bluuebunny/crossref_metadata_2025_split huggingface dataset:
Discordant breast cancer: Low risk genomic, high risk pathologic.
Authors: Blankenship Leann , Ezekwudo Daniel , Jaiyesimi Ishmael A. , Alassi Osama , Stender Michael J. , Gaikazian Susanna S. 
Published: September 2018

e18160 Background: Studies using the 21-gene recurrence score (RS) have shown low risk pathologic features and RS breast cancers do not benefit from systemic chemotherapy (CTx). However, data is lacking for patients with discordant risk factors and which feature, genomic or clinical, plays more of a role in determining outcomes. Methods: Retrospective analysis was conducted to identify breast cancer patients with discordant features, defined as low genomic/high pathologic factors, from 2011 to 2016. Patients were hormone-receptor positive with RS < 18 and had ³ 2 high risk factors: tumor size ³2cm, lymph node (LN) positivity, or grade 2-3 disease. Results: There were 469 patients with low risk RS were identified of whom 118 met discordant risk criteria. Patients management is depicted in Table 1. Of the 118 discordant patients, 22 had breast cancer recurrence as either metastatic (1) or locoregional (21); 11 being ipsilateral while the remainder were contralateral. Patients with ipsilateral recurrences had partial mastectomy and radiotherapy as initial management. CTx was received in 30 patients despite low RS. Recurrences occurred in 31.8% of patients who received adjuvant CTx. The majority of recurrences occurred >5 years after initial diagnosis. Conclusions: Our results show both genomic and pathologic features were important in determining the need for CTx in early stage breast cancer but neither had a greater impact. Thus, we advocate a more comprehensive and individualized approach, taking into account comorbidities, genomic, and pathologic features, for addition of CTx to standard hormonal therapy. Further studies are needed to determine the proper treatment of this unique patient population. [Table: see text]
Evaluating treatment patterns of relapsed acute myeloid leukemia (AML) among the elderly in the United States.
Authors: Zhang Qisu , Xie Lin , Baser Onur , McGuire Michael 
Published: September 2018

e18161 Background: The type and place of treatment in relapsed AML has not been explored in a large national data set. The goal of this study is to examine treatment patterns among elderly patients (pts) with relapsed AML. Methods: Elderly pts (age ≥ 65 years) with an AML diagnosis (ICD-9-CM: 205.x) were identified using Medicare data from Jan 2010 to Dec 2014. The index date was the first AML treatment date within 30 days of diagnosis. Relapsed pts were identified with ICD-9-CM 205.02 or a claim for AML therapy after a ≥ 120-day treatment-free gap. Pts were required to have continuous enrollment 12 months before AML diagnosis and 6 months after, and no pre-diagnosis claims for blood cancer, chemotherapy, radiotherapy, or AML-related surgery. Transfusion dependence (TD) was defined as ≥ 2 transfusions within an 8-week period. The type and place of treatment for relapsed pts with both 1st- and 2nd-line therapy was examined. Results: 1,726 pts who received treatment for relapsed AML were included in the study. The 30- and 60-day mortality rates from the date of relapse treatment were 19.6% and 33.6%. During 1st-line therapy, 28.6% of pts received inpatient chemotherapy only, 59.1% received both inpatient and outpatient therapy (median inpatient length of stay [LOS]: 32 days), and 3.8% received outpatient therapy only. The most frequent outpatient therapies were hypomethylating agents and supportive therapies, e.g. G-CSF, anti-infectives. 11.3% of inpatients were given a bone marrow transplant (BMT). Additionally, 90.1% of pts received blood transfusions at an average rate of 8.9 per year, and 77.2% of pts were TD. During 2nd-line therapy, 19.6% of relapsed pts received inpatient chemotherapy only, 41.2% received both inpatient and outpatient therapy (median inpatient LOS: 7 days), and 9.3% received outpatient therapy only. Outpatient therapies were similar to those seen at 1st line. 10.3% of inpatients were given a BMT. 80.9% of pts received blood transfusions at an average rate of 19.7 per year, and 60.4% of pts were TD. Conclusions: Current treatment options available for relapsed AML pts are associated with a significant treatment burden at both 1st and 2nd lines of therapy, as well as a high early-mortality rate.
Physician communication and patient understanding of molecular testing of tumors.
Authors: Pentz Rebecca D. , Pocock Rachel Hannah , Pinheiro Ana M , Switchenko Jeffrey M. , Dixon Margie D 
Published: September 2018

e18217 Background: Molecular testing is being used with increasing prevalence to diagnose and treat cancer. Novel technical terminology is required to describe this testing to patients; however, it is unknown what language is being used and whether this language is understood, This study aimed to determine how oncologists describe this testing to patients and whether patients understand the technical terms and conceptual topics used by physicians. Methods: Patients and oncologists were consented for this study at one academic and two community hospitals. Conversations including a discussion of molecular testing were recorded; patients were then interviewed to assess their understanding of the terminology and topics described by their physicians. Recordings were transcribed and qualitatively analyzed; descriptive statistics were calculated from the coded data to identify the most frequently used technical terms and conceptual topics, assess overall patient understanding, and calculate an understanding score for each patient. Results: Sixty conversations about molecular testing were observed and recorded between 60 patients and 19 physicians. Thirty-four different technical terms were used by oncologists to describe 5 technical themes (mutation, molecular testing, targeted therapy, driver mutation, and biomarker). Patients understood 45% of undefined technical terms and 43% of defined technical terms. Physicians explained why the molecular testing was ordered in 67% of conversations, with 71% of patients demonstrating understanding, and how the testing would determine the patient’s treatment in 93% of conversations, with 80% of patients demonstrating understanding. Conclusions: Oncologists use variable language to describe molecular testing to patients. Patients do not understand most of the terms being used and defining technical terms does not improve patient understanding. Despite this, oncologists are effectively communicating the purpose of molecular testing and the effect of such testing on patient treatment. Future studies are warranted to determine which language and methods are most effective for describing molecular testing to patients. Guidelines and training for oncologists may be beneficial.
Customized electronic alerts to boost pneumococcal vaccinations in high risk cancer patients.
Authors: Bhatt Ananta , Hort Shoshana , Gelb Daniel J , MacKenzie Todd , Lansigan Frederick 
Published: September 2018

e18227 Background: Streptococcus pneumoniae remains a leading cause of serious illness, including bacteremia, meningitis, and pneumonia among adults in the United States. Approximately 10% of all patients with invasive pneumococcal disease die of their illness, but case-fatality rates are higher for immunocompromised adults including cancer patients. Current Center for Disease Control (CDC) guidelines recommend routine use of 13-valent (Prevnar 13) and 23-valent (Pneumovax 23) pneumococcal vaccines (PV) for immunocompromised patients. We conducted a quality improvement (QI) project utilizing our electronic medical record (EMR) system to improve PV compliance (PVC) rates in our patients. Methods: We created automatic reminders called best practice alerts (BPA) and linked them to a smart order set within our EMR that appeared upon opening patient charts. The smart set ordered the correct vaccine in sequence based on CDC guidelines. From August 2015- January 2017, we implemented this BPA for one of six hematology providers and the remaining providers were provided with verbal guidelines and reminders to administer PV to their patients. Results: At baseline only 22% of 3000 hematology patients within the practice had received PV. The pilot provider with the BPA linked to a smart order set within the EMR improved PVC within his patients from 23% to 66%. Providers who were just given verbal guidelines improved PVC from an average of 22% to 45%. The difference in the improvement between the pilot provider and the reference group is 21% (p < 0.001). Conclusions: In an EMR era, we took advantage of the tools within our system to improve PVC rates. BPA linked to a smart order set within the EMR provided better means of improving PVC than verbal prompts in high-risk immunocompromised patients. Additionally, the increase in PVC throughout the hematology practice is due to primary care providers using similar reminders within the same EMR. The PV BPA will be conducted as a standard of care in our clinic and will be expanded to oncology patients as well.
Baseline characteristics as predictors of adjuvant chemotherapy (AC) toxicities in stage III colorectal cancer (CRC) patients.
Authors: Watanabe Akie , Yang Charlie , Cheung Winson Y. 
Published: September 2018

e18237 Background: Toxicities acquired from AC can impact quality of life. Baseline patient characteristics such as age, sex, ECOG, tumor location, TNM staging, and comorbidities are frequently considered in AC treatment decision-making, but their associations with common toxicity outcomes remain unclear. Methods: We used a population-based cohort of CRC patients to test our hypothesis. We reviewed individuals treated with adjuvant monotherapy (Capecitabine) or combination therapy (FOLFOX or CAPOX) within 12 weeks of curative resection at any 1 of 6 cancer centers in British Columbia, and determined the associations between baseline characteristics and toxicity outcomes. Results: Among 371 patients, median age was 65 (range 26-86) years, 51.5% were men, and 14% were ECOG ≥2. In this cohort, 41% received monotherapy and 59% received combination therapy. For monotherapy, univariate analyses found that age, sex, ECOG, and pre-treatment anemia were associated with hematological toxicities ( P < 0.05). Likewise, tumor location and TNM staging were associated with gastrointestinal (GI) toxicities ( P < 0.05). On multivariate analyses, hematological toxicities were more likely to develop with old age (≥70) (OR 3.30, 95% CI 1.17-9.37, P= 0.025) and pre-treatment anemia (OR 23.18, 95% CI 6.36-84.48, P= 0.001), while GI toxicities were less likely to occur with a left-sided tumor (OR 0.38, 95% CI 0.15-0.99, P= 0.047). In univariate analyses of combination therapy, sex and pre-treatment anemia were also associated with hematological toxicities, while cardiac and/or respiratory comorbidities were associated with neuropathy ( P < 0.05). In multivariate analyses, however, only female sex was predictive of hematological toxicities (OR 5.13, 95% CI 2.08-12.68, P= 0.001) and neuropathy was less likely to develop with cardiac and/or respiratory comorbidities (OR 0.23, 95% CI 0.07-0.81, P= 0.023). Further analyses did not show any consistent correlations between other baseline characteristics and toxicity outcomes. Conclusions: Readily available baseline patients characteristics are associated with the development of specific side effects, which can be used to better inform AC discussions.
The impact of polypharmacy and comorbidities on surgical morbidity and mortality in patients with gynecological malignancies: Results of a prospective study in 237 patients.
Authors: Inci Guelhan , Woopen Hannah , Richter Rolf , Chekerov Radoslav , Muallem Mustafa Zelal , Sehouli Jalid 
Published: September 2018

e18255 Background: Physicians need to risk-stratify their patients preoperatively to adjust the radicality and the indication of surgery. So far, there are only retrospective and limiting data available. Aim of this study is to evaluate the predictive clinical characteristics such as polypharmacy and Charlson-Comorbidity Index (CCI) for postoperative complications in patients undergoing gynecologic cancer surgery. Methods: This is a prospective cohort study of patients undergoing gynecologic cancer surgery at a tertiary care academic center from October 2015 through January 2017. Surgical complications were graded using validated Clavien-Dindo criteria. Using logistic regression, we identified demographic and predictive clinical characteristics for postoperative complications. Results: Out of the 237 enrolled patients 41(17.3%) experienced a grade≥3b complication. Within 30 days of surgery, 9 (3.8%) patients has died. Charlson Comorbidity index (CCI)> 2(p<0.015, OR 2.33, 95% CI 1.18-4.61), polypharmacy (p<0.001, OR 3.40, 95% CI 1.63-7.10), ASA (p<0.0001, OR 2.98, 95% CI 1.65-5.38), BMI>25kg/m2 (p<0.001, OR 4.25, 95% CI 1.86-9.69), preoperative albumin<3.5 g/dl (p<0.009, OR 3.22, 95% CI 1.33-7.79) and potassium < 3.6 mmol/L (p=0.007, OR 5.11, 95% CI 1.55-16.81) were predictive for complications grade≥3b. A multivariable model included duration of surgery (p=0.012, OR 1.26, 95% CI 1.05-1.52), ASA (p=0.01, OR 2.60, 95% CI 1.20-5.60), preoperative albumin<3.5 g/dl (p=0.028, OR 3.37, 95% CI 1.14-10.00), BMI >25kg/m2 (p=0.009, OR 3.81, 95% CI 1.40-10.35) and potassium < 3.6 mmol/L (p=0.02, OR 3.69, 95% CI 1.20-11.38) was predictive of 30-day Morbidity and Mortality. Age (p=0.49, OR 0.89, 95% CI 0.95-1.02), CCI > 2(p=0.88, OR 1.06, 95% CI 0.42-2.69) and polypharmacy (p=0.65, OR 1.26, 95% CI 0.41-3.98) showed no association for postoperative complications. Conclusions: Only ASA, BMI, preoperative albumin and potassium are associated with severe postoperative complications in patients undergoing gynecologic cancer surgery. Subsequent studies should confirm this result to identify better frail cancer patients.
Venous thromboembolism incidence in radiation oncology: Retrospective trial.
Authors: Cherkashin Mikhail A , Berezina Natalia A 
Published: September 2018

e18289 Background: Venous thromboembolism (VTE) prevention in oncology patients during external beam radiation therapy (RT) in outpatient setting is the challenging question. We performed analysis of our own data. The aim of study is the clear assessment of VTE incidence in these patients Methods: In retrospective analysis 5134 patients' medical records were included (2612 with RT and 2522 with chemotherapy). Inclusion criteria were: RT in outpatient setting and chemotherapy in outpatient setting. Exclusion criteria: combined radiochemotherapy, hospitalzation, central venous catheter, palliative treatment. 487 patients were selected for the final analysis and stratified in 3 groups: group I (n = 165) 3D-conformal RT for brain tumors or brain metastasis; group II (n = 158) RT for body tumors (abdominal, retroabdominal, pelvic, chest, breast); group III (n = 164) was control –brain and body tumors on chemotherapy. Mean fraction numbers were 25 (11 - 32), mean total dose – 52 Gy (22 - 66). VTE assessment based on clinical data, ultrasound examination (US) and chest CT. Statistical analysis was performed by OpenEpi, Version 3 software pack. Results: Deep vein thrombosis (DVT) was detected in 10 cases (6.06%) in group I, 4 cases in group II and 4 case in control group. VTE patients has a different tumors (astrocytomas, brain trunk tumors, skull basis cancer, rectal cancer, breast cancer). 3 patients were available for long-term outcomes assessment (12 months after radiation therapy). During 1-year period we haven’t detected thrombosis recurrence. One patient on 11th follow-up month was exposed with repeated course of RT without any complications. The difference between VTE incidence for group I and group III characterized by statistical significance (p = 0.018). Risk difference for these groups was 5% (p < 0.05). Conclusions: Based on study results we suggest that external beam radiation therapy is potentially an independent risk factor for VTE development even in outpatient settings. High degree of clinical suspicion and aggressive diagnostic work-up in case of suspicion is necessary. In our opinion low molecular weight heparins prevention should be considered at least during active radiation therapy.
Oncological supportive-care unit (OSU): An effective toxicity management model.
Authors: Mirabile Aurora , Foglia Emanuela , Frigo Fiorenza , Del Grosso Elisabetta , Barbarini Lucia , Bovio Antonella , Butti Chiara , Ciambelli Fabrizio , Pauli Sergio , Ricci Isabella , Gargiola Elisabetta , Aloisio Enrica , Oliva Giovanna , Artale Salvatore Agatino 
Published: September 2018

e18301 Background: Oncological patients (pts) frequently experience treatment-related toxicities worsening outcome. According to literature data, 23% - 50% emergency department (ED) and/or hospital admissions in this setting could be avoidable and hesitate in higher management costs and worse quality of life (QoL). Cancer treatment adherence rate is 27% - 87%, mostly related to chemotherapy and post-surgical side effects. Since May 2014 we established an OSU to improve clinical outcome and treatment adherence, to reduce ED access/hospital admissions and toxicities management costs. Methods: All OSU data have been recorded in a database which includes daily management costs into an Italian regional regimen called MAC (Complex Ambulatory Macro-activities). ED accesses were recorded by our “First aid ED operative system”. Hospitalizations costs were evaluated according to regional DRG (Diagnosis Related Group) value and Hospital Discharge Register (HDR). All pts admitted to OSU should answer to two validated questionnaires regarding QoL and anxiety: FACT-G (General FunctionalAssessment Cancer Therapy) and HADS (Hospital Anxiety and depression Scale). We compared toxicities management costs 20 months before and 20 months during OSU. Results: From May 2014 to December 2015, 302/719 pts were admitted to OSU for a supportive care therapy. We obtained the reduction of the costs of the ED access/hospital admission to 52%, while the gain in management was 59% (see table). PS ECOG improved in 9 (18%) pts while it was unchanged in 41 (82%) pts. Adherence to oncologic treatment was satisfactory (95%) and the average values of total FACT and HADS in the follow-up phase improved compared to baseline in 63% and 43% of pts respectively. Conclusions: The interim analysis suggests that OSU improves clinical outcome in terms of QoL and treatment adherence. Moreover, our OSU model demonstrated the possibility to reduce toxicity-related ED accesses/hospital admissions and management costs. [Table: see text]
Predictors of no-show among international patients with cancer: A 4-year analysis.
Authors: Bhulani Nizar , Xiao Lianchun , Hassan Manal , Lenzi Renato 
Published: September 2018

e18302 Background: Patient no-show (NSh) for scheduled medical appointments negatively impacts quality of care, impedes optimal use of resources, has negative economic consequences secondary to missed appointments, and uncovered referral processing costs. International patients (IntlPts) present challenging financial/travel arrangements and cultural and linguistic needs. There are currently very limited data regarding numbers of IntlPts visiting the United States for medical care and no data regarding NSh rates. The purpose of this study was to quantify costs and identify IntlPts-related variables correlating with NSh to develop interventions aimed at minimizing the associated negative financial consequences. Methods: A retrospective study of IntlPts accepted and scheduled for an appointment at the International Assessment Center at MD Anderson in fiscal years 2010 – 2013 was conducted. Overall 52 variables were evaluated that included socio-demographic and clinical patient characteristics, financial responsibility, and appointment timeline. For univariate analysis, Chi-square test and Wilcoxon rank sum test were applied. For multivariate analysis, a multivariate logistic regression model was fit. The multivariate logistic model with independent covariates was used to construct a nomogram. The Time Driven Activity-Based Cost method was used to assess the cost of processing referral requests. Results: Of 1031 IntlPts scheduled, 311 (30%) were NSh. NSh was significantly associated (p < 0.05) with country of origin, payer, diagnosis, referral source, disease stage, patient-delayed appointment date, number of symptoms, pain, bleeding, fatigue, dysphagia, jaundice, neurological symptoms, comorbidities, and appointment lag time. Direct operational costs were calculated using process maps and TDABC. Conclusions: These results provide the groundwork to understand operational costs and predictors of no-show of oncology IntlPts. Having knowledge of predictive factors for NSh in a new patient outpatient setting represents a necessary step towards decreasing its frequency, addressing associated costs, optimizing continuity of care, and ultimately improving outcomes and value of the provided care.
Conceptualization of an indication-specific pricing model to assess potential savings to a U.S. health plan.
Authors: Shah Sandip , Black Joseph , Ramesh Vidya , Shao Dong , Narayanan Siva 
Published: September 2018

e18315 Background: Value based pricing has become a topic of increasing public attention and scrutiny. An Indication Specific Pricing (ISP) allows price setting relative to the level of benefit provided in a given indication and patient population, with the potential for price to vary based on value in the concerned indication(s). We quantified the impact of deploying an ISP scheme on 5-year Afinitor (everolimus) expenditures for a hypothetical health plan of 5M covered lives in the U.S., taking into account three indications: HER2- breast cancer, renal cell carcinoma, and pancreatic cancer. Methods: We constructed an Excel-based model to understand future expenditures on an annual basis utilizing an ISP scheme against a more traditional single contracted price. Key inputs for the model include price per pill (average selling price (ASP)), forecasted annual number of patients per indication (based on 5M covered lives), and compliance rate. Results from the Sloan Kettering “DrugAbacus” pricing project were leveraged to estimate indication-level prices based on their assessment of efficacy, tolerability, and unmet need for Afinitor in each of the indications; actual ISP prices originally used by Sloan Kettering in their model were reweighted and adjusted. Results: As the DrugAbacus price calculated for each indication was lower than the current ASP for Afinitor, use of an ISP methodology resulted in a 9.3% decrease in five year expenditures for Afinitor ($136.9M for a traditional single price vs. $124.1M for an ISP model). Conclusions: US Payers could consider assessing the value a therapeutic intervention brings to each approved indication using ISP in an effort to lower total pharmaceutical-related healthcare costs. Drug manufacturers may benefit from considering relative product value in each potential indication to assess commercial attractiveness and focus evidence generation strategies on those indications seen as most valuable, to support price negotiations.