bluuebunny/crossref_metadata_2025_split huggingface dataset:
Predictors of delays in initiation of oral tyrosine kinase inhibitors (TKIs) in EGFR and ALK positive advanced non-small cell lung cancer (NSCLC).
Authors: Goulart Bernardo H. L. , Chennupati Shasank , Egan Kathryn , Fedorenko Catherine R. , Ramsey Scott David 
Published: October 2019

134 Background: Molecular testing practices and cost-sharing policies may result in delayed initiation of TKI therapy. We assessed predictors of delayed initiation of TKIs in metastatic EGFR+ or ALK+ NSCLC. Methods: We identified patients with EGFR+ and ALK+ NSCLC diagnosed between 01/01/2010 and 12/31/2016 in the Washington State SEER registry using validated natural language processing methods. We linked registry records to commercial and Medicare (including part D) claims. Eligible patients had stage IV NSCLC, sensitizing EGFR mutations or ALK+ by FISH, ≥ 1 pharmacy claims for EGFR or ALK TKIs, and ≥12 months of insurance enrollment post-diagnosis. Potential predictors included age, sex, race, Census-level median household income, urban status, insurance type, comorbidity, histology, mutation type, and receipt of chemotherapy prior to first TKI claim (pre-TKI chemo). We defined time to TKI initiation as the interval from diagnosis to first pharmacy claim for EGFR or ALK TKIs. We fitted Cox regression models to identify predictors of delays in TKI initiation, defining covariates with a P < 0.05 in a final multivariate model as independently associated with delays. Results: For 122 patients (median age 70; 65% female; 74% White; median income $66,580; 98% metropolitan; 35% Medicare; 80% EGFR+; 12% using pre-TKI chemo), the median time to TKI initiation was 6.7 weeks (IQR = 3.9 to 14.0). Independent predictors of TKI delays included male sex (HR = 0.51; 95%CI = 0.34; 0.76); Medicare insurance (HR = 0.32; 95% CI = 0.20; 0.53) and pre-TKI chemo (HR = 0.37; 95% CI = 0.20; 0.66). Median time to TKI initiation was 9.7 vs. 5.8; 7.8 vs. 4.1; and 16.0 vs. 6.3 weeks in male vs. female, Medicare vs. commercial insurance, and pre-TKI chemo (yes vs no), respectively. Conclusions: Male sex, Medicare insurance, and chemotherapy prior to TKI are associated with delays in TKI initiation for EGFR+ and ALK+ stage IV NSCLC patients. Possible explanations include higher prevalence of smoking in males resulting in lower priority for molecular testing, high cost-sharing policies for TKIs in Medicare patients, and prolonged time to obtain molecular test results leading patients to start chemotherapy first.
Geographic distribution of clinical trials for breast cancer across the United States, 2011-2015.
Authors: Malapati Sindhu Janarthanam , Singh Sunny R K , Kumar Rohit , Ahmed Jibran , Katiyar Vatsala , Vohra Ishaan 
Published: October 2019

140 Background: Access to clinical trials is paramount for delivery of high quality cancer care. We aim to study the geographical distribution of phase 3 & 4 clinical trials for females with breast cancer across 51 states between 2011 & 2015. Methods: We searched Clinicaltrials.gov registry for phase 3 & 4 clinical trials in US for females with breast cancer & those first posted from 01/01/2011 to 12/31/2015. New cases of female breast cancer from 2011 to 2015 were estimated with U.S. Cancer Statistics Data Visualizations Tool (www.cdc.gov/cancer/dataviz). Results: We found 88 phase 3 & 4 clinical trials over 51 states. The average number (no.) of new cancer cases and no. of trials per state were 22,985 and 34.4 (range: 16 - 57) respectively. On average, each state had 0.003 (SD: 0.002) trials per case. States with maximum number of cases and trials were California, New York, Texas and Florida. These accounted for 30.7% of total cases, but only 12.5% of total trials. Also, these four states had the lowest no. of clinical trials per case while District of Columbia had the highest (0.0123). The states with the lowest no. of clinical trials included Rhode Island, Vermont, Wyoming & Alaska (3.7% of total trials). Table with data regarding states with lowest and highest cancer burden is attached. Conclusions: For breast cancer in females during the years 2011 to 2015, the ratio of available phase 3 & 4 clinical trials to new cancer cases was quite low when examined state-wise. The gap widened as the cancer burden increased resulting in the lowest no. of clinical trials per case in the states with maximum cancer burden. This highlights the need of better allocation of resources and efforts across the nation when conducting clinical trials. [Table: see text]
Mortality disparities in insured patients with cancer.
Authors: Cooper Robert Michael , Chung Joanie , Schottinger Joanne E. , Haque Reina 
Published: October 2019

150 Background: We examined mortality related to socioeconomic status (SES) in an insured Southern California population diagnosed with cancer and how healthcare settings can affect these differences. Methods: We identified adults diagnosed with the eight most common cancers from 2009-2014 from the California Cancer Registry and followed them through 2017. We calculated person-year mortality rates by SES and healthcare system (integrated healthcare system [IHS] or private insurance [PI]). Adjusted hazard ratios for the association between all-cause mortality and SES were estimated using Cox proportional hazards models accounting for covariates (race/ethnicity, demographics, stage, treatments). Results: The cohort was followed a maximum of 8 years. A total of 164,197 adults were diagnosed with cancers of the breast, prostate, lung, colon, melanoma, uterus, kidney and bladder (N=47,039 in IHS and N=117,158 in PI). In the whole cohort, we found an increased mortality risk between the highest and each of the lower SES quintiles. Specifically, the adjusted mortality risk was 16 to 37% greater in the lower SES groups as compared to the highest. We then examined the mortality in the IHS and PI groups separately. Overall mortality for all cancers combined was slightly lower in the IHS group (74.7/1,000 PY) than in the PI group (87.8/1,000 PY). In multivariable models, mortality risk was 6% to 16% greater in the lower SES groups versus the highest SES in the IHS population, while the risk was 19% to 45% greater in the lower SES groups in the PI population. Conclusions: Even among insured patients, and after multivariable adjustment, we found disparities in mortality in the lower SES groups. However, the magnitude of these differences was lower in patients cared for in IHS than those with PI. Preliminary data suggest that IHS may be well positioned to reduce disparity gaps in cancer outcomes. [Table: see text]
Identifying the gap in goals of care communication across care settings in a flagship cancer research and treatment facility.
Authors: Bhatnagar Mamta , Ormond Ellen , Bhosale Swati , Felice Rebecca , Chu Edward 
Published: October 2019

180 Background: There is widespread recognition of the importance of having and documenting timely Goals of Care (GOC) conversations with seriously ill patients. Inpatient oncology teams at UPMC have noted the limited availability in the Electronic Medical Record (EMR) of documentation of patient preferences about end of life care. This project aims to identify the gaps in GOC communication across care settings for cancer patients at UPMC. Methods: We identified sources of information regarding goals of care available to inpatient oncology providers. Using the EMR we accessed the following for each patient of interest: CPR status, GOC documentation, scanned Advance Directives and/or POLST and last two available outpatient notes. Patients of interests were older than 65 years with metastatic cancer and 2 hospital admissions in the past year, or any cancer patient > 90 years. We reviewed outpatient notes for words suggesting that GOC conversations had occurred, and for a subset (50%), we did a detailed review identifying documentation of prognosis, treatment options, treatment decisions and patient values. Results: Of a total 114 high risk patients admitted over a 6-month period, 73 (64%) died within 6 months, with 52 (46%) dying within one month of their last hospitalization. Thirty nine (34%) patients had at least 5 admissions. Only 35% patients had GOC documented using the EMR template, and only 38% had a completed POLST. Rates of CPR status completion were high (95%). However, when tracking CPR status across multiple admissions, 73% of patients were full code on their first admission, with 31% of patients with five admissions remaining full code. The qualitative analysis of outpatient notes revealed that most documentation (87%) reflected continued treatment with minimal discussion of hospice or patient values. Conclusions: In a cohort of patients with advanced cancer, documentation of GOC discussions is limited in both inpatient and outpatient settings. Available documentation suggests minimal discussion of the limited benefits of medical interventions to prolong life. Future efforts will be designed to improve the quality and frequency of documentation of GOC conversations.
Adherence to clinical practice guidelines for the prevention of acute chemotherapy-induced nausea and vomiting in children, adolescents, and young adults with cancer receiving their first cycle of highly emetogenic chemotherapy.
Authors: Beauchemin Melissa , Weng Chunhua , Dupuis L. Lee , Sung Lillian , Hershman Dawn L. , Schnall Rebecca B. 
Published: October 2019

19 Background: Prescribing guideline-recommended anti-emetics for the prevention of chemotherapy-induced nausea and vomiting (CINV) is an effective strategy to prevent a common treatment-related adverse effect in children, adolescents and young adults (AYAs) with cancer that impacts quality of life. The rate of guideline-concordant care (GCC) is not well-understood. Methods: Using electronic health record data Columbia University Irving Medical Center from a 3-year period, we conducted a retrospective single-institution cohort study to investigate how often children and AYAs (age 26 or less) receive GCC to prevent CINV prior to the first administration of highly-emetogenic chemotherapy. We defined GCC from the Pediatric Oncology Group of Ontario guideline for patients < 18 years and the American Society of Clinical Oncology guideline for those ≥ 18 years. Independent variables included: sex, age, insurance status, race, ethnicity, cancer type, chemotherapy regimen, clinical setting (adult or pediatric oncology), and patient location (inpatient or outpatient). Predictors of GCC were determined using multiple logistic regression. Results: Of 91 included patients, 39 (43%) received GCC. Those treated in adult oncology setting (OR 7.5, 95% CI: 2.7–20.7), receiving cisplatin-based chemotherapy (OR 3.5, CI: 1.4–8.5), or with commercial insurance (OR 2.7, CI: 1.1–6.3) were more likely to receive GCC. In multivariable analysis, patients treated in adult oncology had 6.4 higher odds (CI: 2.1–19.1, p<.001) and those receiving cisplatin 4.6 higher odds (1.6–13, p<.01) of GCC. Conclusions: Clinical setting and chemotherapy regimen independently predicted GCC for prevention of CINV in children and AYAs receiving highly-emetogenic chemotherapy. These findings can inform current efforts to optimize implementation strategies for supportive care guidelines by focusing on specific provider- and patient-level factors.
The effect of clinical pathways utilization on total cost of care for the treatment of prostate cancer.
Authors: Sereday Karen Ann , Boulware David C. , Kailasam Vasanth , Shi JuQing , Blazevich Diane L. , Burkett Jason M. , Stewart Sandra C. , Pow-Sang Julio M. , Johnstone Peter Anthony , Rollison Dana Elise , Fields Karen K. 
Published: October 2019

20 Background: Moffitt Cancer Center (MCC) has developed evidence-based cancer care pathways which are integrated into the Electronic Health Record (EHR). We retrospectively compared the 1 year (yr) total cost of care in patients (pts) with newly diagnosed prostate cancer (PCA) treated at MCC based on EHR tool utilization and pathway alignment. Methods: Using existing Cancer Registry data, we retrospectively identified all pts presenting with newly diagnosed PCA between 7/1/2015-6/30/2017 who received all 1st course treatment (tx) at MCC. Pts direct costs were tracked for 1 yr from the Cancer Registry “date of 1st contact.” Tx was categorized as either radiation (RT) +/- hormone tx (HT), surgery (S) +/- HT, active surveillance only (ASO), HT only, palliative care, chemotherapy (CT), or mixed (a combination of S, RT, or CT). Pathway alignment was either electronically tracked through the EHR pathway tool or determined through manual chart review for pts tx’ed off the pathway tool. Results: 477 pts met inclusion criteria, including men with: low or favorable intermediate (n=259); unfavorable intermediate, high, or very high (n=186); and metastatic (n=32) risk group PCA. The majority (n=396, 83%) had tx in alignment with a pathway. The major tx modalities on pathway were S-HT (n=139), RT-HT (n=113), or ASO (n=110) and off pathway were RT-HT (n=52, 64%), S-HT (n=10), or ASO (n=9). Overall, treatment in alignment with a pathway was significantly associated with lower 1 yr total cost compared to off pathway tx (p <0.001) with a mean difference of $5,500 per pt yr. Conclusions: Clinical pathway alignment was significantly associated with less aggressive therapy and lower 1 yr cost of care for PCA pts treated at MCC. Cost of care was highly associated with tx modality selected. Further analyses are needed to understand the association between pathway alignment, patient risk factors and tx modality selection.
Understanding palbociclib practice patterns in a real-world setting.
Authors: Rocque Gabrielle Betty , Blum Joanne Lorraine , Montero Aldemar , Wilks Sharon , Anderson Daniel M. , Salkeni Mohamad Adham , Diab Sami , Migas John J. , Nakhoul Ibrahim , Spell Derrick W. , Sleckman Bethany G. , Cappelleri Joseph C , Wang Yao , Tripathy Debu 
Published: October 2019

200 Background: Real-world practice patterns often differ from treatment in clinical trials. We assessed real-world standard-of-care treatment with palbociclib (PAL) in the context of previously reported PALOMA trial results. Methods: POLARIS is a prospective, observational study of PAL in patients (pts) with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. Baseline demographics, clinical characteristics, initial treatment dose, dose modifications, dose delays, and adverse events (AEs) during the first 6 months (mo) of treatment were analyzed. Results: 412 pts enrolled at 92 US sites had at least 6 mo of PAL treatment; 73% received PAL in the first-line setting and 27% in second or later line. While a majority of pts received the recommended dose of 125 mg/d; 6% and 1% started at 100 mg and 75 mg, respectively. Physician-reported reasons for choosing a lower dose were: comorbidities (31%), pt age (21%), past treatment (10%), patient preference (3%), and other (34%). Selected pt and clinical characteristics, dosing, and treatment outcomes in POLARIS and in PALOMA-2 are shown in Table. Conclusions: In a real-world data set of 6 mo of PAL treatment, most pts started at the recommended dose, with tolerability and safety outcomes consistent with those reported in clinical trials. Differing populations, treatment patterns, and outcome reporting in real world vs trial settings underscore the need to study real-world practices and outcomes. Clinical trial information: NCT03280303 [Table: see text]
Challenges in implementing a mobile-based patient-reported outcome (PRO) tool for cancer patients.
Authors: Yocavitch Liana , Binder Adam , Leader Amy , Garber Gregory D. , Chapman Andrew E. , Handley Nathan 
Published: October 2019

206 Background: Electronic patient reported outcomes (ePROs) can bridge the communication gap with a patient’s care, providing insight into patients’ symptoms between clinical visits and improving both symptom management and overall survival. PROs are typically monitored through standardized questionnaires given to patients at specific times during their treatment. We endeavored to implement a mobile application-based ePRO tool at an urban academic cancer center. Methods: During an 8-week period, cancer patients on active intravenous chemotherapy were approached for enrollment during their infusion appointment. English-speaking patients with a smartphone and an active email address were eligible to download the app and enroll in the program. Two patient coordinators enrolled patients and demonstrated the use of the ePRO tool. Barriers to enrollment were tracked; subsequent utilization by enrolled patients was assessed. Results: 108 patients (63% White, 22% African American, 7% Asian, 2% Hispanic, 6% unknown; mean age 65 years) were approached for enrollment. Among those, 32 (30%) were ineligible. The most common reasons for ineligibility were the lack of a smart phone or active email address. 76 patients (70%) were eligible for enrollment. Of the 76 patients, 19 (25%) declined, 20 (26 %) were unable to complete registration due to technical barriers, and 37 patients (49 %) successfully registered. Of registered patients, 19 (25%) utilized the ePRO tool on at least one occasion. Patients who utilized the ePRO tool tended to be younger, female, and white. Conclusions: A mobile application-based ePRO presented several challenges to implementation in our patient population. Nearly 50% of patients were either ineligible or experienced technical issues that precluded enrollment. Successful ePRO implementation may benefit from a variety of mechanisms by which to collect data, such desktop-based, text-based, and or telephonic-based approaches. Ongoing iterations are in process at our institution.
Influence of timing of goals of care discussion on hospitalization outcomes in metastatic cancer patients.
Authors: Emiloju Oluwadunni , Ford Jean G , Djibo Djeneba Audrey 
Published: October 2019

219 Background: Cancer patients often require acute hospitalizations, and these hospitalizations have been shown to increase in frequency near the end of life. The American College of Physicians recommends that goals of care (GOC) discussions be initiated early for metastatic cancers. Discussing GOC during hospitalization can help reduce readmissions and improve patient satisfaction, by helping to ensure that patients receive goal-congruent care. We aim to examine the association between the timing of GOC discussion and the patient's length of stay and the time to hospital readmission. Methods: We conducted a retrospective review of medical records of patients with stage IV solid tumors who were hospitalized acutely between August 2017 and July 2018. We assessed demographics, timing of GOC discussion, use of palliative care services and hospital readmissions within 90 days. Chi-square tests were used to identify independent associations with having a GOC discussion; and anova was used for continuous variables. We used logistic regression to examine the association with a hospital readmission within 90 days, controlling for potential confounders. Results: The subjects were 26-92 years old and 40.6% were female. Only 46% (n = 112) of patients had a GOC discussion. Age, tumor site, and presenting complaint were not independently associated with having a GOC discussion (p > 0.05). Overall, 34% (n = 82) had a palliative care encounter. Having a palliative care consult and being admitted to critical care were independently associated with having a GOC discussion. Early timing of GOC discussion was inversely associated with admission to critical care units (p < 0.05). Length of stay was positively correlated with having a GOC discussion. Thirty-eight percent (n = 92) had unplanned hospital readmission within 90 days. Having any GOC discussion reduced the odds of an unplanned hospital readmission within 90 days by 79% [OR = 0.21, 95% confidence interval 0.12-0.37]. Conclusions: Among hospitalized patients with stage IV cancer, performing an early GOC discussion is associated with better hospitalization outcomes. It is therefore important to perform GOC discussion early when such patients are acutely hospitalized.
Navigating specialty pharmacies to get oral agents to patients in a timely manner.
Authors: Dorff Tanya B. , Mendelsohn Mary , Christian Amis , Kim Hoim 
Published: October 2019

220 Background: Increasing numbers of oncology patients require oral therapies provided by specialty pharmacies. Our experience indicates patients receiving care in a facility without specialty pharmacy dispensing capabilities are at a disadvantage in receiving their medications in a timely manner. Methods: Metastatic prostate patients receiving oral hormonal therapies were identified for chart review. Findings indicated the median time to medication receipt by the patient was 25 days. Interviews with the team, staff and patients revealed that multiple factors contributed to the delays. Patient expectations were to receive prescribed agents within 7 days. Review of our Community Clinics, who employ a centralized process and have relationships with specialty pharmacies, indicated that medications were received by patients within a week. Successful interventions necessitated the patient partnering with the healthcare team to improve efficiencies and reduce time to drug delivery. Results: Delays were multifactorial and extremely difficult to ascertain from chart review. Reasons for delay were clearly noted in 19 out of 97 patient records out of which over 47% charts indicated the pre-approval process as the cause for the delay. Patients were educated regarding the specialty pharmacy process, the name of the prescribed drug and the pharmacy where the prescription was sent. The patient education sheet encouraged patients to become partners in the process and advised them to check with their insurance for their approved specialty pharmacy. If the approved pharmacy varied from the pharmacy initially chosen, patients were asked to notify the clinic staff to initiate a new prescription to the correct pharmacy. Patient response to the education sheet has been positive. Impact on median time to delivery is not yet known. Conclusions: Streamlining the authorization process of specialty pharmacies would benefit oncology patients, as we identified that most delays occur in specialty pharmacy processing. Healthcare facilities may consider increasing patient education or obtaining a specialty pharmacy dispensing license in order to minimize delays for oncology patients receiving oral oncology medications.