bluuebunny/crossref_metadata_2025 huggingface dataset:
Survival associated with chronic obstructive pulmonary disease among elderly patients with non-small cell lung cancer.
Authors: Shah Shweta , Blanchette Christopher Michael , Kowalkowski Marc , Arthur Susan T , Coyle Joseph P , Howden Reuben
Published: September 2018

e18107

Background: Lung cancer and chronic obstructive pulmonary disease (COPD) are among leading causes of morbidity and mortality worldwide. The association between pre-existing COPD and overall survival (OS) among patients with non-small cell lung cancer (NSCLC) remains unclear. We investigated the impact of pre-existing COPD and its subtypes: chronic bronchitis and emphysema on OS in elderly patients diagnosed with NSCLC at different stages. Methods: Using SEER-Medicare data, we identified patients diagnosed with NSCLC between January 1, 2006 and December 31, 2010, > 66 years of age, and continuously enrolled in Medicare Parts A and B in the 12 months prior to diagnosis. Pre-existing COPD in patients with NSCLC were identified using ICD-9 codes. Kaplan Meier method and log-rank tests were used to examine OS by COPD status and COPD subtype. Cox proportional hazards models were fit to assess the risk of death after cancer diagnosis while adjusting for baseline factors. Results: We identified 66,963 patients with NSCLC. Of these, 22,497 (33.60%) had documented COPD before NSCLC diagnosis. For each stage of NSCLC, median OS was shorter in the COPD compared to the non-COPD group (stage I: 692 vs 1130 days, P < 0.0001; stage II: 473 vs 627 days, P < 0.0001; stage III: 224 vs 229 days; P < 0.0001; stage IV: 106 vs 112 days, P < 0.0001). For COPD subtype, median OS for patients with pre-existing chronic bronchitis was shorter compared to emphysema across all stages of NSCLC (stage I: 672 vs 811 days, P < 0.0001; stage II 582 vs 445 days, P < 0.0001; stage III: 255 vs 229 days, P < 0.0001; stage IV: 105 vs 112 days, P < 0.0001). After multivariable adjustment, COPD patients exhibited an 11% shorter time to death compared to non-COPD patients (Hazard Ratio: 1.11, 95% Confidence Interval: 1.09—1.13). Conclusions: There were marked differences in early stage NSCLC, with a decrease in OS from stage I to stage IV in the COPD group. Patients with chronic bronchitis had shorter OS at every stage of NSCLC compared to emphysema. The results may help inform early detection strategies for NSCLC and treatment selection in early and advanced cancer.
ESKAPEade in hematological malignancies: Dare to review!
Authors: Gentille Sanchez Cesar Giancarlo , Sun Kai , Teegavarapu Purnima Sravanti , Puppala Mamta , Wong Stephen Tc , Qian Qin , Ibrahim Ibrahim Fuad , Rice Lawrence , Pingali Sai Ravi , Iyer Swaminathan Padmanabhan
Published: September 2018

e18110

Background: Patients with hematological cancers are at a high risk for increasingly resistant and severe infections. The Infectious Diseases Society of America has defined commonly resistant bacteria as ESKAPE (Enterococcus, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter, Pseudomonas aeruginosa, Enterobacter/Enterobacteriaceae). We performed a retrospective review of the rate of ESKAPE infections, resistance profile, and outcomes in patients with various hematological malignancies at the Houston Methodist Hospital from 2006 to 2015. Methods: The patient data was obtained from METEOR (Methodist Environment for Translational Enhancement and Outcomes Research), a clinical data warehouse that contains records dating back to January 1, 2006 with over 3 million patients and over 10 million unique patient encounters. We queried for leukemia (AML, CML, ALL, CLL), amyloidosis and myelodysplastic syndrome (MDS) along with hospitalizations due to bacterial infections. Baseline demographics and overall outcomes were also obtained. Results: Out of 6017 patients with Hematological Malignancies, 632 patients were found; 322 had MDS, 225 had AML, 136 had CLL, 49 had ALL, 60 had CML, 97 had amyloidosis and 13 had an unspecified hematological cancer. Of 1091 infectious events, 60.5% were ESKAPE infections. The bacteria most frequently isolated were Enterococcus (24.7%), MRSA (19.8%) and Pseudomonas (18.0%). Patients with MDS (41.5%), AML (20.6%) and CLL (14.4%) were mostly affected. A prevalent resistance to levofloxacin was detected in gram positives and gram negatives (29-54%). Pseudomonas, E. coli, Proteus and K. pneumoniae showed a significant resistance to broad spectrum antibiotics including aztreonam (23-34%), cefepime (7-23%) and imipenem (22%). Proteus had the highest mortality rate (45.2%), followed by Enterococcus (44.2%) and Pseudomonas. (36.7%). Conclusions: Hematological cancers with risk for neutropenia such as MDS and AML were the most affected by ESKAPE. A significant resistance to levofloxacin, a prophylactic antibiotic, was seen. Gram negative pathogens had an increased resistance to broad spectrum antibiotics and higher mortality rates. New strategies for reducing ESKAPE in MDS and AML are required.
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.
Creating simple solutions for safe naloxone use.
Authors: Meadows Jason , McGee Kara , Goldberg Jessica , Stabler Stacy Marie
Published: September 2018

e18185

Background: Naloxone is sometimes required to reverse acute intoxication from opioid pain medications. Although clinical guidelines exist, naloxone dosing is variable in practice. Higher doses can cause pain crisis, acute withdrawal, and possibly increased patient risk. We developed a multi-faceted intervention to increase guideline-concordant naloxone dosing. Methods: We surveyed medical staff and retrospectively collected 6 months of naloxone prescribing data to assess knowledge and frequency of guideline-concordant dosing. We reviewed the electronic order for naloxone and interviewed experienced nurses to facilitate mapping of the process of naloxone administration. We then designed 4 interventions aimed at adult inpatients on medical oncology, general medical and ICU services: 1. Simplify wording of naloxone guidelines; 2. Create naloxone kit containing all necessary equipment and instructions; 3. Auto-populate dose into electronic naloxone order; 4. Administer 5-minute educational inservice to staff (RN, NP, PA, MD). To assess rate of guideline concordance, naloxone prescribing data was collected for the pre-intervention (12 months), intervention (6 weeks), and post-intervention (8.5 months) groups. The survey was repeated after the intervention. For analysis, a generalized linear regression with logit link function and a generalized estimating equation method were used. Results: Over the 22-month study period, 137 patients received 148 naloxone doses. Patients were mean age 63.1 y/o, 54.7% female, and 75.9% white. Of the 90 naloxone doses given pre-intervention, only 24.4% were guideline-concordant. The 10 doses of naloxone given during the intervention period were guideline-concordant in 40% of the cases. Of the 48 naloxone doses given post-intervention, 62.5% were guideline-concordant, a significant increase compared to the pre-intervention group (p < 0.001). The improvement was most dramatic in the non-ICU services (26.4% to 73.5%, p < 0.001). Increases were maintained at 8 months (median concordant rate 53.5%/month (range: 33%-100%). Conclusions: A simple, inexpensive intervention can be used to increase guideline-concordant naloxone dosing and potentially avoid adverse effects of naloxone.
General medical oncologists assessment and use of targeted treatment for patients (pts) with metastatic nonsquamous non-small cell lung cancer (nsqNSCLC).
Authors: Love Neil , Oxnard Geoffrey R. , Sholl Lynette M. , Sequist Lecia V. , Harwin William N. , Kelly Gloria , Miller Kirsten , Paley Douglas , Moss Jonathan , Ziel Kathryn
Published: September 2018

e18186

Background: Current guidelines endorse biomarker assessment for all pts with nsqNSCLC. However, variability in actualizing these recommendations may exist. This pilot project evaluated how MO in a large practice group approach mutation analysis and targeted treatment in nsqNSCLC, both hypothetically and in real pts. Methods: In fall 2016, 10 MO from Florida Cancer Specialists each provided information on biomarkers assessed and therapies administered for 10 nsqNSCLC pts(5 without an identified target and 5 with tumor driver mutations). A survey evaluating general practice patterns was also executed. IRB exemption was obtained and a modest honorarium was provided. Results: All MO reported that ideally all nsqNSCLC pts should be tested for EGFR mutations (EGFRm) and ALK rearrangement (ALKr) but only half stated that they would recommend next-generation sequencing (NGS). Of the 54 pts without a mutation, 52 (96%) had EGFRm and ALKr testing but only 12 (22%) had undergone NGS. Among the 45 pts with an actionable target, 41 (91%) had EGFRm and 4 (9%) had ALKr. 37 (80%) of these pts received first-line TKIs, and all MO agreed they would typically recommend this approach. 8 (20%) EGFRm pts initially received chemotherapy, 5 because the MO and/or pt preferred immediate treatment. All MO indicated that EGFRm pts progressing on first-line EGFR TKIs should be evaluated for T790M and indeed 9 pts with disease progression on an EGFR TKI since November 2015 had undergone plasma or tissue testing, and of these 5 are currently receiving osimertinib. Conclusions: The self-stated and actual practice patterns of MO related to nsqNSCLC biomarker assessment largely adhere to current guideline recommendations, but the limited use of NGS suggests that many pts with potentially targetable mutations other than EGFRm and ALKr are not being identified. These findings support growing evidence that interrogation of case-level data can elucidate practice gaps, and an integrated CME platform is being developed to assess whether discussion of documented deficiencies can enhance quality of care.
Children’s Oncology Group (COG) clinical trials as exemplars of pragmatism in clinical research.
Authors: Mittal Nupur , George Anil , Leanos Lizette , Kent Paul
Published: September 2018

e18188

Background: In 2016, President Obama announced the “Moonshot Cancer Initiative” to advance cancer research. One of the key components of this initiative is promoting enrollment in pragmatic clinical trials and data sharing. As described in 2009 by Thorpe et al, using the 9-domian PRECIS-2 tool, a ‘pragmatic’ trial, as opposed to an ‘explanatory’ trial used to confirm a physiologic hypothesis, is one in which the intervention can be immediately applied into real-world clinical practice (J of Clin Epi:2009). In the US, 60%-90% children are enrolled on COG research trials. State-of-the-art treatment for a child is derived from superior therapy identified in prior trials which then serves as the standard arm of subsequent phase-III trials and becomes the de facto practice guideline and ‘standard of care’ .To accomplish this goal, COG shares its data among the 242 member institutions.Our objective is to assess “pragmatism” in COG trials. Methods: We analyzed the 158 COG phase III clinical trials between 2006-2016 for all 9 domains of the PRECIS-2 (Table 1) and graded them from 1-5 (most explanatory to most pragmatic). Results: Out of 152 phase III clinical trials on the COG website, 138 (91%) scored 5/5 for all 9 PRECIS pragmatic domains and 148 (98%) scored >4. The scoring for all 9 domains is in table 1. Conclusions: COG provides nearly all children in the United States access to pragmatic phase III research as outlined in the Moonshot Goals. Goal of merging evidence-based standard care accessible to all and conducting well- designed clinical research to identify the best therapies has been accomplished by COG and should serve as an example to other cancer organizations. 9 domains of PRECIS-2 to assess pragmatism in clinical trials. [Table: see text]
Using clinical pathways to understand biomarker testing patterns.
Authors: Ellis Peter G. , Lokay Kathleen , Barry Amanda
Published: September 2018

e18189

Background: Via Pathways’ Disease Committees incorporate biomarker testing recommendations into the pathway decision support when the literature supports improved outcome. For several years, the non-small cell lung pathway (NSCLP) has recommended testing for ALK, EGFR, and, more recently ROS1 targeted therapies. The decision support software (VP) requires the practitioner to register testing and results, including the decision not to test. Methods: For the twenty months ending 10/31/16, we analyzed all NSCLP patients treated at UPMC CancerCenter locations for first line, metastatic, non-squamous lung cancer per the VP. Results were analyzed in total and by type of provider (83 community providers vs. 3 academic providers who specialize in lung cancer). Provider’s answers to the biomarker testing question included “positive” results, “negative” results, “test pending”, and “not tested”. Results: Of the 684 treatment starts in the 1stline non-squamous NSCLP, 100 were patients of academic providers (AP) and 584 were patients of community providers (CP). AP indicated testing for ALK and EGFR in 100% of patients (n=100). CP indicated testing for ALK in 91% (n=532) and for EGFR in 92% (n=538). AP indicated testing for ROS1 in 96% (n=93) and CP indicated testing for ROS1 in 81% (n=473). Results are summarized in the table. Conclusions: Data from clinical pathways software can be utilized to understand biomarker testing rates among providers. In this example, the three AP tested for actionable mutations more frequently than the 83 CP, although both rates of testing appeared to be high. This data can be used to generate hypothesis about patterns of care that may include patient parameters, size of network or other factors that can then further analyzed and tested. Pathways serves as an important tool in promoting and monitoring quality care. [Table: see text]
Current alignment between the practice patterns of gastrointestinal (GI) cancer clinical investigators (CI) and general medical oncologists (MO) in the treatment of metastatic GI cancers.
Authors: Miller Kirsten , Ziel Kathryn , Kelly Gloria , Paley Douglas , Moss Jonathan , Love Neil
Published: September 2018

e18193

Background: CI with an interest in specific cancers amass a unique body of knowledge and relevant experiences that may make their practice patterns different from those of MO. This initiative sought to document and compare the stated management approaches of CI and MO. Methods: InMay 2016, as part of a continuing medical education (CME) project, 31 CI elected to complete a 78-item survey assessing their usual treatments for various metastatic colorectal, gastric and pancreatic cancer clinical scenarios. A stipend was provided for participation. On June 4, 2016, 13 clinical questions from the CI survey were posed to 140 MO, 103 US-based and 37 non-US-based, prior to a CME symposium on GI cancers. Responses of the groups were compared. Results: For 10 out of 13 questions, there was relative concordance between CI and MO responses. However,for 3 there was considerable variation (see table). Conclusions: Although CI and MO approach the care of many patients with GI cancers in a similar manner, important and noteworthy variations exist. These findings indicate that the documentation and comparison of treatment recommendations could be a novel strategy to elucidate misalignment between CI and MO and impel either or both to rethink current approaches. Additional work is needed to validate these findings and understand potential implications and applications. [Table: see text]
The morbidity and mortality conference (MMC) concept applied to contemporary oncology practice: Retrospective findings on management of 233 patients (pts) who died of ovarian cancer (OC), colorectal cancer (CRC) and wild-type (no identified targetable mutation) nonsquamous non-small cell lung cancer (WTLC).
Authors: Ziel Kathryn , Birrer Michael J. , Hecht J. Randolph , Wakelee Heather A. , Chen Gigi Qiqi , Deutsch Margaret Ann , Picton Maria Eugenia , Rodriguez Estelamari , Willmott Lyndsay , Kelly Gloria , Miller Kirsten , Moss Jonathan , Paley Douglas , Love Neil
Published: September 2018

e18195

Background: MMC have traditionally evaluated pt management and potential areas for quality improvement. We hypothesized that this approach could be adapted and extrapolated to gain increased insight into how pts with common solid tumors are being treated in general oncology practice and how the approaches used align with evidence-based guidelines. Methods: 102 randomly recruited US-based general medical oncologists from a proprietary database of 4,019 agreed to consult their medical records and provide information on biomarkers assessed, systemic therapies administered and other treatment-related factors for the last pt in their practice to die from OC, CRC and/or WTLC. An IRB exemption was obtained and a modest honorarium was provided. Results: Pts with OC, CRC and WTLC received a median of 3, 3 and 2 lines of therapy, respectively, the majority of which were supported by guidelines, but in more than half of cases, the regimen administered required dose adjustment/discontinuation due to toxicity. Less than half of pts were offered trial participation and only 15 (6%) entered a trial. 19 pts with OC (25%), 25 pts with CRC (32%) and 58 pts with WTLC (73%) did not undergo BRCA, MSI and multiplex genomic testing, respectively, despite the recommendation of available guidelines. Conclusions: The MMC model may be an effective means to document variability as well as consistency in current oncologic care. Data generated via this assessment juxtaposed with current clinical evidence and available guideline recommendations could potentially serve as a powerful educational intervention. These findings require additional validation but provide initial support for future iterations of this exercise. [Table: see text]
A new pancreatojejunostomy of duct-to-mucosa combining back-to-back cross horizontal mattress anastomosisin pancreaticoduodenectomy.
Authors: Wu Wenchuan , Zhang Lei , Pu Ning
Published: September 2018

e18216

Background: Postoperative pancreatic fistula(POPF) is always related to the morbidity and mortality. The objective of our study was to evaluate the safety and efficiency of the novel anastomotic method that termed duct-to-mucosa combining with “back-to-back” cross horizontal mattress inserting pancreatojejunostomy. In this technique, we used 4-0 Coated VICRYL to stitch the posterior of the stump of pancreas into the side of jejunum in the method of horizontal mattress suture. Then, we used 5-0 polypropylene to stitch the posterior of the pancreatic duct into the jejunum interruptedly. After that, a pancreatic duct stent was inputted. The anterior side of the pancreatic duct and the pancreas was stitched the same as the anastomosis of the posterior side. Methods: We investigated the postoperative recovery and complications of 49 patients who underwent pancreaticoduodenectomy from October 2015 to October 2016 retrospectively. The new technique was used in 24 patients, and was compared with the regular interrupted suturing anastomosis technique that was used in 25 patients as controls. We defined, diagnosed and graded POPF accroding to the International Study Group in Pancreatic Surgery criteria. Results: The anastomosis time in the conventional group was less than that in new technique group (21.52±2.26 min vs28.10±6.20 min, P=0.000), but we could find the POPF rate decreased significantly in the new technique group from the following data. There were 2 grade B POPF patients in the new technique group. Meanwhile, there were 8 grade B POPF and 1 grade C POPF patients in the control group (8.3% vs 36.0%, P=0.020). Conclusions: Duct-to-mucosa combining with “back-to-back” cross horizontal mattress inserting pancreatojejunostomy reduced the incidence of POPF effectively in our study. [Table: see text]
Utility of PET/CT in primary identification and management of cancers of unknown primary.
Authors: Cherniawsky Hannah Marie , Sawyer Michael B. , Ghosh Sunita , Cheung Winson Y. , Ho Maria Yi
Published: September 2018

e18219

Background: The role of PET/CT in staging and management of cancers of unknown primary (CUP) is poorly defined. Our study sought to evaluate PET/CT versus standard CT in determining the primary site, lymph node status and solid organ metastases, and assess whether results of PET scans altered management of patients with CUP. Methods: We conducted a retrospective chart review of CUP patients to measure concordance of PET/CT and CT scans in patients diagnosed with CUP at two Western Canadian academic centres; the Cross Cancer Institute and BC Cancer Agencies from 2008 to 2015. Results: We identified 244 patients who had standard CT and PET/CT during their work-up. Of the 70 patients whose primary identification status was recorded, standard CT imaging detected 16.1% of primaries compared to 12.1% on PET/CT. 63.3% of primaries were concordantly identified on both modalities. PET/CT identified 2 primaries not seen on CT whereas standard CT identified 9 primaries not seen on PET/CT. Concordance rates between PET/CTs and standard CTs were 77.9% and 93.9% regarding lymph node status and extent of metastases, respectively. PET/CT identified a greater extent lymph node involvement in patients; 93.8% versus 79.0%. (CCOR = 2.92, 95% CI = 0.87-9.72) and identified a greater extent of solid organ involvement; 96.5% versus 92.4%. (CCOR = 45.25, 95% CI = 7.79-262.78). Data from the CCI of patients who had discordant imaging in either domain or identification of primary showed no cases in which PET/CT alone provided information that changed patient management. Conclusions: Our results suggest PET/CT scans do not provide additional diagnostic information with respect to identifying the primary site but may be superior in clarifying extent of metastases and nodal status though this did not alter therapy. Future studies investigating the impact of PET/CT scans on management and cost effectiveness in CUP are critical.
Thirty-day mortality following interventional line or drain placement among hospitalized cancer patients.
Authors: Kilbridge Kerry L. , Glotzbecker Brett , Stuver Sherri Oliver , Rosenbaum Cecilia H. , O'Horo Susan Kiernan , Day Angela , Jacobson Joseph O.
Published: September 2018

e18222

Background: Percutaneous lines and drains provide a less invasive alternative to operative procedures for patients with cancer. We categorized outcomes for placements among solid tumor patients hospitalized on the medical oncology services of a tertiary care academic center. Methods: Consecutive cases (n=71, Mar-Sept 2016) were identified by electronic medical record orders for non-vascular lines and drains placed in solid tumor patients hospitalized on medical oncology services and confirmed by retrospective chart review. Percutaneous nephrostomy tubes, pleurx catheters (abdominal and thoracic), gastrojejunostomy/gastric tubes, biliary drains, and wound/abscess drains were included. Retrospective chart review was used to categorize 30-day outcomes including those deemed related or possibly related to the placement that resulted in a phone call, office visit, ED evaluation, or hospital readmission. Results: Mean age at placement was 62 years and 53% of patients were female. All patients had metastatic tumor. The majority of patients had an Eastern Cooperative Oncology Group Performance Status of 3-4 (63.4%). Patients with gastrointestinal, gynecological and genitourinary malignancies required more procedures than all other tumor types combined. The 30-day mortality rate following line and drain placement was 32.4%. Of these deaths, 43.5% occurred prior to discharge and 30.4% occurred within two weeks. 40.8% of patients required ED evaluation or hospital readmission and 29.6% of patients required an office visit or phone call within 30 days. Conclusions: Although percutaneous interventions are generally safe and minimally invasive, there is a high 30-day mortality rate associated with line and drain placement among hospitalized patients with advanced cancer. Among patients who expired, over forty percent of deaths occurred during the index hospitalization, suggesting placements are occurring at the end of life, may potentially reflect overuse and may represent a missed opportunity to address goals of care. [Table: see text]