bluuebunny/crossref_metadata_2025_split huggingface dataset:
COVID-related anxiety is prevalent and accurately reflects serious COVID risks in breast cancer patients.
Authors: Weiss Marisa C. , Kjelstrom Stephanie , Buckley Meghan , Leitenberger Adam , Jenkins Melissa , Aliano Ruiz Katherine , Berk Alexandra , Manasseh Donna-Marie , Larson Sharon 
Published: June 2021

12053 Background: A current cancer diagnosis is a risk factor for serious COVID-19 complications (CDC). In addition, the pandemic has caused major disruptions in medical care and support networks, resulting in treatment delays, limited access to doctors, worsening health disparities, social isolation; and driving higher utilization of telemedicine and online resources. Breastcancer.org has experienced a sustained surge of new and repeat users seeking urgent information and support. To better understand these unmet needs, we conducted a survey of the Breastcancer.org Community. Methods: Members of the Breastcancer.org Community were invited to complete a survey on the effects of the COVID-19 pandemic on their breast cancer care, including questions on demographics, comorbidities (including lung, heart, liver and kidney disease, asthma, diabetes, obesity, and other chronic health conditions); care delays, anxiety due to COVID-related care delays, use of telemedicine, and satisfaction with care during COVID. The survey was conducted between 4/27/2020-6/1/2020 using Survey Monkey. Results were tabulated and compared by chi square test. A p-value of 0.05 is considered significant. Data were analyzed using Stata 16.0 (Stata Corp., Inc, College Station, TX). Results: Our analysis included 568 breast cancer patients of whom 44% had ≥1 other comorbidities associated with serious COVID-19 complications (per CDC) and 37% had moderate to extreme anxiety about contracting COVID. This anxiety increased with the number of comorbidities (p=0.021), age (p=0.040), and with a current breast cancer diagnosis (p=0.011) (see table). Anxiety was significantly higher in those currently diagnosed, ≥65, or with ≥3 other comorbidities, compared to those diagnosed in the past, age <44, or without other comorbidities. Conclusions: Our survey reveals that COVID-related anxiety is prevalent at any age regardless of overall health status, but it increased with the number of other comorbidities, older age, and a current breast cancer diagnosis. Thus, reported anxiety is proportional to the risk of developing serious complications from COVID. Current breast cancer patients of all ages—especially with other comorbidities—require emotional support, safe access to their providers, and prioritization for vaccination.[Table: see text]
Prevalence and predictors of peripheral neuropathy after chemotherapy: Outcomes from the Detroit Research on Cancer Survivorship (ROCS) cohort.
Authors: Sreeram Kalyan , Seaton Randell , Kamgar Mandana , Assad Hadeel , Greenwald Mark K. , Ruterbusch Julie J. , Beebe-Dimmer Jennifer Lynn , Schwartz Ann G. , Simon Michael S. 
Published: June 2021

12069 Background: Increased life expectancy for cancer survivors following advances in treatment has led to a greater likelihood of developing long-term complications. Among them is chemotherapy-induced peripheral neuropathy (CIPN), which adversely impacts the functional capacity of survivors. We assessed prevalence and predictors of CIPN in a cohort of African-American (AA) cancer survivors. Methods: The study population included 633 breast, colorectal, prostate and lung cancer survivors who received chemotherapy and participated in the Detroit Research on Cancer Survivorship (ROCS) study. Presence of CIPN was based on self-reported pain, numbness or tingling in the hands or feet, occurring either for the first time or worsening after chemotherapy. If participants reported continued CIPN at the time of survey, their symptoms were reported as persistent. CIPN severity was self-reported as mild, moderate or severe. Logistic regression analysis was used to evaluate socio-demographic and clinical factors (including 12 common comorbid conditions) associated with CIPN prevalence, persistence and severity. Results: Overall, 67% of the cohort reported CIPN at a mean time of 25.3 months (range 2-74 months) after cancer diagnosis, and 51% reported persistent CIPN. The distribution of CIPN severity consisted of 32.2% with mild, 30.8% with moderate, and 36.9% with moderate to severe symptoms. Diagnosis of primary breast (OR 3.99, 95% CI 1.52-10.46) or colorectal cancers (OR 5.24, 95% CI 2.17-12.69) conferred greater CIPN prevalence relative to a diagnosis of prostate cancer. The presence of each additional comorbid condition among those outlined in the survey also conferred a 20% greater prevalence of CIPN (OR 1.2, 95% CI 1.03-1.39). Similar trends were seen among those who reported persistent CIPN. Using age > 65 at diagnosis as the reference group, age < 50 (OR 2.64, 95% CI 1.43-4.88) and age 51-64 (OR 1.96, 95% CI 1.14-3.35) resulted in an increased risk of moderate or severe compared to mild CIPN. Conclusions: In the Detroit ROCS cohort, CIPN was reported in two-thirds of cancer survivors receiving chemotherapy. Out of them, more than one-third reported moderate to severe symptoms, more commonly seen among those age < 65. Consideration of CIPN as a prominent long-term complication of cancer treatment should play a role in treatment decisions and development of new chemotherapy regimens.
The moderating role of informal caregiver’s involvement on the relationship between patient activation and adherence to treatment: Implications for self-management intervention in cancer care.
Authors: Acquati Chiara , Hibbard Judith , Miller-Sonet Ellen , Zhang Anao , Ionescu Elena 
Published: June 2021

12083 Background: With increasing demands for a more active role on the part of individuals with cancer and their families in cancer care, patient activation (PA) is emerging as a key factor to promote self-management, adherence to treatment, and satisfaction with treatment planning. The present work investigated the relationship between patient activation and treatment decision making. Given the role informal caregivers play on patient-reported outcomes, it was additionally assessed whether caregiver involvement acted as a moderator of this relationship. Methods: Survey data collected from 504 cancer survivors recruited through online consumer panels were utilized. The survey contained questions concerning treatment options, quality of life, adherence to treatment, next to presence and involvement of informal caregivers. Additionally, the Patient Activation Measure (PAM), sociodemographic and clinical questions were included. A path analysis Structural Equation Modeling (SEM) controlling for covariates was used to examine the relationship between Patient Activation Measure (PAM), caregiver involvement, and the identified outcomes. Moderator analysis was conducted using multiple group SEM. Results: Respondents were mostly women (57.1%), non-Hispanic white (72.9%), middle aged or older adults (68% ≥ 55 y.o.) The four largest cancer type groups were prostate (16.3%), early stage breast (9.7%), gynecological (8.9%), and colorectal cancer (8.3%). Most of the respondents were diagnosed more than 4 years earlier (52.0%). Participants were evenly split between those who received care at an academic cancer center (29.4%) and those treated at community hospital (31.7%). Patient activation was significantly associated with treatment planning being reflective of survivors ’goals and values ( p < 0.001); adherence to treatment ( p = 0.011); and satisfaction ( p < 0.001). Caregiver’s involvement significantly moderated the association between activation and adherence to treatment. Conclusions: Patient activation was positively associated with all three selected outcomes. However, for cancer survivors reporting low rates of caregiver involvement, patient activation was not associated with treatment adherence. Research is needed to deliver and test patient activation interventions inclusive of informal caregivers to improve self-management.
Assessing duration of breakthrough chemotherapy-induced nausea and vomiting (CINV): A pooled study analysis of NEPA versus aprepitant.
Authors: Navari Rudolph M. , Binder Gary , Bonizzoni Erminio , Clark-Snow Rebecca , Olivari Tilola Silvia , Roeland Eric 
Published: June 2021

12091 Background: The historical standard clinical trial endpoint for preventing chemotherapy-induced nausea and vomiting (CINV) has been assessment of complete response (CR: no emesis and no rescue medication use) over five days. Recent evaluations focused on the duration of breakthrough CINV suggest that long duration of CINV results in more lost work time and impaired activity and is also a strong predictor for CINV in subsequent cycles. A recent pooled analysis of three similarly designed registration trials of NEPA, a fixed oral combination NK1 receptor antagonist (RA) (netupitant)/5-HT3RA (palonosetron), showed significantly higher CR rates during the delayed phase (≥24-120h) for NEPA compared to an aprepitant (APR) regimen. In this post-hoc analysis, we evaluated the extent and duration of breakthrough CINV in these pooled studies. Methods: Chemotherapy-naïve patients who received cisplatin-based chemotherapy and antiemetic prophylaxis of either a single dose of NEPA plus dexamethasone (DEX) or a 3-day APR/5-HT3 RA/DEX regimen from three randomized, double-blind pivotal trials were included. Patients without a CR were defined as treatment failures. Extent of CINV was evaluated using proportions of patients with treatment failure, emesis, and significant nausea (defined as >25 mm on a 100 mm visual analog scale). Over the 5-day overall phase, duration was categorized as 1-2, and ≥3 days. Pearsons chi-square test was employed to compare risks between treatments for each duration category in each of the previously mentioned endpoints. Results: Among all 621 NEPA and 576 APR patients, a significantly greater proportion of APR patients experienced treatment failure, emesis, and significant nausea for ≥3 days. Specifically, among patients with treatment failure, 31% (41/134) who received NEPA and 43% (61/143) who received APR experienced breakthrough CINV for ≥3 days. Conclusions: Expanding on data suggesting single-day NEPA is more effective than 3-day APR in preventing delayed CINV, NEPA is also more effective in minimizing the extent and duration of CINV in patients with breakthrough emesis and nausea.[Table: see text]
Noninferiority study evaluating dexamethasone (DEX)-sparing regimens administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by high-dose cisplatin.
Authors: Celio Luigi , Bonizzoni Erminio , Bria Emilio 
Published: June 2021

12093 Background: Corticosteroids such as DEX continue to play a key role for the prevention of CINV. Although they are generally considered safe when used in combination with other anti-emetic agents, corticosteroids can cause a range of side effects. To reduce the overall exposure to DEX in patients receiving cisplatin-based chemotherapy, we evaluated the non-inferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA, a fixed combination of the NK1 receptor antagonist (RA), netupitant and 5-HT3 RA, palonosetron, compared with NEPA plus the guideline-recommended use of 4-day DEX (reference arm). Non-inferiority was met for both DEX-sparing regimens and the reference arm for the primary endpoint of complete response (CR: no emesis and no rescue use) during the overall (0-120h) phase post-chemotherapy. In this analysis secondary efficacy endpoints were evaluated for the single-dose DEX-sparing group versus the 4-day DEX arm. Methods: In this analysis from an open-label, multicenter study (ClinicalTrials.gov NCT04201769) chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m2) received either NEPA and DEX (12 mg) on day 1 only or NEPA and DEX [12 mg on day 1 plus 4 mg twice daily on days 2-4 (DEX4)]. Efficacy endpoints included complete protection (CR plus no significant nausea), no emesis, and no significant nausea (<25 mm on a 100 mm visual analog scale) during the acute (0-24h), delayed (>24-120h) and overall phases. The non-inferiority margin was set at -15% difference (DEX1 minus DEX4). Results: One-hundred fifty-two patients, 76 in each arm, were included. Non-inferiority was met for the DEX1 arm and the DEX4 reference arm for all efficacy endpoints (Table). Conclusions: A simplified regimen of NEPA plus single-dose DEX offers comparable CINV prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high emetic risk setting of cisplatin-based chemotherapy. Clinical trial information: NCT04201769. [Table: see text]
The equivalency study of novel current standard 3-drugs combination regimen (ondansetron, dexamethasone and olanzapine) to netupitant containing regimen for preventing high dose cisplatin induce nausea and vomiting treatment, double blind placebo control trial.
Authors: Lertanansit Chalermchai , Mahaparn Wasamol , Sriuranpong Virote , Sitthideatphaiboon Piyada , Sintawichai Nattaya , Tanasanvimon Suebpong , Vinayanuwattikun Chanida 
Published: June 2021

12100 Background: Prevention of chemotherapy-induced nausea and vomiting (CINV) is vital in cancer treatment. Here, we compared the efficacy of netupitant-containing regimen; composed of NEPA, dexamethasone, and olanzapine (NEPAs), which is recommended for preventing CINV from high-emetogenic chemotherapy (HEC) to standard 3-drugs; ondansetron, dexamethasone, olanzapine for preventing CINV from high-dose cisplatin (≥75 mg/m2). Methods: This randomized, double-blind, placebo-control trial randomly assigned untreated patients who were received high-dose cisplatin in a 1:1 ratio to either NEPAs or standard 3-drugs combination regimen. Dose of dexamethasone in NEPAs regimen was modified after preplanned interim safety analysis to increase from 4 to 8 mg per day on days 2-4. The stratification factors were concurrent treatment with radiation and sex. The primary endpoint was the overall complete response (CR) rate defined as no vomiting and no use of rescue antiemetic drugs. The protocol allowed crossover to NEPAs for those who received standard 3-drugs and did not reach CR in the first cycle. We collected outcome in the first 2-cycle of treatment. Results: Between January 2019 and December 2020, hundred patients were randomly assigned to either NEPAs (n = 51) or in-house standard 3-drugs (n = 49). Demographic characteristics were well-balanced in both arms. Total events in both arms were 101 events for NEPAs and 78 events for standard 3-drug. Overall CR rate were 70% and 69% in NEPAs and standard 3-drugs, ( p-value 0.87) respectively. According to emesis phase, CR in acute (0- 24 hrs.) and delay phase (24-120 hrs.) were not different in both arms; 91% vs. 89% and 72% vs. 71% in NEPAs and standard 3-drugs respectively. However, mean nausea VAS score was significantly lower in NEPAs (1.63 vs. 2.02, p-value = 0.001). The ad hoc subgroup analysis shown similar efficacy between before and after protocol amendment of NEPAs regimen in term of delay emesis CR rate; 70.9% vs. 73.9% ( p-value 0.73). Conclusions: The NEPA-containing regimen did not show superiority compare to standard 3-drug in terms of complete response rate for CINV prevention among patients receiving high-dose cisplatin. Furthermore, the dexamethasone dosage of 4 vs. 8 mg per day might not affect the efficacy of delay emesis of the NEPAs regimen. Clinical trial information: TCTR20190508001. [Table: see text]
CD4+ T-cell count eligibility by HIV status among participants receiving immunotherapy for cancer diagnoses.
Authors: Odeny Thomas A , Rosenthal Matthew Harry , Lurain Kathryn Anne , Strauss Julius , Uldrick Thomas S. , Gulley James L. , Yarchoan Robert , Ramaswami Ramya 
Published: June 2021

12104 Background: The Food and Drug Administration recommends that patients living with HIV (PLWH) with a CD4+ T cell count (CD4) ≥350 cells/µL should generally be eligible for any cancer clinical trial, but there has been a reluctance to enter patients with lower CD4 counts. Patients with relapsed or refractory cancers may also have low CD4 due to initial cancer therapies, irrespective of HIV status. Immune checkpoint inhibitors (ICI) are safe among PLWH with advanced cancer receiving antiretroviral therapy and CD4 >100 cells/µL. We examined the outcomes of immunotherapy trials by HIV and CD4 status among patients receiving ICI for relapsed/refractory cancers. Methods: We conducted a retrospective cohort study of participants who received ICI for relapsed/refractory cancers in 2 trials (1 specifically in PLWH with CD4 >100 only) from the National Cancer Institute. Primary outcomes were to assess relationship between HIV status and baseline CD4 (<350 vs ≥350 cells/µL) and other characteristics. We stratified 3-year survival by CD4 in PLWH and HIV-negative participants with HPV-related cancers. The Kaplan-Meier method was used to estimate survival rates. Results: Eighty-three participants were included: 26 (31.3%) were HIV-positive and received pembrolizumab and 57 (68.7%) were HIV-negative and received bintrafusp alfa. HIV-negative participants had relapsed HPV related malignancies (cervix, anal, head and neck) whereas participants with HIV had both viral and non-viral associated cancers (Table). While the median screening CD4 was significantly lower among PLWH than HIV-negative participants, there was no difference in the proportion with CD4 <350 (p=0.1). When restricted to HPV related malignancies, 3-year survival rates were 32.2% for CD4 <350 and 21.2% for CD4 ≥350 (p=0.7). Conclusions: In this retrospective study of ICI clinical trials in relapsed and refractory malignancies, there was no significant difference in baseline CD4 (<350 vs ≥350 cells/µL) by HIV status; 50% of HIV-negative participants had CD4<350 cells/µL. Patients with HIV should be included in ICI studies, and CD4 thresholds lower than 350 cells/µL should be considered as to not unfairly exclude PLWH with cancer.[Table: see text]
The enduring negative effects of financial toxicity in young adult cancer survivors.
Authors: Thom Bridgette , Benedict Catherine , Friedman Danielle Novetsky , Watson Samantha , Zeitler Michelle , Chino Fumiko 
Published: June 2021

12117 Background: Due to disruptions in education, workforce entry, and career development caused by cancer and its treatment, young adult (YA) cancer survivors face financial toxicity (i.e., cancer-related financial distress) at rates higher than older survivors. Financial toxicity in YA survivors is associated with avoiding care and diminished psychosocial well-being, but enduring effects on employment, personal finances, and healthcare use and the association with YA’s financial capability are not well studied. Methods: This was a cross-sectional survey of a national sample of YAs with cancer (n = 214) recruited online and via mailing lists. It included the Comprehensive Score for Financial Toxicity (COST), demographic/clinical self-report, and questions on medical cost-coping and healthcare use. Financial capability questions considered respondents’ knowledge about finances, self-efficacy for managing health expenses, and attitudes and behaviors regarding tracking expenses, budgeting, saving, investing, and bill paying. Multiple linear regression assessed associations among financial toxicity, financial capability, and cost-coping. Results: Mean respondent age was 35.4 years ( sd= 5.40) at survey and 27.5 years ( sd= 7.23) at diagnosis. Breast cancer (28%) and lymphoma (17%) were the most common diagnoses; most respondents were white (79%) women (87%) with college degrees (74%). Financial toxicity, as measured by COST, was high (mean = 13.9, sd= 9.3; possible range 0-44, scores < 26 indicate severe financial toxicity). Nearly all of the sample (96%) had health insurance, but 30% said their insurance does not meet their needs. One-half of the sample lacked confidence to manage health expenses. Cost-coping strategies included skipping/delaying: treatment (23%), survivorship care (35%), or medications (39%); 65% relied on a family member to pay for some/all medical bills. Negative events related to medical expenses included using money from savings (58%), taking on credit card debt (45%), post-cancer credit score decrease (44%), borrowing money to pay bills (42%), debt collection contact (37%), lacking money to pay for basic necessities (23%), loan denial (20%), and thoughts about and/or filing for bankruptcy (15%). In multivariate analyses, greater financial toxicity was associated with lower self-efficacy for managing health expenses (β = -0.88, p =.01), poorer financial behaviors (β = -0.54, p =.001), lower income (β = -5.27, p =.001), and skipping/delaying: treatment (eβ= 1.16, p <.001), survivorship care (eβ= 1.13, p <.001), or prescribed medication (eβ= 1.10, p =.001). Conclusions: Our findings illustrate the profound enduring impact of financial toxicity among YAs after cancer treatment. Multilevel interventions are needed to provide YAs the tools to navigate financial aspects of the healthcare system and connect them with resources toward gaining financial independence.
Oncologist phenotypes and associations with response to a behavioral intervention to increase serious illness conversations.
Authors: Li Eric , Manz Christopher , Liu Manqing , Chen Jinbo , Chivers Corey , Braun Jennifer , Schuchter Lynn Mara , Kumar Pallavi , Patel Mitesh S. , Shulman Lawrence N. , Parikh Ravi Bharat 
Published: June 2021

12126 Background: Interventions to increase serious illness conversations (SICs) between oncologists and patients may improve goal-concordant care, patient mood and quality of life. Randomized studies suggest that behavioral nudges to oncologists may prompt more and earlier SICs. Identifying characteristics of oncologists associated with response to such interventions may clarify barriers to SIC adoption. Methods: This was a secondary analysis of a randomized trial showing that machine learning (ML)-based behavioral nudges among 42 oncologist-advanced practice provider (APP) dyads (79 total oncology clinicians total) caring for 14,607 patients in a large academic health system led to a quadrupling of SIC rates (NCT03984773). Latent profile analysis identified oncologist phenotypes based on oncologist, patient, and practice data. We used difference-in-differences analyses among patients with predicted 180-day mortality risk ≥10% (n=2695 [12.6% of cohort]) to test the association between oncologist phenotype and response to the nudge, adjusted for patient and oncologist demographic and practice characteristics. Results: Three oncologist phenotypes were identified: 1) Higher-volume specialists 2) Lower-volume specialists; and 3) Higher-volume generalists. Compared with higher-volume specialists and higher-volume generalists, lower-volume specialists had fewer patients per week (9.2 vs 24.3 vs 53.2), fewer days in clinic per week (1.6 vs 2.5 vs 4.4), a higher proportion of new patients per week (34.9% vs 21.0% vs 17.6%), and higher baseline SIC rates (3.9% vs 1.6% vs 0.8%). Lower-volume specialists had a significantly greater response to the intervention than higher-volume specialists and generalists (see Table), demonstrating a nearly six-fold increase in SIC rate from baseline. Conclusions: Response to an ML-based behavioral nudge to prompt SICs was driven by specialist oncologists with lower patient volume and greater SIC adoption at baseline, although the nudge was associated with significantly higher SIC rates among all phenotypes. While effective among lower-volume oncologists, nudges to prompt supportive care interventions may have limited impact among higher-volume oncologists. Other strategies, including default involvement of specialty palliative care, may be more effective for higher-volume oncologists.[Table: see text]