bluuebunny/crossref_metadata_2025_split huggingface dataset:
Creation of On-PROST: The Ontario patient-reported outcomes of symptoms and toxicity applied clinical research unit.
Authors: Liu Geoffrey , Howell Doris , Perez Cosio Andrea , Krzyzanowska Monika K. , Li Madeline , Rodin Gary , Brundage Michael Donald , Hope Andrew J. ,   Ontario Patient Reported Outcomes of Symptoms and Toxicity Applied Cancer Research Unit
Published: February 2017

47 Background: The 14 Ontario Regional Cancer Centers serve a catchment of 13 million people, centrally coordinated by Cancer Care Ontario. Since 2009, computer kiosks collect the Edmonton Symptom Assessment System (ESAS) patient reported outcomes (PROs). At specific centers, additional PROs such as the Distress Assessment and Response Tool (DART) have been integrated. On-PROST was created in 2011 to customize PROs for disease-, treatment- and phase-specific symptoms and toxicities, and to address core multidimensional impacts of cancer. On-PROST aims to improve patient experience and quality of care through routine collection of standardized sets of PROs for combined use in clinical care and research. Methods: On-PROST structure has five research pillars, each dependent on quality PROs: Health Services Research; Biomarker Research; Radiation Oncology; Palliative/Supportive Care; and the PROs-Cancer Core items. National/international partnerships are being established to develop, standardize and implement PROs relevant across the entire cancer continuum. Results: National consensus was generated for the implementation of the Canadian PROMs-Cancer Core. Key domains on physical, emotional and social health were included, and implementation testing has begun. In parallel, specific On-PROST sub-projects have focused on identifying, validating, and standardizing logic-based sets of PROs for disease-, treatment- and phase-specific symptoms and toxicities. On-PROST projects have focused on topics that complement existing research by other groups (PROMIS, PRO-CTCAE). Initial projects have included: (i) assessment of dysphagia and related symptoms in head and neck and esophageal cancer populations; (ii) short/long term sexual function in prostate and testicular cancers; (iii) a lung cancer radiogenetic toxicity study; and (iv) patient reported outcomes related to physical activity and other modifiable behaviors after cancer diagnosis. Conclusions: The multi-pronged structure of On-PROST will systematically collect disease-, treatment-, and phase-specific PROs at a population level.
Effectiveness of HCC treatments in real-world experiences.
Authors: Misek Glen I. , Keckeisen Mark , Jayanti Venkata K 
Published: February 2017

61 Background: The global incidence of HCC is over 700,000 patients making it the sixth leading cancer. Recently new drugs have been approved to treat HCC. Nevertheless, prognosis is poor with a 5 year survival of 11%. Hence, it is important to understand if there are differences in OS in the Real World (RWE) based on patient demographics, comorbidities and whether current treatments are effective. Methods: A robust global database of HCC patients was constructed from patient chart data with nearly 4,000 unique patient records from the United States, the European Union, and Asia in 2011. Several hypotheses were tested including the impact of ethnicity, presence of Hep B or C or cirrhosis, stage at diagnosis and/or if current treatments used could predict PFS and /or OS. CART and CHAID analyses were conducted to help determine patient segments and treatment flows in conjunction with Kaplan-Meier plots to understand the differences in survival based key patient and treatment attributes. Results: One year survival appears to be associated with geography as it is significantly lower in China/ Korea compared to the United States and the European Union. Significantly higher one year survival rates are observed for HCC patients in the European Union and the United States receiving TACE compared with patients receiving sorafenib first line. However, in Asia there are no differences. Across all three regions sorafenib use does not effect OS in Stage IV patients. Further, no significant differences in one year survival are seen in patients with Hep C or B or cirrhosis compared to those with no history of liver disease. Sorafenib treatment duration in China appears to be substantially lower. Finally, Child-Pugh C patients had lower survival compared to Child-Pugh A or B patients. Conclusions: Early diagnosis, intervention and treatment of HCC appear to be important predictors of survival. Stratifying groups by type of drug treatment including sorafenib use does not appear to have a measurable effect on OS. Efforts aimed towards screening, early detection and treatment initiation during early stages to improve RWE for HCC patients may be more effective than expanding treatment with sorafenib in late stage patients. Given the lack of significance in OS for late stage patients treated with sorafenib across the globe, serious thought should be given its use for late stage patients.
A quality improvement program to increase performance with clinical oncology pathways.
Authors: Espirito Janet L. , Arlen Aimee , Garey Jody S. , Sheth Sheetal , Turnwald Brian , Clayton Matthew , Flinn Jennifer , Butler-Dorian Carla , Nelson Greg C. , Hoverman J. Russell , Patt Debra A. , Cartwright Thomas H. , Busby Leslie T. , Beveridge Roy A. , Neubauer Marcus A. ,   on behalf of the Pathways Task Force
Published: February 2017

65 Background: Several organizations have created oncology pathways (pws) to support evidence-based medicine, and both standardize and improve the quality of care. Information is scarce; however, regarding the requirements for successful implementation of a pws program and monitoring of adherence. Methods: We assessed the efficacy of a quality assurance initiative called Practice Pathways Improvement (PPI) program to increase pws adherence to The US Oncology Network’s physician-developed Level I Pathways. We queried our electronic health record (EHR) iKnowMed to collect data before and after program initiation. Education was provided to address policies and procedures; leadership roles and responsibilities; integration of pws into the EHR and workflow; and the importance of correct data entry into the EHR. We then measured metrics including levels of assessable data (AD) (complete data, no missing or conflicting elements); On-Pathway adherence (ON-PW); and documented rationale for exceptions (EX) of Off-Pathway treatments. Metric performance reports were distributed monthly. Results: Since 2010, 10 practices of varying size (6-342 medical oncologists) and sites (2-47) voluntarily participated. Program duration ranged from 6-12 months (mos). There were 42,266 regimens evaluated during the program, covering 19 disease pws. Baseline averages, results at program end, and current averages (avg) for AD, ON-PW, and EX are shown in the Table. As of June 2012, average follow up was 19 mos (range 13-25). A normal approximation shows significance of p < 0.001. Conclusions: Implementation of a quality assurance initiative containing operational, leadership, and workflow elements along with continued education is important for successful pws adherence. Tailored program components are necessary to meet individual practice needs. Establishing a foundation for a pws process is important to maintain performance over time. As the reimbursement landscape in oncology evolves, the ability to demonstrate quality of care is essential. [Table: see text]
Rates of diagnostic imaging in long-term survivors of young adult malignancies.
Authors: Daly Corinne , Urbach David , Stukel Therese A. , Deitel Wayne , Nathan Paul C. , Paszat Lawrence Frank , Baxter Nancy N. 
Published: February 2017

69 Background: In general, clinical practice guidelines do not recommend the use of diagnostic imaging in long-term surveillance of cancer survivors. Although warranted diagnostic imaging has clinical benefits, the overuse of imaging in cancer survivors may lead to false-positive results, more invasive tests, economic burden and unnecessary radiation exposure. The objective of this study was to determine rates of diagnostic imaging in long-term young adult cancer survivors (YAS) compared to cancer-free controls in Ontario, Canada. Methods: We conducted a population-based retrospective study. Young adults aged 20 to 44 diagnosed with an invasive malignancy between 1992 and 1999 who lived at least 5 years without recurrent disease were identified in the Ontario Cancer Registry. YAS were matched 1:5 to randomly selected cancer-free controls on calendar year of birth, sex, and place of residence. The rate at which YAS received plain radiography, CT, ultrasound and nuclear medicine studies was compared to rates received by controls using Poisson regression. Results: 20,911 survivors and 104,524 controls met our inclusion criteria. YAS received all types of diagnostic imaging at significantly higher rates than controls in the 10 year period after 5-year recurrence-free survival. YAS received CT scanning at a rate 3.6-fold higher than controls (95% confidence interval [CI]: 3.37, 3.62). In contract, the difference in rates of ultrasound between the two groups was more modest (rate ratio [RR] = 1.40, 95% CI: 1.38, 1.43). YAS also received plain radiography (RR =1.66, 95% CI: 1.64, 1.69) and nuclear studies (RR=1.97, 95% CI: 1.89, 2.04) at significantly higher rates than controls, resulting in a 4.6-fold adjusted higher diagnostic radiation dose than controls. Conclusions: Survivors received significantly higher rates of all diagnostic studies after 5-year survival compared to their age-matched cancer-free counterparts. Hazards associated with overuse of imaging such as radiation exposure and heightened anxiety about test results need to be considered. Both patients and providers should be educated about the role of diagnostic imaging in long-term surveillance including the utility of studies without radiation, such as ultrasound.
Rational use of intensity-modulated radiation therapy (IMRT) as determined by radiation oncologists in cooperation with Blue Cross Blue Shield of Massachusetts (BCBSMA).
Authors: Mamon Harvey J. , Steingisser Lee , Fallon John , Walsh Gerard , Jacobson Joseph O. 
Published: February 2017

73 Background: IMRT is a sophisticated radiation technique that allows more precise delivery than conventional external beam radiation (EBRT). Prospective randomized data indicating which patients are most likely to benefit from IMRT are limited, and the rate of IMRT utilization varies widely. Methods: BCBSMA reached out to radiation oncologists to develop a consensus regarding the use of IMRT. Initial discussions started in 2009. The process included discussions within radiation oncology departments and meetings and conference calls with BCBSMA. In April 2011 a survey was sent to radiation oncologists, followed by the formation of a Physician Advisory Council consisting of representatives of 11 large academic and private practices. The council met in June 2011 and continued to develop guidelines over a series of conference calls. Results: The BCBSMA IMRT policies went into effect on 9/1/11. No policies for the use of EBRT were created. It was agreed that IMRT is appropriate for cancers of the head and neck, prostate, and anus. For other sites, emphasis was placed on the QUANTEC recommendations regarding acceptable doses to normal tissues. To justify the use of IMRT, radiation oncologists were asked to demonstrate that conventional EBRT resulted in excess dose to normal tissues, and that IMRT could lower the doses to an acceptable range. In addition, a process was set up for peer-to-peer review to consider the application of IMRT to cases outside of the guidelines. Preliminary analysis of claims compared the case rat /1,000 BCBSMA members over a 6 month pre-IMRT policy implementation base period to a 6 month post-implementation case rate. The number of IMRT cases during the study period was decreased by 20% while the EBRT cases/1,000 members during the study period increased by 14%. During the two prior years, the IMRT cases/1,000 members for IMRT increased 20%, while the EBRT cases/1000 members decreased 3%. Conclusions: The experience in Massachusetts suggests that practicing physicians and insurers can work together to achieve a consensus regarding the appropriate application of high-technology treatments potentially impacting their rate of utilization.
EMR-linked cancer tracker facilitates lung and liver cancer care.
Authors: Taddei Tamar H. , Hunnibell Laura , DeLorenzo Anne , Rosa Mirta , Connery Donna , Vogel Donna , Garla Vijay , Taylor Caroline , Rose Michal G. 
Published: February 2017

77 Background: VA Connecticut Healthcare System has developed a web-based, EMR-linked Cancer Care Tracking System (CCTS) to facilitate tracking and follow-up of patients with imaging abnormalities concerning for lung or liver cancer. The tracker was developed to facilitate the efforts of a multidisciplinary team at the center of which is a cancer navigator. Methods: CCTS was first envisioned in 2007 when VACT hired a care navigator and implemented a radiology coding system to identify potential cancers. This created the need for a tool to process abnormal images and track the clinical steps required to reach a definitive diagnosis and treatment plan. CCTS was initially used for lung cancers and was expanded to track hepatocellular carcinoma (HCC) in 2009 with additional funding. In addition to case discovery, it offers easy access to patient information with live links to the VA EMR, a surveillance feature, and scheduling, alerting, and reporting functions. In 2011, the system was enhanced with a natural language processing (NLP) program that automatically identifies radiology reports describing potentially malignant lung or liver lesions. Results: CCTS has been in daily operation since February 2010, with 1,778 patients and 2,503 patients tracked in 2010 and 2011, respectively. Addition of NLP technology significantly increases the accuracy of identification of patients with lung or liver nodules. The NLP system identified 21% of all new cases with potential malignancies whose management could have been delayed through coding omissions or errors. Benefits of CCTS and our cancer care coordination program have included a decrease of 25 days in the time from abnormal image to treatment of lung cancer, a significant increase in the diagnosis of stage I/II lung cancers from 32% to 48%, and an increase in the incidence of liver cancer from 1% to 5% of all cancers at VACT. Conclusions: A web-based, EMR-linked cancer care tracking system (CCTS) improves cancer detection, prevents loss to follow-up, provides a safety net for radiology coding omissions or errors, and improves provider efficiency. CCTS is an innovative tool to support multidisciplinary cancer care and has broad applicability to any electronic medical record.
Raising the bar: Breast cancer biomarkers IHC4 harmonization from University of California-Athena pathology collaboration.
Authors: Bishop John W. , Engelberg Jesse , Apple Sophia , Balassanian Ronald , Borowsky Alexander D. , Cardiff Robert D. , Carpenter Philip M. , Chen Yunn-Yi , Datnow Brian , Elson Sarah , Hasteh Farnaz , Lin Fritz , Moatamed Neda A. , Perkovich Brandon , Zhang Yanhong 
Published: February 2017

80 Background: Breast cancer treatment depends on the accurate analysis of immunohistochemical biomarkers (IHC4): estrogen and progesterone receptors, Ki-67, HER2. The Athena Harmonization project was undertaken to reduce technical and scoring variances between different laboratories and different pathologists. Methods: Initial assessment: Five breast cancer samples were sectioned and distributed to 5 UC campuses, where IHC4 and HER2 FISH tests were done per usual methods. Samples were selected to cover the range of negative, positive, and moderate for each antigen. Stained slides were circulated to 10 pathologists for scoring. Digital whole slide images (WSI) were made and scored. Technical variance reduction: A Delphi voting process identified an ideal histology slide for each IHC4 antigen. Laboratories adjusted techniques to match the appearance of the ideal slides, followed by pathologist and quantitative image analysis (QIA) validation. Scoring variance reduction: A digital pathology training tool was created where pathologists scored breast cancer tissue microarrays with known scores for the IHC4 antigens. Results: Scoring variance did not exceed clinical thresholds, although there were significant technical and scoring variances between laboratories that could affect research outcomes. The mean values and variance were similar for WSI and glass slides, except for HER2 (higher scores on WSI but without benefit of workstation calibration). Each laboratory adjusted technical parameters to more closely match the ideal IHC4. Early QIA data indicate reduced variance between adjusted and ideal histology slides. Conclusions: Considerable and significant technical and interpretational variances between five University of California laboratories can be overcome by harmonizing protocols, setting new inter-institutional standards for pathology and histology best practices. Quantitative image analysis and whole slide imaging were instrumental. Subsequent harmonization will include cases near thresholds for clinical treatment guidelines.
Early recognition and treatment of febrile neutropenia in a community hospital.
Authors: Mulvey Therese M. , Tripp Carme M. , Camara Gina , Blanchard Elizabeth M. 
Published: February 2017

90 Background: Febrile neutropenia (FN) is a medical emergency leading to significant morbidity if unrecognized. The use of G-CSF has made FN a less frequent presentation to community hospitals. Significant delays in antibiotic initiation were seen in our community hospital system. Antibiotic selection was variable and blood cultures were often not obtained prior to antibiotics. In November 2011, a FN program was initiated to increase recognition of patients at risk for FN, reduce time to antibiotic initiation, improve antibiotic selection using guideline driven antibiotic (GDA) selection, and decrease morbidity. Methods: A FN Card was developed providing a link to the hospital website detailing the approach to FN, obtaining blood cultures, and use of GDA for patients with or without venous access devices. Patients were educated to carry the card with them and present the card to the triage nurse on ER arrival if their home temperature was over 100.4F. A nurse driven protocol was developed for assessment, blood cultures, and early initiation of GDA and an educational program was provided to the ER staffs at all hospitals in our system. Results: In the 6 month lead up to the initiation of the FN program, 31 patients were identified with FN; 22 as the result of malignancy or therapy, 9 because of benign disease. The median time to antibiotics was 6.3 hours, no patient received GDA, and 32% had blood cultures performed. Three months after initiation of the program, 26 patients presented to the ERs over a 12-week period; 20 from malignant disease or its therapy, 6 from benign disease. Seven patients had received a FN card in clinic and 2 presented the card to the ER triage nurse. Median time to GDA was 2 hours and all 26 patients received GDA, 22 patients (85%) had blood cultures performed prior to GDA. Conclusions: A FN educational program including a FN Card linked to the hospital web site resulted in a significant increase in the number of patients recognized early presenting with FN, reduced time to antibiotic initiation, improved GDA selection and improved blood culture rates before GDA. Data regarding reducing morbidity are pending.
S0221: Comparison of two schedules of paclitaxel as adjuvant therapy for breast cancer.
Authors: Budd G. Thomas , Barlow William E. , Moore Halle C. F. , Hobday Timothy J. , Stewart James A. , Isaacs Claudine , Salim Muhammad , Cho Jonathan K. , Rinn Kristine , Albain Kathy S. , Chew Helen K. , Burton Gary Von , Moore Timothy David , Srkalovic Gordan , McGregor Bradley Alexander , Flaherty Lawrence E. , Livingston Robert B. , Lew Danika , Gralow Julie , Hortobagyi Gabriel N. 
Published: February 2017

CRA1008 Background: S0221 is a SWOG-coordinated phase III adjuvant chemotherapy intergroup trial in node-positive and high-risk node-negative operable breast cancer which hypothesized that 1) the weekly AC+G regimen is superior to ddAC x 6 and 2) 12 weeks of weekly paclitaxel (wP) is superior to q 2 week paclitaxel x 6 (ddP). Methods: Between December 2003 and November 2010, 2,716 patients were randomized in a 2 x 2 factorial design to 1) AC+G vs ddAC and 2) P 80 mg/m2/week x 12 vs P 175 mg/m2 q 2 weeks x 6. If there was no significant interaction between the factors, the trial was powered to find a disease-free survival hazard ratio (HR) ≤ 0.82 for weekly vs q 2 week for each factor. At the first interim analysis, the AC randomization was halted for futility, and S0221 was closed to accrual 10 November 2010. S0221 reopened 15 December 2010, after which time all patients received 4 cycles of ddAC and randomization to P weekly x 12 and ddP x 6 continued. Accrual halted at a total of 3,294 in January 2012. Results: By September 7, 2012, 487 events and 340 deaths had occurred, prompting the third planned interim analysis. The Data Safety and Monitoring Committee recommended reporting the results since the futility boundary was crossed. A Cox model adjusting for the AC arms had a HR = 1.08 (95% CI 0.90-1.28; p=0.42), with the 99.5% CI excluding the original alternative hypothesis that the HR=0.82. There was no significant interaction of the two factors. Estimated 5-year progression-free survivals were 82% for weekly P and 81% for ddP. Toxicity data were available for 1,385 patients treated with ddP and 1,367 treated with weekly P. Grade 5 toxicity occurred in 4 patients on ddP and 2 on weekly P. Percent grade 3-4 toxicity per arm are shown in the Table. Conclusions: Either ddPx6 or weekly P x 12 are acceptable schedules of P administration. The differences in leukopenia likely reflect ascertainment bias against weekly P. If this is accepted, weekly P x 12 produces less overall toxicity than 6 cycles of ddP. Support: NCI grants CA32102, CA38926, CA21115, CA21076, CA77597, CA25224, CA77202, CCSRI15469, and Amgen, Inc. Clinical trial information: NCT00070564. [Table: see text]