bluuebunny/crossref_metadata_2025_split huggingface dataset:
Utilizing an innovative digital collaboration tool to impact shared decision making, health equity and trust with a focus on advance care planning for patients with metastatic breast cancer.
Authors: Harry Kadie , Sykes Arabella , Pluard Timothy J. 
Published: June 2022

e24123 Background: Advance care planning (ACP) has been associated with improved quality of life, increased use of hospice and palliative care, and less use of extreme treatments close to death. These conversations often do not occur and documentation rates of ACP in oncology patients have been as low as 10%, with rates of documentation increasing between 30-40% in intervention studies. The present study aimed to examine the effectiveness of an online Advance Care Appointment Companion (ACAC) collaboration tool to improve communication and elevate trust between MBC patients and their oncologist and increase completion rates of ACP documents. Methods: Data were collected from 48 patients with mean age of 66.9 years (SD = 6.97) with MBC during their medical oncology appointments (Time 1) and three months later (Time 2) at the Koontz Center for Advanced Breast Cancer. At Time 1, patients were enrolled on the ACAC platform and then completed questions in the clinic or at home about completion status of a healthcare directive and durable power of attorney (DPOA) for healthcare, comfort in discussing ACP with their care team and loved ones, and goals of care at end of life. A summary of these responses with a provider prompt script was securely sent to the oncologist prior to each appointment and used to discuss ACP over the three-month study period. Descriptive statistics, t-tests, McNemar-Bowker and McNemar’s tests were conducted to examine changes in rates of ACP document completion, patient reported levels of comfort in discussing ACP, and quality of life preferences. Results: The study included a diverse sample of female MBC patients including 79% White, 19% Black/African American, 2% Mixed Race; 6% less than a high school degree, 17% high school or GED, 19% some college, and 58% associate’s degree or above. Results showed a significant increase in completion of a healthcare directive (Time 1 = 10.4%, Time 2 = 37.5%, p < .01) and DPOA (Time 1 = 31.5%, Time 2 = 56.3%, p < .01) and improved comfort discussing ACP with their care team (p < .01) and loved ones (p < .01) from baseline to follow-up. Significantly more patients reported that they would not want CPR (p < .05) at follow-up and all of these patients had reported that they were unsure at baseline. On average, ACP conversations during medical appointment took 5 minutes to discuss. Conclusions: Results show that the ACAC is an inclusive solution which provides equitable access to patients. This tool facilitates enhanced patient provider communication and assists patients with MBC in finalizing decisions regarding their goals of care, leading to increased completion and proper submission of ACP documentation. Future research should examine how the ACAC can decrease financial toxicity, utilize internal resources, and address social determinants of health.
Associations between cancer history, social distancing behaviors, and loneliness in adults during the COVID-19 pandemic.
Authors: Yang Jenny , Zhang Xiaochen , Yu Ivy , Fisher James L. , DeGraffinreid Cecilia , Paskett Electra D. 
Published: June 2022

e24124 Background: Due to COVID-19, social distancing initiatives have been enacted, highlighting differences of social distancing practices and the resulting loneliness in various populations, especially in those with a history of cancer (survivors and those in active treatment).The objective of this study was to examine whether social distancing practices and loneliness differ between individuals with and without a history of cancer during the COVID-19 pandemic. Methods: This study is part of the “Impact of COVID-19 on Behaviors across the Cancer Control Continuum in Ohio” project conducted from June to November 2020. Participants from previous studies (N = 32,989) who had given permission to be re-contacted were invited to complete a survey online, by phone, or by mail. For the current analysis, participants who had complete data on history of cancer diagnosis, COVID social distancing behaviors (staying at home, not having visitors, staying 6 feet apart, wearing a masking indoors, and wearing a mask outdoors), attendance at social gatherings, contact with people outside of their household, and feelings of loneliness were included. Linear and logistic regression models were used to determine the associations between demographics, cancer history, social distancing, and loneliness. Results: Among the eligible participants (n = 5729), 54.9% had a cancer history (n = 3147), while 45.1% did not have a cancer history (n = 2582). The average age was 56.7 years, 35.6% were male, 89.4% were White, 74.7% were partnered, and 74.5% lived in metro counties. Out of all individuals, 69.3% participated in ≥4 of the 5 COVID social distancing behaviors, 31.5% did not attend any social gatherings, and 40.1% reported feeling lonely. Compared to individuals without a cancer history, individuals with a cancer history were more likely to contact no one outside of the household (49.0% vs. 41.9%, p < 0.01) and less likely to report feeling lonely (35.8% vs. 45.3%, p < 0.01). Among individuals with a cancer history, compared to their counterparts, those who were older, Black, Asian, and living in metro counties were adherent to more social distancing behaviors (mean differences = 0.02, 0.62, 0.71, 0.13, respectively, p all < 0.05) and attended fewer social gathering (mean differences = -0.01, -0.29, -0.49, -0.12, respectively, p all < 0.05). Higher adherence to social distancing behaviors was associated with higher odds of loneliness among individuals with (OR = 1.27, 95% CI: 1.72-1.38) and without a cancer history (OR = 1.15, 95% CI: 1.06-1.25). Conclusions: Social distancing practices and loneliness during the COVID-19 pandemic varied between individuals with and without a cancer history. These findings can inform efforts to support and address all aspects of health among individuals susceptible to loneliness during the pandemic, especially those with a history of cancer.
The psychosocial impact of the Australian Rare Cancer Portal on patients with rare cancer.
Authors: Papadopoulos Lia , Georgiou Chloe L. , Kee Damien , Caldwell Reece , Bourne Allison , Haurat Javier , Turner Maureen , Goldstein David , Scott Clare L. 
Published: June 2022

e24127 Background: Patients with a rare cancer (RC) diagnosis face unique challenges affecting psychological wellbeing. Vast geographical distances further compound challenges in accessing RC sub-specialist expertise, clinical trials, research and non-reimbursed therapies. The Australian Rare Cancer (ARC) Portal is a novel model of care delivery that has a positive psychological impact on these patients. Methods: The ARC Portal is a national free online referral platform implemented to overcome barriers to accessing excellent care. It is funded by Omico, with support from BioGrid Australia, Rare Cancers Australia (RCA), and The WEHI Stafford Fox Rare Cancer Program (SFRCP). We have recorded 924 referrals for a diverse range of RC in early (30%) and late stages (70%). Our 162 referring clinicians derive from every Australian state and from both regional and metropolitan centres. Over 50 content experts from Australia and internationally have provided case advice. Referring clinical impact surveys and patient feedback surveys were analysed to identify psychosocial impacts of the ARC Portal. Results: Our model of care keeps patients with their primary oncologists by equipping referrers with increased expertise drawing from, on average, two to five experts. The entirely online consent process overcomes geographical barriers to enrolment, and is of particular importance in the context of the ongoing COVID-19 restrictions removing in person interaction. Provision of expertise and treatment recommendations meets informational needs and increased the patient confidence patients in their treating clinicians. Report recommendations directly altered the treatment delivered to patients in 20/48 of surveyed referrer respondents. Early stage patients are eligible for referral to guide neoadjuvant and adjuvant therapy, and those in remission for anticipatory identification of next lines of therapy. We identify appropriate access to investigator-driven research efforts to overcome financial barriers to genomic sequencing e.g. via the MoST Program funded by OMICO and the WEHI-SFRCP enabling access to molecularly-guided therapy. A lack of reimbursed therapeutic options in RC poses financial stress on patients. The ARC Portal expands patients’ treatment options via links with clinical trial networks, coordination with industry, and cross-referral to the charity, RCA, for fundraising assistance. We provide patients with the opportunity for involvement in research, which for many provides hope, either for themselves, or for others, as they can opt to provide access to biomarker and tumour specimens via the WEHI-SFRCP; the majority of patients (82.5%) have provided consent. Conclusions: The ARC Portal offers patients access to excellent rare cancer care resulting in positive impacts upon patients’ psychological wellbeing. These initial observations require more formal assessment.
The effect of group psychotherapy on quality of life of cancer patients undergoing chemotherapy or endocrine therapy during Covid-19 pandemic: One center experience.
Authors: Abuladze Mariam , Esakia Tamar , Cholikidze Tamta , Barabadze Ketevani , Saganelidze Khatuna 
Published: June 2022

e24133 Background: The announcement of the pandemic by WHO had a great impact on global mental health. Mental disorders like stress, anxiety, depressive symptoms, insomnia, denial, anger, and fear affected the population worldwide. Cognitive-behavioral techniques are effective in improving the control of symptoms, the affective state and coping with the disease. Methods: Female patients were offered to take part in the study by their oncologists. Inclusion criteria included female patients who were diagnosed with cancer during the last 5 years. Intervention included - Online group psychotherapy which was conducted for 3 consecutive months, three times per week, using the interactive ZOOM platform. The Research and Treatment of Cancer (EORTC) quality of life questionnaire QLQ-C30 was used to assess QoL of participants. We asked patients to fill the ERTC questionnaire twice, before the first and after the last psychotherapy sessions. Results: Total of 25 patients aged 18-55 were included in the study, 72% were receiving hormonal therapy, and 28% were receiving chemotherapy. Majority of patients (18) were diagnosed with breast, 4 with cervical and 1 with uterine and 2 with ovarian cancer in last 5 years. All patients were white Caucasian females. Analysis of Variance (ANOVA) showed no difference between groups on pre-RS score; But the study showed significant improvement in post RS (EORTC QLQ-C30) in patients with hormone therapy (Goodness of Fit-R square-0.4471, P-value-0.0024, 95% Confidence Intervals-0.4200 to 1.626), compare to patients with chemotherapy (Goodness of Fit-R square-0.003372, P-value- 0.9016, 95% Confidence Intervals--1.743 to 1.929).All measures were presented as mean with standard deviation and the level of significance was defined as DELTA(D) = 0.05. Conclusions: According to our research, group psychotherapy had a positive effect on quality of life of cancer patients undergoing hormonal therapy and showed no significant impact on patients treated with chemotherapy. More research and a larger sample size is needed for a better interpretation of results.
Naxitamab and granulocyte macrophage colony stimulating factor (GM-CSF) in combination with irinotecan and temozolomide in patients with high-risk neuroblastoma with primary refractory disease or in first relapse: An international, single-arm, multicenter phase 2 trial.
Authors: Chan Godfrey Chi-Fung , Hindsberger Charlotte , Morsing Anni , Lisby Steen 
Published: June 2022

TPS10061 Background: Neuroblastoma (NB) is the commonest extracranial solid tumor in children. At diagnosis, > 50% have high-risk (HR) disease with poor prognosis despite intensive therapy; thus, there is a high unmet medical need. Naxitamab is an anti-GD2 monoclonal antibody indicated under accelerated approval in the US with GM-CSF for the treatment of relapsed/refractory HR NB in the bone and/or bone marrow in patients (pts) ≥1 year of age with a partial response, minor response, or stable disease to prior therapy. Irinotecan and temozolomide (IT) are commonly used salvage chemotherapies following failure of frontline therapy. The objective of this study is to investigate the efficacy and safety of naxitamab plus IT in pts with HR NB with primary refractory disease or first relapse. Methods: Trial 203 (NCT04560166) is an international, single-arm, multicenter phase 2 trial for HR NB patients ≥12 mo of age, with either evaluable primary refractory disease or first relapse following induction and consolidation therapy. The primary endpoint of the study is the centrally-assessed overall response rate (ORR) (complete [CR] or partial response) at or before completion of 4 cycles of treatment. Key secondary endpoints include ORR after 2 cycles of treatment, duration of response (DoR), CR rate, time to first subsequent therapy or death, progression-free survival (PFS), and overall survival (OS). 52 pts will be enrolled to provide 82% power to demonstrate that response rate is significantly higher than 20%. Key inclusion criteria are documented HR NB at time of diagnosis; received frontline induction/consolidation therapy; active disease despite previous aggressive chemotherapy; and measurable tumor (CT/MRI) that is either MIBG-avid/PET-positive or have MIBG scan with uptake at ≥1 site. Key exclusion criteria include prior treatment with duration ≤3 wks (chemotherapy), ≤6wks (autologous stem cell transplant or therapeutic 131I-MIBG), ≤4wks (radiation therapy), or progressed while on anti-GD2; residual NB in the bone marrow only; and CNS/leptomeningeal disease in the prior 6 mo. In addition, there should not be < 50% performance status per Lansky or Karnosky scale and life expectancy < 6 mo. Pts will receive irinotecan 50 mg/m2/day IV and temozolomide 100 mg/m2/day orally (both on Days 1-5) in combination with naxitamab 2.25 mg/kg/day IV (Days 2, 4, 8 and 10) and GM-CSF 250 ug/m2/day sc (Days 6-10) in 21 days cycle. Response rates will be assessed using the 2-sided binomial test at the 5% significance level; DoR, PFS, and OS will be estimated using Kaplan-Meier analysis. Adverse events will be graded per CTCAE. Clinical trial information: NCT04560166.
A pilot clinical study of VAL-413 (oral irinotecan HCl) in patients with recurrent pediatric solid tumors.
Authors: Brown Dennis , Bacha Jeffrey A. , Geller James I. , Thompson Patrick A. , Oesterheld Javier E. , Kanekal Sarath , Leggas Markos , Lopez Lorena , Sankar Neil , Yam Noymi , Wagner Lars M. 
Published: June 2022

TPS10063 Background: Intravenous irinotecan hydrochloride (IRN-IV) is approved for the treatment of adult colorectal cancer. IRN-IV is also widely used off-label for a range of adult and pediatric solid tumors including recurrent Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, Wilms tumor, gynecologic cancers, lung cancer and medulloblastoma. Previously, a regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5 days, every 21 days has been recommended use in treating children with solid tumors (Blaney. ClinCanRes, 2001 ). Protracted administration schedule of intravenous irinotecan is inconvenient for patients, so oral regimens utilizing IRN-IV have been developed (Wagner. ClinSarcRes, 2015 ). Unfortunately, the palatability of the intravenous preparation is poor, leading to reduced compliance especially in younger pediatric patients. Development of an advanced formulation to improve tolerability and patient compliance is an important unmet clinical need. VAL-413 is a novel formulation developed to improve palatability of oral irinotecan. Methods: Eligibility: Up to 20 patients ≥ 1 year and ≤ 30 years of age with recurrent pediatric solid tumors and adequate bone marrow, renal and liver function, for whom irinotecan therapy is a treatment option will be enrolled. Trial Design: Two different dose levels of VAL-413, 90mg/m2/day or 100mg/m2/day will be studied in combination with a fixed-dose of temozolomide using a standard 3 + 3 phase I design. In the event that the starting dose of 90 mg/m2/day is not tolerable due to toxicity, a lower dose of 75 mg/m2/day may be implemented. Treatment: During the first cycle of treatment, each patient will receive 4 daily doses of VAL-413 and one daily dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO). During all subsequent cycles, only VAL-413 will be given with temozolomide in 5-day courses administered every 21 days, as tolerated. Outcome Measures: Toxicity is assessed by NCI CCTCAEv5; tumor response is assessed by RECIST 1.1. A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; and comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed in all patients. This trial is ongoing (CT.gov: NCT04337177). Enrolment of the first dose level is ongoing, with no DLT observed to date. Clinical trial information: NCT04337177.
A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01.
Authors: Patel Snehal , Thompson Jaye , Patel Mira , Daugherty F. Joseph , Osborne C. Kent , Rimawi Mothaffar F. 
Published: June 2022

TPS1110 Background: GP2 is a biologic nine amino acid peptide of the HER2/ neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100. In a prospective, randomized, single-blinded, placebo-controlled, multicenter Phase IIb study, no recurrences were observed in the HER2+ population after 5 years of follow-up, if the patient was treated with GLSI-100, survived and was followed from more than 6 months ( p = 0.0338). Immunotherapy elicited a potent response measured by skin tests and immunological assays. Of the 146 patients that have been treated with GLSI-100 over 4 clinical trials, GLSI-100 was well-tolerated and no serious adverse events were observed considered related to the immunotherapy. Methods: This Phase 3 trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years for a total of 11 injections over 3 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up for a total of 4 years following the first year of treatment with trastuzumab-based therapy. Patients will be stratified based on residual disease status at surgery, hormone receptor status and region. Approximately 498 patients will be enrolled. To detect a hazard ratio of 0.3 in invasive breast cancer free survival (IBCFS), 28 events will be required. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred. This sample size provides 80% power if the annual rate of events in placebo patients is 2.4% or greater. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm. Eligibility Criteria: The patient population is defined by these key eligibility criteria: HER2/neu positive and HLA-A*02; Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy; Exclude Stage IV; Completed at least 90% of planned trastuzumab-based therapy. Trial Objectives: To determine if GP2 therapy increases IBCFS; To assess the safety profile of GP2; To monitor immunologic responses to treatment and assess relationship to efficacy and safety. Accrual: Site selection and study start-up is in progress at multiple sites. Target enrollment is 598 subjects. Clinical trial information: 05232916.
ARV-471, an estrogen receptor (ER) PROTACdegrader, combined with palbociclib in advanced ER+/human epidermal growth factor receptor 2–negative (HER2-) breast cancer: Phase 1b cohort (part C) of a phase 1/2 study.
Authors: Hamilton Erika P. , Schott Anne F. , Nanda Rita , Lu Haolan , Keung Chi Fung , Gedrich Richard , Parameswaran Janaki , Han Hyo S. , Hurvitz Sara A. 
Published: June 2022

TPS1120 Background: ARV-471 is a novel, potent, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) protein degrader that selectively targets the ER. In xenograft models, ARV-471 demonstrated substantially greater ER degradation and antitumor activity compared with the selective ER degrader fulvestrant. In the phase 1 dose escalation portion (Part A) of the first-in-human phase 1/2 study, ARV-471 monotherapy was well tolerated and showed antitumor activity in patients with ER+/HER2- locally advanced or metastatic breast cancer who had previously received endocrine therapy and a cyclin-dependent kinase (CDK)4/6 inhibitor; the clinical benefit rate (rate of confirmed complete or partial response or stable disease ≥24 weeks) was 40% (95% CI: 26%–56%) in 47 evaluable patients. The phase 2 VERITAC expansion cohort (Part B) is further evaluating ARV-471 monotherapy in this patient population. Palbociclib, a CDK4/6 inhibitor, plus fulvestrant is a standard treatment option for patients with ER+/HER2- breast cancer who have had disease progression on endocrine therapy. ARV-471 plus palbociclib resulted in substantially greater tumor growth inhibition in xenograft models compared with palbociclib plus fulvestrant, supporting further investigation of the ARV-471 plus palbociclib combination in patients with ER+ breast cancer. Here we describe Part C of the phase 1/2 study, which evaluates the safety and clinical activity of ARV-471 plus palbociclib in patients with breast cancer who previously received endocrine therapy. Methods: Eligible patients (aged ≥18 years) have histologically or cytologically confirmed ER+/HER2- advanced breast cancer and have received ≥1 prior endocrine therapy and ≤2 prior chemotherapy regimens for advanced disease; prior CDK4/6 inhibitor therapy is permitted. Patients with known symptomatic brain metastases requiring steroids are excluded. ARV-471 and palbociclib will be administered orally once daily in 28-day cycles; ARV-471 will be given continuously and palbociclib for 21 days followed by 7 days off treatment. Primary objectives are to evaluate the safety and tolerability of ARV-471 plus palbociclib and select the recommended phase 2 dose and schedule of the combination (based on the incidence of dose-limiting toxicities during the first cycle and the frequency and severity of adverse events and laboratory abnormalities). Secondary objectives are to assess preliminary antitumor activity of ARV-471 plus palbociclib (based on overall response rate per Response Evaluation Criteria in Solid Tumors v1.1, clinical benefit rate, progression-free survival, and duration of response) and pharmacokinetic parameters. Clinical trial information: NCT04072952.