bluuebunny/crossref_metadata_2025_split huggingface dataset:
Charlson Comorbidity Index (CCI) score to predict early reduced relative dose intensity in patients receiving oxaliplatin for colorectal cancer.
Authors: Ring Sorcha , O'Connor Derbrenn , Cooney Niamh , Bird Brian Richard 
Published: September 2018

e18125 Background: Colorectal cancer (CRC) is commonly treated in both adjuvant and palliative settings with Oxaliplatin. Painful peripheral neuropathy resulting in dose adjustments is a well recognized side effect in up to 30% of cases. Relative dose intensity (RDI), an expression of the percentage of planned dose received at a scheduled time, is a tool used to measure how closely a prescription has been adhered to. Studies have suggested a decreased RDI (<85%) is associated with inferior outcomes. The aim of this study was to calculate the RDI for CRC patients undergoing treatment with Oxaliplatin, to investigate reasons for dose delays and reductions and to calculate a Charlson Co-Morbidity Index Score (CCIS) for each patient Methods: CRC patients treated with Oxaliplatin from 2010-2016 within the BSHC were identified using pharmacy lists and pathology reports. The following exclusion criteria were applied: non first line Oxaliplatin and excluding cycles after three months. Data was obtained through a systematic, retrospective chart review. An audit of the chemotherapy prescriptions allowed the RDI to be calculated and the CCIS was calculated using a colorectal specific Index previously described. Results: We identified 176 eligible patients, 83 charts were available for review and 69 charts contained all necessary information to be included. Xelox (61%), Folfox-6 (35%) and Flox (4%) were the chemotherapy agents involved in this study. The average RDI achieved was 87.47%, with a range of 25%-103.17%. The primary cause for dose adjustments was peripheral neuropathy (64%). The CCIS range was 0 -3, with results demonstrating a significant connection between a higher CCI and lower RDI, see table 1. Conclusions: A CCIS ≤ 1 correlates to achieving a higher RDI, with each of these subgroups achieving above the acceptable cut off for RDI (>85%), as such certain co-morbidities may be early predictors of reduced RDI. [Table: see text]
Guideline adherence and clinical outcome in vulnerable and healthy breast cancer patients: Results of a prospective cross-sectional study in Germany.
Authors: Kuehnle Elna , Siggelkow Wulf , Schrader Iris , Luebbe Kristina , Noeding Stefanie , Moser Alexander , John Jutta , Noesselt Thomas , Arfsten Momme , Hillemanns Peter , Dörk Thilo , Park-Simon Tjoung-Won ,   Hannover Breast Cancer Network
Published: September 2018

e18132 Background: In 2003 the German Cancer Society and the German Society for Breast Disease introduced a number of Quality Indicators (QIs) to improve standards of breast cancer care. Although QIs should be based on clinical evidence, evidence for important subpopulations (i.e. vulnerable patients) is often limited. In this prospective cross-sectional study we assessed conformity and non-conformity of guidelines and their impact on clinical outcome in a real-world setting. Methods: This prospective analysis included patients with primary breast cancer. Patients with stage IV and recurrent breast cancer were excluded. Data was collected from 2012-2016 in six certified breast care centers using a personal questionnaire and data from the patients' medical records. Guideline adherence to a set of 11 QIs was explored. Overall survival (OS) and disease free survival (DFS) were correlated with fulfillment of QIs and tumor characteristics. Results: Survival analysis was conducted in 2390 patients with a median follow-up of 16 months. 88 (4%) patients had a recurrent disease. 31 (1.3%) patients died of breast cancer. Tumor stage, grading, Her2- and hormone receptor status and Ki-67 correlated with DFS and OS. 1725/1907 patients (90.5%) received a guideline adherent treatment. The most prevalent reasons for non-conformity were old age (24.7%) and/or comorbidity (20.9%). Breast cancer specific DFS and OS were not significantly different between patients treated adherent or not adherent to the guidelines. In contrast, survival analysis of death other than breast cancer showed a significantly worse OS (p = 0.006) for patients not treated according to guideline recommendation. Conclusions: Conformity of clinical guidelines was observed in the majority of patients including healthy and vulnerable patients. These patients tended to have a longer breast cancer specific survival. Patients who were not considered suitable for guideline-adherent therapy died more often from other medical reasons rather than from breast cancer. In our study 10% of the patients had a limited life expectancy due to old age and co-morbidities with no assumed benefit from guideline adherence.
Beyond survival and tumor progression: Assessing patients' (pts') function to further define clinical benefit in oncology studies.
Authors: Karagiannis Tom , Marquis Patrick , Petersen Jenny , Meyers Oren , Chui Stephen Y. , Campbell Alicyn Katherine , Strzok Sara , Pompilus Farrah , Piault-Louis Elisabeth 
Published: September 2018

e18138 Background: Little is known of the changes pts experience in day-to-day function as a consequence of cancer and/or treatment. With ongoing and future oncology drug development, gaining a greater understanding of the functional impact of these agents could help complement assessments of survival and quality of life. We set out to understand “function,” the performance of (and changes in) tasks and roles required for everyday living, and which aspects of function are most meaningful from the pts’ perspective to inform future assessment. Methods: We reviewed literature related to functional assessments used in oncology and conducted 20 1:1 semi-structured interviews to explore how pts describe their daily functioning. Results: There was no consensus on the definition of “function” (N = 40 publications). Interview participants represented a broad spectrum of clinical (e.g. eight cancer types, ECOG status 0–3 [n = 4, 7, 6, and 2, respectively], prior treatment exposure [7/20 received taxanes]) and demographic characteristics. Interview participants had difficulty defining “function;” 7/20 did not provide a definition. Pts referred to 60 unique concepts that were organized into four overarching categories: mobility, cognition, activities (basic activities of daily living, domestic life, social context, and exercise), and roles (e.g. caregiver/parent, employee, spouse/partner) within the research. Functional impairments were described as limitations in mobility and/or cognitive abilities. Interviews also revealed 47 stimuli (e.g. signs/symptoms) that were associated with changes in the aforementioned functional categories as well as 20 different adaptations (e.g. frequency, intensity, precaution/prevention, external aids, proactive behavioral changes) that were used to overcome functional impairment. Conclusions: “Function” is a complex concept; impact on mobility, cognition, and the activities and roles that comprise function are unique and depend on the type of cancer, treatment, and life situation. Results point to the assessment of mobility, cognition, activities, and roles as individual concepts for measuring function comprehensively.
The impact of mild left ventricular dysfunction on trastuzumab use and oncologic outcomes in early stage breast cancer therapy.
Authors: Gibson Jordan , Yao Ren Jie , Davis Margot , Simmons Christine E. 
Published: September 2018

e18148 Background: Trastuzumab (T) significantly reduces the risk of breast cancer recurrence, but may be associated with an increased incidence of heart failure. The intention of this study was to assess how T therapy was managed after the development of mild left ventricular ejection fraction (LVEF) drop in a non-trial setting and to evaluate the cardiovascular and oncologic outcomes. Methods: Patients (pts) who received adjuvant T therapy in British Columbia for breast cancer between September 2005 and December 2013 were identified. Pts were eligible if they had a drop in LVEF to 40-49% after starting T. Charts were reviewed for demographic information. Pts were divided into 2 cohorts: those who continued T without interruption, and those who had any interruption or discontinuation. Breast cancer outcomes and cardiac outcomes were compared in each of these groups. Results: Of the 2401 pts who were screened, 261 (10.9%) pts had a drop in LVEF to 40-49%. Of these, 229 (87.7%) had an interruption in T, while 32 (12.3%) did not have an interruption in therapy. The number of pts who experienced a cancer relapse in the T interruption and continuous groups were 38 (16.6%) and 2 (6.25%), respectively (P = 0.19). Even amongst those who received a full 17 cycles of therapy, there was a 11.25% absolute increase in the risk of breast cancer recurrence (17.5% vs 6.25%) in those who had an interruption in their course of treatment compared to those who did not have an interruption (p = 0.15). Cardiac outcomes (subsequent LVEF drop < 40% or CHF) were higher in the group of pts who had treatment interrupted compared to those who had continuation of T (14.8% vs 0%). Conclusions: Interrupting T after the development of mild left ventricular dysfunction was associated with a 10.35% (p = 0.19) absolute increase in breast cancer recurrence. Continuing T was not associated with an increased risk of long term cardiovascular events. While these results are not statistically significant, they are concerning and warrant further investigation.
Do socioeconomic status and comorbidity affect survival in women with breast cancer living in the city of São Paulo, Brazil?
Authors: Ribeiro Karina Braga , Andrade Felipe , Andrade Danubia , Pedro Sibelle , Yoshimura Adriana , Geronymo Beatriz , Andrade Juliana , Goncalves Marina Sahade , Testa Laura , Linck Rudinei Diogo Marques , Hanna Samir Abdallah , Mano Max S. , Sampaio Marcelo , de Barros Alfredo C. S. D. 
Published: September 2018

e18150 Background: Mechanisms underlying social inequalities in breast cancer (BC) survival are not fully understood, being possibly related to the effects of comorbidity, stage at diagnosis and treatment choices. Our study aimed to assess the effect of comorbidity and socioeconomic status (SES) on BC survival in a large metropolitan area in Brazil with universal health care. Methods: This is a retrospective cohort study including all women with invasive ductal BC treated at the Non-profit Program for Breast Cancer Treatment at Hospital Sírio-Libanês, São Paulo, Brazil, between 2006-2011. Charlson Comorbidity Index (CCI) and other study variables were collected from medical charts. Education and Social Vulnerability Index (SVI) measured individual and neighborhood-level SES, respectively. Kaplan Meier analysis and Cox regression model were used to compare five-year overall survival rates (5y-OS) and to estimate crude (cHR) and adjusted hazard ratios (aHR). Results: Our sample comprised 257 women with median age = 58 years. The majority of patients had more than 8 years of education (59%), and they were submitted mostly to conservative surgery (57.2%). Median follow-up time was 84.9 months. Less educated women presented lower 5y-OS (83.3%) compared to more educated patients (95.1%) (p = 0.069); no differences were found according to SVI (p = 0.515). Comorbidities affected prognosis (CCI 0, 5y-OS = 91.6%; CCI 1+, 5y-OS = 84.0%, p = 0.011). Age (p = 0.023), marital status (p < 0.001), pathologic stage (p < 0.001), adjuvant treatment (p = 0.001), type of surgery (p = 0.013), lymph node dissection (p = 0.016), and medication use (p = 0.045) also have influenced 5y-OS. Multivariate analysis has shown an interaction between education and comorbidity (CCI 0, less educated, aHR = 1.20, 95% CI 0.50-2.85; CCI 1+, more educated, aHR = 1.05, 95% CI 0.26-4.21; CCI 1+, less educated, aHR = 3.90, 95%CI 1.38-11.03) and an independent prognostic effect of widow status (aHR = 3.43, 95% CI 1.51-7.80) (adjusted for age, pathologic stage, adjuvant treatment, and surgery). Conclusions: Comorbidity and SES affect survival in women with BC. Interventions to correct these disparities are crucial to obtain optimal results for all.
Hyperglycemia and survival in solid tumors: A systematic review and meta-analysis.
Authors: Barua Reeta , Templeton Arnoud J. , Seruga Bostjan , Ocana Alberto , Amir Eitan , Ethier Josee-Lyne 
Published: September 2018

e18158 Background: Diabetes is associated with adverse cancer outcomes. However, the effect of hyperglycemia independent of diabetes is unclear. Here we report on a meta-analysis exploring the effect of hyperglycemia on outcomes of solid tumors, and the influence of clinical factors on this association. Methods: A systematic search of electronic databases identified publications exploring the effect of hyperglycemia on overall (OS), disease-free (DFS) or progression-free survival (PFS). Definitions of hyperglycemia (fasting blood glucose, random blood glucose or HbA1c) and cut-offs varied between studies. Data from studies reporting a hazard ratio (HR) and 95% confidence interval (CI) or a p -value were pooled in a meta-analysis using generic inverse-variance and random effects modeling. Subgroup analyses were conducted based on method of hyperglycemia measurement (HbA1c, other) and tumor stage (early, advanced, mixed). Meta-regression was performed to evaluate the influence of clinical characteristics including baseline diabetes status on the HR for OS. All statistical tests were two-sided. Results: Eight studies comprising a total of 4342 patients were included. All studies reported HRs for OS. Two studies reported DFS outcomes, and two reported PFS. Hyperglycemia was associated with worse OS (HR 2.07, 95% CI = 1.70 - 2.52; P < 0.001) and DFS (HR 1.61, 95% CI = 1.04 - 2.49; P < 0.001), but did not decrease PFS (HR 1.08, 95% CI = 0.72 - 1.62; P = 0.71). The association with worse OS maintained in subgroups based on method of hyperglycemia measurement (subgroup difference P = 0.65) and tumor stage ( P= 0.47). Meta-regression analyses did not identify any factors significantly altering the magnitude of association between hyperglycemia and OS (see Table). Conclusions: Hyperglycemia is associated with adverse OS and DFS in patients with cancer, and the therapeutic role of optimal glycemic control warrants further investigation. [Table: see text]
A multistate model for follicular lymphoma (FL) patients (pts) who experience early progression.
Authors: Terawaki Hiromi , Caglayan Caglar , Chen Qiushi , Rai Ashish , Ayer Turgay , Flowers Christopher 
Published: September 2018

e18164 Background: FL is the second most frequent lymphoma subtype. Approximately 20% of FL pts experience disease progression within two years of initial chemo-immunotherapy. Currently, there is no standard of care approach for treatment of these pts. Methods: Using Surveillance, Epidemiology, and End Results (SEER) registry data from 2000 through 2009 linked to Medicare claims data through 2011, we identified pts who received second line therapy within 2 years of their initial therapy and incorporated their clinical, demographic, treatment, and outcomes data into a multi-state Markov model to study the impact of first, second and third line therapies. Treatments were categorized as rituximab (R), R-cyclophosphamide and vincristine (RCVP), R- cyclophosphamide, hydroxydaunorubicin, and vincristine (RCHOP), and other R-containing regimens. The Aalen-Johansen estimator was used to estimate the likelihood of being in 1 of 4 health states: dead or alive following treatment (TX) 1, 2 or 3. A Cox proportional hazards regression model was fitted for each possible transition between the model states to identify significant factors affecting time of progression to the next line treatment or death. Results: Data for 5234 pts were incorporated into the model. The median observation time before TX1 was 1.4 months (range 0-125 months). Overall, the median time from TX1 to TX2 was 3.1 (95% CI 2.9-3.2) months and median survival was 33.3 (32.2-34.3) months. For pts who received R, RCVP, and RCHOP as TX1, the median time to TX2 (range) was 5.4 (4.9-5.8), 4.2 (3.6-4.7), and 3.3 (2.9-3.5) months, respectively. These treatments were associated with a median survival of 33 (31-35), 31 (28-32), and 36 (34-39) months, respectively. For pts who received R, RCVP, and RCHOP as TX2 the median time to TX3 was 5.0 (4.3- 5.3), 3.2 (2.7-3.9), and 2.7 (2.3-3.1) months, respectively. Conclusions: This multi-state Markov model using SEER-Medicare data, provides means to examine sequential treatment strategies that influence outcomes for pts with poor-risk FL and factors that influence transition points within each strategy. This modeling approach can help identify where interventions can have the greatest impact for these pts with unmet clinical needs.
Outcomes of solid tumor malignancies in patients of Jehovah’s Witness faith.
Authors: Chang Rachael , Sukumaran Shawgi , Woodman Richard John , Kichenadasse Ganessan , Karapetis Christos Stelios , Koczwara Bogda , Vatandoust Sina , Roy Amitesh Chandra 
Published: September 2018

e18176 Background: Jehovah's Witness (JW) patients with cancer present unique challenges due to their refusal of blood and blood products which limits supportive care options in the setting of cancer treatment. This study was aimed at determining their cancer specific outcomes. Methods: A retrospective analysis of case records of JW with solid tumors presented between 2005 and 2015 was conducted. Patient demographic data, diagnosis, treatment details and survival outcomes were collected and analysed. Results: A total of 63 JW were identified (39 females; 24 males); median age was 70 years (25-90). The most common cancer was breast (n=16) followed by colorectal (n=10). 27 JW had advanced disease (TNM stage 4), 48 patients had ECOG 0-1 and 22 JW had anaemia (Hb<120g/L for women and <130g/L for men) at the time of diagnosis. While surgery and radiation were uniformly accepted when recommended, 7 out of 42 refused chemotherapy. Median OS was 64 months in early stage (TNM stages 1-3) and 11 months in advanced stage. At presentation blood transfusion was considered unacceptable by all patients under any circumstances. 19 patients rejected transfusion even after symptomatic or life threatening anaemia. They had 1 year overall survival rate of 42% compared with 84% for those who did not require transfusion (HR 4.31, CI 1.96- 9.49, P=0.001). When adjusted for age and ECOG, these results were significant in early stage (P <0.026) but not in late stage (P= 0.6). Treatment was suboptimal in 14 JW patients due to early treatment discontinuation or inferior chemotherapy regimen used to avoid pancytopenia. Median OS in this group was 15 months compared to 46 months who had optimal treatment (HR 2.5, CI 1.07- 6.27, P =0.034). 17 JW received bone marrow stimulating agents like erythropoietin or G-CSF. They helped with dyspnoea and maintaining chemotherapy dose intensity. Conclusions: Refusal of blood components may have negative impact on long term cancer outcome of JW due to compromised chemotherapy dose intensity. Strategies to deliver optimum therapy while being sensitive of religious perceptions will help in improving outcomes for this group.
Utility of adding clinical data to a molecular results portal for improving clinical trial prescreening efficiency.
Authors: Levy Mia Alyce , Osterman Travis John , Jain Neha , Mittendorf Kathleen F , Micheel Christine 
Published: September 2018

e18182 Background: Bioportals that aggregate patient genomic results and diagnosis data elements can be used as a tool for identifying potentially eligible patients for molecularly-driven clinical trials. However, over time, increasing numbers of patients will be deceased, making this process less efficient. Methods: We sought to evaluate the addition of minimal clinical data to a clinical trial prescreening workflow utilizing these bioportals. We selected three molecularly-driven clinical trials currently enrolling patients at Vanderbilt-Ingram Cancer Center and evaluated the incremental contribution of genomic and clinical data to refinement of cohort identification. Utilizing data from the enterprise data warehouse (EDW), we assessed the potentially eligible patient population after addition of gene-level, alteration-level, vital status (known to be deceased), and date of last contact data elements to the data extraction query. Results: Utilizing gene-level and diagnosis data elements only, 68 potentially eligible patients were identified for these trials from a total of 7,200 patients whose NGS data was added to the EDW between 2010 and 2016. Addition of alteration-level detail eliminated 29% of these patients. Of the 53 remaining patients, incorporating vital status resulted in paring the potentially eligible cohorts by an additional 42%. Conclusions: This study demonstrates the added value of querying structured clinical and molecular data stored in the EDW to improve prescreen workflow efficiency and decrease manual review requirements. [Table: see text]
Longitudinal assessment of performance using the QOPI measure in Brazilian oncology care.
Authors: Bergerot Cristiane Decat , Philip Errol , Bergerot Paulo Gustavo , De Domenico Edvane Birelo Lopes , Pal Sumanta K. 
Published: September 2018

e18184 Background: The Quality Oncology Practice Initiative (QOPI) provides a standardized approach to assessing performance on a series of evidence- and consensus-based process measures in oncology. In 2015, the QOPI was utilized in a large oncology practice in Brazil to provide a baseline assessment, identify practice deficiencies and guide improvements. Feedback was provided to the oncology team and specific actions identified. This study reports the results of the follow-up QOPI assessment 2 years after the initial baseline was recorded. Methods: From data obtained in 2015 instructions were established for the documentation of physical and psychological symptoms, and of diagnosis and treatment discussions with patient, side effects and infertility risk, informed consent, and genetic services. No significant differences were found in the sociodemographic and clinical characteristics of the patient cohorts. Results: There was an overall increase in performance (60.6% to 77.1%; p < .01). Elements of medical care and of cancer management still consistently and appropriately documented (e.g., pathology, stage, and treatment). There were a significant improvement in performance on measures related to pain assessment (59.5% to 84.5%), and symptom/toxicity management (62.3% to 91.2%). Relatively poor performance persisted however, most notably in the assessment of patients’ psychosocial status (26.5%), discussion of treatment goals (45.6%) and fertility risks (7.4%). Informal feedback was garnered from team concerning areas of ongoing deficiency. Conclusions: There was a significant improvement in adherence to QOPI indicators. Performance in a number of domains remained relatively poor, despite clinical efforts. The reasons are likely multifactorial; and may include a lack of specific resources in a public service (e.g., absence of a fertility service), clinician-based factors that can be culturally driven (e.g., discomfort discussing prognosis), and inconsistent chart documentation. The QOPI provides important guidance in improving oncology care, with the current study suggesting a need for training on psychosocial assessment, as well as the role of an EMR system in ensuring appropriate documentation.