bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of language on distress screening in cancer patients at an NCI-Designated Comprehensive Cancer Center.
Authors: Jones Veronica , Clark Karen L. , Warner Susanne , Rodriguez Jenny , Mortimer Joanne E. , Ferrell Betty R. , Seewaldt Victoria Louise , Kruper Laura , Loscalzo Matthew J. 
Published: September 2018

e18070 Background: Psychological distress has been linked to poor outcomes among cancer patients. In 2007, the Institute of Medicine reported that distress is often unrecognized. While much is known about distress screening in English speaking populations, little is known about the provision of screening in Spanish. Methods: From 2009-2016, over 9000 solid tumor and lymphoma patients treated at an NCI CCC were prospectively administered a validated biopsychosocial distress questionnaire in their preferred language. The data was retrospectively stratified by language and Chi-square and ANOVA tests were performed to detect differences. Results: Spanish-speaking patients had the highest levels of reported distress in every category when compared to any other group. Of the 629 patients that reported Spanish as their preferred language, 400 (63.6%) took the questionnaire in Spanish (SS) with the rest taking it in English (SE). There was no difference in reported gender, marital status, education level or income between the two groups. The SS patients were younger (mean age 56 vs 60.5, P = 0.00) and reported significantly higher distress than the SE patients in every biopsychosocial domain except functional. The greatest difference was seen in “understanding treatment options” (40.1% SS vs 19% SE, p = 0.00) with a significant difference seen also in “fear of medical procedures” (38.2% SS vs 29.9% SE, p = 0.037), “finances” (66.5% SS vs 55.4% SE, p = 0.01), “finding community resources” (34.8% SS vs 26% SE, p = 0.03), “managing emotions” (40.3% SS vs 31.5% SE, p = 0.032), “needing help to coordinate care” (41% SS vs 23.4% SE, p = 0.00) and “transportation” (35.2% SS vs 21.9% SE, p = 0.001). The distress of the SE patients was more similar to that seen in the English-English patients, but was still significantly higher. Conclusions: These provocative data demonstrate distress levels are stratified by preferred language among cancer patients. Spanish speaking patients had the highest levels of reported distress but this difference was more pronounced when they were administered the questionnaire in Spanish. More studies are needed to determine culturally effective ways to identify distress in Spanish speaking populations.
The application of electronic medical records (EMRs) as a virtual comparator arm in a lung cancer clinical trial: A case study.
Authors: Patel Ketan , Ouwens Mario , Shire Norah , Khosla Sajan 
Published: September 2018

e18098 Background: Single-arm and open-label clinical studies are common in oncology drug development, leading to a frequent need for contextualization of results and provision of other means of comparison for cost-effectiveness models. The utility of current approaches such as naïve comparisons, historical control benchmarking, and match-adjusted interventional controls is limited. An alternative approach is the use of routinely collected data from Electronic Medical Records (EMRs). This study sought to determine if overall survival (OS) in advanced non-small cell lung cancer patients from a clinical trial comparator arm could be replicated using EMR data. Methods: De-identified EMR-derived patient data from Flatiron Health were matched via propensity scores to Project Data Sphere clinical trial data for study NCT00457392 of sunitinib plus erlotinib versus erlotinib alone to compare overall survival outcomes. A Cox regression model stratified for dataset was used to estimate the hazard ratio and 95% confidence interval for OS. Results: The Kaplan Meier curves were comparable for the first period after start of treatment, but differed after median survival was reached, with the Flatiron dataset achieving longer median OS. This deviation was strongly associated with differences in post-erlotinib treatment options introduced between the clinical trial period and the EMR period. Splitting the Flatiron data in two, related to the period from which the data were obtained (pre- or post-2013), resulted in a better match for the period closer to the trial [HR: 1.12 (0.93,1.35), P = 0.219] than for the later period [HR: 1.23 (1.01,1.5), P = 0.039]. Conclusions: Our results demonstrate that the time period in which EMR data are collected is important when matching to trial data. EMR data can contextualize the OS benefit for single-arm or uncontrolled trials run in the same time period. Further exploration of time-varying effects on OS is warranted.
Gender and health care outcomes in patients with non-small cell lung cancer: A meta-analysis.
Authors: Torres-Roman Junior S , Flores Claudio J. , Aguilar Alfredo , Bretel Denisse , Rolfo Christian Diego , Raez Luis E. , Pinto Joseph A. , Mas Luis 
Published: September 2018

e18113 Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It is well known that there are differences in the outcome between genders; however the effects of the sex in the prognosis have not been previously properly defined. Our aim was to evaluate in a meta-analysis, differences in healthcare outcomes between women and men with NSCLC in terms of overall survival (OS) and progression-free survival (PFS). Methods: We searched for references of published studies of hospitalary databases indexed in PubMed/Medline. We retrieved 67 references (from 1989 to 2016), of which eleven references were eligible for data extraction. In total, 11 references were evaluable for OS. Meta-analysis for Hazard Ratios (HR) obtained from univariate and multivariate analysis were analyzed in different groups. The meta-analysis was done in the software Review Manager 5.3. Results: In total, 7 studies had information for OS univariate analysis, 7 studies for OS multivariate analysis, only, one for PFS univariate analysis and one for PFS multivariate analysis. The meta-analysis for OS univariate analysis resulted in a HR = 0.75 (P < 0.00001; 95% CI: 0.71 to 0.79) for women compared to men, although there was a high statistical heterogeneity between cohorts (P < 0.0001). In the meta-analysis for OS multivariate analysis was estimated a HR = 0.75 (P < 0.00001; 95% CI: 0.73 to 0.78), with statistical heterogeneity between cohorts (P = 0.0005). Conclusions: Our study quantified a 25%-risk reduction of death for women with NSCLC compare with male men patients with the same diagnosis.
Patient-reported outcomes from a phase 2 study of copanlisib in patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma (iNHL).
Authors: Keating Karen N. , Hiemeyer Florian , Garcia-Vargas Jose E. , Childs Barrett H. , Dreyling Martin H. , Zinzani Pier Luigi 
Published: September 2018

e18123 Background: Information on the degree to which treatment of iNHL impacts health-related quality of life in terms of disease- and treatment-related symptoms is limited. Copanlisib is an investigational pan-Class I phosphatidylinositol 3-kinase (PI3K) inhibitor. In a phase II study in patients with relapsed/refractory iNHL, copanlisib treatment resulted in a high response rate and durable responses. We report here on patient-reported outcomes (PRO) from this trial (NCT01660451, part B). Methods: Patients with 4 subtypes of iNHL were eligible: follicular, marginal zone, small lymphocytic and lymphoplasmacytoid/Waldenstrӧm macroglobulinemia. Patients had to have received ≥2 prior lines of treatment, including rituximab and an alkylating agent. Copanlisib (60 mg, I.V.) was intermittently administered on days 1, 8 and 15 of a 28-day cycle. Health-related quality of life questionnaire FACT-Lym questionnaire (with focus on Total and Lymphoma subscale [FACT-LymS] and LOCF-method applied) was evaluated with Hodges-Lehmann estimate for change in median until week 16, including 95% confidence intervals. EQ-5D and visual analogue scale (EQ-5D VAS) were statistically described. All questionnaires were compiled at baseline and every other cycle in the first year of the study (aligned with radiological imaging). Results: A total of 141 iNHL patients were treated, with completed questionnaires received from 132 patients at baseline and 86 at week 16. The mean±SD (and median) for FACT-Lym LymS score at baseline was 45.27 ± 9.55 (46.5), and 47.20 ± 8.69 (49.0) at 16 weeks. The estimated change in median was +1.0 with 95% CI: [0.5; 2.5] and min: -13.0, max: 23.0, representing an improvement in lymphoma-related symptoms. Accordingly, the FACT-Lym total score was 126.59 ± 22.96 (127.5) at baseline and 127.99 ± 23.60 (130.8) at 16 weeks. Estimated change in median was 0.0 with 95% CI: [-0.5; 3.2] and min: -38.0, max 42.5. Conclusions: This study demonstrated the favorable impact of copanlisib treatment on disease-related symptoms and HRQoL in patients with relapsed/refractory iNHL.
Risks and benefits of phase I trials: Eighteen-year experience from a single institution.
Authors: Kam Audrey E. , Chaudhary Imran , Ghalib Mohammad Haroon , Shah Umang H. , Swami Umang , Kuo Dennis Yi-Shin , Hwang Caroline , Elrafei Tarek N. , Cohen Bruce , Gartrell Benjamin Adam , Kaledzi Elizabeth , Chuy Jennifer W. , Cheng Haiying , Rajdev Lakshmi , Haigentz Missak , Mani Sridhar , Goel Sanjay 
Published: September 2018

e18146 Background: Phase I trials are a critical component of drug development; yet are considered non-therapeutic. This leads to recruitment barriers due to provider and patient discomfort. The largest meta-analysis of phase I studies has previously shown a response rate (RR) of 10.6%. Herein we report the results from our institution. Methods: Records of patients enrolled on phase I trials at our institution from January 1999 to December 2016 were reviewed. Recorded data included adverse events (AE); treatment related responses and deaths. Kaplan-Meier analysis and t-test were performed on the reviewed data. Results: During this period 774 patients were accrued on 64 phase I trials [43.8% cytotoxic, 45.3% biological, 6.2% both and 4.7% viral agents]. Primary cancer diagnoses included colorectal (25.2%), ovarian (17.6%), lung (7.8%), uterine (6.6%) and breast (6.1%). In total, 609 patients were evaluable for response, 41.1% had stable disease (SD) and overall RR was 7.7% (complete RR = 1.0%). Patients with overall clinical benefit (SD+response) had lower mean baseline WBC (4.83 vs 5.94 k/uL, p = 0.0008), ANC (2.92 vs 4.12 k/uL, p = 0.00007), platelets (209 vs 246 k/uL, p = 0.00007), LDH (280 vs 346 U/L, p = 0.0055) and higher serum albumin (3.97 vs 3.86 g/dL, p = 0.011) as compared to patients with progressive disease. Grade 3/4 non-hematological and hematological AE were seen in 28.5% and 19.9% patients, respectively. Treatment-related mortality was 0.8%. Patients with baseline LDH below the median (247 U/L) for the cohort had a higher median survival (312 days vs 201 days, p < 0.001, HR 0.61 95% CI 0.51-0.73). The median and mean duration on study were 56 and 87 days, respectively. Conclusions: This is one of the largest single-institution series of phase I oncology trials. Our RR of 7.7% [95% CI 5.9-10.1%] falls within the 95% CI of the RR of a majority of third line (and greater) chemotherapy regimens for solid tumors. Thus, the concept of 'non-therapeutic' nature of phase I studies needs reconsideration.
Treatment outcomes with first-line (1L) nab-Paclitaxel + gemcitabine (AG) and FOLFIRINOX (FFX) in metastatic pancreatic adenocarcinoma (mPAC).
Authors: Cartwright Thomas H. , Parisi Monika , Espirito Janet L. , Wilson Thomas , Pelletier Corey , Patel Manish , Babiker Hani M. 
Published: September 2018

e18147 Background: AG and FFX have demonstrated improved overall survival (OS) compared to gemcitabine (GEM) as 1L treatment (tx) for mPAC. Limited comparative data exists on AG vs FFX. This study compared time to treatment failure (TTF), OS, and patient (pt) demographics in mPAC pts receiving 1L AG vs FFX, and evaluated outcomes by performance status (PS) in a real-world setting. Methods: This was a retrospective observational cohort study of adult pts diagnosed with stage IV mPAC treated with 1L AG, FFX, or GEM monotherapy between 04/2013 and 10/2015 with at least 3 mo follow-up, to 01/2016. We report results for AG vs FFX; AG vs GEM analysis is ongoing. Data were programmatically extracted from the iKnowMed electronic health record database of pts in The US Oncology Network. Eligibility included ≥3 doses of A (for AG) or ≥2 doses of fluorouracil (for FFX), and excluded pts on clinical trial or with other cancer diagnoses during the study period. Categorical variables were compared with chi-squared tests. TTF and OS were assessed using the Kaplan-Meier method. Results: 2,901 pts with mPAC receiving chemotherapy during the study period were initially identified. 486 total pts met all eligibility criteria, with 255 AG and 159 FFX pts. Median age was 68 and 61 yrs for AG and FFX respectively (p < .0001). ECOG PS was 0-1 in 77% of AG pts and 91% of FFX pts (p = 0.0004). Median TTF and mOS in all pts was 3.5 [95% CI 3.0-3.9] and 9.8 mo [95% CI 8.2-11.5] respectively. There was no statistical difference in mTTF or mOS for the AG vs FFX cohorts (mTTF 3.7 vs 4.3 mo, log-rank p = 0.25; and mOS 9.8 vs 11.4 mo, log-rank p = 0.38). Among pts with ECOG PS 0-1, TTF for AG vs FFX was 4.2 vs 4.3 mo respectively (log-rank p = 0.47); and OS for AG vs FFX was 12.1 vs 11.4 mo (log-rank p = 0.68). Conclusions: Although pts in the AG cohort were older and had worse PS, mTTF and mOS were not statistically different from pts in FFX. Results were similar after stratifying by PS. Limitations include the retrospective and non-randomized nature of the study. However, this represents real world outcomes where randomized data do not exist. Analysis of toxicities and resource utilization is ongoing and will aid in optimizing tx selection in these pts.
Building an oncology EMR database for outcomes research.
Authors: Kallich Joel D. 
Published: September 2018

e18157 Background: Electronic medical records (EMR) are a resource affording many advantages. As structured data fields grow, unstructured data decreases, the potential number of research questions which can be addressed exponentially increases. Over many years working with oncology practices, we licensed HIPAA compliant EMRs into a common data format, resulting in a data base (DB) of over 1 million patients. Methods: We provide a historical perspective, information, and analysis of successes and challenges encountered working with this data, with suggestions for similar projects. Results: See table below. Conclusions: EMR DBs will be the big data sources for the analysis of cancer treatment in the US, including safety surveillance, quality improvement efforts and cost effectiveness research. Careful attention to previous efforts should facilitate adoption of new health information technology to the practice of medicine in oncology. [Table: see text]
Using a multi-disciplinary process-mapping approach for care plan program design.
Authors: Jones Meredith 
Published: September 2018

e18203 Background: The Center for Medicare and Medicaid Innovation has challenged oncology practices to engage in practice transformation activities through participation in the Oncology Care Model (OCM). One difficult requirement of OCM is the creation of care plans inclusive of the 13 IOM components. Though OCM does not require that care plans be given to patients, true practice transformation exists not only with care plan creation, but with delivery and education to patients and caregivers. Many challenges to care plan implementation exist, starting with the lack of staff dedicated to the care planning process. Methods: Two multi-disciplinary teams representing the Medical Oncology Clinic were formed to simulate and process-map current workflow, incorporating care plan generation and delivery. First, teams process-mapped current workflows utilizing existing staff to establish a baseline. Second, teams added care planning to the baseline and determined whether existing or new staff would be needed to accomplish the OCM care plan requirements. Both teams received the same 6 care planning steps: 1. Enter patient demographics into software, 2. Give patient survey, 3. Enter clinical information in software, 4. Generate plan, 5. Print/deliver plan, and 6. Scan into EMR. Results: Both teams completed process mapping with minimal variation at baseline. However, the teams disagreed on responsible staff for each care planning step. Both teams agreed, though, that 4 out of 6 steps must be completed by RNs, NPs or Physicians. Both teams also indicated that current RN staffing levels would not accommodate capacity to add care planning responsibilities to existing positions, due to the time-consuming nature of the care planning process. Conclusions: Multi-Disciplinary teams recommended addition of RN Care Coordinator positions to oversee the care planning process. Successful implementation requires hiring adequate numbers of RN Care Coordinators that, with a reasonable caseload each, will manage the process, track patients and evaluate outcomes. Future opportunities exist to research the impact that the addition of both care plan delivery and RN Care Coordinators have on patient satisfaction and outcomes.
Advanced support for quality of life in oncology: Brazilian private and public health insurance cancer patients' point of view.
Authors: Almeida Gustavo Fernandes Godoy , Freitas Mauricio Assuero Lima de , Costa Marcela Silva , Cordeiro Rafaela Batista da Silva , Barros Filho Evandro Lopes de , Reis Gabriela Pereira Barreto dos , Santos Juliana Oliveira , Jatoba Luisa Conceicao Violet , Luna Estevao Michel Santana de , Silva Lauro Vinicius Machado da , Machado Alexandro , Barbosa Gabriel Brito , Freitas Thais Milla Franco de , Mattos Luiz Alberto Reis ,   Advanced Support for Quality-of-life in Oncology (ASQO)
Published: September 2018

e18229 Background: Cancer patients suffer from burden symptoms and adverse events which compromise quality-of-life. Early palliative care involvement of metastatic non-small cell lung cancer patients has demonstrated increased overall survival. Advanced Support for Quality-of-Life in Oncology - ASQO - addresses cancer and its treatment complications aiming a safe cure or symptom control and dignified death. Measure cancer patients' background and interest about their disease is critical for planning care. To study the point of view of cancer patients about ASQO and compare private and public Brazilian health insurance cancer patients. Methods: An interview was performed and SPSS was used to find means and rates. The protocol was approved by Federal University of Pernambuco ethics committee and all patients signed informed consent Results: 48 patients were interviewed, 28 at Hospital das Clinicas Federal University of Pernambuco and 20 at ÓNKOS Oncology. Attached tables show demographic data and patients’ background, interest and opinion. The topics on which more and less patients’ background were “Chances of cure” (85%) and “Fertility” (25%); Fertility (59%) and participation in clinical research (40%) were the subjects for which more and less patients wanted additional information; Among those patients who wanted additional information about any topic, the theme on which more and less comments were made were “Pain” (100%) and individualization of treatment (10%); Goals of treatment (89%) and fertility (41%) were the subjects that more and less patients were satisfied with the information received Conclusions: In Brazil, the majority of cancer patients don’t have the opportunity to discuss treatment goals and fertility is not widely discussed with them. This translated into highest percentage of interest in the subject and a higher degree of dissatisfaction with the information received, despite median age of 58 years in the study population. The high prevalence of uncontrolled pain reflected in 100% of responders have made additional comments, indicating a need for health professionals education to adequately manage this symptom. Clinical trial information: CAAE 50921215.8.0000.5208.
Patients' perception about difficulty of treatment with trifluridine/tipiracil and pharmaceutical care: Effectiveness and safety.
Authors: Diaz Marca , Llorente Alberto , Touris Manuel , Vidal Yolanda , Mosquera Alicia , Lopez Elena , Vazquez Maria Francisca , Sanchez Bibiana , Duran Goretti , Gonzalez-Anleo Cristina , Garcia Anais , Lopez Rafael , Lamas Maria J. , Bernardez Beatriz 
Published: September 2018

e18249 Background: Trifluridine/tipiracil (TAS) is a new alternative in metastatic colorectal cancer patients (pts) previously treated with fluoropyrimidines, oxaliplatin and irinotecan. Objective:to analyze patients` perception about difficulty of dosage regimen with TAS, the effectiveness and safety. Methods: Retrospective observational study, including pts treated with TAS during expanded access in Spain. Oncology pharmacists, as integral part of cancer team, provide direct patient care medication therapy review, pharmacotherapy management, disease management, medication safety, dispense the medication and other clinical support that may lead to improved quality and clinical outcomes for cancer patient at the beginning of treatment with TAS. About perception we applied a survey with a numeric rating scale (0-10 integers) with 3 questions: difficulty of dosage at the beginning, at the end of 3rd cycle, and the relevance of the information provided by the oncology pharmacist. Variables studied: sex, age, KRAS status, treatment line, ECOG performance status (PS), dose reduction, previous chemotherapy and adverse events (AE) classified according to CTCAE v4.0. Effectiveness variable: progression-free survival (PFS). Results: 12 pts (10 men; 7 mutated KRAS) were included; median age 60.5 years (range 52-81). TAS line: 3rd line (4), ≥ 4th (8). PS 1 in 10 patients; 2 pts PS 2. Dose reduction was necessary in 41.7% pts. Currently 5 pts are still alive and in the survey they scored the dosage regimen with ≤5 points at the beginning and the same after 3 cycles. The relevance of, information provided by the oncology pharmacist was evaluated with 10 points. Effectiveness: median PFS 3.1 months (0.5-8.3), 2 pts continue on treatment ( medianfollow-up 8.1 months). Overall survival is not evaluable. Grade 3/4 hemotologic toxicities were most common (anemia 8,3%, neutropenia 25%). Conclusions: The perceived dosage difficulty is low, contrary to expectations. It is important to emphasize the evaluation of the information provided by the oncological pharmacist. Our study supports an effectiviness similar than the efficacy. Hematological is the most important and common toxicity.