bluuebunny/crossref_metadata_2025_split huggingface dataset:
Delay discounting as a predictor of adjuvant endocrine therapy adherence among breast cancer survivors.
Authors: Vaughn Jennifer , Ammerman Chesley , Stein Jeffrey 
Published: May 2020

e24172 Background: Despite the demonstrated mortality benefit, 30-70% of hormone-responsive breast cancer (BC) survivors struggle to adhere to adjuvant endocrine therapy (ET). Little is known about patient-specific behavioral traits and their role in ET non-adherence. To gain a survival benefit, patients must adhere to ET for years. In contrast, the benefits of discontinuing ET (i.e., avoiding toxicity) are immediate. Thus, adherence requires one’s behavior to be guided by future outcomes, rather than immediate gratification. We therefore hypothesized that ET adherence may be related to the behavioral economic process of delay discounting (DD; i.e. devaluation of delayed outcomes), which provides a measure of how individuals value the future. Methods: BC survivors (age 18-80) prescribed adjuvant ET within the last 5 years were recruited. ET adherence was measured by pill count and self-report. DD was measured using two methods: monetary DD was measured using a validated task in which participants made repeated, hypothetical choices between a larger amount ($100 or $1000) available after a time delay or half of this amount ($50 or $500) available now. Across trials, the delay to the larger amount is titrated based on previous choices until reaching a delay at which the participant becomes indifferent to waiting for the larger reward. Cancer DD was measured using an investigational task adapted from the adjusting-delay task described above. This task presented repeated, hypothetical choices between preventing BC recurrence after varying time delays and avoiding ET side effects immediately. Results: Eighty nine BC survivors participated. Average pill count adherence was near 50%, but self-reported adherence was near 100%. Monetary DD was significantly associated with pill counts; adherence improved with increasing log indifference delays (standardized b 0.328, p = 0.005). Self-report adherence (categorized as discontinued/never started, suboptimal, and perfect) was significantly associated with Cancer DD and income (OR 3.764, p < 0.001 and OR 1.01, p = 0.04, respectively) but not monetary DD (OR 0.978, p = 0.951). No association was found between ET non-adherence and medication type, side effect severity, menopausal status, age, education or minority status. Conclusions: DD may promote ET non-adherence among BC survivors. Behavioral therapies which reduce DD may provide a targeted strategy to improve adherence. More research is needed to develop tools that reliably assess ET adherence and that tailor DD assessments to the cancer survivor population.
Surviving metastatic non-small cell lung cancer (mNSCLC): The lived experience and supportive care needs of patients (pts) receiving immunotherapy (IT) or targeted therapy (TT).
Authors: Lai-Kwon Julia Elizabeth , Heynemann Sarah , Flore Jacinthe , Duffy Mary , Kokanovic Renata , Jefford Michael 
Published: May 2020

e24185 Background: IT and TT have improved survival for many pts with mNSCLC. However, the lived experience of these pts is under-studied. We conducted a single centre, qualitative study to understand concerns and supportive care needs of this novel survivor population. Methods: Eligible pts had mNSCLC, aged >18, English speaking and > 6 months post initiation of IT/TT without progressive disease. Semi-structured interviews were conducted focusing on physical, psychological, social and functional impacts of diagnosis, therapy and prognosis. Interviews were audio-recorded and transcribed. The framework method of analysis was used. Results: 20 pts were interviewed between May-December 2019; median age 62 years (range 34-83), 13 (65%) female; median time since diagnosis of mNSCLC 27 months (range 10-108). 12/20 (60%) had tumours with a targetable molecular alteration (EGFR/ALK/BRAF). 6 were receiving IT, 11 TT, 2 IT and chemotherapy, 1 IT and TT. Dominant themes included: the experience of chronic toxicities (cutaneous, gastrointestinal, fatigue); psychological concerns (living with uncertainty, fear of cancer progression [FCP], scan-related anxiety, stigma around smoking, loneliness) and coping strategies (living in the present, practising self-care with exercise and meditation, early discussions with their treating team regarding future treatment options, and accessing psychology services); the desire for tailored information (internet resources, support groups, challenges in accessing pertinent information); and the desire for assistance with practical issues (financial planning, returning to work, challenges of long-term clinical trial participation, difficulty planning for the future). Conclusions: Longer term survivors of mNSCLC report significant physical, psychological and functional concerns and unmet needs. Self-management strategies for chronic toxicities, professional psychological services to manage FCP and scan-related anxiety, and tailored information regarding work and financial planning may mitigate these concerns. Future work should examine these issues in a larger population.
Understanding therapy preferences of cancer patients with the use of therapy preference scale.
Authors: Dhakal Prajwal , Wichman Christopher S , Pozehl Bunny J , Vose Julie , Bociek Gregory , Bhatt Vijaya Raj 
Published: May 2020

e24186 Background: Patients’ (pts) preferences, crucial in selecting an appropriate treatment (tx), are understudied in cancer pts. We developed a novel self-reported questionnaire “Therapy Preference Scale” (TPS) (J Geriatr Oncol. 2019:677-679, J Clin Oncol 2019 37: e23179-e23179). Our single-center prospective observational study utilized TPS to gain in-depth understanding of pts’ preferences of various aspects of cancer tx. Methods: Eligible pts were adults aged ≥19 y with a diagnosis of cancer. Pts were asked to complete TPS; this 30-item scale captures pts’ rating of the importance of safety, efficacy and other characteristics of cancer tx (on a scale of 0-10), and importance of one over the other aspects of tx (using a 4-item Likert scale). Demographics, cancer-specific and therapy-related data were collected. Descriptive statistics were used for analysis. Results: Total 100 pts were enrolled- 52% were receiving cancer tx; 40% had completed tx; 8% were newly diagnosed and had not yet started tx. Pts were willing to accept short term SE for increased life expectancy but valued maintenance of cognition, functional ability and QoL. 70% valued maintaining cognition, functional ability and quality of life (QoL) than increased life expectancy; 75% would accept cancer tx if it improved QoL but 88% would reject a harsh tx for improved life expectancy of ≤6 months. Conclusions: Avoiding long term side effects (SE), life threatening infections, tx burden and financial toxicity were most important to pts. Harsh tx with ≤6 months improvement of life was unacceptable. These findings will help physicians understand pt preferences and guide selection of tx that will meet pts’ goals of care, and may also have implications for insurance policies and drug approval. [Table: see text]
Communicating cancer and its treatment to Australian Aboriginal patients with cancer: A qualitative study.
Authors: Olver Ian N. , Gunn Kate M , Knott Vikki E , Chong Alwin , Spronk Kristiaan , Cunningham Joan 
Published: May 2020

e24188 Background: To enable clinicians to effectively communicate about cancer and its treatment to Aboriginal and Torres Strait (Aboriginal) people with cancer who need to make informed choices about the Western medicine offered, we sought strategies from health professionals with experience in that field. Methods: Semi-structured interviews were conducted face-to face or via telephone with the experienced health professionals and audio-recorded. Thematic analysis using a bottom up, essentialist/realist approach was employed to analyse the data, when data saturation was reached. Results: The 23 health professionals interviewed were medical and radiation oncologists, oncology nurses and Aboriginal health workers. Twelve were female, 11 were male with 5 identifying as Aboriginal. Six themes emerged. (1) Create a safe environment, engender trust and build rapport. This involves avoiding assumptions, allowing time, considering the physical environment, asking about home and family, being aware of gender issues and noting non-verbals. (2) Employ specific strategies to explain cancer, treatment and its side effects by using simple language, employing visual aids such as drawings, metaphors and relatable analogies such as trees with roots, weeds, abandoned rusty cars and blocked pipes. Use repetition and ensure alignment with patient needs. Warning about upcoming sensitive issues minimised the chance of disengagement. (3) Obtain support from those who can assist in communication. This includes interpreters, aboriginal liaison officers and health workers, and patient escorts. (4) Consider the culture which involves collective decision-making, strong connection to country and community, with cultural obligations and unique understanding of cancer which can involve curses, shame and utilise bush medicine. (5) Develop personal qualities of good communicators, including showing respect, patience, empathy, honesty, being person centred and embracing personal reflection. (6) Understand the contextual complexity of multiple languages, possible disengagement with treatment, difficulty maintaining contact with patients, conflicts between Western medicine and Aboriginal culture and late stage presentations. Be aware of practitioner bias. Conclusions: These insights will help foster more positive interactions with the health system and promote optimal outcomes for Aboriginal people with cancer and enable the creation of educational modules for inexperienced clinicians.
S1801: A randomized phase II trial of adjuvant versus neoadjuvant pembrolizumab (PEM) for melanoma.
Authors: Patel Sapna Pradyuman , Othus Megan , Moon James , Tetzlaff Michael T. , Buchbinder Elizabeth Iannotti , Sondak Vernon K. , Lowe Michael C. , Campos Danae , Sharon Elad , Korde Larissa A. , Carson William Edgar , Ribas Antoni , Grossmann Kenneth F. 
Published: May 2020

TPS10090 Background: Although long term outcomes for most patients with early-stage melanoma is excellent following surgery, patients who have high-risk features such as lymph node involvement have poorer outcomes. Adjuvant therapy (AT) is currently considered for patients with stage III melanoma and selected patients with resected stage IV melanoma. Currently, AT for melanoma is anti-PD-1 or targeted therapy in the presence of a BRAF mutation. At this time we are not able to predict which patients will derive benefit from AT and experience cure. While curative surgery is the goal of early treatment of primary melanoma, some cases with bulky nodal involvement are at high risk of local or distant recurrence despite upfront surgery. Neoadjuvant treatment (NAT) offers the benefit of an early on-treatment pathological sample that can be profiled for biomarkers and correlated with survival. Treating with anti-PD1 while tumor transiently remains in the body may generate a stronger immune response from tumor-infiltrating lymphocytes against in vivo tumor antigens compared to the traditional adjuvant setting where antigen is presented by microscopic residual tumor burden. Pilot studies using NAT with have been initiated in melanoma. Multidisciplinary coordination in these cases is paramount. In these studies, an improvement in relapse-free survival and overall survival has been observed; additionally, pathologic response rates to NAT have been estimated in small studies. Methods: S1801 is a randomized phase II study of AT versus NAT with PEM (NCT03698019). Patients with measurable, clinically detectable and resectable cutaneous, acral, and mucosal melanomas without brain metastasis are eligible. Patients are randomized 1:1 to the AT or the NAT. Patients getting AT receive surgery first followed by 18 doses of PEM 200 mg IV every 3 weeks. Patients getting NAT receive 3 doses of pre-operative PEM followed by surgery and then 15 doses of adjuvant PEM. Radiation may be given on either arm after surgery, at the investigator’s discretion. Primary endpoint is event-free survival measured from the date of randomization to the date of first documented progression that renders the patient unable to receive planned protocol surgery, failure to begin AT within 84 days of surgery, relapse after surgery, or death due to any cause. Safety monitoring is conducted with disease progression and toxicity thresholds. The key Translational Medicine objective of this trial is to determine the pathologic response rate to NAT with 3 doses of PEM. Enrollment is at 94 of a planned 500 patients. Clinical trial information: NCT03698019.
A phase I dose-escalation trial of alpha-tocopheryloxyacetic acid and concurrent trastuzumab in patients with treatment refractory HER2+ metastatic breast cancer.
Authors: Gwin William R , Childs Jennifer , Higgins Doreen , Burton Kellie Ann , Kuano Kristin , Corulli Lauren , Dai James , Akporiaye Emmanuel T , Disis Mary L. 
Published: May 2020

TPS1103 Background: Metastatic HER2+ breast cancer, while initially responsive to trastuzumab, pertuzumab, and TDM-1, eventually progresses. The FDA recently approved trastuzumab deruxtecan, showing benefit in progression free survival but not in overall survival to date. Thus, additional therapies are needed for patients who progress on these HER2 directed agents. In metastatic HER2+ breast cancer, HER2-specific Th1 immune responses and higher CD4+ Th1 and CD8+ TIL levels are associated with a survival benefit. As this Type 1 immunity occurs in a minority of patients, additional immune modulation is needed. Alpha-tocopheryloxyacetic acid (α-TEA) has been reported to augment Type 1 immunity through increasing activated effector memory CD4+ and CD8+ T cells and decreasing immune suppressive CD4+CD25+ regulatory T cells in the tumor microenvironment. When given concurrently with an anti-HER2 antibody (7.16.4) in a pre-clinical tumor model, α-TEA synergized with 7.16.4 to induce tumor regression. We hypothesize that α-TEA and trastuzumab combination therapy in metastatic HER2+ breast cancer will be well tolerated, induce a clinical response, and augment anti-tumor Th1 immunity. Methods: Trial Design: Phase I dose escalation trial of α-TEA in combination with trastuzumab. Patients with metastatic HER2+ breast cancer will receive one of four doses sequentially of α-TEA: 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, and 4.8 mg/kg. Toxicity is assessed at baseline and through end of study. Blood and tumor tissue will be collected for immunologic monitoring and evaluation. Clinical response will be evaluated according to RECIST 1.1. Eligibility : Patients with progressive metastatic HER2+ breast cancer who have previously progressed on trastuzumab/pertuzumab and TDM-1. Specific Aims: Determine: (1) safety of four escalating doses of α-TEA with concurrent trastuzumab, (2) clinical response rate of α-TEA with concurrent trastuzumab (3) if concurrent α-TEA and trastuzumab increases activated effector memory CD4+ and CD8+ T cells, and (4) if concurrent α-TEA and trastuzumab increase the number of HER2-specific T cells. Statistical Methods: (1) The sample size of 24 and cohort size of 6 are determined by simulation experiments and practical consideration, (2) clinical response will be evaluated; overall PFS and OS will be calculated, (3) activated effector memory CD4+ and CD8+ T-cells will be analyzed (4) HER2-specific IFN-g/IL-10 ratios will be evaluated. Targeted Accrual : Twenty-four (24) patients. Clinical trial information: NCT04120246 .
Building resilient oncologists: A feasibility study of a resiliency curriculum for hematology oncology fellows.
Authors: Chatwal Monica Sheila , Vinci Christine , Reich Richard R. , Boulware David C. , Fan Wenyi , Reagan Angela , Gray Jhanelle Elaine 
Published: May 2020

TPS11043 Background: Rates of burnout and career dissatisfaction have declined slightly, but remain high among oncologists (Berg, AMA 2020). As hematology oncology fellows prepare to join this workforce, the ACGME now mandates wellness be a part of their training curriculum. Yet, there are few, if any, structured and effective programs specifically for these trainees. Based on feedback from our prior mindfulness-based wellness curriculum, we created a more varied and comprehensive resiliency program with the use of our institutional resources to incorporate and evaluate as part of our fellowship curriculum (ASCO, Abstract 10508), and potentially expand to other fellowships. Methods: This is a single-center, non-randomized, pilot project to assess the feasibility, acceptability, and impact of a resiliency training program. All hematology oncology fellows at our institution were eligible for enrollment, and participation was voluntary. A total of seven monthly, 1 hour sessions were conducted through the academic year. Each session focused on a particular topic - alternative forms of wellness through art and music, self care, mindfulness and stretching, reflective writing, and healthy boundaries and work life integration - which have all been studied individually in wellness and burnout with positive results. Sessions were co-led by a peer and “expert” guest speakers from our training institution. Participants completed questionnaires pre and post-program, and feedback evaluations after each session. Questionnaires included the Perceived Stress Scale (PSS), Five Facet Mindfulness Questionnaire (FFMQ), Connor Davidson Resiliency Scale (CDRS-10), and modified Maslach Burnout Inventory (MBI), as well as demographics and open response questions. The primary aim was feasibility (enrollment, completion, and compliance rates), and the secondary aim was acceptability (usefulness of the intervention). Examination of stress, mindfulness, resiliency, and burnout were exploratory. Enrollment and data collection are complete, with 18 of 29 (62%) eligible participants consented. Data analysis is in process.
B-TREUH: A single-arm phase II pilot study of euthyroid hypothyroxinemia in metastatic breast carcinoma.
Authors: Trehan Shruti , Cheng Suzan S. , Hercbergs Aleck 
Published: May 2020

TPS1115 Background: It is estimated that there are approximately 155,000 people living with metastatic breast cancer in the US. Studies exploring the connection between hypothyroidism or hyperthyroidism and breast cancer have yielded varying results with up to 33% prevalence of thyroid disease in these patients. L-thyroxine (T4) is the most commonly prescribed agent in the US to manage hypothyroidism. However, there are data suggesting that T4 is a pro-oncogenic agent with proposed mechanisms such as stimulation of mitogenesis, angiogenesis, resistance to apoptosis. In addition, T4 May counter anti-PDL-1 and radiation effects. Triiodothyronine (T3), which is deiodinated form of T4 and also commercially available, is felt to be less oncogenic and less mitogenic. Therefore, exogenous supplementation of T3 would decrease the T4 levels creating the desired state of EUTHYROID HYPOTHYROXINEMIA. The study hypothesizes that replacing L-thyroxine (T4) with Triiodothyronine (T3) in hypothyroid patients with metastatic breast carcinoma, while they simultaneously continue to receive standard systemic therapy, with titrating T3 dose to achieve a state of Euthyroid Hypothyroxinemia would result in improved disease outcomes. Methods: Eligible participants are adults with metastatic breast carcinoma with estimated life expectancy of > 3months, hypothyroidism, and with normal TSH on L-thyroxine (T4). Following consent, participants will discontinue L-thyroixne (T4) and initiate Triiodothyronine (T3) dose based on current T4 dose after an appropriate washout period. Drug titration will be in accordance with thyroid function testing to maintain levels of free T4 at < 50% normal range. The treatment period will continue for 9 months with periodic assessment of disease status, quality of life (FACT-B) and laboratory measures. The primary endpoint is the progression free survival at 12 months while the secondary endpoints are prevalence of hypothyroidism in the cohort, overall survival, quality of life, and duration of time to achieve the Euthyroid Hypothyroxinemia state. Given many uncertainties to calculate power precisely, the sample size is estimated to be approximately 30 patients. Clinical trial information: NCT03787303 .
A phase II/III randomized, blinded study of tozuleristide for fluorescence imaging detection during neurosurgical resection of pediatric primary central nervous system (CNS) tumors: PNOC012 (Pacific Pediatric Neuro-oncology Consortium).
Authors: Leary Sarah , Blatt Jason E. , Cohen Alan R. , Cohen Kenneth J. , Cole Bonnie , Governale Lance , Gupta Nalin , Hauptman Jason S. , Jackson Eric M. , Kebriaei Meysam A. , Kline Cassie , Kobets Andrew , Lee Amy , Miller Dennis Michael , Mueller Sabine , Ojemann Jeff , Prados Michael , Rahman Maryam , Wright Jason N. , Bendel Anne Elizabeth ,   BB-006/PNOC012 Study Group
Published: May 2020

TPS2575 Background: Tozuleristide (also known as BLZ-100 or Tumor Paint) is a fluorescent imaging drug designed to specifically label and accumulate in tumor tissue, thus enabling more precise surgical tumor resection intraoperatively. Tozuleristide achieves tumor targeting through the peptide portion of the molecule, a modified chlorotoxin peptide, and its imaging properties from a coupled near-infrared fluorescent dye, an indocyanine green. Tozuleristide has been studied in 4 Phase 1 studies, including a trial in pediatric brain cancer subjects. No tozuleristide SAEs or dose limiting toxicity were observed in the 97 subjects treated in the Phase 1 program at doses up to 30 mg in adults or 17.3 mg/m2 in pediatrics (Hansen S et al, WMIC 2018, P196). Eighty percent of pediatric subjects receiving tozuleristide had tumors considered fluorescence positive, including high and low grade glioma, ependymoma, and medulloblastoma. Methods: This study randomizes subjects in a 1:10 ratio to standard of care or tozuleristide arms. The primary efficacy objectives and endpoints are based on equivocal regions of tissue encountered in surgery. Prior to fluorescence assessment, the surgeon assesses the suspected nature of the tissue (more likely tumor/less likely tumor). Tissue specimens of equivocal regions are collected for blinded central pathology assessment. Sensitivity and specificity of the surgeon’s designation, fluorescence assessment, and ratios of surgeon to fluorescence assessments comprise the primary efficacy analyses. Tozuleristide is given as an IV bolus dose of 15 mg/m2 to pediatric subjects 1 to 36 hours prior to surgery. Subjects must have a MRI documented lesion consistent with a CNS tumor for which resection is planned. Measures of safety include adverse events, laboratory measures of hematology, liver and kidney function and changes in vital signs and ECGs. Pharmacokinetic blood samples are collected up to 3 hr post dose. Fluorescence imaging is assessed during surgery using an investigational “Canvas System” imaging device attached to a surgical microscope. Collected pathology specimens will also be subjected to further genetic, molecular and pathology studies, including fluorescence assessment of frozen tissue sections. SAEs and patient reported outcomes are collected for 3 months. The SMC for the study last reviewed the data for this study in July 2019 and recommended the trial continue as planned. Clinical trial information: NCT03579602 .