bluuebunny/crossref_metadata_2025 huggingface dataset:
Efficacy of DAN-222, a novel investigational polymeric nanoparticle with topoisomerase I inhibitor, as monotherapy in breast cancer models and when combined with PARP inhibitor.
Authors: Wright Ashley P , Bradley Jodi D , Hagerty Timothy , Wyatt Emily A
Published: June 2021

1081

Background: Patients with BRCA-positive HER2-negative breast cancer benefit from PARP inhibitor therapy, but additional benefit is still desired. PARP inhibition alone does not prevent all mechanisms for repairing damage to DNA such as homologous recombination repair. An attractive combination for treating such patients would be combining a topoisomerase I inhibitor with a PARP inhibitor given the dual mechanism this would provide for DNA damage and inhibited repair, leading to tumor cell death. This combination has been tried in multiple phase 1 studies, but myelotoxicity prevented the combination from being evaluated further. DAN-222 is a novel investigational polymeric nanoparticle conjugated with camptothecin, a topoisomerase I inhibitor, that provides significant accumulation of drug in tumor tissues via the enhanced permeability and retention (EPR) effect and significantly reduced bone marrow exposure compared to native chemotherapy. These observations underscore the potential advantages of DAN-222 alone as well as in combination with other agents such as PARP inhibitors in solid tumors. Here, we report the effects of DAN-222 monotherapy and in combination with a PARP inhibitor on the growth inhibition in an HRD+ TNBC breast cancer (MDA-MB-436) and an HRD- ovarian (OVCAR3) xenograft mouse model. Methods: HRD+ breast cancer tumor cells (MDA-MB-436) were implanted into female NCr nu/nu mice and HRD- ovarian cancer tumor cells (OVCAR3) were implanted into female CB.17 SCID mice. Mice were randomized to vehicle or treatment arms until tumors reached 2000 mm3 or day 45 (MDA-MB-436) or 1000mm3 or day 45 (OVCAR3). The groups evaluated include multiple dose levels of DAN-222 as monotherapy and those also combined with niraparib. Results: Results were consistent in both the HRD+ and HRD- tumor models with profound dose-response of DAN-222 monotherapy inhibiting tumor growth. Additionally, synergy was demonstrated when DAN-222 was combined with niraparib, clearly evident with low doses of both products when used in combination. The table below highlights the synergy of the combination of DAN-222 at 0.3 mg/kg and niraparib at 25 mg/kg above each agent alone on the tumor growth inhibition in the MDA-MB-436 xenograft. Conclusions: Combining a PARP inhibitor with a topoisomerase I inhibitor delivered via this polymeric nanoparticle delivery system (DAN-222) has synergistic efficacy in both HRD+ and HRD- xenograft tumor models. These data support continued development of DAN-222 to treat solid tumors and its combination use with PARP inhibitors.[Table: see text]
Distant metastases after diagnosis: Racial disparities in breast cancer outcomes.
Authors: Blanter Julia , Ramer Ilana , Ray Justina , Gallagher Emily J. , Bickell Nina A. , Tiersten Amy
Published: June 2021

1084

Background: Black women diagnosed with breast cancer are more likely to have a poor prognosis, regardless of breast cancer subtype. Despite having a lower incidence rate of breast cancer when compared to white women, black women have the highest breast cancer death rate of all racial and ethnic groups, a characteristic often attributed to late stage at diagnosis. Distant metastases are considered the leading cause of death from breast cancer. We performed a follow up study of women with breast cancer in the Mount Sinai Health System (MSHS) to determine differences in distant metastases rates among black versus white women. Methods: Women were initially recruited as part of an NIH funded cross-sectional study from 2013-2020 to examine the link between insulin resistance (IR) and breast cancer prognosis. Women self-identified as black or white race. Data was collected via retrospective analysis of electronic medical records (EMR) between September 2020-January 2021. Distant metastases at diagnosis was defined as evidence of metastases in a secondary organ (not lymph node). Stage at diagnosis was recorded for all patients. Distant metastases after diagnosis was defined as evidence of metastases at any time after initiation of treatment. Univariate analysis was performed using Fisher’s exact test, multivariate analysis was performed by binary logistic regression, and results expressed as odds ratio (OR) and 95% confidence interval (CI). A p value <0.05 was considered statistically significant. Results: We identified 441 women enrolled in the IR study within the MSHS (340 white women, 101 black women). Median follow up time for all women was 2.95 years (median = 3.12 years for white and 2.51 years for black women (p=0.017)). Among these patients, 11 developed distant metastases after diagnosis: 4 (1.2%) white and 7 (6.9%) black (p=0.004). Multivariate analysis adjusting for age, race and stage at diagnosis revealed that black women were more likely to have distant metastasis (OR 5.8, CI 1.3-25.2), as were younger women (OR for age (years) 0.9, CI 0.9-1.0), and those with more advanced stage at diagnosis. Conclusions: Black women demonstrated a far higher percentage of distant metastases after diagnosis even when accounting for age and stage. These findings suggest that racial disparities still exist in the development of distant metastases, independent from a late-stage diagnosis. The source of existing disparities needs to be further understood and may be found in surveillance, treatment differences, or follow up.
U.S. radiation oncology and medical oncology department faculty diversity trends by sex and underrepresented in medicine status over five decades.
Authors: Kamran Sophia C. , Niemierko Andrzej , Vapiwala Neha
Published: June 2021

11010

Background: Academic faculty are critical in training future generations of oncologists to care for our increasingly diverse cancer patient population. It is unclear if the growing imperative to address disparities in racial/ethnic and gender representation in the medical field has resulted in corresponding progress in the composition of academic radiation and medical oncology (RO, MO) departments. Herein we report trends in faculty diversity, overall and by academic rank, among US radiation and medical oncologists over the past 5 decades. Methods: Data were acquired from the Association of American Medical Colleges (AAMC) Faculty Roster between 1970-2019 for academic RO and MO departments to determine sex and race/ethnicity trends over five decades. Underrepresented in Medicine (URM) was defined as individuals identifying as Black, Hispanic, and Native American. Linear regression models were used to estimate slopes and associated p-values. Results: Total faculty complements grew over time in both RO and MO departments. The number of URM female faculty increased by 0.85/year in RO and 0.79/year in MO (P-trend<0.001), compared to non-URM female faculty, which increased by 11.3/year in RO and 7.9 in MO (P-trend<0.001). URM male faculty increased by 1.4/year in RO and 1.1/year in MO (P-trend<0.001), compared to non-URM male faculty, which increased by 25.5/year for RO and 12.2/year for MO (P-trend<0.001). Males represented the majority of URM and non-URM faculty for both RO and MO. The proportion of females grew more than the proportion of URM faculty over the study period for both RO and MO. There were also significant differences in diversity by faculty rank. Although MO outperformed RO in terms of the proportion of female faculty members with more advanced rank, female faculty members had a lower academic rank than their male counterparts in both specialties. At every rank, there was a low number of URM faculty represented among both MO and RO (Table). Conclusions: Gender and racial/ethnic diversity of academic RO and MO faculty has increased over time but has not kept pace with the diversity of the US population served, particularly with respect to URM status. The proportion of female faculty in both specialties demonstrates more promising growth, and may inform measures to achieve similar progress in recruiting and retaining URM faculty in both MO and RO.[Table: see text]
Impact of COVID-19 on work-related fatigue and satisfaction among oncology providers in Latin America: An analysis of the HOLA COVID-19 study.
Authors: Velazquez Manana Ana I. , Bernabe Ramirez Carolina , Olazagasti Coral , Bergerot Paulo Gustavo , Soto Perez De Celis Enrique , Corona-Cruz Jose Francisco , Riano Ivy , Adaniel Christina , Ramirez Francisca , Anampa Mesias Jesus Del Santo , Cajina Carmen , Mena Evelin , Gracia Elias , Menendez Alvaro G. , Bezares Raimundo , Castillo Fernandez Omar Orlando , Duque Duran Liseth , Corrales Luis-Alberto , Bergerot Cristiane Decat , Duma Narjust
Published: June 2021

11014

Background: The well-being of oncology providers (OP) is in jeopardy with increasing workload, limited resources, and personal challenges that result from the COVID-19 pandemic. We aim to evaluate the impact of COVID-19 on work-related (WR) satisfaction and fatigue among OP in Latin America. Methods: We conducted an international cross-sectional online survey of OP practicing in Latin America. The survey was administered in English, Spanish, and Portuguese. Data was analyzed using descriptive statistics and Chi-square tests. Results: In August 2020, 704 OP from 20 Latin American countries completed the survey (77% of 913 who started the survey). Table outlines baseline characteristics. Higher frequency of WR fatigue (67% vs. 58%, p=0.010) and exhaustion (81% vs. 70%, p=0.001) were reported by OP who cared for patients with COVID-19, compared to OP who cared for patients without COVID-19. Providers that observed delays in referrals to radiation (p=0.002) and surgery (p=0.04) reported WR fatigue at higher rates than their counterparts. Higher exhaustion (p=0.016) and dissatisfaction (p=0.046) were reported by OP who lacked access to supportive services, as social work. A significantly higher proportion of women reported WR fatigue (72% vs. 56%, p=0.003) and exhaustion (86% vs. 68%, p=0.001), when compared to men. Women were more likely than men to endorse higher current levels of fatigue when compared to pre-COVID-19 (61% vs. 46%, p=0.0001). To reduce stress, women were more likely than men to cut the time spent watching the news (p=0.002). Both genders declined research collaborations and speaking opportunities. Conclusions: Fatigue and dissatisfaction with work-life were prevalent among OP in Latin America. Higher rates of WR fatigue were seen in women, OP caring for patients with COVID-19, and OP with patients who experienced cancer care delays. Our data imply that OP may be a prime target for psychosocial support, particularly as current challenges will continue for the foreseen future. Baseline characteristics (N=704).[Table: see text]
How to teach Breast ERAS protocols: Surgical residents’ perspectives and perioperative practices for mastectomy patients.
Authors: Jogerst Kristen , Coe Taylor , Gupta Nikita , Cronin Patricia , Fingeret Abbey , Pockaj Barbara A.
Published: June 2021

11033

Background: Breast enhanced recovery after surgery (ERAS) protocols emphasize multimodal analgesia to decrease pain and expedite home recovery, but variability remains for same-day discharge and pain management. The purpose of this qualitative study is to examine how residents learn and apply breast surgery ERAS protocols, how they conceptualize pain management for breast surgery patients, and what influences their decision to discharge a patient home on the day of surgery. Methods: A semi-structured interview guide was adapted from existing instruments in the pain management qualitative literature. Surgical residents who rotated on the breast surgery service within the previous 12 months were interviewed by a single researcher. Interviews were recorded, transcribed, de-identified, and independently inductively coded by two researchers. A codebook was developed and refined using the constant comparative method until interrater reliability (Cohen’s kappa) reached greater than 0.9. Codes were grouped into coding categories and explored for thematic analysis. Results: Twelve interviews were completed with plastic and general surgery residents. Participants spanned post-graduate years 1-4. Preferred discharge narcotic regimens for mastectomy patients ranged from 5-30 tablets of 5mg oxycodone and participants rarely reported the same quantity. Ultimately, 365 primary codes were collapsed into 26 parent codes, with a Cohen’s kappa of 0.93. Six emerging themes were identified. Three themes describe how participants learned through a mixture of templated care, formal education, and informal experiential learning. Two themes delineate how residents would teach breast surgery ERAS protocols: by emphasizing buy-in and by connecting the impetus behind ERAS with the implementation in daily workflow. One theme illustrates the patient-centered culture and how that impacts postoperative management and same-day discharges. Conclusions: Residents learn breast surgery ERAS and postoperative pain management from imitating their seniors, observing patient encounters, completing templated orders, and translating concepts from other ERAS services, more so than from a formal lecture. When implementing new same-day discharge protocols for mastectomy patients, it is important to consider how informal learning and local culture influence postoperative pain management and discharge rates.
Results of NC-6300 (nanoparticle epirubicin) in an expansion cohort of patients with angiosarcoma.
Authors: Riedel Richard F. , Chua Victoria S. , Kim Ted , Dang Jonathan , Zheng Kitty , Moradkhani Ania , Osada Atsushi , Chawla Sant P.
Published: June 2021

11543

Background: NC-6300 is a polymeric micelle exhibiting increased tumor accumulation compared to small-molecule epirubicin through enhanced pharmacokinetics and controlled release within the tumor through a pH-sensitive linker conjugated to epirubicin. In a phase 1b trial, which accrued twenty-nine patients with various types of sarcoma as well as solid tumors, observed dose-limiting toxicities included thrombocytopenia, stomatitis, lung infection, and febrile neutropenia. The maximum tolerated dose and the recommended phase 2 dose were determined to be 185 mg/m2 and 150 mg/m2, respectively. The objective response rate (ORR) in soft tissue sarcoma subset (n = 17) was 18% with both angiosarcoma patients achieving partial response. To further evaluate the anti-tumor activity of NC-6300 in angiosarcoma, we conducted an expansion cohort of 10 additional angiosarcoma patients. Methods: Eligible patients, at least age 18 years old, with histologically confirmed angiosarcoma, including cutaneous and non-cutaneous variants, not amenable to curative treatment with surgery or radiotherapy were included. No more than two lines of prior systemic therapy were allowed. NC-6300 was administered at the dose of 150 mg/m2 intravenously on Day 1 of a 21-day cycle. Treatment was continued until disease progression or unacceptable toxicity. Disease assessment was performed every 6 weeks using RECIST v1.1. The primary endpoint was median progression-free survival (mPFS). Results: Ten patients (cutaneous: 2 pts; non-cutaneous: 8 pts) were enrolled and deemed evaluable. Median line of prior systemic treatment in the advanced disease setting was 1.0 and seven patients (70%) received prior anthracycline therapy. Objective response rate (ORR) was 30% (cutaneous: 1 pt, non-cutaneous: 2 pts) and mPFS was 5.4 months (95% CI: 1.2-NA). Across all angiosarcoma patients included in the phase 1 portion and expansion cohort (phase 1b portion: 2 pts, expansion cohort: 10 pts), ORR and mPFS was 42% and 7.3 months (95%CI: 3.3-NA), respectively. All patients enrolled in the expansion cohort experienced grade 3/4 AEs and no treatment related death was observed. Most frequent grade 3/4 AEs were neutropenia without fever (80%), thrombocytopenia (40%), anemia (20%) and leukopenia (20%). AEs led to NC-6300 dose reduction and medication withdrawal were seen in 70% and 10% of patients, respectively. Conclusions: Promising anti-tumor activity was observed in this cohort of patients with cutaneous and non-cutaneous angiosarcoma. The safety profile of this expansion cohort was consistent with previous clinical study results of NC-6300. Our study results warrant further development of NC-6300 for angoisarcoma. Clinical trial information: NCT03168061.
Treatment patterns, and survival of patients with metastatic undifferentiated pleomorphic sarcoma: A National Cancer Database (NCDB) study.
Authors: Rangoonwala Hussain I , Dahl Mary Elizabeth , Gootee Jonathan , Gundepalli Sai Giridhar , Aurit Sarah J , Silberstein Peter T.
Published: June 2021

11561

Background: Undifferentiated Pleomorphic Sarcoma (UPS) is regarded as one of the most common types of soft tissue sarcoma. Although prior studies have highlighted its metastatic potential, there have been no database studies that delineate the clinical/social characteristics and outcomes in UPS patients with metastatic disease. Utilizing the National Cancer Database (NCDB), we want to observe the complex interplay between treatment approaches and non-biologic modifiers. Methods: 737 patients diagnosed with metastatic UPS above the age of 17 years between 2004 and 2015 were identified utilizing the NCDB. Patients were identified with ICD-O-3 morphologic code 8830/3. Demographic factors (Race/ethnicity, biological sex, Median household income/education at zip code level, facility type, insurance) were studied in relation to the type of treatment they received: No treatment; chemotherapy only; chemotherapy and radiation therapy; chemotherapy and surgery; chemotherapy, surgery, and radiation; radiation therapy and/or surgery; and other treatments. Survival tables were utilized to generate 1-year and 3-year survival rates, and Kaplan-Meier method with associated log-rank list was used to examine the differences in unadjusted survival. Results: Approximately 17% of our cohort were left untreated, whereas 83% received treatment. Patients who were untreated were likely to be older, on Medicare, and had a Charlson-Deyo (CD) score of 2 or above. Patients who were more likely to receive treatment were younger educated males with private insurance, residing in areas of higher income, and receiving care at an academic program. Patients who only received chemotherapy were more likely to belong to areas with lower income and had a CD score of 0. Patients who received a combination of chemotherapy, surgery, and radiation therapy were more likely to belong to areas of high income, private insurance owners, and received care at an academic facility. Patients who received chemotherapy with surgery and without radiation therapy were more likely to be younger males from areas of highest income, and received care at an academic facility. Patients who had better unadjusted survival were younger educated patients on private insurance or Medicaid, with distant lymph nodes metastases at diagnosis, who received a combination of chemotherapy, radiation therapy and surgery at an academic program. Patients who had poorer unadjusted survival were untreated older patients on Medicare, and with bone metastases. Conclusions: This is one of the most comprehensive studies involving patients with metastatic UPS that analyzes demographic variables in relation to the treatment approach. Some of the major determinants that influence outcomes in these patients included age, insurance status, treatment at academic facility, CD score, and type of metastases at diagnoses.
The comparative effectiveness of direct oral anti-coagulants and low molecular weight heparins for prevention of recurrent venous thromboembolism in cancer: The CANVAS pragmatic randomized trial.
Authors: Schrag Deborah , Uno Hajime , Rosovsky Rachel Pam Greenerger , Rutherford Cynthia , Sanfilippo Kristen Marie , Villano John L. , Drescher Monic R , Jayaram Nagesh H. , Holmes Chris E. , Feldman Lawrence Eric , Zattra Ottavia , Cronin Christine , Basch Ethan M. , Weiss Anna , Connors Jean M. ,   CANVAS Investigators
Published: June 2021

12020

Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWH for preventing recurrent VTE but have higher risk of bleeding. However, the balance of benefits and burdens remains uncertain. Objective: The CANVAS pragmatic trial compared recurrent VTE, bleeding and death in cancer patients following an initial VTE treated with either DOAC or LMWH therapy. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial, with randomized and preference cohorts. Between 12/16 and 4/20, 671 participants were randomized and followed for 6-months. Between 12/16 and 12/17, 140 participants declined randomization, chose their preferred anticoagulant and were followed for 6-months. The preference cohort was closed when predetermined stopping criteria were met. Final follow-up was 11/30/20. Randomized patients were assigned 1:1 to receive either a DOAC or a LMWH. If assigned to LMWH, transitions to warfarin were allowed. Physicians and patients could choose among any DOAC or LMWH. Doses were suggested based on FDA-approved labeling but not mandated. Patients from 67 practices in the US with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of symptomatic or radiographically detected VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified-into to treat popululation, (all subjects who received study drug). The 1° outcome was recurrent VTE. The aim was to establish noninferiority of anticoagulation with a DOAC as defined by the upper limit of the 2-sided 90% CI for the difference in the event rate at 6 months of < 3%. Secondary outcomes included death and bleeding. Hypothesis testing included only the randomized cohort but propensity score adjusted results for the preference and combined cohorts are also shown. Results: The non-inferiority criteria for recurrent VTE was met. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in a noninferior risk of recurrent VTE with no differences in rates of bleeding or death in randomized patients. Clinical trial information: NCT02744092. [Table: see text]
Real-world outcomes in older adults treated with immunotherapy: A United Kingdom multicenter series of 2,049 patients.
Authors: Olsson-Brown Anna Claire , Baxter Mark , Dobeson Caroline , Feeney Laura , Lee Rebecca , Maynard Alec , Mirza Shagufta , Parikh Shefali , Rodgers Lisa Jane , Salawu Abdulazeez , Shotton Rohan , Tinsley Nadina , Heseltine Jonathan , Cotton Jenny , Hughes Daniel , Zhao Steven , Parry James , Jones Christopher , Rowe Michael , Tivey Ann ,   The U.K. National Oncology Trainee Collaboration for Healthcare Research (NOTCH)
Published: June 2021

12026

Background: Immune checkpoint inhibitor (ICI) therapy is now commonly used in a range of tumours and settings. Most data relating to outcomes and rates of immune-related adverse events (irAE) is derived from clinical trial or registry populations and small case series. Limited data exist for patients aged > 75 years. Here we present a multi-centre, real-world analysis of the outcomes and incidence of irAEs in older adults managed within a single comprehensive public health service. We also compare these outcomes to younger patients in the same cohort. Methods: A retrospective analysis of 2049 patients treated with ICIs was undertaken across 12 centres. All patients were managed within the UK National Health Service outside of a trial setting between June 2016 and September 2018. Patients received either ICI monotherapy (MT) or duel combination ICI therapy (CT) for malignant melanoma (MM), non-small cell lung cancer (NSCLC) or renal cell cancer (RCC). Data were collected using a standardised, collection tool. IrAEs ≥ grade 2 or all-grade endocrinopathies were recorded as per the Common Terminology Criteria for Adverse Events (V5) (CTCAE). Statistical analyses were performed using T-tests, Mann-Whitney and Chi-squared. Kaplan-Meier analysis and log-rank test were used for overall survival (OS) analysis. Results: 409 (20%) of patients were aged > 75 years(a), 1413 (69%) aged 50-75(b) and 227 (11.1%) aged < 50(c). There was no difference in sex, ethnicity or PD-L1 status (in the NSCLC cohort) between groups. Older patients were less likely to receive combination therapy (3%(a) v 13%(b) v 34%(c), p < 0.001). There was no difference in median OS across age groups in the cohort as a whole (p = 0.822) or for the individual tumour groups when treated with single agent ICI. Across the total cohort patients aged > 75 had no increased risk of any irAE (35%(a) v 33%(b) v 41%(c),p = 0.074). However there was an increase in irAEs in older patients treated with MT (36%(a) v 26(b) v 25%(c), p = 0.011) However there was no difference in the > 75s with regard to severe (G3/4) toxicity, toxicity type, admission or discontinuation due to toxicity in the aPD-1 group. In the overall cohort younger patients were more likely to develop irAEs and be admitted. Conclusions: Patients aged > 75 years treated with anti-PD1 therapy in the standard of care setting derive similar survival benefit to younger patients. There was no increase in ≥G3 toxicity. Our data support the safety of single agent aPD-1 ICI therapy in older adults and provide reassurance relating to the impact of toxicity.[Table: see text]
Investigating the prevalence and risk of chemotherapy-induced neuropathy among cancer patients.
Authors: Jordache Philip , Danahey Keith , Reizine Natalie Marie , O'Donnell Peter H.
Published: June 2021

12078

Background: Neuropathy is a common side effect of some chemotherapies. Clinical and other factors may confer neuropathy risk, but rates and risk factors across neuropathy-causing chemotherapies are incompletely understood. Methods: We examined 15 chemotherapy drugs known to confer neuropathy. Within a broad population of cancer patients who underwent treatment with these agents at the University of Chicago Medicine between 2012-2018, we determined prevalence of chemotherapy-induced neuropathy, defined as patients with initiation of a neuropathy treatment medication (amitriptyline, carbamazepine, duloxetine, gabapentin, or pregabalin) after starting chemotherapy. We then analyzed chemotherapy-induced neuropathy risk for different drugs and based on clinical demographic factors. Results: We analyzed 7,866 patients (65.3% White, 53.7% Female, 27.6% Black/African-American, 5.6% Hispanic or Latino, 3.1% Asian/Mideast Indian, 2.4% More than one Race, 0.2% American Indian or Alaska Native, 0.2% Native Hawaiian/Other Pacific Islander). The overall prevalence of chemotherapy-induced neuropathy was 24.3% across our patient population. Black/African-American patients had an increased risk of chemotherapy-induced neuropathy compared to the rest of the patient cohort (OR 1.4, 95% CI 1.3-1.6, P = 1.6e-10). Females also exhibited an increased risk of chemotherapy-induced neuropathy compared to males (OR 1.2, 95% CI 1.1-1.3, P = 1.5e-3). Conclusions: Certain chemotherapy agents confer substantial risk of chemotherapy-induced neuropathy, and risk is increased in Blacks and females. Future work will investigate additional risk-modifying factors including the potential role of germline polymorphisms on chemotherapy neuropathy risk.[Table: see text]
Receipt of palliative care (PC) in acute myeloid leukemia (AML) using data from the National Cancer Database (NCDB).
Authors: Chan Bryan Lee , Taylor Allison O. , Doucette Kimberley , Ahn Jaeil , Ma Xioyang , Lai Catherine
Published: June 2021

12087

Background: AML is an aggressive disease with high mortality and significant impact on quality of life. Palliative care (PC) services have become integral in managing patient’s symptoms during treatment as well as at the end of life. We hypothesize that socioeconomic factors such as achieving higher levels of education, and higher incomes, increases the odds of receiving PC. Methods: This is a retrospective analysis using NCDB data of 124,988 newly diagnosed non-M3 AML patients over 18 yrs from 2004-2016. Unadjusted and multivariate adjusted logistic regression analysis (MVA) evaluated the impact of socioeconomic variables on the receipt of PC. In the MVA, we adjusted for demographic variables and facility characteristics including facility type, facility volume, age, sex, race, Hispanic origin, income, education, urban/rural residence, Charlson-Deyo score, great circle distance, Medicaid expansion status state group, and insurance status. Patients with Medicaid expansion < 39yrs were excluded due to low patient numbers. Results: For the 124,988 patients, median age was 63 years (range 18-90) with 54% males and 86% White. 25% of patients lived in regions with the highest education level defined as < 6.3% of adults over 25 without a high school diploma. 35% of patients had a household income bracket of ≥ $63,333. A total of 3% of patients received PC. MVA showed that patients within the highest income bracket of ≥ $63,333 were less likely to have used PC services (OR 0.82, p < 0.01). More educated patients residing in regions with < 6.3% of adults without a high school diploma had higher odds of receiving PC treatment compared with patients with less education (OR 1.23, p < 0.01). Residence in states with Medicaid expansion in January 2014 or later was associated with greater utilization of PC services (Jan 2014 expansion states: OR 1.33 and late expansion states/after Jan 2014: OR 1.43, p < 0.01) compared to residence in non-expansion states. No difference was seen across races; except Hispanics with decreased use of PC services(OR 0.8, p = 0.022). Conclusions: In this large cohort, a small percentage of patients received PC. Higher education was associated with higher likelihood of using PC, while, surprisingly, higher income was associated with a lower likelihood of PC. Additionally, the higher use of PC services with Medicaid expansion suggests a broad impact of public health insurance in providing increased access to PC services.
Implementation of electronic patient-reported outcomes for symptom monitoring in a large multi-site community oncology practice.
Authors: Patt Debra A. , Wilfong Lalan S. , Hudson Kathryn Elizabeth , Patel Amila , Books Holly , Ortega Lance , Pearson Ben , Boren Rhonda , Patil Shrutika , Olson-Celli Kristin , Basch Ethan M.
Published: June 2021

12103

Background: Among patients receiving chemotherapy, symptomatic adverse event monitoring with electronic patient-reported outcomes (ePRO) is associated with improved clinical outcomes, satisfaction, and compliance with therapy. Standard approaches for ePRO implementation are not established warranting evaluation in community cancer practices. Objective: Evaluate implementation of ePRO symptom monitoring across a large multi-site community oncology practice network. Methods: Patients initiating a new systemic therapy at one of 210 practice sites in the Texas Oncology Practice were invited to use in the Navigating Cancer ePRO platform, with rolling implementation from July-December 2020. Participating patients received a weekly prompt by text message or email (patient choice) to self-report common symptoms and well-being via web or smartphone. Severe self-reported symptoms triggered a real-time notification alert to nursing triage to address the symptom. Enrollment and compliance were systematically tracked weekly with evaluation of barriers and facilitators to adoption and sustainability. Results: 4375 patients planning systemic treatment enrolled and participated, with baseline characteristics are shown in Table 1. 73% (1841/2522) of enrolled patients with follow up completed at least one ePRO assessment, and among these individuals, 65% (8762/25061) of all available weekly ePRO assessments were completed. Over a 10-week period, compliance with weekly symptom reporting declined from 72% to 52%. Patients on oral therapy had higher compliance rates overall. Barriers currently being addressed include lack of a second reminder text/email prompt, inconsistent discussion of reported ePROs by clinicians at visits, and COVID-related changes in workflow. Facilitators included patient and staff engagement on the importance of PROs for symptom management. Conclusions: ePROs can be effectively implemented in community oncology practice. Utilization of ePROs is high, but diminishes over time without attention to barriers. Ongoing work to address barriers and optimize compliance are underway.[Table: see text]
Evaluating a high-dimensional machine-learning model to predict hospital mortality among elderly cancer patients.
Authors: Qiao Edmund , Qian Alexander , Nalawade Vinit , Lee Terrence C. , Kotha Nikhil V. , Voora Rohith S. , Dameff Christian , Coyne Christopher John , Murphy James Don
Published: June 2021

1512

Background: Elderly hospitalized cancer patients face high risks of inpatient hospital mortality. Identifying patients at high risk of hospital mortality could help with risk stratification, and potentially help inform future interventions aimed at improving outcomes. We evaluated the predictive capacity of a high-dimensional machine-learning prediction tool to predict inpatient mortality, and compared the performance of this new tool to existing prediction indices. Methods: We identified cancer patients 75 and over who presented to an emergency department (ED) and were subsequently hospitalized from the National Emergency Department Sample (NEDS) between 2016 and 2018. We used an extreme gradient boosting approach to predict the risk of death during hospitalization. Model covariates included patient demographics, hospital characteristics, and International Classification of Diseases, version 10 (ICD-10) diagnosis codes recorded during the ED visit. The data were split 75%/25% into training/testing datasets. We constructed the model with training data and evaluated performance within the test data using area under the curve (AUC), with an AUC of 1.0 indicating perfect prediction. We compared the performance of this risk prediction model to standard prediction indices including the Hospital Frailty Risk Score, modified 5-item frailty index, and Charlson comorbidity index. Results: We identified 1,892,690 weighted-hospitalizations among elderly cancer patients, of which 133,379 (7.0%) who died in the inpatient setting. Our final predictive model included 238 features, which contained 5 demographic variables, 3 hospital characteristics, and 230 ICD-10 diagnosis codes. The predictive model achieved an AUC of 0.92. Our comparator models including the Hospital Frailty Risk Score, modified 5-item frailty index, and Charlson comorbidity index achieved AUCs of 0.67, 0.56, and 0.60, respectively. Conclusions: Using a high-dimensional machine-learning model enabled a high level of precision in predicting hospital mortality among elderly cancer patients, substantially out-performing existing prediction indices. High-dimensional prediction models show promise in helping to identify patients at risk of severe adverse outcomes, though additional validation is needed as well as research studying how to implement these tools into practice.
Insurance coverage and care affordability in cancer survivors in 2016-2019.
Authors: Barnes Justin Michael , Adjei Boakye Eric , Schootman Mario , Graboyes Evan Michael , Osazuwa-Peters Nosayaba
Published: June 2021

1520

Background: The Affordable Care Act (ACA) led to improvements in insurance coverage and care affordability in cancer patients. However, the uninsured rate for the general US reached its nadir in 2016 and has been increasing since. We aimed to quantify the changes in insurance coverage and rate of care unaffordability in cancer survivors from 2016 to 2019. Methods: We queried data from the Behavioral Risk Factor Surveillance System (2016-2019) for cancer survivors ages 18-64 years. Outcomes of interest were the percentage of cancer survivors reporting insurance coverage and the percentage reporting cost-driven lack of care in the previous 12 months. Survey-weighted linear probability models adjusted for covariates (age, sex, race/ethnicity, income, education, marital status, and state Medicaid expansion status) were utilized to estimate the average yearly change (AYC) in the outcomes across 2016-2019. Mediation analyses evaluated the mediating effect of insurance coverage changes on changes in cost-driven lack of care. Results: A total of 178,931 cancer survivors were identified among the survey respondents. The percentage of insured cancer survivors between 2016 and 2019 decreased from 92.4% to 90.4% (AYC: -0.54, 95% CI = -1.03 to -0.06, P =.026). This translates to an estimated 164,638 cancer survivors in the United States who lost insurance coverage in the study period. There were decreases in private insurance coverage (AYC: -1.66, 95% CI = -3.1 to -0.22, P =.024) but increases in Medicaid coverage (AYC: 1.14, 95% CI = 0.03 to 2.25, P =.043). The decreases in any coverage were largest in individuals with income < 138% federal poverty level (FPL) (AYC: -1.14, 95% CI = -2.32 to 0.04, P =.059; compared to > 250% FPL, Pinteraction=.03). Cost-driven lack of care in the preceding 12 months among cancer survivors increased from 17.9% in 2016 to 20% in 2019 (AYC: 0.67, 95% CI = 0.06 to 1.27, P =.03), which translates to an estimated 167,184 survivors in the US who skipped care due to costs. Changes in insurance coverage mediated 27.5% of the observed change in care unaffordability overall (p =.028) and 65.7% in individuals with income < 138% FPL relative to > 250% FPL (p =.045). Conclusions: Between 2016 and 2019, about 165,000 cancer survivors in the United States lost their insurance coverage and a similar number may have skipped needed care due to cost. Loss of insurance coverage was mostly among individuals with low socioeconomic status. Interventions to improve health insurance coverage among cancer survivors, such as the recent executive order to strengthen the ACA and further efforts promoting Medicaid expansion in additional states, may be important factors to mitigate these trends.
Are National Cancer Institute Cancer Centers (NCI-CC) providing adolescents and young adults (AYA) with cancer focused clinical services? A national survey.
Authors: Daunov Katherine , Daunov Michael , Noskoff Kara , Gan Hilary , Davies Simon , Larbi Olivia , Farrell Megan , Hadley Whitney , Baffa Amelia Renee , Giesel Jennifer , Egler Rachel A. , Huang Alex Yee-Chen , Letterio John J. , Lee Richard T.
Published: June 2021

1534

Background: AYA patients with cancer have inferior outcomes compared to their pediatric and adult counterparts. The NCI recommends they be treated by AYA focused healthcare professionals within an AYA oncology program. This survey captures the current landscape of AYA oncology care in the United States. Methods: An online survey was sent to 272 cancer centers in September 2020, in coordination with Teen Cancer America and included all clinically designated NCI-CC. The survey asked about the presence of an AYA program, types of patients, dedicated resources, clinical space, type of providers, associated support services, educational efforts, importance of AYA oncology care, and how well these services are provided. Results: In total, we received 93 responses, a 34% response rate, including 50 NCI centers, a 72% response rate. Only half (49%) of NCI-CC reported having an AYA program, and 70% were started in the past 5 years. One-third (32%) of centers reported plans to start an AYA program. Most programs included patient ages from ≥15 (56%) to ≤39 (63%) with a variety of cancers – most commonly hematologic (49%) and sarcoma (49%) and least commonly lung (36%), breast (38%), and head and neck cancer (38%). AYA programs are generally embedded in both adult and pediatric oncology services (63%). On average, cancer centers reported seeing 25-50 new AYA patients/month and 100-200 follow-up visits/month. Few programs reported a dedicated inpatient space (4%) or outpatient space (9%). Most NCI-CC have supportive services available for all oncology patients, but fewer of these services were dedicated specifically to AYA patients: navigators (92% vs. 71%), social work (98% vs. 57%), psycho-oncology (96% vs. 54%), dietician (98% vs. 24%), physical therapy (98% vs. 18%), chaplaincy (98% vs. 18%), and child life (83% vs. 26%). Other services available to the AYA population included sexual health (62%), academic support (62%), and career resources (36%). A minority of centers (30%) provided AYA training to their staff. A majority of NCI-CC felt AYA programs were important-very important (60%). They reported providing good-excellent overall AYA care (59%), but this dropped to 22% for sexual health and education of staff, which was relatively consistent across centers (Table). Conclusions: This survey is the first ever national survey to assess AYA oncology programs. Despite greater emphasis on the AYA cancer population, only half of NCI-CC report having a dedicated program, and areas of improvement include education of staff and sexual health services for patients. Self-report of providing good to excellent AYA care in specific areas.[Table: see text]
Determinants of enhanced vulnerability to Covid-19 in U.K. cancer patients: Results from the OnCovid study.
Authors: Pinato David James , Scotti Lorenza , Gennari Alessandra , Colomba Emeline , Sita-Lumsden Ailsa , Loizidou Angela , Zambelli Alberto , Bower Mark , Salazar Soler Ramon , Bertuzzi Alexia Francesca , Brunet Joan , Generali Daniele Giulio , Grisanti Salvatore , Rizzo Gianpiero , Ottaviani Diego , Felip Eudald , Prat Aleix , Tabernero Josep , Diamantis Nikolaos , Cortellini Alessio ,   OncoVid study group
Published: June 2021

1574

Background: Despite high contagiousness and rapid spread, SARS-Cov-2 has led to heterogeneous outcomes across affected nations. Within Europe, the United Kingdom is the most severely affected country, with a death toll in excess of 100.000 as of February 2021. We aimed to compare the national impact of Covid-19 on the risk of death in UK cancer patients versus those in continental Europe (EU). Methods: We performed a retrospective analysis of the OnCovid study database, a European registry of cancer patients consecutively diagnosed with Covid-19 in 27 centres from February 27 to September 10, 2020. We analysed case fatality rates and risk of death at 30 days and 6 months stratified by region of origin (UK versus EU). We compared patient characteristics at baseline, oncological and Covid-19 specific therapy across cohorts and tested these in multivariable Cox regression models to identify predictors of adverse outcome in UK versus EU patients. Results: Compared to EU patients (n = 924), UK patients (n = 468) were characterised by higher case fatality rates (40.38% versus 26.5%, p < 0.0001), higher risk of death at 30 days (hazard ratio, HR 1.64 [95%CI 1.36-1.99]) and 6 months after Covid-19 diagnosis (47.64% versus 33.33%, p < 0.0001, HR 1.59 [95%CI 1.33-1.88]). UK patients were more often males, of older age and more co-morbid than EU counterparts (p < 0.01). Receipt of anti-cancer therapy was lower in UK versus EU patients (p < 0.001). Despite equal proportions of complicated Covid-19, rates of intensive care admission and use of mechanical ventilation, UK cancer patients were less likely to receive anti-Covid-19 therapies including corticosteroids, anti-virals and interleukin-6 antagonists (p < 0.0001). Multivariable analyses adjusted for imbalanced prognostic factors confirmed the UK cohort to be characterised by worse risk of death at 30 days and 6 months, independent of patient’s age, gender, tumour stage and status, number of co-morbidities, Covid-19 severity, receipt of anti-cancer and anti-Covid-19 therapy. Rates of permanent cessation of anti-cancer therapy post Covid-19 were similar in UK versus EU. Conclusions: UK cancer patients have been more severely impacted by the unfolding of the Covid-19 pandemic despite societal risk mitigation factors and rapid deferral of anti-cancer therapy. The increased frailty of UK cancer patients highlights high-risk groups that should be prioritised for anti-SARS-Cov-2 vaccination. Continued evaluation of long-term outcomes is warranted.
Can COV Direct: Effectiveness of a tele-medicine self- care interventions for cancer survivors during COVID 19 pandemic.
Authors: Warrier Narayanankutty Edavalath , Sankar Uma V , P. S. Sreedharan , Parameswaran Prasanth V. , K. V. Sajeevan , V Nirmal
Published: June 2021

1583

Background: Good mental health improves the overall quality of life. Anxiety and depression in post-treatment cancer survivors is common and can affect adversely on the individual. CanCovDirect is a novel, tele-medicine self-care intervention for cancer survivors. We practiced a randomized controlled superiority trial to compare CanCovDirect with usual standard care (SC) in this population.Methods: Individuals completing cancer treatment within the past 3 years who had symptoms with or without anxiety or depression were recruited from clinical and community settings in Northern Kerala. We allocated the participants using block randomization (CanCovDirect plus SC or to SC alone). Assessments of anxiety and depression severity (Centre for Epidemiological Studies-Depression scale [CES-D]; primary outcome) and secondary outcomes anxiety symptoms (Hospital Anxiety and Depression Scale) health-related quality of life (Short Form Survey-12 mental and physical component summaries), were conducted at baseline, as well as 3 and 6 months (primary time point). Analyses of outcomes were adjusted for covariates using linear regression. Results: Participants recruited between June 2020 and November 2020 were randomly assigned to CanCovDirect (n = 152) or SC (n = 152). Among 350 participants randomly assigned, 304 (86.85%) completed the primary outcome at 6 months. CanCovDirect participants reported less severe anxiety and depressive symptoms on the CES-D than SC participants at 6 months, adjusted effect size (ES) 1.68 (95% CI, 1.28 to 2.05). CanCovDirect participants also had significantly greater quality of life compared with SC. Exploratory analysis suggested that types of cancer was a modifier of the primary outcome (interaction term P value =.04); the intervention was effective in women (ES, 0.62; 95% CI, −0.45 to 0.89). Conclusions: CanCovDirect is an essential method of managing mild-moderate depression and anxiety symptoms in cancer survivors.