bluuebunny/crossref_metadata_2025_split huggingface dataset:
Environmental effects on head and neck cancer in India
Authors: Mishra A. , Singh V. P. , Verma V. 
Published: August 2020

e17059 Background: Head and neck cancer in India has unique demographic profile, environmental exposure, dietary habits, and personal and family history. Methods: 1,000 cases were analysed. Results: Males dominated (82%) in fifth (29%) and sixth (33%) decades. Majority was uneducated (76%) and poor. Passive tobacco smoking was seen in-house (85%) as well as in the work-place (80%). Approximately 69% smoked more than 100 cigarettes/bidis in their lifetime. Majority acquired regular smoking habit in second (73%) and third (18%) decades and continued smoking for more than 20 years (66%) with 10–20 cigarettes daily (range 1 to 43). However 30% never used tobacco. The main alternative forms were bidi (27%) and smokeless-tobacco chewing products (47%). A past history of cancer and the subsequent radiation treatment was found in 3% while GERD in 33%. Multivitamins/minerals for chemoprevention was used in 65% for 1 to 12 months. Alcohol consumption was seen in 26% where the age of initiation was in second and third decade and the total years of consumption mainly varied from 10–30 years. Having a predominant agriculture-based-economy, the majority of males (38%) were farmers with significant exposure to pesticides and fertilizers; while females predominantly housewifes (17%). The family history was appreciated in 1% with natural parents known in all. The most common sites involved were oral cavity (28%), oropharynx (30%), and larynx (32%). Majority presented with advanced stage (III = 39%; IV = 23%). The consumption of fruit and vegetable juice was less common as compared to fresh consumption as such. Green salads, potatoes, and fiber cereals were significantly used (4–6 times a week). Beans, peas, and corn was not common while beef and pork consumption rare owing . The ‘staple’ diet was wheat, rice, pulses with additional meat mainly in Muslims (once a day). The use of cooking oil, butter, eggs biscuits, cheese, cakes, and cookies was uncommon (less than once a week), but milk was abundant. Conclusions: Hence, it seems that poor, education/literacy, poor socioeconomic status, tobacco smoking (passive and active) at an early age for prolonged duration, tobacco-related products and exposure to pesticides/fertilizers predispose Indian population for head and neck cancer, rather than a positive family history, dietary factors, radiation exposure, or alcoholism. No significant financial relationships to disclose.
Objective measure of patients’ understanding of their role in a randomized trial: A multicenter case-control study
Authors: Leroy T. , Christophe V. , Clisant S. , Antoine P. , Vanlemmens L. , Fournier E. , Penel N. 
Published: August 2020

e17500 Background: Informed consent process is the key-element of the ethical considerations of clinical trials. Several reports have shown that even having been through this process, enrolled patients misunderstand the modalities and goals of randomized clinical trials (RCT). The purpose of this study is to compare individuals’ objective understanding about RCT between patients already included (cases) and patients treated under standard care who have never received information about clinical trials (controls). Methods: We submitted a standardized questionnaire to both populations to explore the objective understanding of RCT. This questionnaire includes 10 ended-questions (q) exploring: understanding of underlying legislation (3 q), understanding of conditions of study withdrawal (3 q), understanding of randomization (2 q) and understanding of uncertainty (2 q). Results: 75 cases and 107 controls were included in the present study. Three questions are associated with a rate of good responses close to 70% in both populations: anonymity of collected data (66% in controls vs 81% in cases), existence of legislation protecting patients (73% vs 76%) and right to withdraw in case of toxicity (73% vs 82%). Understanding of cases is statistically better (p < 0.05) for 6 other questions: physicians duty to tell everything about the trial (44% vs 68%), right to withdraw from the study without giving any reason (38% vs 73%), withdrawing does not jeopardies the quality of further care (40% vs 71%), all the patients do not receive the same treatment (56% vs 73%), allocation at random (12% vs 52%) and uncertainty about benefits (20% vs 38%). At last, the rate of correct responses is similar and very low for the question exploring the uncertainty about toxicity (43% vs 44%). Conclusions: Informed consent actually improves enrolled patients’ understanding of RCT. Nevertheless, additional efforts should be made to increase the quality of the transmission of information about randomization and uncertainty. [Table: see text]
Interobserver and interlaboratory variability of mismatch repair protein expression in ovarian tumors
Authors: Coppola D. , Nicosia S. , Lee J. , Kim J. , Schildkraut J. , Narod S. , Sutphen R. , Sellers T. , Pal T. 
Published: August 2020

e17505 Background: Immunohistochemistry (IHC) for mismatch repair (MMR) protein (MLH1, MSH2, MSH6) expression has been a useful strategy for identifying tumors with MMR deficiency. However, despite its wide use, interpretation of results suffers from poor reproducibility. Methods: To assess inter-observer (IO) and inter-laboratory (IL) variability of MMR protein expression, 41 epithelial ovarian cancer (EOC) samples were arrayed in triplicate for construction of a tissue microarray (TMA). Six slides were made from this donor TMA block, of which 3 were stained at the Moffitt Cancer Center (MCC) and 3 were stained at the University of South Florida (USF), using different lab procedures. IHC for MMR protein expression was performed using the avidin-biotin-complex (ABC) method with appropriate controls. Subsequently, all slides were independently scored for protein expression by two pathologists. The Concordance Correlation Coefficient (CCC) value was computed to evaluate IO and IL concordance, with a value >0.75 indicating excellent concordance. Results: The CCC value for the IO analysis was 0.95 (for MCC-stained slides; 95% C.I.: 0.89–0.98) and 0.85 (for USF-stained slides; 95% C.I.: 0.66, 0.93), indicating excellent concordance. The CCC value for IL analysis was 0.53 (95% C.I.: 0.37–0.66). Conclusions: Our findings demonstrate that variability in IHC protocols may contribute to the interpretation of IHC results. Our data suggest that when pathologists are given the same slide, there is excellent agreement between two observers; however, when the same slides are stained in a separate laboratory using the same method (ABC) but different protocol, there may be considerable disagreement. These findings are of great clinical significance due to the widespread use of IHC as diagnostic, prognostic and therapeutic tools in cancer care. No significant financial relationships to disclose.
The association of pretreatment patient characteristics on the allocation of treatment in stage II ovarian cancer
Authors: Brewster W. R. , Chase D. M. , Fedewa S. , Chen A. , Ward E. 
Published: August 2020

e17508 Background: In high-risk early stage ovarian cancer, surgery followed by adjuvant chemotherapy demonstrates improved survival in prospective trials. The objective of this research was to document patterns of care in the treatment of stage II epithelial ovarian cancer and those factors associated with less than optimal treatment. Methods: The study population was selected from patients diagnosed with ovarian cancer in 2003 to 2005 and reported to the National Cancer Database, a hospital-based cancer registry. 2,252 (93.8%) patients had sufficient information for analysis. Demographics, health insurance, Charlson co-morbidity score, area-level income, and facility characteristics were analyzed as factors potentially associated with treatment. Multivariate logistic regression was performed to assess factors associated with optimal treatment versus suboptimal treatment. Results: Among the women 2,252 women included in the study 1,533 (68.0%) received surgery and chemotherapy and 719 (32.0%) received surgery alone. In multivariate analysis, Black and Hispanic patients were significantly less like likely to receive optimal treatment as compared to white patients (OR = 0.54, 95% CI 0.36–0.82; OR = 0.51, 95% CI = 0.34–0.79, respectively). Women 75 years of age or more were significantly less likely to receive optimal treatment (OR = 0.43 95% CI 0.28–0.67) compared to women less than 53 years. Treatment in a comprehensive cancer facility or teaching hospital compared to community cancer hospitals was positively associated with optimal treatment (OR = 1.40 95% CI 1.02–1.92; OR = 1.89 95% CI 1.38–2.59). Among the 719 patients not receiving chemotherapy, 205 had no reason recorded, and the majority with information (456/514) stated that chemotherapy was not part of planned therapy. Only 33 patients (6.4%) were recorded as refusing recommended chemotherapy. Conclusions: Although only a small proportion of newly diagnosed cases, Stage II ovarian cancer patients have a high probability of benefiting from adjuvant chemotherapy, which improves the likelihood of long-term survival and cure. Further studies are needed to address the patient, clinician and health system factors associated with suboptimal treatment. No significant financial relationships to disclose.
Creation of a library of harmonized standard research variables and case report forms (CRFs) for oncology research
Authors: Reeves D. M. , Helton E. , Speakman J. , Ness E. , Komatsoulis G. 
Published: August 2020

e17512 Background: Oncology clinical research can be facilitated through use of a set of core variables to collect, aggregate, analyze and report data across a number of diverse research settings. These elements can be captured in Case Report Form (CRF) templates, and cloned to expedite the activation of a clinical trial and the collection of data. Through the efforts of the Cancer Biomedical Informatics Grid or caBIG community, the creation of a set of CRFs to support NCI-sponsored trials has been underway since the summer of 2007. Methods: A schematic to represent commonly-used CRFs in oncology trials was created as a roadmap for the project. Priorities were established, and community broadcasts used to recruit workgroup members with clinical, biostatistical, and regulatory expertise. CRFs were contributed by the community-at-large, including the pharmaceutical industry and NCI cooperative groups. Variables from a set of CRFs were partitioned into one of four groups: mandatory, conditional, optional, or not to be included in a CRF. After all the variables for a CRF were finalized by consensus, data elements were created and registered into an NCI ISO/IEC 11179 metadata repository that facilitates the reuse of data elements and CRFs. Results: Eight workgroups have completed their work by the end of 2008, with additional groups underway. The results of the first eight groups were harmonized with the Clinical Data Acquisitions Standards Harmonization or CDASH version 1.0, a standard for CDISC. After approval, the variables are assembled into CRFs with instructions that are available through NCI's data standards repository in a variety of electronic formats. The variables will undergo a rigorous change management process with regular review and versioning as required. Conclusions: The identification and reuse of standards to support the conduct of oncology research depends upon our ability to manage data sets that can be aggregated and analyzed in a timely manner. The caBIG CRF harmonization and standardization variables are being implemented now through a series of early adoption activities and a phased deployment plan that will result in the reuse of a single set of variables to support the conduct of oncology clinical trials. No significant financial relationships to disclose.
Is tumor burden a better predictor of drug activity than progression-free survival?
Authors: Fridlyand J. , Kaiser L. , Fyfe G. 
Published: August 2020

e17521 Background: Improving the ability of Phase (Ph) II trials to better predict Ph 3 outcome is critical. Percentage change in tumor burden (%SLD) is a potentially earlier marker of drug activity than an early evaluation of progression-free survival (PFS) and includes aspects of tumor response not captured by PFS. We describe a statistical evaluation of the ability of %SLD vs PFS to identify an active agent in randomized Ph 2 trials. Methods: Ph 2 trials were simulated with data from bevacizumab (B) and trastuzumab (T) mBC and mCRC Ph3 trials of > 1800 patients total. 2/3 B trials and 1 T trial showed improved PFS (+) & OS (+ or trend), and 1 mBC B study was negative. We repeatedly sampled patients, with their treatment assignments, tumor assessments and PFS values from these studies to emulate randomized Ph 2 trials with different sample sizes, enrollment patterns and follow-up. We determined the probability of correctly identifying an approvable regimen, based on 5% 1-tailed tests of PFS (log-rank) and %SLD (last & nadir, Wilcoxon). All endpoints have equal follow up given a landmark. Results: We performed analyses on 6–8 week assessments and on up to 20–24 week assessments in patients enrolled over 6 months. The estimated probability of a correct Ph 3 decision is reported below for a 100-patient Ph 2 trial. We found:1) For B, PFS consistently outperforms %SLD; 2) for T, %SLD is modestly better than an early PFS, especially with shorter patient follow up. The results were similar across other assessments and varying enrollment times. Conclusions: More trial data are needed to determine if the usefulness of %SLD for decision making is dependent on the drug's MOA/indication. For B, its utility is inferior to PFS at all time points, with the last %SLD generally outperforming the nadir %SLD. In the T study the %SLD analyses displayed a slight advantage. PFS and %SLD should be incorporated into Ph 2 design, analysis, and decision making. [Table: see text] [Table: see text]
A qualitative study of exceptional survivors of cancer
Authors: Meleth S. , Allen L. , Kvale E. , Meredith R. , Spencer S. , Heslin M. , Nabell L. , Posey J. , Partridge E. 
Published: August 2020

e17522 Background: An exceptional survivor of cancer is an individual who has outlived actuarial predictions for his/her particular form of cancer or experienced a complete regression. This pilot study was designed to determine if there were any biological, psychosocial, cultural or lifestyle characteristics exceptional survivors of cancer that can be measured and transferred through interventions to other cancer patients. Methods: The sample consisted of 21 survivors of cancer who were identified by oncologists at UAB as exceptional survivors. The study gathered qualitative data through semi-structured interviews and two validated scales measuring resilience, sense of coherence. A new cancer ‘catastrophizing’ scale based on the pain catastrophizing scale (PCS) was tested for its concordance with the two validated scales. The diagnosis and treatment information on these patients was collected through a questionnaire completed by the patient's oncologist. Results: Eight oncologists referred twenty-five patients to the study. Twenty-one patients agreed to participate. A unifying theme across all patient interviews was a deep spiritual connection with a supreme being. Praying for healing, intercessory prayer, and seeking guidance through faith with respect to best treatment options were common. The patients verbalized faith in physicians and were willing to seek more experimental treatments largely due to their spirituality. In general, the survivors were highly resilient as measured by the resilience scale and had a high sense of coherence as measured by the sense of coherence scale. They were also unlikely to conceptualize the diagnosis as a ‘catastrophe’ as measured by the new cancer catastrophizing scale. Conclusions: This study provides preliminary evidence of a relationship between spirituality and exceptional survivorship. Findings suggest exceptional survivors may be more willing to participate in clinical trials than other populations of cancer patients. Future studies should prospectively follow cancer patients to ascertain the temporal nature of the association between spirituality and exceptional survivorship. No significant financial relationships to disclose.
A model to optimize health care assistance for women with breast cancer: The Núcleo Mama Porto Alegre Project
Authors: Caleffi M. , Viegas-Butzke J. P. , Baldisserotto F. D. , Bedin-Junior A. , Weber B. , Duarte-Filho D. , Skonieski G. P. , Graudenz M. , Ribeiro R. A. 
Published: August 2020

e17526 Background: The promptness of breast cancer (BC) diagnosis and treatment is cornerstone in reducing the disease's mortality. In Brazil, the main problem to achieve this is lack of access to the insufficient referral centers, which in turn are not used to perform early diagnosis and treatment. To address this problem in our city, we created the Núcleo Mama Porto Alegre (NMPOA) model, through a partnership among the private, public and third sectors. The cohort is composed by 9,218 women, of which 4,500 are in the 40–69 age group and have annual clinical examination and mammography (MMG) at NMPOA, and the remainder (<40 and >=70) have clinical follow-up at primary care facilities. All clinical visits, exams and treatment are conducted in the NMPOA center. Our aim is to demonstrate the effectiveness of a model for underserved population to shorten the time between 1st medical appointment and the start of BC treatment. Methods: We analyzed all BC cases diagnosed up to now. We evaluated 3 time periods of the patient's care: median time (MT) between the medical appointment and MMG, MT between MMG and biopsy, and MT between biopsy and the first treatment as indicated: definitive surgery, neoadjuvant chemo- or hormone therapy. Results: 48 cases were evaluated. Clinical staging were the following: stage 0: 16.6%; I: 37.5%; IIA: 18.8%; IIB: 12.5%; IIIA: 10.4%; and IV: 4.1%. MT between the first visit and MMG was 0 days; between MMG and biopsy, 3 days; and between biopsy and first treatment, 23 days. Conclusions: Our model shows much faster results than the usual delay time in Brazil (4–6 months between first visit and treatment). A nationwide BC screening program in Brazil must be implemented with efficient infrastructure and well trained personnel in order to rapid investigate breast lesions, assuring quick access to treatment and therefore diminishing BC mortality. No significant financial relationships to disclose.
Toward incident reporting (IR) systems: A safety culture survey within the oncology network of a northern Italian region
Authors: Aita M. , Zanier L. , Rijavec E. , Merlo V. , Menis J. , Della Mea V. , Deroma L. , Donato R. , Puglisi F. , Fasola G. 
Published: August 2020

e17527 Background: Physicians are reluctant partners in error reporting. Insufficient evidence exists on what may affect IR in a specific cultural and organizational context. The primary endpoint of our study was to offer a critical perspective on the dominant attitudes toward IR systems among health operators of Friuli-Venezia Giulia cancer network. The survey was part of a Health Department patient safety project. Methods: A preliminary PubMed and ASCO database search was performed (keywords: incident/error reporting, attitudes, barriers, blame/safety culture, cancer, oncology, chemotherapy). Two web-based questionnaires were administered to health personnel of Oncology Units (OU) with developing and existing IR systems, respectively. Data were collected in a MySQL database and managed by PhpMyAdmin. SAS 9.1 was used for the analysis of frequency distributions. Results: Target population: 14 OU; 2 University Hospitals, 1 Scientific Institute for Research, Hospitalization, and Health Care (SIRHHC) (2 OU), 10 Hospital Centers; 262 operators (83 physicians, 172 nurses, 2 pharmacists, 5 technicians). Overall response rate: 44.6%; physician/nurse 59/36%; University Hospital (n = 99)/SIRHHC (n = 55)/Hospital Center (n = 101) 73%/9%/38%. Knowledge of risk management issues: 86% (90% of untrained operators from IR-free centers). Eighty-six percent of all operators showed a favourable attitude toward voluntary IR systems. Main reasons: patient safety improvement (65%); organizational growth (38%); professional duty (20.5%). A 78.5% preference for computerized forms was recorded. On a five-point scale, IR features rating 5 in >50% of the answers were: simplicity (85%); getting a feed-back (76%); exhaustivity (66%); adoption of organization more than individual recommendations (59%). Specific training, feedback guarantee and plainness of reporting forms were suggested by 90, 64, and 51% of all operators as essential measures for system acceptance and user satisfaction. Conclusions: Logistic and organizational factors (i.e., time constraints, work overload, resource allocation to incident reporting more than investigation and learning back) should be taken in account by county health directors aiming for successful reporting systems. No significant financial relationships to disclose.
300% increase rate in juvenile cancer cases unrelated to AIDS: Is it real?
Authors: Gercovich F. G. , Gil Deza E. , Martin Reina G. , Garcia Gerardi C. , Abal M. , Santillan D. , Tognelli F. , Calarame J. , Rivarola E. , Morgenfeld E. 
Published: August 2020

e17535 Background: Juvenile Cancer (JC) involves patients between 18 and 29 years old (adult pt less than 30 yo) and can be or not associated to AIDS. The non-AIDS JC pt challenge the clinical oncologist in many ways: there are few preventive measures, avoiding delayed toxicities is mandatory (fertility, cognitive impairment) and there is a lack of evidence-based treatments for uncommon tumors. The aim of this paper is to evaluate the incidence and clinical outcome of JC non AIDS related at the IOHM. Methods: A JC search in the patient database of the IOHM was made. The inclusion criteria was: new cancer pt diagnosed between 18 and 29 yo. The following variables were analyzed: age, gender, date, absolute and relative annual incidence and diagnosis. The tumors were classified as expected (germinal, hematological, sarcoma, melanoma, CNS, thyroid, cervix, trophoblastic disease) or unexpected (breast, colon, ovarian, gastric, pancreatic, head and neck). The Mean Annual New Case (MANC) incidence for pt older than 30 yo (non-JC) and JC in two different four year periods (“A”: 2001–2004, “B”: 2005–2008) were calculated in order to analyze the relative risk between both populations for these periods. Results: A total of 12.828 new pt were managed at the IOHM between January 2001 and January 2008, with 336 of them (2.6%) being JC. Mean age (range) = 23.3 years (18–29). Gender: male = 180 (53%) and female = 156 (47%). Diagnosis: Expected tumors 269 pt (80%) (testicular tumors = 89 pt; lymphoma = 75 pt; sarcoma = 35 pt; melanoma = 17 pt; others = 53), Unexpected tumors 67 pt (20%) (gastrointestinal = 23 pt; breast cancer = 17 pt; ovarian = 13 pt; head and neck = 7 pt; others = 7 pt). MANC for Non JC in A=1458.25 pt/y; MANC for Non JC in B = 1748.75 pt/y (RR Non JC B/A = 1.2). MANC JC in A = 18.5 pt/y; MANC JC in B = 52.75 pt/y (RR JC B/A = 2.85). Conclusions: 1) In our database, 336 cases of JC out of 12.828 new cancer patients between were found 2001 and 2008; 2) Expected tumors represent 80% of the cases; 3) An unexplained trend of new cases of JC is seen in this 8-year period. The comparison of the first 4 years and the second 4 years shows a relative risk increase of 300% of cases in this population. If other investigators confirm this data, a severe public health problem may be unrecognized. No significant financial relationships to disclose.