bluuebunny/crossref_metadata_2025_split huggingface dataset:
The impact of affordable care act on the treatment disparities for stage-IV colorectal cancer: A contemporary analysis.
Authors: Jayakrishnan Thejus Thayyil , Bakalov Veli , Chahine Zena , Finley Gene Grant , Monga Dulabh K. , Wegner Rodney E. 
Published: May 2020

e19082 Background: Patients with advanced cancers are among the most vulnerable group of patients. We sought to analyze the impact of Affordable Care Act on the interaction of socioeconomic factors with treatment enrollement and survival in patients with metastatic colorectal cancers. Methods: We queried the National Cancer Database (NCDB) for patients with Stage-IV colon (C-Ca) and rectal cancers (R-Ca) diagnosed from 2004-2015 and excluded those who did not receive any therapies within 6 months of diagnosis. Enrollment rates were calculated as receipt of primary therapy as the incident-event (numerator) over time-to-initiation of therapy (denominator) and used to calculate incident-rate ratios that was further analyzed using Poisson regression analysis- reported as enrollment-rate ratios (ER, < 1 indicating lower enrollment rate). Multivariate Cox-proportional hazard model was performed for survival analysis and reported as calculate Hazard Ratios (HR). Results: We identified 59,211 C-Ca and 4,818 R-Ca for the analysis. Median ages were 64 years vs. 60 years and included 52% vs. 60% males respectively. For C-Ca enrollment to primary therapies were significantly associated (p-value < 0.05) with gender, race, insurance status, educational status and treatment facility. HR < 1 was associated with high-income vs. low-income group- 0.90(0.87-0.94),p-value < 0.005. The HR for non-Hispanic Blacks (NHB) vs. Whites (NHW) improved from 1.1(1.03-1.11),p-value < 0.005 to no-significant difference post-ACA. For R-Ca, the enrollment rates were favorable for NHB vs. NHW and ER improved from 1.15(1.0-1.32),p-value = 0.054) to 1.29(1.06-1.58),p-value = 0.013 post-ACA. Despite this, the HR for mortality were unfavorable - 1.19(1.06-1.33),p-value = 0.003 that persisted through the post-ACA period. The HR was favorable for the insured group in both cancer groups (0.84 for R-Ca,0.86 for C-Ca). Conclusions: Socioeconomic factors influence outcomes for this vulnerable group of patients in terms of enrollment to therapies and survival. The Affordable Care Act appears to have had a positive impact overall but more needs to be done including broadening insurance coverage.
Application of neo-bioscore to a real-world cohort: Potential implications for patient selection, for escalation, and de-escalation of therapy.
Authors: Simmons Christine E. , Willems Kaylie , Chia Stephen K. L. , Tesch Megan , Kespe Kaitlyn , LeVasseur Nathalie 
Published: May 2020

e19094 Background: Recent studies have demonstrated that escalation of therapy for patients with residual disease after neoadjuvant therapy for breast cancer may result in better long-term outcomes. However, refining patient selection based on prognosis has not been widely adopted. The Neo-Bioscore is a validated independent prognostic tool that can be readily applied clinically. The utility of this tool to predict the expected magnitude of benefit from escalation of therapy for ER+, HER2+ and TNBC disease has not yet been explored. Methods: A retrospective review of prospectively collected data from May 2012-May 2019 of patients treated with neoadjuvant chemotherapy followed by surgery was undertaken. The Neo-Bioscore was calculated for each patient. Kaplan-Meier method was used to generate disease-specific survival (DSS) curves, and 5-year DSS rates were estimated. These estimates were compared to those predicted by the original validation cohort. The potential benefit of further adjuvant therapy was extrapolated from data available in the published literature. Results: A total of 471 patients were included in this study; all were women, and the median age was 56 (range 24-88). 324 had residual disease at the time of surgery (68%). Median follow up from diagnosis was 4.4 years. 5-year DSS for each Neo-Bioscore category is seen in the Table below. This correlated with the predicted DSS with a correlation coefficient of X. For patients with residual disease, utilization of adjuvant capecitabine for those with ER+ or TNBC and utilization of adjuvant TDM-1 for those with Her2+ disease would have minimal impact on DSS in those with Neo-Bioscore of 0-2, modest benefit for those with Neo-Bioscore of 3-4, and would be of high benefit for those with Neo-Bioscore of 5 or higher. Conclusions: Neo-Bioscore is a tool that can be readily applied to a real-world cohort without additional pathological information, with good correlation to the predicted outcomes in validation studies. The impact and utility of the Neo-Bioscore to stratify patients for selection of adjuvant therapy will need to be validated, but may help better inform treatment in resource constrained environments. [Table: see text]
Rising incidence of clostridium difficile infection and associated clinical outcomes in hospitalized cancer patients: A national perspective.
Authors: Dalal Shivani , Patel Krunalkumar , Radadiya Dhruvil , Patel Kirtenkumar 
Published: May 2020

e19095 Background: Cancer patients are more prone to Clostridium difficile infection (CDI). Several factors such as increased exposure to antibiotics (either in the form of prophylaxis or treatment), being on chemotherapy, and frequent exposure to healthcare settings are responsible for this. Rate of CDI in these patients ranges from 10-20%. Here, we performed a retrospective analysis using the national inpatient sample to study the trend and to see whether CDI leads to poor outcomes in these patients. Methods: We have used National Inpatient Sample database from the year 2009 to 2015 to identify hospitalized adult patients with cancer using ICD-9 CM codes. Similarly, We also identified patients with concurrent CDI amongst all cancer patients. Our primary aims were to study the trend of CDI and associated outcomes in from of mortality, cost of hospitalization and length of stay. Incidence of CDI per 10,000 discharges in those patients over the study period was assessed. Outcomes related to CDI in cancer patients were compared with those without CDI. Categorical and continuous variables were compared between matched cohorts using Chi-square and Student’s t-test, respectively. Statistical significance level was set at < 0.05. All analyses were performed with the use of SAS (version 9.4). Results: Total of 6,035,966 cancer patients was identified over the study period. Out of which, 57,167 (0.9%) had concurrent CDI. Age, sex and race were comparable in both the groups. Incidence of CDI increased from 89 cases to 101 cases per 10,000 cancer patients (p-trend: < 0.05). Inpatient mortality was significantly higher in cancer patients with CDI compared to without CDI(12.1% vs 4.7%, p < 0.0001). Cost of hospitalization was almost 3 times higher ($36,243 vs $12,910, p < 0.0001).Median length of stay was almost four-fold longer (16 days vs 4 days, p < 0.0001). Patients with Medicare and Medicaid had higher percentages of CDI cases while patients with private insurance had lower percentages. Conclusions: Incidence of CDI in cancer patients is on the rise. CDI lead to higher mortality, cost of hospitalization, and length of stay in cancer patients. Preventive strategies in form of judicious use of antibiotics and prompt identification with treatment may help with reducing mortality and associated healthcare burden.
Patient-reported diarrhea impact on physical functioning and quality of life in clinical trial data submitted to the U.S. Food and Drug Administration.
Authors: Chen Ting-Yu , King-Kallimanis Bellinda , Merzoug Lyna , Fiero Mallorie , Gao Jennifer J , Beaver Julia A. , Bhatnagar Vishal , Kluetz Paul Gustav 
Published: May 2020

e19105 Background: Patient-reported outcomes can provide symptom and function data that complement standard oncology endpoints. Frequently, trials will conclude there was no clinically meaningful detriment to health-related quality of life (HRQL) or function, even when notable toxicity is observed. It is possible that mean change from baseline analyses obscures meaningful change in subgroups experiencing symptomatic toxicity. In this study, we explore how patients’ response to a diarrhea item related to physical function (PF) and HRQL in trials submitted to US FDA. Methods: We analyzed 3 randomized, double-blind breast cancer trials (early to late line metastatic) where diarrhea was a more common AE-symptom in the treatment arm, but there was not a large detriment in the mean change from baseline for HRQL and PF. Trials included the EORTC Quality of Life Questionnaire (QLQ-C30), which captures patient-reported HRQL, symptoms, and functioning. Higher scores (range 0-100) indicate better functioning and HRQL. Symptoms were measured with a 4-point scale; not at all to very much. Descriptive statistics were used to analyze diarrhea, PF, and HRQL over time. Results: Patients reporting very much diarrhea at month 3 had worse PF and HRQL compared to patients reporting no diarrhea . The range of difference between patients who reported very much diarrhea and those with none was 8-18 points for PF across trials. For HRQL scores, the range was 13–17 points worse. This trend was also seen in the control arm and at other times. Conclusions: In this set of breast cancer trials with differences in diarrhea by arm, reporting “no meaningful difference in PF or HRQL between the arms” is insufficient and potentially misleading. A more informative interpretation is that an exploratory analysis of HRQL and PF did not show in the investigational arm; there was a greater proportion of patients reporting diarrhea on the treatment arm; and patients reporting more frequent diarrhea reported lower HRQL and PF compared to patients with no diarrhea, regardless of arm. [Table: see text]
Patterns and determinants of chemotherapy-associated Clostridium difficile infection among cancer patients in the United States: A population-based study.
Authors: Nadpara Pramit 
Published: May 2020

e19111 Background: Elderly cancer patients comprise a population that is vulnerable for Clostridium difficile infection (CDI). In addition to the frequent hospitalizations, the administration of chemotherapeutic agents has been associated with the development of CDI. The objective of this study was to identify the patterns and determinants of chemotherapy-associated CDI (Chemo-CDI), in a nationwide sample of elderly patients. Methods: We used NCI’s Surveillance, Epidemiology, and End Results registry linked Medicare (SEER-Medicare) 2007-2012 files. We included patients’ aged ≥65 year, with diagnosis of lung/breast/ovarian/colorectal/prostate cancer, or lymphoma/multiple myeloma/leukemia during 2008-2011. We excluded those not receiving chemotherapy, with non-continuous Medicare enrollment, or HMO enrollment. Chemotherapy receipt was identified using appropriate ICD-9/HCPCS/CPT codes. Incidence of CDI following chemotherapy were determined by identifying any claim with primary/secondary diagnosis of CDI during the two-month follow-up period. Recurrent Chemo-CDI was identified by presence of any claim that was > 2 weeks and ≤8 weeks from the index CDI diagnosis date. Covariates including antibodies/proton pump inhibitors usage were captured and included in the analysis. Chi-square tests, and hierarchical generalized logistic models were conducted to identify determinants of Chemo-CDI. Results: We identified 41,470 elderly patients with lung/breast/ovarian/colorectal/prostate cancer, or lymphoma/multiple myeloma/leukemia diagnosis during the study years. While few (266) patients developed Chemo-CDI within one year of diagnosis, more than 50% (136) of those patients developed recurrent Chemo-CDI. Patient characteristics were not associated with risk of developing Chemo-CDI, however, significant differences were observed in antibiotics/proton pump inhibitors exposure across all cancer types (p < 0.001). Treatment for Chemo-CDI mostly comprised of Metronidazole and oral Vancomycin. Conclusions: While the incidence of Chemo-CDI is lower among patients receiving chemotherapy, the rate of recurrent Chemo-CDI was significantly higher. Strategies to prevent CDI recurrence in this population are therefore warranted. Future studies should also explore the association between increased disease burden and comorbidity, and the risk of developing Chemo-CDI.
Mental distress among adolescent and young adult (AYA) and adult cancer survivors.
Authors: Adjei Boakye Eric , Polednik Katherine M. , Sharma Arun , Molina Yamile , Pham Vy , Deshields Teresa L. , Osazuwa-Peters Nosayaba 
Published: May 2020

e19116 Background: Mental distress is associated with poor treatment adherence and adverse psychosocial outcomes, and cancer survivors, especially adolescent and young adults (AYA), may experience greater distress than older adults and the general population. We tested this hypothesis by examining the association between AYA vs. adult cancer survivors vs. the general population without a history of cancer, and mental distress. Methods: Using the 2014-2017 National Health Interview Surveys, 2,516 AYA cancer survivors (aged 15 – 39 years) were identified. We then used propensity score matching (matched on sociodemographics, comorbidities, smoking status and visit to mental health professional in past year) to create 2,516 older cancer survivors (aged ≥ 40 years); and 2,516 adults without cancer (general population) as the comparison groups. Mental distress (outcome of interest) was measured using the validated Kessler nonspecific mental/psychological distress (K6) scale. The 6-item K6 scale examines how frequently within the past 30 days an individual felt nervous, hopeless, restless or fidgety, worthless, sad, and that everything was an effort. Responses were summed to yield a score ranging between 0 and 24 and classified as none/low (0≤K6 < 5), moderate (5≤K6 < 13), and severe (K6≥13) mental distress. Two separate weighted multinomial logistic regression models estimated the odds of mental distress in study population (AYA vs. adult cancer survivors; and AYA vs. general population), adjusting for known covariates. Results: Mental distress was more prevalent among AYAs than adult cancer survivors (moderate: 24.0% vs 18.3%; and severe: 5.7% vs 4.2% [ P= .0002]); and the general population (moderate: 24.3% vs 16.7%; and severe: 6.1% vs 5.3% [ P< .0001]). Similarly, prevalence was higher among adult cancer survivors than the general population (moderate: 16.8% vs 13.6%; and severe: 3.2% vs 2.7% [ P= .0002]). In the multivariable multinomial analyses, AYAs had greater odds of mental distress (aORmoderate = 1.44; 95% CI 1.09, 1.89; and aORsevere = 1.77; 95% CI 1.21, 2.58) vs. adult cancer survivors. AYAs also had greater odds of mental distress vs. the general population (aORmoderate = 1.39; 95% CI 1.08, 1.79), but no significant difference in severe distress. Conclusions: About 1-in-4 AYA cancer survivors report some mental distress, and distress is more prevalent among this younger age group than older adults with cancer and the general population. Psychosocial care may be especially needed in this younger population to mitigate adverse psychosocial outcomes.
Impact of bolus versus continuous infusion of doxorubicin (DOX) on cardiotoxicity in patients with breast cancer (BC) and sarcomas: Analysis of real-world data.
Authors: Cranmer Lee D. , Hess Lisa M. , Sugihara Tomoko , Zhu Yajun Emily 
Published: May 2020

e19123 Background: Doxorubicin continues to play a central role in management of breast cancer and sarcomas. Dose-dependent cardiomyopathy is a challenge in its use. Strategies have been proposed to mitigate this, including administration by continuous intravenous (CIV) infusion as an alternative to bolus (BOL) administration. This study used real world data to explore the impact of DOX administration mode on cardiotoxicity, duration of DOX and time to treatment failure (TTF). Methods: This study used IBM MarketScan claims to identify patients age ≥ 18 who received at least 2 DOX administrations after cancer diagnosis. Patients with history of cardiac events/toxicities were excluded. Cardiac events were compared for BOL versus CIV overall, by tumor site and by regimen during three follow-up periods, early (within 1 year), middle (>1 to 5 years) and late (>5 years), from DOX initiation using Fisher’s exact test. Duration of DOX and TTF, defined as time from initiation of DOX to subsequent systemic therapy, hospice or death, were evaluated using Kaplan-Meier method and unadjusted Cox proportional hazards models. Results: 62,597 patients were eligible, including 38,961 with BC and 1,772 with sarcoma. Most patients had codes for both modes; 1,941 and 7,094 patients had exclusive BOL and CIV codes, respectively. For these patients, mean duration of DOX was longer for BOL vs. CIV (83.9 vs. 65.4 days, p<0.001). Cardiac events for BOL vs. CIV were 6.5% vs. 5.6% (p=0.098) during the early period, 4% vs. 5.1% (p=0.046) middle period, and 0.5% vs. 0.9% (p=0.068) late period. This pattern was consistent for BC and sarcoma and among those who were pre-treated. There were no differences in cardiac events for BOL vs. CIV for the chemotherapy naïve or DOX monotherapy groups (all periods p>0.10) but statistically different for the breast during the middle period, sarcoma at any time, and pretreated subgroup middle period (all p<0.05). TTF favored CIV over BOL among patients with BC (p<0.0001) but BOL over CIV in sarcoma (p=0.002). TTF was not significantly different between BOL and CIV for BC monotherapy (p=0.067) but was significant for sarcoma monotherapy favoring BOL administration (hazard ratio 0.72, 95% confidence interval 0.54-0.95, p=0.02). Conclusions: These data suggest that cardiac events may occur at a similar rate irrespective of mode of DOX administration. Further analyses are needed to understand how these relationships are impacted by other potential risk covariates (eg, age, gender) and by protective factors (eg, dexrazoxane).
Annual lung cancer screening by chest X ray to avoid further examinations.
Authors: Kimura Tatsuo , Fukumoto Shinya , Fujii Hideki , Nakano Akemi , Nadatani Yuji , Tauchi Yukie , Suzumura Tomohiro , Ogawa Koichi , Kawaguchi Tomoya , Kawada Norifumi 
Published: May 2020

e19124 Background: Chest X ray (CXR) has been the most common screen procedure for detection of lung cancer. However, if patients had old inflammatory shadows such as tuberculosis, calcification and fibrotic changes, it would become increasingly difficult to detect the lung cancer. In that case, a comparative review of the CXR to the previous one helps the detection of new shadows. We examined whether the repeat participants (pts) who received the medical checkup annually, may have a profit for the lung cancer detection screening. Methods: Our clinic “MedCity21” is a university outpatient clinic to undergo a complete medical checkup in private health screening program. The pts with abnormalities detected in CXR were announced by call request and invited to our specialty clinic for chest CT scan as further examination. We examined the varieties of abnormal shadows by CXR and CT scans, and compared the differences between the repeat and the first-time pts using the chi-square tests, in 2018 and 2019 respectively. Results: In 2018, a total of 12540 with repeat / first-time pts of 6898/5642 pts (55/45%) were enrolled. The CXR abnormalities requiring further examinations were a total of 335 (2.6%) with those of 138/188 pts (p < 0.01). After the call requests, a total of 239 (71.3%) with those of 109/130 pts in 2018 received chest CT scan in our specialty clinic. In 2019, a total of 13690 pts with those of 7748/5942 (56.6/43.4%) were enrolled. The CXR abnormalities requiring further examinations were a total of 323 (2.4%) with those of 137/186 pts (p < 0.01). After the call requests, a total of 224 (69.3%) pts with those of 104/120 pts received chest CT scan in our specialty clinic. The varieties of abnormal shadows by CT scans showed that 8.3/20.8% (p < 0.01) in 2018 and 11.5/21.7% (p = 0.04) in 2019 of old inflammatory shadows, 11.0/6.9% (p = 0.27) in 2018 and 14.4/1.7% (p < 0.01) in 2019 of acute inflammatory shadows, respectively. The nodule was detected in 11.9/11.5% in 2018 and 8.7/10.8% in 2019 with no significant differences. Lung cancer was detected in 3/3 pts in 2018, and 1/3 pts in 2019. Conclusions: The repeat pts in each year, had significantly lower rate of CXR abnormalities detection, and had lower rate of the detection of old inflammatory changes as significant. In private health screening program, the repeat pts may have higher profits for the avoidance of further examination for lung cancer detection than the first-time pts.
Factors associated with oral chemotherapy adherence in specialty pharmacies.
Authors: Monestime Shanada , Page Ray D. , Jordan William M. , Aryal Subhash , Rasu Rafia 
Published: May 2020

e19137 Background: Specialty pharmacies are expanding in the oncology setting and often favored by payors because of economic and operational benefits. However, challenges exist in coordination of care, patient safety, cost/reimbursement, and operational efficiency. While in-house specialty pharmacies mitigate these challenges due to close proximity of health care providers, these challenges can impact medication adherence. To date, limited data are available on adherence rates and factors associated with oral chemotherapy (OC) adherence in specialty pharmacy settings. Methods: Adult cancer patients who received their first OC between Aug.-Oct. 2018 were analyzed. Pharmacies were contacted to obtain OC pick-up dates over 6 months or until treatment completion. Patients were adherent if the proportion of days covered (PDC) was ≥90%. Descriptive and bivariate logistic regression models were performed to examine demographics, specialty pharmacy type (external vs. internal), distance from pharmacy to home, and chronic comorbidities. Results: Of the 80 patients analyzed, the mean age was 63.59 (SD ±11.8), 51.21% were female, 68.75% were white, 61.25% were married, 82.50% were smokers, 53.75% were on government insurance, 73.75% were using an internal pharmacy, and the mean distance traveled to pharmacy was 17.06 miles (SD±22.66). Thirty-five patients (43.75%) were adherent (mean PDC = 78%, range, 17-100%). Patients who went to an internal pharmacy were 1.81 times likely to be adherent than those who went to an external pharmacy [OR: 1.81, 95% CI (0.64- 5.11)]. We found that males were 1.21 times more likely to be adherent than females [OR: 1.21, 95% CI (0.50- 2.93)] and smokers were 2.21 times more likely to be adherent than non-smokers [OR: 2.21, 95% CI (0.63-7.78)]. Multiple chronic conditions were significantly associated with a decrease in OC adherence, even after controlling for covariates [OR: 0.66, 95% CI (0.66- 0.95); p = 0.02]. Conclusions: Patients with fewer comorbidities receiving OC from specialty pharmacies were significantly more adherent than those with multiple comorbidities. Further studies examining the impact financial toxicity has on adherence for patients with chronic conditions are warranted.