bluuebunny/crossref_metadata_2025_split huggingface dataset:
Gastrointestinal symptoms and diagnosis preceding ovarian cancer diagnosis: Delays in diagnosis and resulting effects on treatment allocation.
Authors: Chase Dana Meredith , Harrow Brooke , Perhanidis Jessica , Monk Bradley J. 
Published: May 2019

e18195 Background: Ovarian cancer (OC) has a very poor clinical prognosis, with an average 5-year survival rate of < 50%. Symptoms indicating OC are often nonspecific and overlap with gastrointestinal (GI) diagnosis (eg, gastroesophageal reflux disease [GERD], diverticulosis, irritable bowel syndrome [IBS]). Thus, OC diagnosis can be difficult, with most cases diagnosed at an advanced stage. This study examined whether women with a prior GI diagnosis are more likely to undergo neoadjuvant chemotherapy (CT) as their initial OC treatment modality compared to those without a prior GI diagnosis who may be likely candidates for primary debulking surgery (PDS). Methods: This retrospective study identified patients with newly diagnosed OC in the United States from January 2014–July 2018 using MarketScan Commercial and Medicare Supplemental Databases. Analysis was limited to women with commercial or Medicare coverage for ≥12 months before and ≥1 month after the index date (defined as the earliest date of an OC diagnosis or surgery) who underwent CT or PDS. Patients with GI symptoms were identified by diagnosis codes from claims in the year before the OC index date. Logistic regression analysis was used to test the hypothesis that women with a prior GI diagnosis are diagnosed with more advanced OC as signaled by their initial OC treatment (CT vs PDS) compared to women without a prior GI diagnosis. Results: Of the 5865 patients with OC identified, 23% had a diagnosis of ≥1 of the following GI disorders before their OC diagnosis: IBS, inflammatory bowel disease, diverticulosis, and GERD. Of these patients, 40% and 60% had GI disorders that occurred 6–12 months before and < 6 months before their OC diagnosis, respectively. Women with a GI diagnosis were more likely to undergo CT versus PDS as their first OC treatment (odds ratio [OR], 1.37; P < 0.0001), even when controlled for age, region, insurance plan type, and index year (OR, 1.23; P = 0.0021). Conclusions: In this administrative claims database, nearly one-quarter of women with OC had a prior GI diagnosis within the past year and were at greater odds of being diagnosed with more advanced disease requiring CT prior to surgical intervention.
Patient characteristics, treatment received, and outcomes of non-metastatic breast cancer patients in Haiti: Report from retrospective cohort.
Authors: Fadelu Temidayo , Damuse Ruth , Pecan Liz , Dubuisson Cyrille , Greenberg Lauren , Danjoue Satyre , Lormil Joarly Kerwick , Rebbeck Timothy , Shulman Lawrence N. 
Published: May 2019

e18196 Background: Few studies have reported outcomes of breast cancer (BC) patients in Haiti. Since 2013, University Hospital Mirebalais, a tertiary government hospital, has offered treatment for BC, in partnership with Dana-Farber Cancer Institute and Zanmi Lasante, a Haitian non-profit. Standard chemotherapy and hormone therapy are available, but HER2 therapies and radiation are not. Here, we comprehensively describe patient characteristics, treatments delivered and outcomes of non-metastatic BC patients in this program. Methods: We conducted a retrospective observational study including 339 patients with non-metastatic BC, who presented between January 1, 2013 and June 30, 2016. We conducted detailed chart abstraction of patient characteristics, clinical diagnostic and treatment data, and outcomes. Our endpoint was disease-free survival (DFS) defined as time from presentation to cancer recurrence, progression or death. We used Kaplan-Meier estimation to plot survival curves, censoring at the time of last follow-up. Log-rank test was used to examine subgroup differences. Results: The median age in the cohort was 49, inter-quartile range of 42 to 58; 35.7% were post-menopausal. Invasive ductal carcinoma was the most common histology (65.5%). At presentation, 52.8% had T3/T4 disease, while 54.6% had locally advanced disease, and 37.5% were poorly differentiated. There was incomplete documentation of stage (18.3%), ER status (44.2%) and histologic grade (39.5%). 156 patients received neoadjuvant therapy with hormonal therapy (26.2%), chemotherapy (67.9%), or both (5.8%), while 227 received adjuvant therapy (25.5%, 26.5% and 48.0% respectively). 275 patients (81%) completed surgical resection. Median follow up time for the cohort was 24.8 months. 23 patients died; 75 had recurrences; and 9 had progression. Median DFS was 50.8 months (95% CI, 40.6 to 57.0). There was no DFS difference by ER status. Median DFS for early-stage patients was not reached compared to locally advanced patients of 40.4 months (95% CI, 34.0 to 49.7), P-value < 0.0001. Conclusions: Non-metastatic BC patients in Haiti present with more advanced disease and have poorer prognostic factors compared to high-income countries. Although these patients have comparatively worse outcome, curative treatment is feasible in Haiti.
Patient-reported disease burden in chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and follicular lymphoma: Results from a national patient advocacy survey.
Authors: Price Mark , Ravelo Arliene , Sae-Hau Maria , Torney Peggy Ann , Gonzalez Victor , Weiss Elisa S , Mansfield Carol , Mange Brennan , Comenencia Ortiz Eydith , Masaquel Anthony , Dawson Keith Lamont 
Published: May 2019

e18198 Background: Evaluations of patients’ (pt) burden and priorities are increasingly important as novel treatments are developed. We aimed to better understand pt-reported disease burden in chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). Methods: We developed a survey to understand pt disease burden, designed in consultation with medical experts, pt advocacy organizations, and survey scientists. Concept elicitation and cognitive pretesting were conducted. The survey was administered electronically to pts who had received either initial or subsequent treatment within the past year and consisted of categorical Likert options that quantified the impact of disease on physical function, sleep, cognition, work, emotional health, and quality of life (QoL). Results: The Leukemia & Lymphoma Society and the Lymphoma Research Foundation recruited 424 pts: 309 with CLL, 59 with DLBCL, and 69 with FL; 51% were female. Mean age was 66 (range: 22–95). Results suggest that pts experience substantial disease burden across all surveyed subtypes. The most noteworthy results are highlighted in the following table that indicates the percentage of pts who agreed or strongly agreed to statements about disease burden. Additionally, large proportions of pts worried about their disease returning or getting worse (72% of pts with CLL, 83% of pts with DLBCL, and 79% of pts with FL), indicating high impact regardless of the indolent or aggressive nature of their disease. Most pts indicated that delaying disease progression was important to them (96% of pts with CLL, 96% of pts with DLBCL, and 92% of pts with FL). Employment status changed for 31% of pts who were working full or part time or on contract because of their diagnosis and treatment. Conclusions: Pts with CLL, DLBCL, and FL report experiencing substantial disease burden. Data from studies focusing on pt-reported disease burden can be used for education of the clinical community to address the key concerns of pts.[Table: see text]
Real-world evidence in the treatment of metastatic non-small cell lung cancer in a single institution of Colombia in the period August 2015 to August 2018.
Authors: Pino Luis Eduardo , Ospina Serrano Aylen Vanessa , Triana Ivan Camilo 
Published: May 2019

e18204 Background: In Colombia, lung cancer is the first cause of mortality. However, there is a large gap in terms of the information available regarding the characteristics and survival of these patients in the country. Methods: This is an observational, descriptive study of a cohort of patients with stage IV non-small cell lung carcinoma who initiated medical treatment at Fundación Santa Fe de Bogotá, a high complexity hospital. We analyzed clinical characteristics, oncogenic addiction expression, PDL1 expression, treatments, progression free survival (PFS), overall survival (OSm) and treatment related complications. Results: Twenty-six patients were included during the 3 years. The OSm for all the cohort was 19.6 months(m). In the group without PDL-1 expression and negative for oncogenic addiction that received treatment with chemotherapy the OSm was 16.9m and the PFS 9.6m. The OSm for the group with EGFR mutation that received target therapy was 24,7m and the PFS 13.11m. The patients with ALK rearrangement treated with target therapy had an OSm 17m and PFS 5m. The group with expression greater than 50% for PDL-1 that received only immunotherapy OSm was 9.5m and PFS 9m, and in the group with expression for PDL-1 between 1-49% the median OSm and PFS has not been reached. In relation with grade 3 toxicity, 7% of patients that received chemotherapy had kidney failure, 7% emesis and 15% hyporexia. Patients that received target therapy 9% had diarrhea and 9% hepatotoxicity. 9% of patients with bevacizumab presented bleeding and 8% of patients with immunotherapy had autoimmune colitis, in all these cases the medication was suspended. Hypothyroidism was the most frequent complication with the immunotherapy, and it was resolved with substitution therapy. Conclusions: Clinical characteristics and outcomes of this cohort were similar to other lung cancer patients series. Factors like cigarette, nutritional status and ECOG were no significant in the survival. 34,6% of patients had EGFR mutation and 7% had ALK rearrangements. Related to PDL1 we found 26% expresser patients. The highest OS and PFS was for the group with the EGFR mutation and for the group with PDL-1 expression between 1-49%.
A systematic review of surrogate endpoints (SEPs) for overall survival (OS) in metastatic colorectal cancer (mCRC).
Authors: Anand Seerat , Tannenbaum Daniel , Horn Robert Asa , Morris Van K. , Johnson Benny , Eng Cathy , Kopetz Scott , Overman Michael J. , Raghav Kanwal Pratap Singh , Dasari Arvind 
Published: May 2019

e18206 Background: Although progression free survival (PFS) and overall response rate (ORR) are common endpoints in mCRC trials, validation of these as SEPs for OS across the evolving landscape of systemic treatment in mCRC, with novel therapeutics and expanding lines of treatment, is limited. We aimed to evaluate the potential surrogacy of PFS and RR for OS and explore variations across trial factors. Methods: We identified phase 3 randomized trials of systemic therapy in mCRC between 1986 - 2016 from 4 electronic databases. Data regarding endpoints and trial variables were extracted from published reports. Spearman’s coefficient (r) and linear regression were used to evaluate rank correlations between A) PFS and ORR with OS of both treatment and control arms (arm level analysis); B) net improvement in outcomes using hazard ratio (HR) for PFS and relative risk (RR) for ORR with HR for OS (trial level analysis). Results: A total of 128 trials containing 233 and 230 arms reporting on PFS and ORR, respectively, were identified. Arm level analysis revealed that correlation of PFS and ORR with OS was 0.69 (95%CI: 0.6 – 0.7) and 0.79 (95%CI: 0.7 – 0.8), respectively ( P < 0.001). Of 86 trials with reported HR for OS, PFS and ORR ratios were obtained for 84 and 74 trials, respectively. Trial level analysis revealed that correlation of PFS and ORR treatment effect with OS was 0.71 (95%CI: 0.6 – 0.8) and 0.58 (95%CI: 0.4 – 0.7), respectively ( P < 0.001). Level of correlation for PFS and ORR varied with line of therapy, type of therapy and trial size (Spearman r shown in table). Conclusions: Both ORR and PFS are appropriate SEPs for OS for systemic therapy in mCRC but their relative value varies notably with line/type of therapy and study size. Judicious use of these SEPs in clinical trials accordingly to supplant OS may help improve trial designs and performance.[Table: see text]
Patient reported outcomes in cancer patients: Psychological, physical and functional importance.
Authors: Shrotriya Shiva , Estfan Bassam N. , Sharma Mukta , Rayamajhi Supratik , Walsh Declan 
Published: May 2019

e18209 Background: Patient-reported outcomes (PROs) allow consistent monitoring of patients’ symptoms and quality of life. We evaluated their prevalence among cancer patients. We also evaluated the association of PROs, Emotional Thermometer (ET) distress with demographic and disease characteristics. Methods: PROs were prospectively collected as cross sectional data. This was later combined with retrospectively obtained clinical data from the EMR. Predictors of ET component (Distress, Anxiety, Anger, Depression) was determined by linear regression analysis. The predictors of those who required Help with tablet computers was determined by logistic regression. Results: The mean age was 58 (±14) years; 54% male. The common cancer diagnoses were breast 17%, hematological (leukemia) 17% and lymphoma 12%. Few (7%) participants required help (N = 1076) with the tablet-based surveys. Age ≤ 30 and 51–70 years scored lower in mean depression ET. African Americans had higher ET Anger scale. African Americans scored higher in need of Help –ET. Age 31-50 years was at 13% lower risk and 51–70 years was at 72% lower risk of requiring help. Those with self-care problems were at higher risk of requiring Help with tablet computer. Conclusions: Many cancer patients visiting the cancer center had high pain/discomfort, anxiety/depression, problems with usual activities and mobility problems. Younger patients (31-50 years) had more distress and depression (ET). African Americans reported more problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression (EQ5D). Those with self-care problems were at risk to require help with tablet-based surveys.
Opportunity for performance measurement: 30-day mortality following cancer surgeries across U.S. hospitals.
Authors: Lipitz-Snyderman Allison , Lavery Jessica A. , Bach Peter , Li Diane G. , Yang Annie , Strong Vivian E. , Russo Ashley , Panageas Katherine 
Published: May 2019

e18221 Background: While public reporting of surgical outcomes for non-cancer conditions is common, measures of outcomes following surgery for cancer have generally been excluded. This is true even though numerous studies show large variations between hospitals. We assessed whether prerequisites for quality reporting are present for the measure of 30-day cancer surgical mortality: low burden for timely reporting, hospital variation, and potential for public health gains. Methods: We used Fee-for-Service (FFS) Medicare claims to examine the extent of variation in 30-day mortality between 3,860 U.S. hospitals performing cancer surgery for patients ≥66 years, 2011-2013. Hierarchical mixed-effects logistic regression models adjusted for patient and hospital characteristics and with a random hospital effect were fit to obtain hospital-specific risk-standardized mortality rates (RSMRs) and 99% confidence intervals (CI). From these models we calculated a hospital odds ratio to describe the difference in the mortality risk for a hospital above versus below average quality and estimated the potential reduction in mortality under a scenario of improved quality for the lowest performers. Outcomes included extent of hospital variability in 30-day mortality after cancer surgery; and impact on lives saved from improving performance at outlier hospitals. Results: Over the three-year observation period, the median number of cancer surgeries performed per hospital was 34. For individual cancer sites, it was < 10, except for breast (median 17) and colorectal (median 14). The median RSMR overall was 2.41% (99% CI 2.28%, 2.66%). Breast had the lowest RSMR (median 0.24%) and gastroesophageal the highest (median 5.72%). In aggregate and for most individual cancers, variation between hospitals exceeded that due to differences in patient and hospital characteristics, and was robust to excluding emergent cases. For individual cancer sites, relative differences exceeded 20% in the risk of 30-day mortality between patients undergoing surgery at a hospital below average quality versus above average quality, with the potential for an estimated 500 deaths prevented annually given hypothetical improvements. Conclusions: Quality measurement and reporting of 30-day mortality for cancer surgery is worthy of consideration.
The prognostic value of patient-reported outcomes (PROs) for survival outcomes in cancer patients: A systematic review.
Authors: Cottone Francesco , Collins Gary S. , Giesinger Johannes M. , Sommer Kathrin , Deliu Nina , Vignetti Marco , Anota Amelie , Efficace Fabio 
Published: May 2019

e18223 Background: Several studies have indicated that PROs may independently predict survival outcomes across various cancer populations. We aimed to synthesize current evidence in this research area and to investigate methodological quality of these studies. Methods: We conducted a systematic review of published studies (from January 2016 to December 2017) in oncology, which included at least one PRO domain in a multivariable prognostic model for survival outcomes. We used absolute and relative frequencies to assess the main characteristics of the studies, including tumor site, type of PRO questionnaire, type of PROs assessed (e.g., symptoms or functional scales) and their statistical significance for survival outcomes. As such studies pose important statistical challenges, we also investigated methodological issues based on a comprehensive set of predefined criteria. Results: Out of 385 candidate articles, 65 studies met eligibility criteria. Out of these, n = 56 (86%) reported at least one PRO as a statistically significant prognostic factor in a multivariable prognostic model and thirty-two studies (49%) were done with patients with metastatic/advanced cancer. Overall, the most used instrument to assess PROs was the EORTC QLQ-C30 questionnaire (n = 29, 45%) and the most frequent tumors were lung (n = 18, 28%), esophagogastric (EG) and gynaecological (GY) cancer (each n = 11, 17%). Among these, statistically significant prognostic PRO scales from the EORTC-QLQC30 included fatigue, pain and appetite loss for lung; nausea/vomiting, pain, dyspnea, appetite loss and constipation for EG and physical and role functioning for GY. With respect to methodological quality, we found important drawbacks. For example, only 24% assessed multicollinearity among PRO scales and only 29% assessed performance of the prognostic multivariable model (e.g., evaluating discrimination and calibration). Conclusions: In recent years, a remarkable number of studies has found that PROs provide prognostic information beyond well-established clinical and socio-demographic factors. However, some key methodological limitations have been found, which deserve special attention in future studies.
Perioperative therapy in patients with metastatic colorectal cancer.
Authors: Alese Olatunji B. , Zakka Katerina Mary , Huo Xingyue , Jiang Renjian , Shaib Walid Labib , Wu Christina , Akce Mehmet , Sullivan Patrick S. , Behera Madhusmita , El-Rayes Bassel F. 
Published: May 2019

e18231 Background: Knowledge about perioperative systemic therapy in metastatic colorectal cancer (mCRC) is limited. We aim to describe the nationwide pattern of use and survival outcomes of patients with mCRC treated with surgical resection. Methods: Data were obtained from all US hospitals that contributed to the National Cancer Database (NCDB) between 2004 and 2013. Univariate and multivariate analyses was done to identify factors associated with patient outcome. Results: A total of 61,940 patients with stage IV CRC older than 18 years were identified. Mean age was 63.4 years (SD±14), with a male preponderance (54.8%). About 80% were Caucasian and 69.9% had colon cancer. Compared to medical treatment only, resection of both primary and metastatic sites (13.5%; HR 0.40; 0.37-0.44; p < 0.001), or primary site resection alone (49.2%; HR 0.52; 0.48-0.56; p < 0.001) were associated with improved overall survival (OS). Other co-variates associated with improved survival included younger age group, year of diagnosis (2009-2013), colon tumor location, and < 3 metastatic sites (Table). Five-year OS for resection of primary and metastatic site (28.2%) was higher than for primary site resection alone (14.9%) or no surgical treatment (4.7%). Conclusions: Resection of metastatic sites or primary tumor was associated with improved survival in patients with stage IV CRC.[Table: see text]
Clinical and molecular characteristics of non-small cell lung cancer patients from rural Maine.
Authors: Harb Antoine , Curtis Adam , Skacel Laura , Babcock Michael , Skacel Marek 
Published: May 2019

e18237 Background: Non-Small Cell Lung Cancer (NSCLC) is the most common malignancy worldwide and the leading cause of malignancy-related mortality in the United States. The state of Maine in particular, has one of the highest rates of lung cancer in the country. Methods: We reviewed all NSCLC patients (adenocarcinoma (AC) and squamous cell (SC) histology) diagnosed between January 2017 and June 2018 at Northern Light Cancer Institute. 261 patients with clinical follow-up were identified. We correlated their clinical characteristics with molecular abnormalities identified by Next Generation Sequencing (NGS) and Fluorescence in situ hybridization, PD-L1 status by immunohistochemistry, disease-free and overall survival. Results: 210 patients had AC and 51 SC. They were evenly split between men and women. The median age at diagnosis was 68 years. 99% of patients were Caucasian. 15 patients were never smokers, the rest were equally divided between active and previous smokers. 44% had early stage disease (I/II) and 56% had late stage disease (III/IV) on presentation. 36.4% had a PD-L1 high status. The frequencies of the molecular aberrations identified in AC and SC are listed in the table below: Treatment differed by stage, including surgery/Radiation +/- adjuvant chemotherapy for early stage disease, definitive chemo-radiation followed by immunotherapy for stage III disease. Stage IV patients were treated with immunotherapy, combination chemo-immunotherapy, targeted therapy, palliative radiation and hospice referral. After a median follow-up of 10.6 months, overall survival (OS) was 66%. Disease free survival (DFS) was 33%. Using univariate (chi-square), multivariate (logistic regression) and Kaplan-Meier (log rank) analyses, we identified that in addition to a high clinical stage, which was associated with shorter OS and DFS, high PD-L1 status, and the presence of p53 mutation, were independent predictors of shorter OS, and p53 mutation of shorter DFS. Conclusions: NGS-based molecular testing deployed in real-time non-academic setting proved to be a valuable tool to identify therapeutic and prognostic targets in NSCLC. Besides those endorsed by the NCCN guidelines, p53 mutation is a common abnormality associated with adverse outcomes. While high PD-L1 expression is a desirable immunotherapy marker, its presence also predicted adverse overall outcomes in our patients.[Table: see text]