki , Nio Kenta , Iguchi Haruo 
Published: February 2020

819 Background:Cancer-associated thrombosis (CAT) represents the second-leading cause of death in cancer patients and venous thromboembolism (VTE) occurs in about 20% of hospitalized cancer patients. CAT is important for safety cancer treatment.However, the risk factors for CAT in Japanese cancer patients have not been well studied. Methods: We retrospectively examined cases that had received chemotherapy or palliative treatment from April 2017 to February 2018 in our hospital using medical records. Results: Fifty-five cases with 37-94 years (23 males and 32 females) were examined. Primary sites of cancers were as below; pancreatic: n = 14 (25%), colorectal: n = 12 (22%), gastric: n = 7 (13%), breast: n = 4 (7%), lung: n = 3 (5%), esophageal: n = 3 (5%), head and neck: n = 3 (5%), and others: n = 9 (16%).Forty-two patients (76%) were received chemotherapy, and 12 (22%) of them were diagnosed with CAT at the beginning or during the course of chemotherapy (CAT group). The sites of CAT were as follows; lower extremity type venous thrombosis: n = 10, cerebral infarction: n = 3, pulmonary artery thromboembolism: n = 1, portal vein thrombosis: n = 1, subclavian vein thrombosis: n = 1, and others: n = 2. In 12 patients with CAT, primary sites of cancers were as below; pancreatic: n = 6 (45%), gastric cancer: n = 3 (27%), colorectal, esophageal and ovarian cancer: n = 1 (9%), and 8 patients (67%) received anticoagulant therapy, including 7 patients treated with DOACs. 3 patients (38%) discontinued anticoagulant therapy because of gastrointestinal bleeding and 2 patients (25%) had recurrence of VTE during anticoagulant therapy. Overall survival (OS) tended to be shorter in CAT groups than non-CAT group (median OS: 118 days vs 190 days; p = 0.158). Conclusions: As reported in Western countries, the incidence of CAT was about 20%, and higher in Japanese pancreatic and gastric cancer patients. As shorter overall survival in CAT group might be responsible for development of thromboembolism, thromboembolism prophylaxis for high-risk Japanese patients may be recommended. Additionally, the present study showed that recurrence rate of CAT was higher than that of previous clinical trials.
Diagnostic evaluation of immune checkpoint inhibitor (CPI) colitis: The role of CT scan.
Authors: Durbin Sienna , Mooradian Meghan , Zubiri Leyre , Allen Ian Matthew , Fintelmann Florian , Kambadakone Avinash , Pisuchpen Nisanard , Reynolds Kerry Lynn , Dougan Michael Lawrence 
Published: February 2020

821 Background: CPI therapy has expanded rapidly in recent years and represents a major advancement in the treatment of many cancers, including hepatocellular carcinoma, gastric cancer, and colon cancer. However, these therapies are associated with significant toxicities. CPI colitis is one of the most common toxicities and can be fatal, especially when not diagnosed and treated promptly. The current gold standard for diagnosis is endoscopy with biopsy, an invasive procedure that is resource- and time-intensive. CT has emerged as a possible alternative. The primary objective of this study is to identify the diagnostic performance of CT in the evaluation of CPI colitis. Methods: With IRB approval, we conducted a retrospective cohort study of patients who received CPI therapy between 2009-2019 across a single healthcare system. Patients were included if they underwent both abdominal CT and upper/lower endoscopy with biopsy within 72 hours of each other. We reviewed the electronic medical record to identify possible cases of colitis based on either CT or pathology. All cases were labeled as either true positive or false positive based on pathology. We examined clinical characteristics, including CTCAE grade and treatment received. We calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of CT for diagnosing CPI colitis when compared to the gold standard of tissue diagnosis. Results: Of the 4,474 patients screened, 141 met inclusion criteria. Average age was 63 years (23 – 91); 43% were male. Most common tumor types were melanoma (36%) and NSCLC (20%). Seventy-four percent of patients were treated with anti-PD-1/PD-L1 monotherapy. Forty percent had signs of colitis on CT scan and 59% had biopsy-proven CPI colitis. Sensitivity and specificity of CT were 51% and 74%, respectively. PPV of CT was 74% and NPV was 51%. Of those with confirmed CPI colitis, 78% had symptoms that were classified as grade 3 or above. Seventy-three percent received IV steroids and 38% received infliximab. Conclusions: CT demonstrates moderate specificity and PPV and remains an important diagnostic test but does not replace endoscopy/biopsy in the evaluation of CPI colitis.
Efficacy and safety of larotrectinib in patients with TRK fusion gastrointestinal cancer.
Authors: Berlin Jordan , Hong David S. , Deeken John F. , Boni Valentina , Oh Do-Youn , Patel Jyoti D. , Nanda Shivani , Brega Nicoletta , Childs Barrett H. , Hyman David Michael , Drilon Alexander E. 
Published: February 2020

824 Background: Tropomyosin receptor kinase (TRK) fusions arise from rearrangements of the neurotrophic tyrosine receptor kinase ( NTRK) 1, 2, or 3 genes and an unrelated gene, creating constitutively active oncogenic drivers that have been detected in a range of adult and pediatric malignancies, but are generally rare in patients with gastrointestinal (GI) cancer. Larotrectinib is a selective TRK inhibitor approved for the treatment of adult and pediatric patients with TRK fusion cancer. Here, we report efficacy and safety data for patients with TRK fusion GI tumors. Methods: Patients with a TRK fusion GI cancer treated with larotrectinib in a phase II clinical trial, NAVIGATE (NCT02576431), were included in this analysis. Larotrectinib was administered at 100 mg twice daily, until disease progression, unacceptable toxicity, death, or withdrawal. Response was assessed by the investigator using RECIST v1.1. Results: As of February 19, 2019, 14 patients with TRK fusion GI cancer (median age 68 y, range 32–84 y) were enrolled. GI tumor types were colon (8), cholangiocarcinoma (2), pancreas (2), appendix (1), and hepatic (1). Fusions involved NTRK1 (n = 12) and NTRK3 (n = 2). Nine patients had ≥2 prior lines of therapy. The best response on last prior therapy was 1 partial response (PR). Overall best responses on larotrectinib were: colon cancer, 4 patients had a PR and 4 had stable disease (SD); pancreatic cancer, 1 patient had a PR and 1 had SD; cholangiocarcinoma, 1 patient had a PR and 1 had progressive disease; appendix cancer, 1 patient had SD; response in 1 patient with hepatic cancer was not determined. Median time to response was 1.8 months (range 1.7–2.1). With 5 patients ongoing and censored, the median progression free survival was 5.3 months (95% CI 2.2–9.0). Median overall survival was 33.4 months (95% CI 2.8–36.5). Larotrectinib was well tolerated, with most adverse events being grade 1 or 2. Conclusions: Although the sample size is limited, there is evidence of clinical activity with larotrectinib in TRK fusion GI cancer, with a manageable safety profile. TRK fusion GI cancer may represent an under-diagnosed subset of patients with viable treatment options. Clinical trial information: NCT02576431.