bluuebunny/crossref_metadata_2025_split huggingface dataset:
Disorders of taste (dysgeusia) in head and neck cancer patients on concomitant CT/RT.
Authors: Bhattacharyya Gouri Shankar , Malhotra Hemant , Babu K Govind , Vora Amish , Barman Tapati 
Published: September 2018

e18199 Background: Head & Neck cancer is a major problem in India and developing countries related to use of tobacco. Locally advanced oral cavity cancers form a majority of cancers of this region. Common method of treatment of this region is to use concomitant radiation with chemotherapy and/or biotherapy. One of the side effects of regional treatment is loss of taste or dysfunction of taste. This although common has not been properly evaluated or reported. Its impact although conceivable is not used in dietary modifications or tailoring treatment. Methods: Taste discrimination was assessed using high medium and low concentration of sweet salty sour and bitter tasting solution. Cross-sectional observational study was designed to describe the prevalence of taste dysfunction in a group of Head & Neck cancer survivors with oral cancers. Survivors were required to be disease free for at least 3 months symptomatically and imaging wise. Only patients found fit on cognitive assessments as well as capable of comprehending language were asked to fill a simple seven question graded chart. Results: Non parametric approach was done for taste score. Descriptive statistics were used for taste scores and self-reported taste changes. 90 patients were included. Age group 49y – 80y. 58 patients were above the age of 65y. 1/3rd of the patients were females. All patients were locally advanced patient and the commonest site was oral cavity and oro-pharynx – 80%. Participants performed poorly on the taste test. The commonest disturbance in taste was in sweet and sour. 20% of patients had bitter and metallic taste in mouth. 1/3rd of patients had no taste. Patients with maintained taste did not lose weight. Long term taste dysfunction persisted in about 30% of patients. Conclusions: Head & Neck cancer survivors have taste dysfunctions. Taste recognition is demonstrated at low and high concentrations as well as persistent bitter and metallic phantom taste. It may persist for long periods of time. Recognizing this problem is important so the clinicians can help survivor scope with the problem.
How to measure faculty clinical activity in a comprenhesive cancer center.
Authors: Alvarez-Gallego Rafael , Rodriguez-Pascual Jesus , Ugidos Lisardo , Garcia-Rico Eduardo , Munoz Cesar , Cubillo Antonio 
Published: September 2018

e18202 Background: The faculty clinical activity in a comprehensive Cancer Center is difficult to measure. Time clinical units is the most common procedure worldwide. In our group we have developed a new system based on the daily real activity of each medical oncologist of our team. Methods: We collected the daily activity from january to december 2016 of each doctor considering different values( from 1 to 4)depending on the complexity of the activity. Follow up visit of a patient (1), treatment visit (2). Clinical trial visit or Inpatient visit (3) and New Patient First visit (4). Then we added all the daily values of each medical oncologist. Results: 2016 Clinical activity growth measured by traditional time methods was consider 31,5%. When we applicated our new method it was 33,4%. The clinical activity of each Oncology Unit changed clearly when we applied our method. For example , breast cancer unit change from 25% to 20 % of the global activity, GI Unit from 47% to 50%, Lung Unit from 13% to 15% . In Genitourinary and Gynecological cancer and Prostate tumor units there are no change. This changes draw the different complexity of each Oncology Unit. It was clearly usefull to get a better information of the real clinical activity of each team and cancer center. Conclusions: This tool can be useful to unifique and compare the different complexity in the clinical activity of Medical Oncology Teams, units and hospitals allocating resources based on this new system.
Raising all boats in supportive oncology: Initial impact of the Coleman Supportive Oncology Collaborative (CSOC).
Authors: Weldon Christine B. , Gerhart James , Dale William , Patel Urjeet , Khosla Paramjeet , Lo Shelly S. , Newsom Carol , Robinson Patricia A. , Knightly Eileen , Berardi Rosa , Diaz Aidnag , Penedo Frank J. , Trosman Julia Rachel 
Published: September 2018

e18205 Background: The Institute of Medicine (IOM) and Commission on Cancer (CoC) recommend systematic delivery of supportive oncology and survivorship care to all cancer patients. CSOC aims to improve the quality of supportive care across Chicago-area providers. Methods: 35 CSOC participating institutions (cancer centers, support centers, hospice) formed care delivery design teams Distress, Survivorship & Palliative. Teams collaboratively developed solutions to supportive oncology gaps: patient screening tools, care delivery processes, provider training, and quality metrics to assess supportive oncology quality and the CSOC impact. Six implementation centers (2 safety-net, 3 academic & 1 public) reviewed charts at baseline (2014 diagnoses) and after the initial implementation period (2015 diagnoses), compared by frequencies and Fisher’s exact test. Results: Eight metrics contained patient data at 2 time points; improvements were seen in 7/8 metrics. Conclusions: CSOC developed supportive oncology screening, and care processes aligned with IOM and CoC standards. Significant improvements were shown after implementation across diverse settings. Ongoing work will further evaluate the impact of CSOC efforts on patient care. [Table: see text]
Prediction of factors affecting clinical trial accrual at Cancer Therapy and Research Center, San Antonio.
Authors: Iruku Praveena 
Published: September 2018

e18207 Background: Oncology is a very rapidly emerging science with need for more investigational drugs. It is highly essential to accrue patients into clinical trials to develop new drugs. According to the available data, about 38 % of the CTEP/NCI supporting oncology trials close due to inadequate accrual. We here by present a retrospective analysis of factors which affect clinical trial accrual in our institution. Methods: Eligible studies included treatment and supportive care intervention studies either open or closed to accrual between 09/1999 and 012/2015 at our center. Data abstracted includes coordinating group, sponsor type, presence of competing trials, trial phase, disease category, single institutional study, author, primary purpose of the study, interventional modality, targeted therapy, advanced disease, randomization, presence of placebo, rare cancer category and new investigational agents. Successful clinical trial accrual was defined as accruing 4 or more patients. Statistical analysis was performed in the statistic software R (R Foundation for Statistical Computing, Vienna, Austria). We used Chi-square test and Fisher’s exact test. The significance level was set to alpha = 0.05. Results: Retrospective univariate analysis at our institution showed that the variables significantly associated with clinical accrual are Authored by principal investigator, type of sponsor, phase of the trial and number of interventions in the study. Using a random forest model with the above mentioned predictors, we computed an AUC of 64.1 % . We have also developed a histogram of predictions which has identified atleast 5 studies with an 80% failure probability to accrue. Conclusions: Clinical trial accrual is absolutely necessary for development of investigational drugs and progress of research in Hematology/Oncology especially with the rise in incidence of many malignancies. We have identified a few factors that may impact accrual in our institution, and we propose to prospectively validate it in our future endeavor. The major limitations of our study are its retrospective nature and being a single site analysis.
Evaluation of an interactive patient-reported outcome (I-PRO) system in outpatients receiving oral chemotherapy..
Authors: Rasschaert Marika Anna , Van den Brande Jan , Papadimitriou Konstantinos , Specenier Pol , De Keersmaecker Sven , Altintas Sevilay , Huizing Manon , Ravelingien Jo , Rolfo Christian Diego , Peeters Marc 
Published: September 2018

e18208 Background: Health Information Technology (HIT) is increasingly integrated in clinical cancer care. Simultaneous routine assessment of patient reported outcomes (PROs) reliably improve symptom management, patient-provider communication and ultimately survival. Methods: his pilot study is a single center experience with the development and validation of an I-PRO tool (AMOCT). After obtaining informed consent, outpatients, using oral anticancer treatment, recorded their medication intake and 17 PRO measures (PROM) using this I-PRO tool. The device allowed real time data collection via a central platform. The registered data were processed by an algorithm, which stratifies the data into different grades according to international standards of care (CTCAE v4.0). In response to registration of data, patients received either automated symptom management suggestions or were referred to their caregivers. Patient clinical and demographic information is collected from medical records and analyzed using descriptive statistics. Results: 63 Patients were included, 51% male, mean age 61.5 (range 28-83). 41% Of patients used capecitabine, 24% regorafenib, 16% TAS 102, 5% pazopanib and 5% sunitinib. Of the 1873 PROM-scores, 308 scores needed nurses’ attention, ultimately leading to dose reductions in 7 patients (12%). Most often due to weight loss, skin toxicity and asthenia. 41 Patients stopped registration: 51% because treatment ended, 27 % died, 10% dropped out, 5% progressed, 5% were lost to follow up and 2% never started. This tool was well adopted and demonstrated treatment compliance in > 85% patients. Conclusions: This study confirms the feasibility of the program, in an outpatient setting. This I-PRO tool provides a means to register compliance and toxicity of treatment. The compliance to the I-PRO tool will be confirmed, with further development of this program in a multicenter, randomized design. Evaluation of quality of life, PROM’s and further exploration of the relationship between optimal pharmacovigilance and improvement of patient’s outcome will ensue.
Efficacy of an educational program for patients with pancreatic and biliary cancers, and their caregivers.
Authors: Ando Reiko Makihara , Doutani Chikako , Kanehira Sayaka , Nishizawa Mariko , Hirata Kyoko , Miura Hitomi , Nishio Moe , Suzuki Tomoko , Fujimaki Yumiko , Goto Naoko , Shimizu Rieko , Inoguchi Hironobu , Shiba Satoshi , Sakamoto Yasunari , Kondo Shunsuke , Morizane Chigusa , Ueno Hideki , Shimizu Ken , Okusaka Takuji 
Published: September 2018

e18221 Background: We first introduced an educational program delivered in a classroom environment for patients with pancreatic and biliary cancers and their caregivers in 2007. Physicians, pharmacists, nurses, clinical psychotherapists, dietitians, and medical social workers attended and talked about their specialties. We conducted a prospective observational study from Jan. 2016 through Dec. 2016 to assess the efficacy of this educational program. Methods: This study was approved by our institutional review board and informed consent was obtained from all the participants. The 2-hour program included an overview of disease and information about treatment and management. The participants completed a questionnaire assessing their knowledge and including the Distress Thermometer both before and after the program. In addition, the participants completed a questionnaire regarding their satisfaction with the program to assess their informational needs. Results: Thirty-three patients and 50 caregivers were enrolled. Although no significant differences were seen in the mean baseline knowledge levels of the patients and caregivers, the mean baseline distress level was greater for the caregiver than for the patients. After attending the program, both the knowledge and distress levels were significantly improved for both the two groups. Regarding the satisfaction questionnaire, more than 90% of the participants reported being satisfied with the contents of the program and responded that the program was useful for their life. However, the percentage of respondents who reported being satisfied with hearing other participants’ stories was less than 40%. Conclusions: This study suggests that an educational program can improve knowledge and distress levels in patients and caregivers. We are planning to improve our program to further satisfy the needs of patients and caregivers, such as providing an opportunity to communicate with other participants, and to perform further evaluations.
Creating and developing games throughout interdisciplinarity and patient participation.
Authors: Mozzilli Simone Lehwess , Sassi Elisa , Rossi Ludmilla , Sonaglio Viviane , Francisco Fernanda , Duarte Adriana , dos Santos Lisandra Panzoldo , Yabu Gica , Sredni Simone Treiger 
Published: September 2018

e18231 Background: In an increasingly technological world, digital information about childhood cancer that is easily accessible to pediatric patients, their families and healthcare providers is still missing.  In this scenario, we decided to bring all our stakeholders – patients, caregivers, healthcare professionals, creatives and entrepreneurs - together to create an application for tablet and mobile devices that would help children demystify cancer and its treatment. Methods: Materials and platforms used included:  1- Interdisciplinarity: which involves the combination of two or more academic disciplines into one activity; 2- Design Thinking: a human-centered methodology for a rapid ideation (idea generation) with the ability to visualize and adapt the results in near real-time;  3- Agile UX: a methodology which integrates the user experience design team and the developer team;  4- Patient Centered Design;  5- Project Management Platforms; 6- Collaboration and Communication Tools. Results: 1- Development of an application with 20 minigames for iOS and Android platforms, in a language that is easily accessible to children with an attractive an colorful interface where the child can identify him/herself with a custom designed character that guides them through different steps of the treatment. The initiative was highlighted in the AppStore and resulted in almost 4 million views. 2- Acquisition and expansion of interdisciplinarity for all stakeholders.  3- And most importantly, development of empathy and compassion for our patients. Conclusions: The interdisciplinarity and the effective participation of all the stakeholders in the project, allowed an integrated access to information, facilitating the understanding, identification, codification and availability of information that resulted in generation of easily accessible knowledge to our targeted population.  The greatest transformation was not only in the technological advance itself, but in our new way to associate knowledge with human factors in order to educate, empower and improve the quality of life of children fighting cancer. www.beaba.org/games The app is currently available only in Portuguese, but we are raising funding to translate to other languages.
Characteristics of breakthrough therapy designation requests (BTDRs) submitted to the Office of Hematology and Oncology Products (OHOP), FDA.
Authors: Suzman Daniel L. , Kluetz Paul Gustav , McKee Amy E. , Ward Ashley Flynn , Marcus Leigh Jessica , Casak Sandra J. , Pazdur Richard 
Published: September 2018

e18236 Background: Breakthrough therapy designation is an FDA program intended to expedite the development of drugs and biologics that provide preliminary clinical evidence of a substantial improvement over existing therapies. The factors needed to demonstrate this improvement in oncologic therapies have not been well-described. Methods: We reviewed the characteristics of BTDRs submitted to OHOP from program initiation to the present. Results: From November 2013 through July 2016, there were 134 BTDRs for 96 drugs submitted to OHOP, not including 14 BTDRs intended for benign hematologic or supportive care indications. The most common drug mechanisms of action (MoA) were tyrosine kinase inhibitor (TKI) (37; 28%), immunotherapy (24; 18%), and targeted antibodies (21; 16%). Of the 134 BTDRs, 56 (42%) were granted. BTDRs were granted most frequently for TKIs (22; 59%) and immunotherapy (14; 58%) and were rarely granted for cytotoxic (1; 10%) or endocrine (0) therapies. BTDRs based on randomized trials were more frequently granted than those based on single-arm trials (49% vs 39%), as were BTDRs based on OS versus ORR or PFS (57% vs 41%). In BTDRs based on single-arm trials, the median number of patients was higher in those granted versus denied or withdrawn (41 vs 26 patients). Among BTDRs granted based on ORR in solid tumors, the ORR ranged from 24% to 94%, reflecting variation in available therapies, MoA, toxicity, and durability of response. Conclusions: The likelihood of a successful BTDR increases with randomized trial design and larger sample size. Additional considerations include MoA, duration of ORR, and choice of endpoint. [Table: see text]
RAS mutation testing and cetuximab use for colorectal cancer at VA Hospitals.
Authors: Lee Steve Young , Becker Daniel Jacob , DuVall Scott , Lynch Julie Ann 
Published: September 2018

e18244 Background: Extended RAS testing in colorectal cancer predicts response to therapy with EGFR-directed therapies cetuximab and panitumumab. In 2010 VA policy recommended testing of all potentially treatable metastatic colon cancer patients for KRAS mutations. We explored the uptake of RAS testing within the VA system and characterized mutation frequency and cetuximab use. Methods: We extracted records of VA patients with first primary colorectal cancers diagnosed between 2011 and 2015 from the VA Central Cancer Registry (VACCR). We included patients who had RAS testing from 4 commercial laboratories contracted with the VA . We gathered genomic testing results from the commercial vendors. We calculated descriptive statistics of mutation sites and used multivariable logistic regression to evaluate predictors of mutations and cetuximab use. Results: Colon cancer diagnoses decreased in the VA from 4285 cases in 2011 to 3275 cases in 2015 and we observed a concurrent increase in KRAS testing from 4.7% in 2011 (202 cases) to 10.3% in 2015 (336 cases) (p < 0.001). KRAS tested patients were 65.7% white, 26.1% black, 3.1% Hispanic, and 2.8% female. Among 1717 patients tested, 588 had mutations (34.2%), with 441(75%) in codon 2, 117 (19.9%) in codon 13, 23 (3.9%) in codon 61. There were no differences in mutation rates by age, race, ethnicity, or gender categories. A total of 189 patients received cetuximab; 11 of 558 (1.9%) KRAS mutants and 178 of 1095 (16.2%) KRAS wildtype received cetuximab. Across all patients, increasing age in years predicts for cetuximab non-use (OR 0.983, 95% CI 0.97-0.99); gender, race, and ethnicity did not. Conclusions: We found a significant increase in KRAS testing between 2011 and 2015, with mutation patterns reflective of the US population. We found a low rate of inappropriate cetuximab use among patients with KRAS mutations, as well as an also low rate of cetuximab use among KRAS wild type patients among which it may be indicated. Further study is warranted to understand patterns of appropriate and inappropriate use of targeted agents.
Health care associated infections (HAIs) a growing challenge in low-middle-income countries: A Brazilian prospective cohort study.
Authors: Costa Jose Iran , Mello Maria Julia Gonçalves , Barros Isabella R . da Cunha , Ramos Camila jacó , Neves Naiá de miranda , Telles O Lima Jurema 
Published: September 2018

e18253 Background: Healthcare associated infections (HAIs) are responsible for morbidity and mortality among oncologic patients. The aim of this study was to determine the risk factors and the profile of HAI in patients admitted in cancer center. Methods: a prospective cohort study approved by the institution’s ethics committee.It was completed standardized initial assessment and conducted telephone follow-up after thirty days and sixty days from hospital discharge records and supplemented with analysis and hospital information system.Data were analyzed using Cox proportional hazards models. Results: 220 patients between 20 and 87 years of IMIP Adult Oncology service, from December 2015 to June 2016. Among the 220 cancer patients included in the study, the prevalence of HAI was 73.6% and the mortality was 40.4%. 90% percent of patients were initially treated at emergency service. Elderly patients had a higher risk of developing HAI(p < 0.001) as well as people who had longer period of hospitalization(p < 0.001), advanced cancer, people who reported fever on admission, who were diagnosed with Febrile neutropenia(p < 0.001) .The most frequent infections were urinary tract infection, followed by pneumonia and bloodstream infections, which are caused most commonly by Gram-negative microorganisms, and Klebsiella pneumoniae ESBL the most common.Conclusions: HAI is a prevalent problem in the whole course of cancer care with significant morbidity and mortality. Health professionals, especially in the emergency department, must be able to identify and appropriately treat HAI. Bacterial multidrug resistance was prevalent, and may be in the future because of great loss of scientific advances made in the oncology area to date. Institutional policies for prevention, surveillance and HAI therapy must be priority in cancer population.
Safety and efficacy of direct oral anticoagulants (DOAC) in cancer patients: Meta-analysis of randomized controlled trials (RCT).
Authors: McBride Ali , Katragadda Chinmayee , Abraham Ivo 
Published: September 2018

e18264 Background: The DOACs apixaban, edoxaban, rivaroxaban, dabigatran offer advantageous alternatives for venous thromboembolism (VTE) treatment in cancer patients, however, there lacks a prospective assessment in this population. We conducted a meta-analysis of RCTs comparing these DOACs to controls to evaluate the safety and efficacy of these new agents for patients with active cancer. Methods: We systematically searched PUBMED, EMBASE, Cochrane Reviews, CINAHL and Clinicaltrials.gov. Two authors (CK, IA) screened and reviewed abstracts and full text, with disagreements resolved by third author (AB). Data extracted included major bleeding and clinically relevant nonmajor bleeding for safety; recurrent VTE and VTE death for efficacy. Analyses included Mantel-Haenszel random effects risk ratios (RR); I2 for heterogeneity; and meta-regression by publication year. Results: Of 2307 records reviewed, 8 RCTs were retained. Pooled analysis yielded safety RR 0.82 (95%CI = 0.56-1.21, I2 = 44% ) and efficacy RR 0.94 (95%CI = 0.68-1.31; I2 = 0%). Meta-regression revealed no publication year bias. Conclusions: Current guidelines have not supported the use of DOACs in clinical cancer practice due to the paucity of data in this setting. Our results indicate no differential efficacy and no increased bleeding risk for DOACs in cancer patients. Additional prospective research is required to determine long term effects in subgroups of cancer patientss at higher risk for VTE or bleeding events. [Table: see text]