bluuebunny/crossref_metadata_2025_split huggingface dataset:
An administrative stage inference algorithm for use in patients receiving chemotherapy for colorectal cancer.
Authors: Brooks Gabriel A. , Landrum Mary Beth , Keating Nancy Lynn 
Published: September 2018

e18121 Background: Claims data are often used for evaluating cancer care outcomes; however, such data lack information about cancer stage. We developed a claims-based stage inference algorithm to classify chemotherapy-treated patients with localized vs. metastatic colorectal cancer (CRC). Methods: We used the SEER-Medicare linked data (2010-‘11) to develop and validate an algorithm to predict cancer stage (localized vs. metastatic) among patients receiving chemotherapy within 6 months of CRC diagnosis. We used claims to identify treatments received (surgery, radiation, and chemotherapy agents) during the 6 months before and after the first dose of chemotherapy. The sample was split 1:1 into development and validation cohorts. After testing in the development cohort, the final algorithm was evaluated in the validation cohort. SEER data served as the gold standard for cancer stage. Results: We identified 25,258 patients with fee-for-service Medicare and a new diagnosis of CRC. 6,907 patients (27%) received chemotherapy for CRC within 6 months of diagnosis. The median age of chemotherapy-treated patients was 73, 49% were female, and 76% were white; 69% had localized cancer (AJCC stage 1-3) and 31% had metastasis at diagnosis (stage 4). Split-sample validation of the final classification algorithm demonstrated sensitivity and specificity of 87% (95% CI 86-89%) and 76% (73-78%) for localized cancer and 73% (70-75%) and 91% (90-92%) for metastatic cancer. The overall accuracy of classification was 83%. Stratified analyses demonstrated preserved algorithm performance across subgroups of age, sex, race, geography, and comorbidity. Misclassification was most common among patients with metastatic disease who were treated with surgery followed by fluoropyrimidine chemotherapy with or without oxaliplatin. 2-year overall survival was 79.8% (stage 1-3) and 35.4% (stage 4) for SEER stage groups, vs. 79.6% and 35.8% for predicted stage groups. Conclusions: A claims-based algorithm can classify extent of disease in chemotherapy-treated CRC patients with an accuracy of 83%. This algorithm will allow more clinically-relevant patient stratification for claims-based evaluations of cancer care outcomes.
Evolving oncology clinical pharmacology strategies oncology: An analysis of approved small molecule cancer drugs by the FDA 2011-2016.
Authors: Masson Eric , Reeves Matthew , Rabbie Sarit , Carlie David J , Tomkinson Helen 
Published: September 2018

e18130 Background: Understanding the clinical pharmacology properties of new drugs is essential, enabling correct prescribing with respect to dose, interactions and organ impairment. In the era of targeted therapy and resurgence in oncology R&D there is a need to consider how and when to define clinical pharmacology, since many drugs are given accelerated reviews, limiting the development time. This assessment was undertaken to understand how FDA review the clinical pharmacology components of NDAs. Methods: The Clinical Pharmacology and Biopharmaceutics Review documents of small molecule approvals in oncology by FDA from 2011 -2016 were analysed. Information regarding clinical pharmacology studies, in addition to post marketing requirements (PMR) was analysed. Results: Of 42 small molecules identified, 35 had clinical pharmacology review information. There were 16 accelerated approvals and in only 3 approvals were there no PMRs issued. A particular issue concerns the dose, 14 NDAs had identifiable issues in review, resulting in a 10 PMRs which include conducting a further pivotal study with additional doses. The majority of submissions (33) included clinical assessment of drug effect on the QTc interval. 7 PMRs were issued, 4 requesting completion of ongoing studies. A number of PMRs (24) were issued to assess organ impairment and DDI assessment (12). In all orally administered drugs a food interaction study was conducted with 1 PMR issued. In 32 submissions an excretion balance study was conducted, only 1 of the remaining 3 drugs was issued a PMR. Conclusions: Whilst a number of PMRs for clinical pharmacology studies were issued it is encouraging that these did not limit approval, ensuring patient access. For accelerated approvals, there will be insufficient time to complete many studies prior to filing. However, there were a significant number of PMRs regarding dose, reflecting FDA concerns that there is inadequate characterisation of the dose. Clinical pharmacology characterisation of NMEs is still required, but could be conducted through PMRs to enable early patient access. A major focus for sponsors should be a clearer understanding of the dose response relationship.
Collection and utilization of oncology big data.
Authors: Pant Shubham , Owonikoko Taofeek Kunle , Magid Diefenbach Catherine S. , Kim Sungjin , Chen Zhengjia , Towle Elaine L. , Pierce Lori J. , Mileham Kathryn Finch 
Published: September 2018

e18134 Background: Big Data includes data sets whose size is beyond the ability of typical database software tools to capture, store, manage, and analyze. We sought to gain insight on ASCO members’ perspectives towards Big Data in Oncology. Methods: The survey was conducted as part of the ASCO Leadership Development Program and was electronically distributed to US-based ASCO members. Survey questions explored demographics, practice type, EHR utilization, perceptions about Big Data, and awareness and understanding of ASCO Big Data initiative, CancerLinQ. Statistical analysis was conducted and the data were reviewed. Results: Seventy percent of survey respondents were physicians (n = 1261); 50% had some knowledge of Big Data but only a minority (38%) planned to champion participation in Big Data initiatives. The most frequently cited barriers to participating in Big Data collection were perceived added burden of data retrieval and submission (68%), privacy breach (49%) and potential misuse of patient data (49%). The most valuable aspect of Big Data for practices was population level information for patient management (75%); the most important factor in choosing a Big Data organization was emphasis on privacy and confidentiality of data (53.5%). Participants from NCI-Designated Cancer Centers were more likely to share oncology patient data. Years in practice was inversely correlated with a willingness to share data. Only 25% of respondents were very likely to share oncology data with Big Data organizations, with participants in oncology practice for > 30 years least likely to share data as compared to those with less than 5 years (p = 0.010) and those 11-20 years in practice (p = 0.004). Physicians in practice for > 20 years were least likely to trust information from Big Data (p = 0.004). A majority of patients had heard about Cancer LinQ mostly from ASCO sources, however only 25% were familiar with the details. Conclusions: Big Data has the great potential to provide physicians with novel insights and enhance care for cancer patients although some concerns and barriers exist. Education, outreach and physician champions are keys in further realizing the promise of Big Data for cancer patients.
Adjustments for confounding variables in observational population-based studies in oncology and comparison to results from randomized controlled trials.
Authors: Soni Payal Dilip , Abugharib Ahmed , Allen Steven G , Khan Imran A , Soliman Moazz , Simons Robert Eric , Dess Robert Timothy , Spratt Daniel Eidelberg 
Published: September 2018

e18135 Background: Observational population-based studies (OBS) allow large scale analyses to be done, and are increasingly used to compare cancer treatment modalities. Given the immense heterogeneity in these cohorts and the high potential for bias, we investigate how often appropriate statistical strategies are used to address confounding factors and the agreement of these studies with results from randomized controlled trials (RCT). Methods: A systematic literature search was conducted in MEDLINE using controlled vocabulary to identify OBS between 2000 and 2011, identifying 1814 studies. Studies reporting on survival that compare local therapies were included. Study details were extracted including survival outcomes, whether adjustments were made for age, stage, comorbidities, and if propensity score analyses or sensitivity analyses were performed. Studies with robust adjustments were compared to representative RCT results. Results: A total of 155 treatment comparisons met inclusion criteria. Median follow-up was available in 37% and median/mean age in 64% of comparisons. Age and stage were not adjusted for in 12% and 8% of studies, respectively. Only 10% adjusted for comorbidities, and 15% (n = 24) used either propensity adjustment (n = 21) or sensitivity analyses (n = 8). Of these 24, 11 had corresponding RCTs, and six had discordant findings. In five of the six studies, the RCT showed no survival difference while the corresponding OBS suggested more treatment was better than less, suggesting potentially unadjusted confounding. Greater degree of statistical adjustments correlated with year of publication, and all studies that used propensity adjustment and sensitivity analysis were after 2007. Conclusions: During the decade of OBS analyzed, the majority did not report the median follow-up or age, adjust for comorbidities, or perform robust statistical analyses to correct for potential bias. Even among studies with rigorous statistical adjustments, over half had discordant findings from RCTs. Given these findings, comparative OBS in oncology should be seen as hypothesis generating and caution should be used when interpreting the results.
Lymph node metastasis and prognostic value of NPC based on the UICC lymph node staging for cervical lymph node levels.
Authors: Lang Jin Yi , Feng Mei , Xu Peng , Wang Weidong , Yang Guangquan , Lu Shun 
Published: September 2018

e18136 Background: Nasopharyngeal carcinoma (NPC) is the most common cancer originating in the nasopharynx. The neck lymph node (LN) metastasis is very common in NPC; it plays an important role in tumor staging which is guide the choice of treatment. Methods: 324 patients were pathologically diagnosed as non-metastatic NPC from Jan. 2005 to Dec.2010 were recruited retrospectively to analysis. All of them treated with standard IMRT. The clinical data including CT/MRI images, followed up were collected, while the OS, DFS, DMFS and RRFS were calculated. Survival analysis was performed by Kaplan-Meier method, and COX regression model was used for multivariate analysis. Results: The median follow-up time was 66 months (6-134 months). The 5-year LRFS,NRFS,DMFS,DFS and OS was 93.5%, 97.4%, 73.4%, 69.1% and 79.2%,respectively. The most common metastatic LN levels were II level 83.9%, retropharyngeal LN level 69.1%, followed by III level 16.9%, Va level 8% ,IV level 5.2% and Vb level 4%. All the retropharyngeal LNs were involved in the lateral group while no medial ones was found. In cervical LN, necrosis was involved in 40.0% patients with positive nodes and extracapsular invasion was noted in 58.6%. Bilateral positive LN was involved in 66.5%, and there was 11.4% in the lower cervical region. Univariate analysis showed that LN diameter greater than 3 cm, extracapsular invasion, LN necrosis and LN laterality are independent prognostic factors for DMFS and DFS (P < 0.05). T staging and N staging were independent prognostic factors for the DMFS (P = 0.024, 0.012, respectively). Lower cervical involvement had no significant effect on DMFS and DFS. Multivariate analysis showed that T staging, extracapsular invasion and laterality were independent prognostic factors (P < 0.05) for DFS, and extracapsular invasion was an independent prognostic factor (P = 0.048) for DMFS. Conclusions: Our results suggested II level and retropharyngeal LN have the highest metastasis rate. All retropharyngeal LN were involved in the lateral group but not medial one. Laterality, maximum diameter and necrosis are independent prognostic factors for DFS and DMFS. The involvement of the lower cervical region had no significant effect on DFS and DMFS.
Practice patterns and clinical outcomes of therapy-related acute myeloid leukemia (TAML) in the US.
Authors: Pant Manisha , Giri Smith , Dhakal Prajwal , Bhatt Vijaya Raj 
Published: September 2018

e18139 Background: tAML, compared to de novo AML, has higher adverse features and a shorter overall survival (OS). The use of chemotherapy and hematopoietic cell transplant (HCT), and OS of tAML outside of clinical trials has not been studied well. Current study was designed to identify the treatment patterns and OS of tAML based on a national database. Methods: A total of 1,611 cases of tAML were identified between 2001-2011 using the National Cancer Database (NCDB). Data on age, race, gender, income, insurance and educational status, Charlson comorbidity index (CCI), receipt of chemotherapy and HCT were abstracted. Log-rank test was used to test equality of survivor function among the variables. Factors that attained statistical significance during bivariate analysis were factored into multivariate analysis using Cox Regression model. Results: Median age at diagnosis was 63 years (range 18-90), with 54% < 65 years, 59% females and 80% Caucasians. 67% underwent chemotherapy (20% single agent, 45% multiple agents and 2% unknown). 19% received HCT. Median OS was 6.7 months (m) with 1-year OS of 33%. Median OS was lower among patients ≥65 versus < 65 years (4.1 vs. 9.5 m; p < 0.001), those with higher comorbidity burden (7.8 m for CCI of 0, 6.0 m for CCI of 1, and 3.8 m for CCI of 2; p < 0.001), and diagnosed before versus during/after 2008 (5.6 vs. 7.7 m, p = 0.05). Median OS was higher among patients who received chemotherapy (8.4 vs. 3.7 m; p < 0.001) and HCT (22.6 vs. 4.9 m, p < 0.001), as compared to those who did not. Cox regression model showed the predictors of OS to be: receipt of HCT (hazard ratio, HR 0.36); use of multiagent chemotherapy (HR 0.80); age≥65 years (HR 1.25), higher comorbidities (HR of 1.21 for CCI of 1, and 1.45 for CCI of 2) and diagnosis on or after 2008 (HR of 0.81). Conclusions: Over half of patients with tAML are younger adults ( < 65 years), however, the receipt of chemotherapy and HCT is relatively low. OS is poor in general but improves with the use of multiagent chemotherapy and HCT. OS is worse in older patients and those with comorbidities. Given a dismal prognosis, older patients may be managed by leukemia team with expertise in geriatric oncology and should be encouraged to participate in clinical trials of novel therapies.
Cognitive computing in oncology: A qualitative assessment of IBM Watson for Oncology in Mexico.
Authors: Sarre-Lazcano Catherine , Armengol Alonso Alejandra , Huitzil Melendez Fidel David , Arrieta Oscar , Norden Andrew D , Urman Alexandra , Perroni Mariana , Landis-Mcgrath Alice , Medina-Franco Heriberto 
Published: September 2018

e18166 Background: Watson for Oncology (WFO) is a Memorial Sloan Kettering trained cognitive computing system designed to extract structured and unstructured data from medical records; ingest a large body of published evidence and guidelines; and provide evidence-based treatment options tailored to an individual patient. In Mexico, 160,000 new cases of cancer are diagnosed per year, causing almost 80,000 deaths. 70% of cases are diagnosed at a late stage (Secretariat of Health, 2016). Given the burden of cancer on morbidity and mortality in Mexico, WFO was evaluated as a potential tool to help oncologists select treatment options for their patients. Our objective was to gain feedback on the experience of using WFO in a Mexican population by a panel of local oncology experts, retrospectively comparing their treatment recommendations to the options provided by WFO. Methods: Patient cases with lung, breast, gastric, colon and rectal cancer diagnosed within the last 5 years were included. Physician users were asked to describe the perceived utility of WFO and to compare the treatment options proposed by WFO with local treatment decisions and guidelines. Results: A total of 100 cases were processed using WFO. Oncologists found WFO to be very useful. They felt that it would be particularly beneficial in clinics that lack subspecialist expertise, and for training medical students and residents. Differences between WFO recommendations and those of the Mexican oncologists were attributed primarily to limited access to high-cost therapies in Mexico and differences between U.S. and Mexican cancer treatment guidelines. Conclusions: WFO is a cognitive computing tool that has the potential to improve the consistency, efficiency, and overall quality of cancer care in Mexico. By surfacing relevant literature and evidence, WFO may provide support for coverage of effective yet high-cost therapies.
Use of alternative medicine for cancer and its impact on survival.
Authors: Johnson Skyler Bryce , Gross Cary Philip , Park Henry S. , Yu James B. 
Published: September 2018

e18175 Background: There is limited available information on the patterns of utilization and efficacy of alternative medicine (AM) for patients with cancer. The primary objective was to compare survival between patients with cancer receiving AM and conventional cancer treatment. The secondary objective was to determine cancer patient characteristics associated with selection of AM. Methods: Patients diagnosed with non-metastatic breast, prostate, lung, or colorectal cancer were identified between 2004-2013 using the National Cancer Database (NCDB). Alternative medicine use was defined as ‘Other-Unproven: Cancer treatments administered by nonmedical personnel’ administered as sole anti-cancer treatment among patients who did not receive chemotherapy, radiotherapy, surgery, and/or hormone therapy. Treatment selection was evaluated by the chi-square test, t-test, and logistic regression. Patients were 2:1 matched on age, clinical group stage, Charlson-Deyo comorbidity score, insurance type, race, year of diagnosis, and cancer type. Overall survival was analyzed using the Kaplan-Meier method, log-rank test, and Cox proportional hazards regression. Results: We identified 281 patients who chose AM in lieu of conventional cancer treatment. Approximately 44% of these patients had breast cancer, followed by prostate (25.5%), lung (18.4%) and colorectal cancer (12.1% of patients). Independent covariates associated with increased likelihood of AM use included breast or lung primary site (vs. prostate), higher socioeconomic status, Intermountain West or Pacific location (vs. Northeast), stages II or III (vs. I) and Charlson-Deyo comorbidity score of 0 (vs. 1). Alternative medicine was independently associated with greater risk of death compared to conventional cancer treatment overall (HR: 2.50, 95% confidence interval 1.88-3.27) and in subgroups of patients with breast, lung, and colorectal cancer. Conclusions: Alternative medicine utilization in patients with cancer is rare and varied by geographic, socioeconomic, and disease-related factors. Patients who chose alternative medicine for primary treatment of their curable cancer had greater risk of death compared to those who chose conventional cancer treatment.
Oncology patients with emergency based admissions: Targets for improvement.
Authors: Slim Jennifer Nadine , Loch Michelle Marie 
Published: September 2018

e18180 Background: Oncology patients frequently utilize emergency room services with increased admission rates and, often, significant consequences on health care costs. National Hospital Ambulatory Medical Care Survey data from 2011 reports non-ischemic heart disease, chest pain and pneumonia as the most common emergency room discharge diagnoses for adults. Previous studies on cancer survivors found that the most common emergency room admission complaints were fever without neutropenia, pain and febrile neutropenia suggesting alternate active problems are more relevant in oncology patients. Other studies have indicated acute conditions and refractory symptoms are leading admission concerns. We would suggest that looking within populations of oncology patients and comparing those admitted emergently to those not admitted would provide further insight for prospective research targets. Methods: We utilized anonymous data obtained from an EPIC query involving oncology patients seen in LSU oncology clinic from July 2014 to August 2015. We were able to determine how many emergency room based admissions were attributed to these patients. Specifically, we reviewed the active problem lists, malignancy diagnosis, patient age and gender. Any identified disparities could identify oncology patients at increased risk for future admissions. Results: 1,627 patients were seen in our oncology clinic with 163 emergency room based admissions. Males accounted for 87 of these admissions. Only two patients had 3 or fewer co-morbid diagnoses. The most common diagnoses among patients with emergency room based admission were abdominal pain, anemia, and chest pain. According to the Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project (HCUP) a cancer diagnosis was not listed in the top 10 diagnoses that account for 30% of all hospital stays. Conclusions: We would suggest the risk factors and management strategies are unique to survivors. An indepth review of the specific admission diagnoses and outcomes from admission could provide additional targets for future interventions. Further study focused on interventions unique to oncoloyg patients are warranted.
Clinical trials: A key tool in improving breast cancer survival in Nigeria.
Authors: Fatiregun Omolara A. , Olopade Olufunmilayo I. , Popoola Abiodun 
Published: September 2018

e18198 Background: Clinical trials has continued to sharpen the treatment guidelines in managing breast cancer in the United States. The trends in breast cancer management in developed countries and the shifts in treatment paradigms have impacted on breast cancer diagnosis from an incurable entity in the early 1900s’ to the situation today where most women are diagnosed in early stage and cured while advanced staged women are living with the disease for several years. Clinical research in breast cancer is in its infancy stage in Nigeria. There is an urgent need for more clinical trials in Nigeria geared towards developing treatment algorithms in a bid to increase survival in Breast cancer patients. Methods: A systematic review of all research published on breast cancer since 1963 till 2017 in Nigeria .We reviewed all articles found on PubMed and Google scholar search engines by searching “ Breast cancer in Nigeria”. Using the PRISMA and NIH guidelines, we reviewed classified them based on their study designs into different levels of evidence. Information extracted from studies include, year of publications, study designs and level of evidence. Studies selected were group into seven levels of evidence .Meta-analysis was not considered in the review due to vary study designs and difficulty n pooling then together. Results: Out of 430 published articles cited relating to Breast cancer, only 282 articles where eligible for the systematic review. 56.4%(159) of studies done on breast were cross sectional studies, followed by case – control studies 11.7% (33), then case reports & series 10.4%(29) ,2.8%(8) , only 1.1% (3)of studies cited were clinical trials registered on Clinical Trials.gov on breast cancer treatment. On Levels of Evidence, Level 6 accounted for 54.9 %( 155) followed by Level 7, 18.1 %( 51), level 1, 2, 3 were 0%, 1.1%, 8.9%.Conclusions: A vast majority of research done on Breast Cancer done in the Country are still at the Levels 4, 6 and 7 of Evidence. Clinical trials in Breast cancer treatment are rare in Nigeria, they however provide Level 1, 2 or 3 evidence which helps to develop treatment protocols for Breast cancer Treatment in Nigeria. , it is pertinent to develop more clinical trials so as to improve quality of care and life in breast cancer patients.