bluuebunny/crossref_metadata_2025 huggingface dataset:
Forecasting the global need for high-dose methotrexate to prevent and mitigate shortages.
Authors: Howard Scott C. , Ilbawi Andre Michel , Lewis Brian , Lam Catherine
Published: May 2019

6571

Background: Causes of drug shortages in low-income and middle-income countries are numerous and often more than one cause contributes. Shortages are especially problematic when they involve drugs like high-dose methotrexate (HDMTX), which is required for several highly curable cancers and has no good substitute. Morocco is currently experiencing a national shortage of high-dose methotrexate that has so far lasted several months and has impacted the care of all patients whose protocol includes HDMTX. In this case, a single supplier left the market due to government-imposed pricing that made continued sales increasingly unprofitable. Practicing hematologist/oncologists in Myanmar, the Philippines, Vietnam, and Cambodia also reported shortages that reached patients during 2018. Methods: We created a forecasting model to identify the total annual national need for HDMTX and number of patients based on incidence by age, age distribution, and numbers of doses in typical protocols for osteosarcoma, primary CNS lymphoma, pediatric B-cell NHL, and ALL, curable cancers for which HDMTX is essential. Results: More than 200,000 patients per year need HDMTX (approximately 950,000 doses, see Table). 86% of these live in low- and middle-income countries, where access to inexpensive generic drugs is especially important. Conclusions: This forecasting tool will facilitate national purchasing and negotiating to assure continuous supply of HDMTX. It can be adapted for other drugs, and is especially relevant for low-cost generic drugs, which are disproportionately affected by shortages. [Table: see text]
Investigation of HBOC germline mutations in women diagnosed with breast cancer in Trinidad and Tobago.
Authors: Parkinson Gerneiva , Chagpar Anees B. , Alleyne-Mike Kellie , Nunez-Smith Marcella , Zhou Alicia , Servais Lily , Hofstatter Erin Wysong
Published: May 2019

6574

Background: Trinidad and Tobago (T&T) is the southern-most Caribbean island, and according to the WHO/PAHO, it has the 2nd highest breast cancer mortality rate in the region. Notably, a large proportion of breast cancer cases in T&T occur at a young age; with nearly 36% of them being diagnosed under the age of 50. There is a known association between a younger age at diagnosis and Hereditary Breast and Ovarian Cancer syndrome (HBOC). Yet, the prevalence of HBOC mutations remains unknown in T&T, as genetic counseling and testing services are extremely limited in the region. Therefore, we sought to determine the prevalence and spectrum of HBOC mutations in T&T. Methods: At the National Radiotherapy Center, T&T’s main oncology unit, female breast cancer patients, who met NCCN criteria for further genetic counseling and testing were recruited through chart reviews. After pre-test counseling, enrolled subjects had a detailed interview about their personal breast cancer diagnosis and family history. A saliva sample was collected using an Oragene kit, and analyzed by Color Genomics Inc. for 30 genes associated with hereditary cancers. Finalized results were returned to patients by genetic counselors from Color Genomics. Results: A total of 118 female patients who met NCCN guidelines for HBOC testing received genetic testing. A majority were 50 years of age or younger (69/118, 59%). The cohort was ethnically diverse: 34% African, 15% Asian, 48% multiple ethnicity, and 3% other/unknown. A pathogenic or likely pathogenic variant (positive result) was identified in 21.2% of the cohort (25/118) - most commonly identified in the BRCA1 gene (13/25, 52%), followed by BRCA2 (5/25, 20%), PTEN (2/25, 8%), BRIP1 (1/25, 4%), CHEK2 (1/25, 4%), MSH6 (1/25, 4%), PALB2 (1/25, 4%), and RAD51C (1/25, 4%). Conclusions: We found a strikingly high HBOC germline mutation prevalence rate of 21.2% among a cohort of female breast cancer patients meeting NCCN criteria for HBOC testing in T&T. Given the growing implications of germline HBOC mutations for breast cancer treatment and prevention, our results demonstrate an urgent need for funding, as well as the development of robust genetic counseling and testing services in T&T.
Emergency department visits for prescription and synthetic opioid overdoses among patients with cancer.
Authors: Jairam Vikram , Yang Daniel X. , Yu James B. , Park Henry S.
Published: May 2019

6579

Background: Patients with cancer may be at high risk of opioid dependence due to physical and psychosocial factors, although little data exists to inform providers and policymakers. Our aim is to examine overdoses from prescription and synthetic opiates leading to emergency department (ED) visits among patients with cancer in the United States. Methods: The Healthcare Cost and Utilization Project Nationwide Emergency Department Sample (HCUP-NEDS) was queried for all patient visits with a primary diagnosis of prescription or synthetic opioid overdose between 2006 and 2015. Baseline differences between patients with and without cancer were assessed using chi-square and ANOVA testing. Overdose rates by primary cancer site were normalized using prevalence data from the Surveillance, Epidemiology, and End Results (SEER) Program. Weighted frequencies were used to create national estimates for all data analyses. Results: There were 682,820 weighted ED visits for synthetic opioid overdose, among which 34,547 (5.1%) visits were also associated with a diagnosis of cancer. During this timeframe, ED visits for opioid overdose among patients with cancer increased 2.5-fold, compared to 1.7-fold among those without cancer. 16.5% of patients with cancer had metastatic disease. Patients with cancer presenting for opioid overdose had higher risk of hospital admission (74.8% vs 49.6%), respiratory intubation (13.2% vs 12.2%), mortality (2.1% vs 1.1%), and cost-of-hospital-stay ($32,665 vs $31,824) compared to their non-cancer counterparts (all P < 0.05). Primary cancers with the highest normalized overdose rates (ED visits per 10,000 patients) were esophagus (134), liver & intrahepatic bile duct (124), and cervical cancer (124). Other common cancers had the following normalized overdose rates: lung (105), head and neck (70), and breast (26). Conclusions: Approximately 5% of all ED visits due to prescription and synthetic opioid overdose are among patients with cancer. The rate of increase in ED visits due to opioid overdose from cancer patients was nearly 50% higher than that from non-cancer patients over the 10-year study period. Patients with esophageal, liver, and cervical cancer may be at highest risk.
Is immunotherapy toxicity associated with improved overall survival among older adults with advanced cancer?
Authors: Johns Andrew , Grogan Madison , Hoyd Rebecca , Bridges John F.P , Wei Lai , Patel Sandipkumar , Li Mingjia , Husain Marium , Kendra Kari Lynn , Otterson Gregory Alan , Burkart Jarred Thomas , Rosko Ashley Elizabeth , Andersen Barbara L. , Carbone David Paul , Owen Dwight Hall , Spakowicz Daniel , Presley Carolyn J
Published: May 2019

6580

Background: There is growing evidence that checkpoint inhibitor immunotherapy (IO) toxicity is associated with improved treatment response. There is a paucity of evidence examining the relationship between toxicity and overall survival (OS) in older adults. Methods: We performed a single institution retrospective cohort study of adults who received IO for advanced cancer from 2011-2017. Baseline clinical characteristics were abstracted from the electronic health record. Immune-related toxicities were graded by physicians based on Common Terminology for Adverse Events criteria, v4.0. Bivariate analysis with chi-squared statistics was used to describe baseline characteristics of patients ≥70 years (y) vs. <70y. Survival outcomes were estimated by the Kaplan-Meier method (time zero = start of first-line IO) and compared using the log-rank test. The association of age and ≥ grade 3 toxicity with OS was tested with a Cox proportional hazards model. Results: Among 676 patients treated with IO, 238 (35.4%) were ≥70y. There was no difference in baseline characteristics of each age group except cancer type (P<0.01). The incidence of ≥ grade 3 toxicity did not differ by age (<70y: 14.5% vs. ≥70y: 13.5%, P=0.71). Median OS was significantly longer for adults <70y (16.4 vs. 13.2 months, P<0.01) or those with ≥ grade 3 toxicity (18.3 vs. 14.7 months, P<0.01). When stratified by age and toxicity, patients <70y with ≥ grade 3 toxicity had longer OS vs. those without ≥ grade 3 toxicity (P<0.01). However, there was no OS difference among adults ≥70y with vs. without ≥ grade 3 toxicity (P=0.78). Adjusted hazard ratios with an interaction term are below. Conclusions: Though the incidence of ≥ grade 3 toxicity did not significantly differ by age, there was no significant OS advantage for older adults with ≥ grade 3 toxicity as compared to younger adults. Caution should be used in considering a toxicity-survival relationship in older adults.[Table: see text]
Caveat medicus: Harrowing experiences of clinicians who identify and publish near-fatal oncology associated adverse drug reactions.
Authors: Godwin Ashley Caitlin , Bennett Charles L.
Published: May 2019

6584

Background: Less than 1-10% of adverse drug reactions are reported. It is even more rare to find clinicians who choose to publish these reports in the literature. We identified clinicians who had treated a patient for an oncology-associated serious adverse drug reaction and published these findings. This is the first study that has investigated personal experiences of clinicians choosing to publish information about serious oncology-associated drug reactions they see in their patients. Methods: Clinicians treating individual patients who developed oncology-associated serious adverse drug events were asked to participate. Inclusion criteria included having index patient information, reporting case series, and being collaborative with investigators from two National Institutes of Health funded pharmacovigilance networks. Thirty-minute interviews addressed feedback from pharmaceutical manufacturers, FDA personnel, and academic leadership, and recommendations for improving pharmacovigilance. Responses were analyzed using constant comparative methods of qualitative analysis. Results: 18 clinicians met inclusion criteria and 14 interviewees are included. Toxicities included central nervous system infections, arterial/venous thromboembolism, gastrointestinal toxicity, cardiac arrhythmias, and cancer development/progression. These investigations were frequently followed by label warnings and/or convening of Food and Drug Administration (FDA) Advisory Committee reviews of safety findings. Five studies were disseminated in four high-impact factor medical journals (JAMA, Lancet, Annals of Internal Medicine, and New England Journal of Medicine). Six clinicians received feedback characterized as supportive from academic leaders, while four clinicians received feedback characterized as negative. Responses from pharmaceutical manufacturers were characterized as negative by 12 clinicians. Responses from FDA employees were characterized as negative by six clinicians. Three clinicians recommended that pharmacovigilance should include simplified clinician reporting systems. Conclusions: Our study finds that clinicians who published reports of serious oncology-associated drug reactions experienced negative feedback from pharmaceutical manufacturers. Feedback from FDA employees and academic clinicians were viewed as supportive by some and negative by others. Most clinicians recommended that future pharmacovigilance involve big data analyses.
Real-world effectiveness of approved anticancer agents among Medicare beneficiaries.
Authors: Green Angela , Curry Michael A. , Bach Peter , Mailankody Sham
Published: May 2019

6589

Background: The overall survival (OS) among elderly patients (pts) treated with novel anticancer agents in the real world may be inferior to the OS reported in pivotal trials for drug approval. Pts ≥ 65 yrs old constitute 60% of cancer pts, yet only 40% of cancer clinical trial participants. Elderly pts have greater comorbidities and experience a higher risk of toxicity from cancer drugs. Using the Surveillance Epidemiology and End Results-Medicare database (SEER-Medicare), we compared the OS among elderly pts treated with FDA-approved cancer drugs for advanced solid tumors to the OS reported in the clinical trial. Methods: We identified cancer drugs FDA-approved for metastatic solid tumors between 1/1/08-12/31/12. In a retrospective analysis, for each indication we identified pts in SEER-Medicare meeting disease eligibility criteria (stage, histology, prior therapies) in the trial associated with approval. Pts were diagnosed with cancer from 2010-2013 with follow-up through 2014. Treatment (tx) was determined from national drug codes in Medicare Part B for intravenous (IV) drugs and Part D for oral drugs. Indications were included if ≥ 30 pts receiving tx met eligibility. Kaplan-Meier methods were used to calculate median OS and cancer-specific survival (CSS) in Medicare pts. Median duration of therapy (DOT) was estimated from date of the first through completion of the last prescription claim for oral drugs and number of cycles for IV drugs. Results: OS data were available and sample size parameters met for 14 drug indications. The median OS among SEER-Medicare pts was shorter than the reported trial OS of tx arms for 13 of 14 drug indications (median difference -7.6 mos, range +3.4 to -28.7 mos). CSS was similar to OS among Medicare pts. Median DOT among SEER-Medicare pts was shorter than the reported trial DOT of tx arms for 13 of 14 indications (median difference -2.9 mos, range 0 to -8.9 mos). Conclusions: The OS and DOT among SEER-Medicare pts treated with FDA-approved cancer drugs was inferior to the reported OS in pivotal clinical trials for nearly all indications analyzed. The shorter DOT among Medicare pts may explain survival differences. Trials leading to regulatory approval may not be generalizable to cancer pts ≥ 65 yrs.
A living systematic review of immune checkpoint inhibitors in cancer patients: A novel platform for evidence synthesis in oncology.
Authors: Riaz Irbaz Bin , Siddiqi Rabbia , Malik Saad , Cathcart-Rake Elizabeth Jane , Gajic Ognjen , Montori Victor , Wang Zhen , Herasevich Vitaly , Go Ronald S. , Rajkumar S. Vincent , Murad M. Hassan
Published: May 2019

6596

Background: Several previous systematic reviews and meta-analyses have attempted to summarize toxicity of Immune checkpoint inhibitors (ICIs). However, very soon after each one of these reviews has been published, it became outdated. ICIs are currently used in 14 different cancers and data is rapidly evolving from new clinical trials. A living Systematic review, which is defined as a systematic review that is continually updated to incorporate relevant new evidence as it becomes available, is necessary in this situations. Therefore, we performed an updated systematic review and a meta-analysis which will serve as a foundation of a living Systematic review. Methods: MEDLINE, EMBASE and Cochrane were searched to identify phase 2 and 3 RCTs of PD-1/PD-L1 ICIs. Included studies compared either immunotherapy alone or combination with existing standard of care treatment and reported data for AE’s of interest. DerSimonian-Laird random effects Meta-Analysis was performed to derive pooled odds Ratio (OR) estimates for AE’s of interest. An infrastructure of a living systematic review is being developed and it includes monthly literature searches, cumulative meta-analysis and an online reporting platform. Results: We screened 6746 studies and 31 phase 3 and 2 phase 2 RCTs (n = 21,421) were included in the analysis. 22 RCTs used PD-1/PD-L1 ICIs as a single agent and 11 as a combination therapy. Selected toxicity estimates are summarized in a table. Conclusions: The meta-analysis updates previously published toxicity estimates and provides additional information about the risk of toxicities in single versus combination regimens. We have initiated the first living systematic review in oncology that will be continuously updated, incorporating relevant new evidence as it becomes available, and will provide accurate and up to date toxicity estimates to support clinical decision making. [Table: see text]
Where’s my doctor? the impact of the primary oncologist’s visit with their hospitalized patients.
Authors: Bakow Brianna R. , Schiffman Fred , Mega Anthony E.
Published: May 2019

6603

Background: Continuity of care is a cornerstone of the patient-practitioner relationship and patient satisfaction. The inpatient continuity visit (ICV), a face-to-face patient-provider interaction, involves a discussion regarding hospital course and care goals and decisions. We theorize that the ICV influences patient satisfaction. Previously, patient satisfaction has been related to patient perception of physician conduct, including communication skills. Currently, there are no studies investigating the impact of an ICV on inpatient oncology patients on a hospitalist service. Objectives: To assess the relationship between the ICV and patient satisfaction. We hypothesized that one or more visits by the outpatient oncologist would enhance satisfaction of oncology inpatients. Methods: Subjects (N=82) were comprised of adult inpatients on the oncology unit at Miriam Hospital, a teaching hospital of the Alpert Medical School of Brown University. All participants had an oncologist at the hospital based cancer center. A survey, given at discharge, included a 5-point Likert scale ranging from greatly worsened to greatly improved to assess the impact of the ICV on patient satisfaction. Results: Of 82 participants, 46 reported a visit by their outpatient oncologist. Forty-two (91.3%) reported that this visit either greatly or somewhat improved satisfaction with their hospital stay, while 8.7% reported no impact. Of patients whose oncologist visited once, 94.4% reported either greatly or somewhat improved satisfaction compared to 89.3% who had more than one visit. Out of 36 subjects who did not receive a visit, 16.7% reported that the lack of visit either greatly or somewhat worsened their hospital stay, while 83.3% reported no impact. Conclusions: Our study suggests that an ICV improves satisfaction of care in cancer patients on a hospitalist service. Furthermore, one of every six subjects who did not receive an ICV reported a negative impact on satisfaction. Results highlight a possible intervention to the discontinuity of care that may be perceived by patients. While the practicality of this intervention requires evaluation, the efficacy of a single continuity visit to improve satisfaction is reassuring.
Multi-institution quality improvement in supportive oncology: Results of the Coleman Supportive Oncology Collaborative (CSOC).
Authors: Khosla Paramjeet , Trosman Julia Rachel , Roggenkamp Betty , Lillis Teresa , Martin Joanna , Lo Shelly S. , Pasquinelli Mary , Knightly Eileen , Bowman Anne , Chow Selina Lai-ming , Patel Urjeet , Berardi Rosa , Diaz Aidnag , Kircher Sheetal Mehta , Weldon Christine B.
Published: May 2019

6606

Background: The Institute of Medicine and Commission on Cancer recommend systematic delivery of supportive oncology care for cancer patients. The CSOC is focused on quality improvement (QI) of supportive care across Chicago cancer centers (Weldon ASCO ’17). Supportive oncology includes distress, practical, family, physical, nutrition, pain, fatigue and care concerns. To support QI, cross-institution teams developed unique, relevant tools, methods, care delivery processes, patient handouts and online training. Methods: Ten centers (5 academic, 1 VA, 1 public, 2 safety net, 1 community) implemented supportive oncology screening and care delivery quality improvements. Centers collected data for relevant Quality Oncology Practice Initiative (QOPI) metrics. Analyses used simple frequencies and Fishers exact test. Results: Five of six QOPI measures were improved at statistically significant levels from 2014 to 2017, p < .00001. Improvements are more modest in 2016 & 2017 as 4 of the centers started this QI in 2017. Conclusions: The CSOC achieved significant improvements in supportive oncology screening and identifying and addressing patients’ needs and concerns. Additional work is needed to improve these measures to achieve the best quality of cancer care possible for every patient based on their needs and concerns. [Table: see text]
Utilization of value stream mapping to improve chimeric antigen receptor (CAR) T-cell patient experience at an academic medical center (AMC).
Authors: Porter Julie , Kong Katherine A. , Latchford Theresa , Bergman Debbie , Doran Sonni , Fajardo Nimfa , Goldstein Gary , Rodin Melissa , Segura Smith Andrea , Spiegel Jay Y. , Miklos David Bernard
Published: May 2019

6607

Background: Value Stream Mapping (VSM) is commonly used to identify waste, reduce process cycle times and implement process improvements in the product and manufacturing space. VSM was applied to analyze and improve the patient experience for individuals receiving CAR T cell therapy at this AMC, with emphasis on safety and quality of care, efficient patient flow and improved communication across the care team. Methods: Fifty-three multidisciplinary representatives from 21 teams across the AMC participated in at least one of the five 4-hour VSM sessions. Comprehensive VSM workflows were created for each step in the current CAR T cell patient journey, from initial referral through post-infusion care. Future state analysis was performed, with emphasis on identification of information technology improvements, communication and pain points. Baseline outcome metrics were established to assess effectiveness of future state VSM improvements. Results: Visual mapping of the CAR T cell patient journey identified several opportunities for improvement. A total of 72 improvement projects were outlined, which could be grouped into four main categories: (1) establish channels for improved care team communication, (2) build information technology infrastructure to support efficient patient flow and quality of care, (3) develop teaching tools for patient and care team education, and (4) delineate standard of care and clinical trials operational workflows. Baseline outcome metrics were measured across the patient population (n = 33), including time from consent to cell collection, length of inpatient stay, intensive care unit (ICU) utilization, and percent of readmissions within 7 days. Outcome metrics will be tracked and reported after future state changes to determine effectiveness of VSM-based process improvements. Conclusions: CAR T cell therapy is a novel therapy, which poses new challenges for coordination across a multidisciplinary care team at an AMC. The VSM approach is a useful tool to identify process and infrastructure improvements that can improve the patient journey. This approach can be generally applied to drive process improvements across clinical care.
Characterization of oncologic patient visits at the emergency department (ED) at an Austrian tertiary care center.
Authors: Minichsdorfer Christoph , Pauzenberger Bettina , Laggner Anton , Zielinski Christoph , Fuereder Thorsten
Published: May 2019

6609

Background: Oncologic patients frequently seek out the ED as first contact point. Besides the rare classic oncologic emergencies other causes are supposed to be more frequent. However, little is known about reasons of patients with active malignancies to consult the ED. Methods: Retrospective data regarding emergency visits of patients with a medical history of active cancer or adjuvant therapy, who were taken by ambulance to the ED in the time period from 01.01.2017 – 31.07.2017, was collected. For OS Kaplan-Meier curves were created and univariate COX proportional hazards model analysis was used and log rank tests were performed. For statistical analysis the chi2-test was used to investigate significant relations between the three months mortality (3MM) and patient characteristics. 3MM was defined as death within 3 month of the first ED consultation. Results: From a total of 1029 patient contacts 743 met the inclusion criteria. In total 552 patients were included. The median age was 67 years (Minimum: 18y; Maximum: 95y). The vast majority of patients (480, 87%) were in a palliative setting. 243 patients (44%) were under active treatment. The biggest group of patients suffered from lung cancer (18%) followed by hematologic malignancies (14%), pancreaticobiliary tumours (11%), breast cancer (8%) and colorectal cancer (7%). In total 111 patient contacts (15%) were treatment associated, 384 patient contacts (52%) were tumor related, the remaining (248, 33%) were unrelated to either. In 533 cases (72%) inpatient treatment was necessary. The average length of stay was 9, 36 days. Furthermore the 3MM was significantly higher in elderly patients > 65y (p = 0,001), palliative patients not undergoing active treatment (p = 0,003) and patients with elevated CRP levels ( > 0,5mg/dl) (p = 0,001) at time of ED contact. In addition in our univariate analysis factors that significantly decreased the OS were age > 65, visceral metastasis and palliative patients without active treatment. Conclusions: The majority of cancer patients in this study were in a palliative setting. Moreover, cancer associated complications posed the most frequent cause for ED consultation. We could identify a higher risk for mortality for elderly patients, patients with visceral metastasis and patients undergoing best supportive care. The results may help to inform both cancer patients and primary care units about frequent complications.
Qualifying sites for oncology clinical trials.
Authors: Kurbegov Dax , Kim Edward S. , Hurley Patricia A. , Waterhouse David Michael
Published: May 2019

6619

Background: Current methods to assess trial sites for clinical trial participation are onerous, with unnecessary redundancies and “no-value” steps that impact clinical trial participation. This project assessed the impact of current sponsor and contract research organizations (CRO) methods to evaluate sites for trials. Methods: A survey was conducted with community- and academic-based trial sites. Samples of feasibility questionnaires (FQs) used by sponsors and CROs were also compiled. An ASCO sponsored multi-stakeholder meeting was held to identify strategies to more effectively assess trial sites. Results: 113 oncology practices (63 community, 50 academic) reported completing 11 FQs and 4 pre-study site visits (PSV) on average per month. On average, each FQ took 4 hours (528 hours/site and 59,664 hours for all respondents, annually) and each PSV took 10 hours (480 hours/site and 54,240 hours for all respondents, annually) to complete. Thus, the total staff hours required to complete site feasibility assessments was 113,904 annually. Respondents reported that content in both FQs (82%) and PSVs (91%) was redundant to information previously provided and FQs were redundant between different sponsors (86%). The 42 sample FQs had a median 45 questions (range 13 to 96). Respondents noted that sponsors/CROs provided insufficient study documentation to accurately complete FQs. It took 7 months on average from first contact to first patient enrolled. Respondents also provided feedback about standardizing and streamlining site qualification processes. Conclusions: The current methods of assessing site feasibility for clinical trials poses tremendous burden on site resources and is not sustainable. New methods are needed that standardize, harmonize, and streamline criteria and site assessments. Such changes will reduce burden and costs for all stakeholders, and will expedite and increase patient enrollment onto clinical trials.
Decreasing postoperative opioid prescriptions in ambulatory extended recovery patients.
Authors: Fearon Nkechi , Chesnut Gregory Thomas , Benfante Nicole , Assel Melissa , Mauzoul Shirley , Levine Marcia , Broach Vance , Vickers Andrew , Eastham James Andrew , Twersky Rebecca , Simon Brett A , Laudone Vincent Paul
Published: May 2019

6621

Background: Over-prescription of opioids after surgery contributes to the opioid abuse epidemic. Optimum post-operative opioid dosing is not defined. We evaluated prescribing patterns among different surgical services and created a standardized practice to reduce dispensation of unnecessary opioids. Methods: Opioid-naïve patients over 18 who underwent urologic, gynecologic, or breast surgery between March 2018 and January 2019 were eligible. A 4-month pre-intervention evaluation of number of opioid pills prescribed, number of pills taken, additional refills, and pain-control was obtained by contacting patients 7-10 days post-operatively. Findings were used to standardize prescriptions. Following implementation, patients undergoing surgery for the following 4-months were contacted to assess the impact of standardized opioid prescriptions. Data was compared with the institution’s electronic prescription system. Results: Pre-intervention, 368 eligible urology and gynecology patients (75.6%) responded and were prescribed between 6 and 40 opioid pills. Urology patients received median 28 (20, 30) tablets and 33% reported taking none. Gynecology patients received a median 20 (19, 28) tablets and 41% took none. Of 238 mastectomy patients, 176 (74%) reported taking median 3 and 4.9 of 20 prescribed opioid pills and 39% or 61% took no opioid pills (without vs with reconstruction). Prescriptions were standardized to 8, 7, and 10 tablets for urology, gynecology, and breast services. Post-intervention surveys revealed opioid tablets taken to be unchanged with minimal increase in refill requests. Conclusions: Prior to standardization, a large variation in opioids prescribed was observed. Standardizing opioid prescriptions resulted in fewer opioids dispensed without impacting pain control or refill requests.
Relationship of emergency department use pre- and post-cancer diagnosis in safety-net adults.
Authors: Hong Arthur , Sadeghi Navid , Cox John Vernon , Lee Simon Craddock , Halm Ethan
Published: May 2019

6626

Background: Safety-net adults generate a high rate of emergency department (ED) visits within the 180 days after a new cancer diagnosis, many of which could be alternatively triaged to an urgent care clinic. It is unclear how much of this ED use is attributable to the cancer and treatment vs. ED-seeking behavior. To identify patients at risk of frequent ED use, we explored whether a patient’s pre-cancer ED visit use predicted ED use after diagnosis. Methods: We identifiably linked adults from the tumor registry in the Dallas County safety-net health system to a regional hospital database with claims-like data for all patients from 98% of non-federal hospitals in North Texas. We applied a mixed-effects multivariate logit model, using frequent ED use (≥4 visits) in the 6-12 months or 12-18 months before diagnosis to predict frequent ED use after diagnosis, adjusting for demographics, comorbidities; cancer type, stage, initial treatment modalities; and grouping visits at the patient level. Results: Of 8,610 adults diagnosed from 2012-2016, 76.2% had Medicaid or were uninsured, 30.9% had lung, breast, or colorectal cancer, and 25.9% had advanced-stage cancer at diagnosis. In the 180 days after diagnosis, 42.5% of patients had zero ED visits, 45.7% had 1-3 visits, and 11.8% were frequent ED users (≥4). In multivariate analysis, patients with frequent ED use in the 6-12 months before a cancer diagnosis had 6.7 higher odds (95% CI: 4.8, 9.3) of having frequent ED use after diagnosis, compared to patients who had zero ED visits prior to diagnosis. This compared to 1.3 higher odds (95% CI: 1.1, 1.5) of frequent ED use if the patient had advanced-stage cancer, and 2.1 higher odds (95% CI: 1.8, 2.4) if chemotherapy was part of initial treatment. Although most post-diagnosis frequent ED users generated zero visits (62.2%) or 1-3 visits (30.7%) in the 6-12 months prior to diagnosis, 38% of patients with frequent ED use pre-diagnosis continued frequent ED visits after diagnosis. Results were similar for ED use 12-18 months prior to diagnosis. Conclusions: Among safety-net adults, prior ED-seeking behavior strongly predicted ED use after a new cancer diagnosis. This may represent a high-risk group that might benefit from care delivery innovation.
A weighted criterion-based approach to value assessment of oncology drugs.
Authors: Ezeife Doreen Anuli , Cusano Ellen R. , Fares Aline Fusco , Sung Mike , Dionne Francois , Mitton Craig , Earle Craig , Chan Kelvin K. , Leighl Natasha B.
Published: May 2019

6627

Background: The rising cost of anti-cancer therapy has motivated recent efforts to quantify the overall value of new cancer treatments. Multi-criteria decision analysis offers a novel approach to establish an explicit framework to evaluate new cancer treatments. Methods: We recruited a diverse multi-stakeholder group who identified and weighted key criteria to establish the Drug Assessment Framework (DAF). Strength of evidence (SOE) modifiers deducted points for lower quality evidence. Through one-on-one meetings with stakeholders, face and content validity of the DAF were established in an iterative process. Construct validity assessed the degree to which DAF scores were associated with the pan-Canadian oncology drug review (pCODR) funding decisions and European Society for Medical Oncology Magnitude of Clinical Benefit score (ESMO-MCBS, version 1.1). Sensitivity analyses were performed on the final results. Results: The final validated DAF includes ten criteria: overall survival, progression-free survival, response rate, quality-of-life, toxicity, unmet need, equity, feasibility, disease severity and caregiver well-being. The first five clinical benefit criteria represent 64% of the total weight. DAF scores range from 0 to 300, reflecting both the expected impact of the drug and the quality of the supporting evidence. When the DAF was retrospectively applied to the last 60 drugs (in blinded fashion) reviewed by pCODR (2015-2018), the mean total DAF score was 94 (range, 18-179). Drugs with positive pCODR funding recommendation had higher DAF scores than drugs not recommended for reimbursement (103 vs. 63, t-test p = 0.0007). Funded drugs had fewer SOE points deducted than those that were not funded (median 0 vs. 24 points deducted, Wilcoxon p = 0.03). The correlation coefficient for DAF and ESMO-MCBS was 0.37 (95% CI, 0.10 to 0.59). Sensitivity analyses that varied the subjective criteria either positively or negatively did not change the results. Conclusions: Using a structured and explicit approach, a criterion-based valuation framework was designed and validated. The DAF can provide a transparent and consistent method to value and prioritize cancer drugs, in order to facilitate the delivery of affordable cancer care.
Clinical and economic outcomes of pegfilgrastim in metastatic colorectal cancer.
Authors: Wilfong Lalan S. , Garey Jody S. , He Bo , Hayes Jad , Ives Hope , Hoang Susan Nga , Neubauer Marcus A.
Published: May 2019

6636

Background: Febrile neutropenia (FN) resulting from myelosuppressive chemotherapy can lead to increased hospitalizations and mortality. Pegfilgrastim can be used to reduce the risk of FN; however, few studies address pegfilgrastim’s value in patients with metastatic solid tumors. This observational study compared outcomes for pegfilgrastim-treated (peg-tx) and peg-untreated (no peg) patients with metastatic colorectal (CRC) at US Oncology practices (USO) participating in the Oncology Care Model. Methods: Patients with metastatic CRC treated at USO from July 1, 2013 – December 31, 2014 and a qualifying baseline OCM episode were included. Propensity scoring was used to match (1:2) peg-tx and no peg cohorts based on line of therapy, number of comorbidities, age, gender, ECOG performance status, chemotherapy neutropenic fever risk, and dose reduction. Outcomes assessed included all-cause and infection-related hospitalization rates; total cost of care per 6-month OCM episode; and overall survival (OS). Results: Matched peg-tx and no peg samples were 149:298. The all-cause hospitalization rate was higher in the peg-tx vs. no peg population, 45% vs. 32% (OR 1.7, (1.1, 2.5), p = 0.011). Infection-related hospitalization rates were no different in peg-tx vs. no peg cohorts, p = 0.367. Cost of care was significantly higher for peg-tx patients vs. no peg ($58,787 ± $20,490 vs. $37,811 ± $19,593 respectively, p < .001). OS was 19.5 months (peg-tx) vs. 19.7 months (no peg), p = 0.882. Conclusions: While peg use in curative treatment settings for high risk patients is standard of care, in our Medicare population use in metastatic CRC did not result in a lower all-cause or infection-related hospitalization rate or impact in OS. There was a higher 6-month total cost of care associated with those patients who received peg during chemotherapy.
Desire to address costs at time of treatment decisions among patients with metastatic breast cancer.
Authors: Lei Yvonne Y. , Quain Katharine M. , Dizon Don S. , Jimenez Rachel , Shin Jennifer Adrienne , Sepucha Karen , Perez Giselle Katiria , Peppercorn Jeffrey M.
Published: May 2019

6640

Background: Costs of cancer care may impact access to therapy, adherence, and distress among patients. However, the degree to which patients with metastatic breast cancer (MBC) wish to discuss financial issues when making treatment decisions is unknown. Methods: In a single arm feasibility trial, 40 women with newly diagnosed or progressive MBC completed a 1-page survey regarding goals and priorities for discussion with the oncology team. The survey included 17 potential priorities for discussion in the domains: treatment options, symptom management, emotional concerns, planning for the future, and lifestyle. We evaluated participants’ interest in prioritizing discussion of financial issues and sociodemographic and clinical correlates of this preference. We examined the relationship between desire to discuss financial issues and both distress on the Distress Thermometer (DT) and satisfaction with cancer care using Fisher’s exact test. Results: Among 40 participants, 11 (28%) reported interest in discussing financial issues when making treatment decisions, 29 (72%) were not interested. Average age was 57 (range 31-73), and the majority were white (85%) and college graduates (66%). Only 18% of white patients were interested in addressing cost, while 83% of non-white patients were interested (p < 0.01). Those with a college education were less likely to prioritize financial discussion compared to no college (16% vs. 47%, p = 0.04). Patients interested in discussing cost were more likely to have a household income < $50,000 (50% vs. 22% > $50,000, n.s.) and to have Medicaid (50% vs. 25% other insurance, n.s.). Additionally, patients with higher levels of distress (35% vs. 21% DT < 4, n.s.) and those on novel targeted or biologic therapy (42% vs. 21% other therapy, n.s.) were more likely to prioritize discussion of costs. Desire to discuss cost was not related to satisfaction with care. Conclusions: A substantial minority of patients with MBC, particularly those from less advantaged backgrounds, wish to discuss financial issues at time of treatment decisions. Financial toxicity research should recognize that not all patients desire this discussion and evaluate methods to screen for financial concerns and barriers to care.
Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (febrile) neutropenia and expanded access based on budget neutral basis.
Authors: Wang Weijia , Balu Sanjeev , Campbell Kim
Published: May 2019

6645

Background: Pegfilgrastim (pegfil) injection is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Assuming biosimilarity of biosim-pegfil and pegfil in the prevention of febrile neutropenia, we estimated cost minimization of conversion from pegfil to biosim-pegfil and subsequent potential expanded access due to cost savings. Methods: A cost minimization model was conducted based on a hypothetical panel of 20,000 patients using average selling price (ASP) for one chemotherapy cycle. ASP was obtained from 1Q 2019 payment allowance limits. The simulation included two steps: 1) cost minimization was calculated per cycle (biosim-pegfil and pegfil is administered 1 dose per cycle) when patients were converted to biosim-pegfil from pegfil on ratio of 10% to 100% at 10% intervals and at a discount from 15% to 35% at 5% intervals, and 2) expanded access to biosim-pegfil was calculated based on budget neutrality. Since pegfil has two forms of availability (Neulasta and Neulasta-Onpro) with the same price, results were to either conversion scenario. Results: Per-cycle per-patient cost minimization from converting pegfil to biosim-pegfil ranged from $702.27 (15% discount) to $1,638.63 (35% discount). For 20,000 patients, this yields savings of over $14 million (15% discount) to $32 million (35% discount) at 100% conversion rate. When half the patients were converted to biosim-pegfil, savings could range from > $7 million (15% discount) to > $16 million (35% discount). With 100% conversion rate and 15% discount, 3,529 additional patients could be treated with the savings generated. At 50% conversion rate, cost savings could be applied to another 1,765 patients with 15% discount, 3,333 patients with 25% discount, and 5,385 patients with 35% discount, respectively. Conclusions: Conversion from pegfil to biosim-pegfil can lead to potential cost savings and these savings can be applied to offer increased access to supportive care with biosim-pegfil for patients receiving chemotherapy on a budget-neutral basis. For payers with larger populations, savings can be substantial. More studies are warranted to evaluate such potential cost savings due to use of biosim-pegfil over reference pegfil.
Scope of practice of advanced practice providers (APP) in US community oncology.
Authors: Klink Andrew , Bapat Bela , Smith Yolaine , Nabhan Chadi , Feinberg Bruce A.
Published: May 2019

6646

Background: Oncology practices are increasingly employing nurse practitioners (NPs) and physician assistants (PAs) known collectively as advanced practice providers (APPs) to improve practice workflow, increase efficiency, and enable physicians to focus on complex patient care. Understanding variations in scope of practice for APPs may help establish a benchmark against which future changes are measured. Methods: US community physicians responded to a web-based survey from Sep to Nov 2018. Physicians were asked how frequently their APPs performed certain tasks on a 5-point scale (i.e., never, occasionally, sometimes, frequently, and always). Responses have been summarized using descriptive statistics. Results: In this study, 163 physicians were surveyed, most (81.0%, n = 132) used APPs in their practice. Among physicians using APPs, 91.7% (n = 121) used NPs and 49.2% (n = 65) used PAs. Most physicians stated that APPs were frequently/always involved in providing patient education (84.1%), ordering imaging and laboratory studies (68.9%), and/or making supportive care decisions (62.1%). Over 85% (57.6%-59.8% occasionally/sometimes; 28.0%-28.8% frequently/always) of physicians agreed that APPs discussed imaging reports and end of life (EOL) care (57.6% occasionally/sometimes, 28.8% frequently/always) with patients. Regarding procedures: 51.9% (28.0% occasionally/sometimes; 24.1% frequently/always) responded that APPs performed bone marrow biopsies and intrathecal chemotherapy. Regarding systemic therapy: 68.2% (58.3% occasionally/ sometimes; 9.8% frequently) allowed APPs to modify existing regimen e.g., dose/schedule change; 39.4% responded that APPs made decisions about new therapy selection. Conclusions: While substantial variation in the role of APPs in community oncology practices was observed, similar themes emerged. APPs appear to be integral in patient education, ordering laboratory and imaging studies, and discussing EOL care. Fewer are involved in managing and selecting supportive care and systemic therapy. Longitudinal and longer follow up are warranted to ascertain whether the scope of these practices change over time.
National cancer expenditure analysis in the United States Medicare population, 2013.
Authors: Ruiz Emily S , Seiger Kira , Mostaghimi Arash , Schmults Chrysalyne
Published: May 2019

6647

Background: Cancer is the second leading killer in the United States, but there is no comprehensive analysis evaluating total cancer costs by cancer and treatment modality. Methods: Data from the 2013 inpatient (100%), outpatient (100%), and carrier (5%) Medicare Limited Data Set Standard Analytic Files were queried for claims filed for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for all cancer diagnoses. Claims associated with the ICD-9 codes for professional fees were analyzed by Current Procedure Terminology (CPT) code to determine resource allocation by disease. Outpatient oral chemotherapy costs were obtained from the National Average Drug Acquisition Cost database for 50 drugs used for cancer treatment in 2013. Results: $27.9 billion was spent on cancer treatment of which $12 billion (43%), $6.5 billion (23%), and $1.1 billion (4%) was allocated to professional, inpatient facility, and outpatient facility fees, respectively. Oral and hospital-based chemotherapy accounted for 17% ($4.7 billion) and 15% ($4.3 billion) of all cancer costs, respectively. Lung/thoracic cancer ($2.9 billion) had the highest total annual cost and multiple myeloma ($9,019, SD $19,962) is the most expensive cancers to treat annually per patient. Average out-of-pocket expenses are $470 (SD 287), which is 12% of the annualized per patient costs. Conclusions: In 2013, cancer accounted for only 5% of Medicare spending. Chemotherapy costs accounted for approximately a third of total spending and are likely to rise as innovation continues. Out-of-pocket spending can place a financial burden on cancer patients requiring more expensive treatments.