bluuebunny/crossref_metadata_2025_split huggingface dataset:
Biomarker testing, treatment (Tx) and survival outcomes in Medicaid compared to commercially insured (CI) patients with advanced NSCLC (aNSCLC).
Authors: Yim Yeun Mi , Wu Ning , Wong William Bruce 
Published: May 2019

e18119 Background: Prior studies suggest cancer patients with Medicaid may have worse outcomes, however there is limited understanding on the drivers behind these observations. This study aimed to describe the association between insurance type with Tx patterns, biomarker testing, and survival outcomes in a real-world aNSCLC population. Methods: The Flatiron Health EHR-derived database was used to identify patients < 65 years of age diagnosed with aNSCLC between 1/1/2011 to 10/31/2018. Logistic regression was used to assess the association between insurance type and (1) the likelihood of receiving first-line Tx of cancer immunotherapy (CIT)/other targeted therapy, or no Tx, and (2) the likelihood of receiving EGFR/ALK testing. Median OS, estimated by Kaplan Meier, was compared between patients with CI and Medicaid coverage, and hazard ratios were derived from Cox proportional hazard models adjusting for baseline characteristics. Results: 6639 aNSCLC patients were identified with CI (n = 6022) and Medicaid (n = 617). After adjusting for baseline characteristics, Medicaid patients were less likely to receive ALK or EGFR testing [OR 0.59, 95% CI (0.49, 0.72)]. Medicaid patients were also less likely to receive CIT or targeted therapy [OR 0.49, 95% CI (0.36,0.67)] and more likely to not receive any systemic Tx [OR 1.45, 95% CI (1.22, 1.73)]. Medicaid patients had a higher risk of death than commercially insured patients, however this difference varied by Tx group (table). Conclusions: Medicaid insured patients were associated with a higher risk of mortality compared to CI patients. Factors influencing this difference may be access to biomarker testing, subsequent receipt of CIT/targeted therapy and differences in care among untreated patients. [Table: see text]
Lower survival outcomes in patients receiving an initial cancer diagnosis after presenting to the emergency department.
Authors: Conley Hannah L. , Delgado Raven V. , McCallen Justin D. , Harris Eleanor Elizabeth , Ju Andrew Wenhua , Rathbun Kimberly 
Published: May 2019

e18122 Background: Survival outcomes in cancer are better in patients who are diagnosed at an early stage, which can potentially be detected through screening and routine visits to a primary care physician. Patients who receive their initial cancer diagnoses following a visit to the Emergency Department (ED) may present at a later Stage when survival outcomes are worse. The characteristics of patients who receive their diagnosis following an ED visit versus those who do not are not well reported in the literature. Methods: A retrospective review was conducted in which a cohort was identified of all patients who presented to the ED in a hospital system in eastern North Carolina from 10/1/2014 to 9/30/2015 with a visit associated with an oncologic ICD-9 code. The chart was reviewed to determine if the initial results that directly led to the cancer diagnosis were obtained through the ED visit. Patient characteristics, cancer characteristics, and survival outcomes were collected. Factors significant on univariate analysis were included in a multivariate analysis. Chi-square tests, Kaplan-Meier log rank tests, and Cox regression analysis were used. Results: Initial diagnosis through the ED was recorded in 38.5% of patients (n = 400/1039). Median overall survival following diagnosis was lower in individuals diagnosed through the ED (13 vs. 41 months, p < 0.001), in men (21 vs. 35 months, p < 0.001), and in patients with a Charlson Comorbidity Index (CCI) of ≥9 (18 vs. 37 months, p < 0.001) on univariate analysis. Patients diagnosed through the ED were more likely to be Stage IV (p < 0.001). There was no association on multivariate analysis between the rate of diagnosis through the ED or overall survival with insurance status or race; however, it was difficult to determine the insurance status of a patient at the time of the initial ED visit, possibly due to retroactive coverage and other issues. Conclusions: Patients who received a cancer diagnosis through the ED have significantly shorter overall survival times from diagnosis. This remained significant when controlling for CCI, gender, age, and Stage. Further investigation into the public health factors that may contribute to patients receiving their cancer diagnosis in the ED is needed. A prospective study may be needed to record the insurance status at the initial ED visit.
Prescription patterns and associated cost during periods of cancer drug stockouts in a resource-limited setting.
Authors: Davey Sonya , Grover Surbhi , Setlhako Dipho Irene I , Ralefala Tlotlo Bathethi , Manshimba Patrick , Gross Robert , DeMichele Angela , Shulman Lawrence N. , Martei Yehoda M. , Bilker Warren B. 
Published: May 2019

e18129 Background: Cancer drug stockouts occur at high frequencies globally, however their clinical effects are understudied in sub-Saharan Africa (SSA). We aim to describe prescription patterns and cost of systemic chemotherapy in cancer patients in Botswana during periods of stockout. Methods: Using a retrospective cohort study of the ten most common solid tumor malignancies treated with systemic chemotherapy at Princess Marina Hospital (PMH), Gaborone in 2016, we conducted a subset analysis of suboptimal events, defined as a cycle with ≥ 7 days delay or therapy switch from initiated guideline regimen, that occurred during drug stockout vs non-stockout periods. We estimated financial cost of therapy per cycle using Management Sciences for Health International Price Indicator Guide. Chi-squared and Wilcoxon rank sum were used for comparisons. Results: 167/378 patients contributed to 320 suboptimal events. 63% (201/320) of events occurred during a drug stockout, of which 43%, 43% and 14% were delays, switches, or both, respectively. There were significantly more delays (56% vs 44%, p < .0001) and switches (75% vs 26%, p < .0001) during stockout periods vs no stockout. The majority of switches during drug stockouts occurred in breast cancer patients receiving curative therapy: 48% (20/42) were “paclitaxel + trastuzumab” ($4673) to “paclitaxel alone” ($35) in HER2 positive patients resulting in a 99% cost decrease; and 29% (12/42) were paclitaxel ($35) to docetaxel ($108) resulting in a 209% cost increase per cycle switched. Colon cancer patients receiving palliative-intent therapy were the second most frequent patients with therapy switches during stockout periods: 42% (8/19) were “capecitabine + oxaliplatin” ($259) to “capecitabine alone” ($105) resulting in a 59% cost decrease. Conclusions: Breast cancer patients form the majority of patients treated with systemic chemotherapy at PMH and experienced the most delays and switches in therapy during drug stockout periods. Changes in drug prescription patterns during stockout periods may be associated with switches leading to inferior but less costly regimens, and in some cases costly regimens with higher toxicity. Interventions that minimize cancer drug stockouts are imperative and further studies to understand impact of stockout on survival are needed in SSA.
Participation of African Americans in clinical trials supporting FDA approval of cancer drugs.
Authors: Al Hadidi Samer , Mims Martha P. , Miller-Chism Courtney Nicole , Kamble Rammurti T. 
Published: May 2019

e18135 Background: African Americans comprise 12% of the total United States population. Lifetime probability of developing cancer in African Americans is 37.55%. The 5-year relative survival rate is 68% in Caucasians and 61% in African Americans for all cancers combined. Concerns exist that African Americans are underrepresented in trials of cancer medications. We sought to examine African Americans participation for pivotal cancer medications trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications. Methods: On the basis of publicly available FDA reviews, the authors assessed enrollment of African Americans in trials supporting 75 drug approvals from 2014 to 2018. Prevalence-corrected estimates for the participation of African Americans were calculated as the percentage of African Americans among trial participants divided by the percentage of African Americans in the disease population (participation to prevalence ratio [PPR]), with a range between 0.8 and 1.2 reflecting similar representation of African Americans in the trial and disease population. Results: A total of 61763 patients enrolled in clinical trials, which resulted in subsequent FDA approval. The proportion of African Americans enrolled in the clinical trials that led to cancer medication approval in the 5-year period was 7.44%. The calculated PPR for participation of African Americans in clinical trials that led to drug approval for all cancers combined was 0.31. The results were consistent across major cancer subtypes including breast cancer (PPR of 0.29), prostate cancer (PPR of 0.18), and lung cancer (PPR of 0.15). Skin cancer, colorectal cancers and hematological malignancies results were also consistent with low PPR. Conclusions: African Americans were under represented in trials of drugs for all cancer types combined. Efforts should be made to increase the proportion of participation of African Americans in clinical trials.
Expanded access for cancer patients: The 5-year FDA CBER experience.
Authors: Colbert Laronna S. , Bross Peter F. , Liu Ke 
Published: May 2019

e18158 Background: Expanded access (EA) refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s disease rather than to generate scientific data that is generally derived from clinical trials. FDA has long facilitated expanded access to investigational drugs for patients with serious or immediately life-threatening diseases and who lack therapeutic alternatives. EA requests include single-patient use protocols under existing INDs, single-patient investigational new drug applications (INDs or SPIs), and intermediate-size or treatment protocols/INDs. Methods: We searched the Center for Biologics Evaluation and Research (CBER) internal databases and reviewed all EA requests for cancer patients to receive investigational products regulated by CBER's Office of Tissues and Advanced Therapies (OTAT) from 2014-2018. These products included cellular and gene therapies, cancer vaccines and microbe-based therapies. Results: From 2014-2018, OTAT received 395 EA requests for solid tumor (ST) or hematologic malignancies (HM). One-hundred ninety-seven (197) requests were for individuals who could not be enrolled in an ongoing oncology clinical trial to receive an investigational agent (single-patient use protocols). Of 197 requests, 7 (3%) were either withdrawn or canceled by the treating physicians (sponsors). The remaining 190 (100%) were approved. One hundred seventy-three (173) EA requests, 102 for ST and 71 for HM, came from sponsors to make available to patients an investigational agent for which there were no ongoing clinical trials (SPIs). Of 173 requests, 45 (26%) were withdrawn or cancelled by the sponsors. Of the remaining 128, 127 (99%) were approved. One request was denied. Twenty-five of 395 EA requests were for intermediate-size or treatment protocols/INDs. Conclusions: From 2014-2018 there has been an increase in oncology EA requests for products regulated by CBER/OTAT, which pose unique challenges for evaluating their risks and benefits. Despite the complexities of these novel biological products, nearly all EA requests were approved.
Reassessing existing expanded access programs and planning forward in the time of Right to Try.
Authors: Cropp Anne , Hassan Alita , Alummootil Sarah 
Published: May 2019

e18172 Background: Desperately ill patients who have exhausted treatment options often seek access to therapy through investigational therapies. Participation in a clinical trial may be one option. When a clinical trial is not an option, physicians and patients are left with Expanded Access (EA), and Right to Try (RTT). The 21st Century Cures legislation requires pharmaceutical manufacturers to make information on their EA policy, contact information, and response time readily accessible. RTT became law in 2018, and this path is rarely an option. Methods: To determine best practice in the age of changing legislation of pre-approval access to investigational drugs, we compared pathways by which pharmaceutical companies are providing access to investigational medications. Data has been gathered on presentation of policy, intake of expanded access requests, and education to the public on the company’s internal pathway to access. We conducted a survey of the top 100 Pharma companies to assess compliance with regulations, policy availability, and RTT information. Results: The data has shown that companies show a range of compliance in expanded access. Many companies have published all required aspects outlined in the legislation to be fully adherent to the guidelines with additional education and guidelines for patients and physicians. Others have provided the minimum requirement to be compliant: a policy and contact information. We also see companies that have not established a stance of process in expanded access and therefore provide no public facing information on their policy and pathways toward treatment. Information on RTT remained elusive. Conclusions: While RTT is increasingly requested as a possible path, the mechanism to request RTT remains a barrier and source of confusion to physicians and patients. Companies should take the opportunity to clearly define their policy and process for Expanded Access as well as reevaluate the organization of their current procedure to ensure highest efficiency and full compliance with legislation.
Racial and socioeconomic disparities in follicular lymphoma survival.
Authors: Sheppard Richard Stephen , Adekunle Adewumi , Beale Stefani , Ahluwalia Meena 
Published: May 2019

e18173 Background: Follicular Lymphoma (FL) is a the second most common Non Hodgkin's Lymphoma (NHL) diagnosed in the United States with 2.6 per 100,000 men and women per year from 2011 to 2015 when age adjusted as per the National Cancer Institute with the number of deaths of 0.5 per 100,000 men and women per year. It known that FL is one of the most clinically indolent NHL and due to this, survival rates are generally more favorable when compared to other B Cell Lymphomas. With this study, we aim to analyse socioeconomic and racial disparities in the survival rates for FL. Methods: The authors identified patients diagnosed with FL between 1973 and 2015 using the Surveillance, Epidemiology, and End Results (SEER) database. Overall survival was estimated and compared between racial/ethnic groups using the log-rank test. Our outcome variables were 1-year, 5-year and mortality. Our independent variables were race and socioeconomic status. We controlled for age, demographic characteristics, time of diagnosis, pathological classification, treatment and socioeconomic status. Results: A total of 66 127 patients were identified; 90% of the patients were White, 4% Black, and 4% Asian. We noted significant differences in disease presentation, socioeconomic status, and outcomes. Asian/Pacific Islander had the lowest survival with a mean of 228 survival months, Blacks had a mean survival months of 237, and Whites had a mean survival months of 234. Conclusions: Disparities exist in the care and outcomes of FL. A low socioeconomic status is correlated with decreased survival.
Risk of neutropenia-related hospitalization (NRH) related to duration of short-acting granulocyte colony stimulating factor (sG-CSF) for primary prophylaxis.
Authors: Li Shuling , Liu Jiannong , Gong Tingting , Guo Haifeng , Gawade Prasad L. , Kelsh Michael Anthony , Bradbury Brian D. , Belani Rajesh , Lyman Gary H. 
Published: May 2019

e18181 Background: In clinical trials, efficacy of 1011 days of primary prophylactic (PP) sG-CSF is similar to a single dose of pegfilgrastim for preventing febrile neutropenia (FN). However, most patients receive < 10 days of PP sG-CSF in clinical practice. This study assessed the effect of PP sG-CSF duration on the risk of NRH. Methods: Using Medicare 20% sample data, we conducted a nested case-control study within a cohort of patients aged ≥66 y with breast, colorectal, lung, ovarian, or prostate cancer or NHL who initiated first cycle of chemotherapy 1/1/20089/30/2016, had ≥1 y continuous coverage in Medicare parts A and B before cycle day 1 (baseline), and received PP sG-CSF. We identified NRH cases (ICD-9, 288.0X; ICD-10, D70.X) from cycle day 5 to end of cycle 1. We matched each case to up to 4 controls based on age (± 1 y), tumor type, regimen risk for FN (intermediate/high [ > 10%], other), and year using incidence density sampling. Duration of sG-CSF (days of use from cycle day 1 to the day before case date) was categorized as < 5 and ≥5 days. We used conditional logistic regression adjusted for race, sex, and Charlson comorbidity index (CCI) at baseline to estimate relative risk of NRH related to duration of sG-CSF. Results: Of 1431 patients receiving PP sG-CSF, 68 cases matched 231 controls. Cases were similar to controls in age (76 vs 75 y), tumor type (NHL, 62% vs 62%; lung cancer, 25% vs 25%), intermediate-/high-risk regimen (65% vs 67%), and male sex (50% vs 48%) but had slightly higher CCI (3.9 vs 3.3). The percentage of patients with ≥5 days of PP sG-CSF use was 26% in cases and 41% in controls. The adjusted OR (95% CI) for NRH was 0.48 (0.250.93) for ≥5 vs < 5 days of PP sG-CSF; results were consistent across sensitivity analyses (Table). Conclusions: Among elderly cancer patients receiving PP sG-CSF, ≥5 days of sG-CSF use was associated with substantial reduction in the risk of NRH.[Table: see text]
Upper extremity deep venous thrombosis in 10 common malignancies: Analysis of incidence, risk factors, and effect on mortality from the California Cancer Registry.
Authors: Poh Christina , Brunson Ann , Mahajan Anjlee , Keegan Theresa , Wun Ted 
Published: May 2019

e18190 Background: Upper extremity deep venous thrombosis (UE DVT) is a known complication in patients with cancer. However, the cumulative incidence by cancer type, risk factors associated with UE DVT and impact on survival is not well-described. Methods: Using the California Cancer Registry , we identified patients with 10 common malignancies (2005-2014) and linked this to the California hospitalization and emergency department databases to find patients with an incident UE DVT event using specific ICD-9-CM codes. We determined cumulative incidence of UE DVT adjusted for the competing risk of death. Using Cox proportional hazards regression, stratified by tumor type and adjusted for other prognostic covariates including central venous catheters (CVC), we identified risk factors for developing UE DVT and the impact of UE DVT on overall survival. Patients with venous thromboembolism prior to malignancy diagnosis were excluded. Results: Among 785,444 patients with malignancy, 6,099 (0.8%) had an incident UE DVT. The 24-month cumulative incidence of UE DVT varied by cancer type (Table). Most UE DVT (62.2%) occurred in patients with CVC. VTE after cancer diagnosis and CVC substantially increased the risk for UE DVT across all cancers. UE DVT was also associated with worse overall survival for all malignancies with hazard ratios ranging from 1.52 to 3.72. Conclusions: UE DVT is a rare but important complication among patients with malignancy, with incidence highest in leukemia and lowest in prostate cancer. Although uncommon, UE DVT may affect prognosis in patients with malignancy as it is associated with an increased hazard of death. Table: 24-month cumulative incidence of UE DVT, adjusted for the competing risk of death, in 10 common malignancies among California cancer patients, 2005-2014. [Table: see text]
Factors associated with receipt and overall survival of concurrent chemoradiotherapy versus single modality therapy in unresectable stage III NSCLC.
Authors: Gomez Jorge E. , Ryan Kellie , Bobbili Priyanka J. , Dua Akanksha , DerSarkissian Maral , Duh Mei Sheng 
Published: May 2019

e18191 Background: While concurrent chemoradiotherapy (cCRT) is standard of care for patients (pts) with unresectable stage III non-small cell lung cancer (NSCLC), some pts receive single modality therapy. This study identified predictors of therapy and differences in overall survival (OS) in a Medicare population. Methods: This retrospective study used Surveillance, Epidemiology and End Results -Medicare data (2009-2014). Stage III NSCLC pts aged ≥65 yrs, with ≥1 claim for systemic therapy or radiotherapy (RT) within 90 days of diagnosis were included. cCRT pts had overlapping claims for chemotherapy and RT ≤90 days from start of therapy; remaining pts were grouped by first therapy received. Sequential CRT patients and those with surgical resection of tumor were excluded from this analysis. Logistic regression was used to analyze predictors of cCRT. Multivariable Cox proportional hazards models were used to compare OS between therapies. Results: Of 4,544 pts identified, 51% received cCRT, 21% systemic therapy, and 27% RT. Across groups, cCRT patients were likely younger (p < 0.001), White (p < 0.001), male (p = 0.015), and with a good predicted performance status (PS) (p < 0.001). After adjustment, several variables were predictive of receiving cCRT (Table). Median OS was 14.7 months (mo) for cCRT vs. 10.9 mo for systemic therapy (adjusted hazard ratio [HR]: 1.36, 95% CI: 1.24-1.49, p < 0.001) vs. 7.8 mo for RT (adjusted HR: 1.55, 95% CI: 1.42-1.69, p < 0.001). Conclusions: Only 51% of pts received cCRT. Age, race, stage, PS and comorbidity index were predictive of cCRT. Given the survival benefit, physicians should be encouraged to pursue cCRT in all eligible pts. Further efforts to develop less morbid therapies are critical in this population. [Table: see text]