bluuebunny/crossref_metadata_2025_split huggingface dataset:
Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: A multicenter retrospective study.
Authors: Zhao Yannan , Xie Ning , Li Wei , Chen Wenyan , Lv Zheng , Zheng Yabing , Sun Tao , Liu Jieqiong , Zhang Jian , Hu Shihui , Wang Yajun , Gong Cc , Li Yi , Xie Yizhao , Ge Rui , Xu Fei , Wang Biyun 
Published: June 2021

e13057 Background: Eribulin is a nontaxane microtubule inhibitor approved in China for patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxane. The aim of this study was to evaluate the efficacy and safety profile of eribulin and explore potential predictive factors for the efficacy of eribulin among Chinese women with metastatic breast cancer (MBC) in real-world practice. Methods: A total of 272 consecutive MBC patients who were treated with eribulin from November 2019 to October 2020 in 9 institutions nationwide were included in this study. Eribulin was administered intravenously at a dose of 1.4 mg/m2 on days 1 and 8 of a 21-day cycle. Efficacy outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and clinical benefit rate (CBR). Adverse events (AEs) were graded according to The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 5.0. Results: Eribulin showed a median PFS of 3.9 months (95% confidence interval [CI] 3.3–4.3); however, the OS data were immature. The ORR was 16.2%, and the CBR was 21.7%. A total of 51.8% of patients received eribulin monotherapy, and 48.2% of patients were treated with eribulin combine with targeted therapy or other chemotherapy. The number of metastatic sites, duration of previous taxane treatment for MBC, and combination regimen with bevacizumab were significant in Cox multivariate analysis (p=0.048, p=0.039, and p=0.045, respectively) and were significantly associated with PFS of eribulin. The most common AEs with eribulin treatment were hematological toxicities, including neutropenia, leukopenia, and anemia. Conclusions: This is the first cohort of eribulin real-world data base on retrieval currently after eribulin launched in China. Eribulin was effective with a manageable toxicity profile in clinical practice. Furthermore, when prescribed in combination with other agents, eribulin did not increase the toxic effects of each agents. Eribulin monotherapy or combine with other agents is alternative for the heavily pretreated patients with MBC. [Table: see text]
Genomic landscape of cell-free DNA in a diverse cohort of metastatic breast cancer patients.
Authors: Cheng Shirley , Nguyen Edward , Pagano Ian , Fukui Jami Aya 
Published: June 2021

e13066 Background: Breast cancer is the most prevalent cancer and the second leading cause of cancer deaths among women in the United States. Once the primary breast cancer has metastasized to other parts of the body, despite treatment, patients have an incurable disease. Compared to the primary tumor, often the metastasized tumor sites have different mutational profiles that are not represented in the initial biopsy. Liquid biopsy is becoming a more commonly accepted method in clinical practice to determine the heterogeneity of metastatic tumors by analyzing cell-free DNA (cfDNA). Several studies have demonstrated that cfDNA can be utilized as an effective prognostic tool and can reveal multiple clinically targetable alterations in metastatic breast cancer (mBC). Methods: We characterized the genomic landscape of cfDNA in a diverse patient population and across different subtypes of mBC. We performed a retrospective chart review in patients (n = 41) with metastatic breast cancer from a medical oncology clinic within the Hawaii Pacific Health system. Patients who had at least one cfDNA testing by Guardant360 were evaluated. Patient demographics, age at diagnosis, race, subtype and mutations were reviewed along with treatment information. Results: We found no statistically significant differences in genomic landscape according to race, however there were differences seen in tumor genomics according to age and subtype. Older patients were less likely to have detectable disease on liquid biopsy compared to younger patients (age 70+ and 60-69 vs 30-39; xp 0.02). Consistent with subtype, mutations in ESR1 (n = 12) and PIK3CA (n = 14) were more commonly seen in hormone positive (HR+) mBC where known tailored treatment options are available (ie. fulvestrant and alpelisib respectively). Postmenopausal patients were more likely to have ESR1 mutations than premenopausal patients (50-59 and 70+ vs 30-39 and 40-49, xp 0.009). About half (n = 20) had TP53 mutations, followed by PIK3CA (n = 14), ESR1 (n = 12), CCND1 (n = 7) and MYC (n = 6). Conclusions: We evaluated 41 unique cases of mBC and correlated them with their genomic profiles. We plan to further investigate genomic changes according to treatment with subsequent repeat liquid biopsies. We hope to utilize these findings to help prognosticate and guide future treatment options.
Development of the oncology opportunity cost assessment tool.
Authors: Handley Nathan , Binder Adam F , Gentsch Alexandra , Granberg Rachel , Heyer Arianna , Davis Garrison , Nord Garrison , Rising Kristin 
Published: June 2021

e13502 Background: While awareness of direct patient-level costs of cancer care are growing, less is known about the patient-level opportunity cost of care. Opportunity costs of care may include time spent seeking care, lost wages, lost leisure time, and other indirect costs associated with seeking care. Despite acknowledgment of the importance of considering patient opportunity costs in care treatment decisions, assessment of opportunity costs experienced by individual patients or caregivers is not routinely performed by healthcare providers in general, or oncology providers in particular. The purpose of this work was to develop an instrument, the Oncology Opportunity Cost Assessment Tool (OOCAT), to evaluate patient opportunity cost of seeking oncology care. Methods: Survey development was an iterative process with multiple rounds of stakeholder engagement. First the research team developed a list of potential opportunity cost themes informed by their own experiences. Next, we met with an established patient advisory group within the cancer center to expand this list of themes. We then conducted focus groups with patients and caregivers to explore in further depth their logistical and financial considerations related to seeking care. Findings were used to further expand the list of opportunity cost themes, with this list reviewed in real time with the focus group participants to ensure perspectives were appropriately captured. We then generated a set of survey items to represent each of the themes listed. We generated two items to represent each unique theme. The first item of the instrument sought to quantify the opportunity cost of the theme (e.g. time spent parking); the second component ascertained the patient-perceived importance of the theme using a 7-point Likert scale. Upon drafting of the initial OOCAT, we performed cognitive interviews with a random sampling of patients in order to ensure content validity and clarity of instrument items. Results: We completed 4 virtual focus groups with a total of 23 participants (17 patients and 6 caregivers) followed by cognitive interviews with 13 patients. The resulting OOCAT consists of 17 items that examine time requirements, financial implications, and logistical and quality of life challenges for both patients and caregivers associated seeking oncology care. Conclusions: The OOCAT is a 17-item instrument designed to quantify patient-level opportunity costs of seeking oncology care. Further studies work is needed to validate the OOCAT survey and assess the impact of incorporating quantified assessment of opportunity cost into decision regarding when and where to seek oncology care.
A medication acquisition program to facilitate access to nonstandard targeted oncologic therapies.
Authors: Doctor Vicki , Markman Maurie , Parikh Ankur Rasik , Conte Bellinda 
Published: June 2021

e13505 Background: Precision oncology provides targeted approaches to cancer diagnosis and treatment, but also carries significant risks to reimbursement and patient access. A recent survey found that up to 60% of authorization denials are due to the therapy being off-label and experimental. The Cancer Treatment Centers of America's Medication Acquisition Program (CTCA-MAP) was initiated in October 2015 with the goal of helping patients successfully navigate a medication acquisition process following prior authorization denials for off-label therapy. Methods: A consecutive series of cancer patients who were non-responsive to standard-of-care, and for whom off-label targeted therapies have been matched to a potentially actionable genetic or molecular variant were enrolled into CTCA-MAP following the denial of payer preauthorization. The CTCA-MAP appeals payer denials, and simultaneously coordinates applications to patient assistance programs. Each payer appeal is customized to the patient's disease profile and unique tumor genomics and is based on any available evidence supporting the therapy’s use and safety in the patient’s tumor type. Results: A total of 825 patients (338 males and 487 females; median age 57 years) were enrolled into the program from October 2015 to October 2020. The most common tumor types were breast (n = 157), colorectal (n = 96), pancreas (n = 72), lung (n = 68), ovarian (n = 35) and prostate (n = 35). 682 (82.7%) patients were able to access therapy through patient assistance programs (n = 548), overturned payer appeals (n = 133) or conversion from patient assistance to insurance (n = 1) within a median of 16 days from the date of program referral. Only 5 (0.6%) patients were unable to access therapy through payer appeals or philanthropic programs. The remaining 138 (16.7%) patients could not complete the program due to disease progression or death. The overturned payer appeals led to insurance coverage for an estimated USD 7.95 million in drugs (calculated as the multiplication of drug cost per cycle and the number of cycles received). Conclusions: The CTCA-MAP provides a mechanism through which cancer patients with potentially actionable genetic variants can acquire access to existing off-label targeted therapies when standard-of-care is no longer effective, or when they are ineligible for a clinical trial. This program's outcomes to date demonstrate a need for a concerted advocacy effort to increase accessibility for cancer patients to these innovative targeted therapies.
Incidence of asymptomatic COVID-19 positivity in cancer patients and effects on therapy.
Authors: Ross Nicole , Handorf Elizabeth A. , Meeker Caitlin R. , Chen Giana , Baldwin Donald , Vijayvergia Namrata 
Published: June 2021

e13506 Background: As the coronavirus disease 2019 (COVID-19) pandemic threatens the delivery of cancer care, challenges to providing safe and quality care persist. Screening measures including SARS-CoV-2 polymerase-chain reaction (CovPCR) testing prior to invasive procedures, therapy administration, were instituted to address risk of spread from asymptomatic (AS) pts. Studies have documented poor outcomes with COVID-19 in cancer pts with rate of AS COVID-19 ranging from 0.6%- 8%. (Liang et.al, 2020; Al-Shamsi, et.al, 2020, Shah et.al. 2020). In the general population, rates of AS cases was estimated to be 17% (Byambasuren, O., 2020). This study aimed to examine the incidence and characteristics of AS COVID -19 in cancer pts, and determine its effect on cancer care delivery at a tertiary care center. Methods: With IRB approval, a retrospective chart review was conducted on cancer pts undergoing CoVPCR screening. Pts were considered AS if they had no recent fever (≥100.5 °F), cough, headache, loss of taste/smell, shortness of breath, diarrhea, or high risk exposure. This analysis compared cases (positive CoVPCR) identified by screening of AS pts to control (negative CoVPCR) pts (matched by planned procedure type and month of screening). Each COVID case was matched to 2 negative controls on month and planned procedure type. Patient characteristics and outcomes were compared between cases and controls using conditional logistic regression or Mantel-Haenszel tests. Results: Between 03/2020 and 09/2020, 4143 AS pts underwent CovPCR testing and 75 were chosen for analysis (25 cases; 50 controls). The incidence of AS COVID-19 in cancer pts was 0.6% (25/4143). Median age was lower in the cases (64 vs 70y, p = 0.04). Gender, race, primary cancer diagnosis, and co-morbidity distribution was similar between cases and controls. Of the cases, 10 pts (40%) never underwent the planned oncologic intervention while 11 (44%) had a delay related to the positive CoVPCR (2 pts had no intervention planned). Only 1 pt (2%) in control arm didn’t undergo the planned procedure. The mean duration of delay was 18 days (range 0-49 days, SD 16.72) in cases versus Zero days in control. Four (16.7%) cases developed symptoms within 14 days of positive CoVPCR testing but the PCR value did not predict this conversion. Conclusions: Incidence of AS COVID in our cancer pts was significantly lower than general population. Active screening delayed oncologic care but with institution of safety measures like separate treatment rooms and scheduling procedures at the end of the day have ensured safe and prompt cancer care delivery during the pandemic. Future research needs will address incorporating vaccination status into the screening algorithm to limit widespread CoVPCR screening, thus improving care delivery and cost effectiveness.
The use of quasi-experimental design methods to evaluate and improve the impact of acute care centers on oncologic emergencies.
Authors: Sweetenham John W. , Chaudhry Basit Iqbal , Teng Benjamin , Yue Andrew , Connor Nora 
Published: June 2021

e13515 Background: Reducing avoidable hospital and emergency department (ED) use are national priorities in cancer care. Acute care centers (ACCs) that expand access for patients with oncologic emergencies are increasingly implemented as alternatives to inpatient and ED care. The impact of these ACCs is uncertain. Additionally, how to rigorously evaluate these interventions and to iteratively improve their effectiveness remains unclear as infrastructure interventions such as ACCs are not amenable to experimental manipulation. Methods: We are developing a novel quasi-experimental framework for evaluating and improving the effectiveness of an ACC intervention at the Simmons Comprehensive Cancer Center (SCCC) of the University of Texas Southwestern. SCCC covers one of the largest geographic regions of any academic medical center in the country, creating challenges addressing access to care. Drawing on the Andersen model for healthcare utilization we hypothesize that ACC effectiveness is mediated through enabling factors, particularly distance. Our initial evaluation framework draws on an untreated control group design with multiple pretest and post-test samples. The control group is comprised of patients living in zip codes farther away from the ACC. Additional analytic work will assess the feasibility of adding a matching cohort group structure based on factors such as onset of illness and matching individual patient episodes based on risk adjustment parameters. If the ACC is later expanded to other sites, the design can be further developed by adding a switching replications methodology to augment the quasi-experiment. Data collection draws on claims data provided through SCCC’s participation in Medicare’s Oncology Care Model (OCM). Results: Over OCM’s initial four performance periods (each six months long), all-cause risk adjusted hospitalization rates for SCCC patients ranged from 25.2% to 27.2%. All-cause risk adjusted OCM ED use ranged from 28.1 to 29.9%. Seeking to improve performance for both, SCCC leadership initially implemented a temporary urgent care clinic in August 2018. This initial prototype clinic was formalized into an operational ACC in August 2020. Evaluation of the impact of this ACC intervention is ongoing. Conclusions: ACCs represent potentially important means to reduce avoidable hospital and ED use. However, complex infrastructure interventions are not amenable to experimental evaluations assessing their impact, and it remains difficult to gain insights into how to tailor services through these interventions to support patients with oncologic urgencies and emergencies. Quasi-experimental approaches when integrated alongside ACC interventions represent promising mechanisms of evaluation and continuous quality improvement.
A solution to reducing avoidable emergency department visits: Implementation of an outpatient oncology acute care clinic.
Authors: Charania Sadaf , Devlin Judy , Brucker Edie , Simon Shayna , Hong Christine , Nair Kavitha , Bazzell Angela F. , Sweetenham John W. 
Published: June 2021

e13517 Background: Emergency Department (ED) utilization by oncology patients accounts for more than 4.5 million visits in the United States annually, leading to hospitalization four times the rate of the general population.1,2 Many ED visits are the result of symptoms related to cancer or cancer treatment that can be managed on an outpatient basis. Unnecessary admissions lead to possible delays in cancer treatment and increased burden on healthcare resources.3 Simmons Acute Care (SAC), an advanced practice provider (APP)-led clinic, was established in August 2020 to provide an alternative model of oncology care to address these issues. Methods: A multidisciplinary team of key stakeholders was formed to develop an action plan. Institutional data was reviewed to identify the timing and volume of ED visits by oncology patients. Clinic hours were set Monday through Friday, 7:00am – 7:00pm, and referrals were made from primary oncology providers. Evidence-based clinical pathways were developed to standardize patient management, and a data collection plan was implemented to measure outcomes. Internal communications to patients and presentations at staff and faculty meetings occurred to inform patients and clinical staff/providers. Results: From August to December 2020, 165 patient visits were completed in SAC, 141 patients discharged home, 14 patients directly admitted to the hospital, and 10 patients transferred to the ED for a higher level of care. Based on data from 2020, the average cost of an ED visit for an oncology patient was $5,500 and increased to $28,500 if the patient is admitted. Patients with hematologic and gastrointestinal malignancies represented approximately 30% of all visits. Gastrointestinal symptoms were the most frequent presenting chief complaint. Conclusions: Supporting oncology patients in the ambulatory setting provided a reduction in admissions and unnecessary ED visits, leading to cost savings/avoidance to the patient and health system. Based on internal cost analyses, there are potential savings of over $2 million to the organization during this 5-month period. Additional studies are underway to assess patient satisfaction, as well as the economic impact for patients. 1. Rui PKK. National Hospital Ambulatory Medical Care Survey: 2015 emergency department summary tables. https://www.cdc.gov/nchs/data/nhamcs/web_tables/2015_ed_web_tables.pdf 2. Hong AS, Froehlich T, Clayton Hobbs S, Lee SJC, Halm EA. Impact of a Cancer Urgent Care Clinic on Regional Emergency Department Visits. J Oncol Pract. 2019;15(6):e501-e509. doi:10.1200/JOP.18.00743 3. Roy M, Halbert B, Devlin S, Chiu D, Graue R, Zerillo JA. From metrics to practice: identifying preventable emergency department visits for patients with cancer. Support Care Cancer Off J Multinatl Assoc Support Care Cancer. Published online November 7, 2020. doi:10.1007/s00520-020-05874-3
Implementation of a clinic to facilitate the transition from pediatric to adult cancer survivorship care.
Authors: Smith Stephanie M , Jin Alexander , Simon Pam , Clayton Alison , Benedict Catherine , Liedtke Michaela , Muffly Lori S. , Schapira Lidia 
Published: June 2021

e13519 Background: Transitions from pediatric to adult care settings are challenging for adults with a history of complex childhood illness such as cancer. We developed a new clinical model to support young adult survivors of leukemia and bone marrow transplant (BMT) with transitioning from pediatric to adult focused survivorship care. Methods: We established the GREAT (Getting Regular Evaluations After Treatment) survivorship clinic as a collaboration between the adolescent/young adult (AYA) cancer program, pediatric oncologists, and specialists in adult hematologic malignancies. New patient appointments consist of two back-to-back visits: (1) a medical survivorship visit with a pediatric oncologist and an oncologist who specializes in hematologic malignancies/BMT to review the treatment history, medical issues, risk of late effects, and surveillance recommendations, and (2) an AYA-focused visit with a nurse practitioner to review fertility, education/career, and psychosocial concerns. Patients receive a treatment summary through the Passport for Care, based on pediatric survivorship guidelines. The clinic team then communicates with the patient’s primary care provider (PCP) or assists the patient with finding a PCP. Results: Since August 2020, we have seen 17 patients (12 telehealth, 5 in-person, 53% male, 47% non-Hispanic white, 41% Hispanic/Latino, 12% Asian). The median age at clinic visit was 28 years (range 24-39) and median time since treatment was 15 years (range 1-29). Patients were referred through the AYA cancer program: 8 had been regularly followed in the pediatric survivorship clinic, 2 had not been seen in pediatric oncology/survivorship for many years, 3 were treated as children but most recently seen by adult oncologists, and 4 were treated by adult oncologists and referred for AYA-specific survivorship care. Twelve (71%) patients had a PCP they see regularly, while 2 did not have a PCP and 3 were not sure. Communication with PCPs consisted of faxing the clinic note and calling the PCP’s office. All PCPs were receptive and expressed interest in receiving survivorship care recommendations; some preferred to order late effects surveillance imaging/labs, while others preferred the GREAT clinic team to do so, illustrating the value of two-way communication. Thirteen (76%) patients participated in post-clinic interviews. All stated they would recommend the clinic to others. Common themes from interviews included understanding more about their past treatment and having greater confidence managing their health. Conclusions: The model for facilitating care transitions was highly regarded by young adult cancer survivors and highlights opportunities for improving self-management and care coordination. Future directions include expanding to more cancer types, addressing barriers to primary care follow-up, and exploring shared care or co-management with PCPs.