bluuebunny/crossref_metadata_2025_split huggingface dataset:
Shifting perceptions of alternative therapies in cancer patients during the COVID-19 pandemic: Results from the Complementary and Alternative Medicine Exposure in Oncology (CAMEO) Study.
Authors: Weil Christopher R. , Hutten Ryan J. , Barney Brandon M. , Fagerlin Angela , Gaffney David K. , Gill David Michael , Whipple Gary , Rhodes Terence Duane , Scherer Laura , Suneja Gita , Tward Jonathan David , Werner Theresa Louise , Johnson Skyler B , Evans Jaden D. 
Published: June 2022

e24130 Background: Complementary and alternative medicine (CAM) use has been associated with worse survival outcomes in cancer patients compared to standard of care therapies. CAM has received a significant increase in public awareness and interest in the COVID-19 pandemic era. We sought to understand how the COVID-19 pandemic affected CAM use and perceptions in cancer patients. Methods: Data was collected from adult cancer patients prospectively enrolled on a cross-sectional survey conducted at an NCI-designated cancer center and a comprehensive cancer center between 2020 and 2021. The survey included questions assessing changes in patient attitude towards CAM and likelihood of using CAM, both relative to prior to COVID-19. Analyzed CAM users included those taking vitamin, mineral and herbal supplements, alternative medicines and special diets, and excluded mind-body practices as the focus of this analysis was on enteral and parenteral CAM therapies. Differences in the impact of COVID-19 on CAM use beliefs and practices between CAM users and non-users were analyzed with χ2 and two-sample t-tests. Results: Out of 749 respondents, 578 (77%) used any CAM and 470 (63%) used enteral or parenteral CAM. Results shown in table. Compared to prior to COVID-19, CAM users were more likely to view CAM more favorably (12% vs 5%, p < 0.01), while non-users were more likely to have an unchanged opinion (90% vs 84%, p = 0.03). Females had higher rates of viewing CAM more favorably than males (80% vs 58%, p = 0.04). Patients who viewed CAM more favorably had higher rates of self-reported incurable cancer (36% vs 11%, p = 0.04), declining recommended hormone therapy (22% vs 0%, p < 0.01), and higher trust of social media (19% vs 0%, p = 0.02) and websites (24% vs 0%, p < 0.01). Since the start of COVID-19, CAM users were more likely to report increased likelihood of using CAM (12% vs 6%, p = 0.01). Patients who were more likely to use CAM had higher rates of declining recommended chemotherapy (12% vs 0%, p = 0.02), and higher trust of social media (15% vs 2%, p = 0.01) and websites (28% vs 7%, p < 0.01). Conclusions: During the COVID-19 pandemic, attitudes on CAM use in oncology patients have become increasingly polarizing. Patients with favorable attitudes toward CAM were likely to decline recommended standard of care therapy and more like to use CAM since COVID-19. This data helps characterize shifting attitudes toward CAM and may help guide shared decision-making between physician and patient.[Table: see text]
Perceived risk of breast cancer and god health locus of control in high risk African American and caucasian women.
Authors: Nguyen Minh-Tri , Thompson Cheryl L. , Knight Joy 
Published: June 2022

e24142 Background: African American women are more likely than any other racial groups to present with a later stage of breast cancer. Survival rates among African American women with breast cancer are lower than that of their Caucasian counterparts. Studies have shown that women who believe that they can control their health through their own behavior may be more likely to report a lower perceived risk that women who believe that others (such as God or “powerful others” or chance) control their health outcomes. There is a limited body of literature on the effects of spiritual locus of health control and a patient’s perceived risk of breast cancer. Herein, we studied the association between God Locus of Health Control (GLHC) and perceived risk of breast cancer among 85 women recruited from a high-risk clinic. Methods: Consented participants that agreed to the study were asked to fill out the Patient Reported Outcomes Measurement Information Systems (PROMIS) initiative questionnaire. The PROMIS initiative standardizes measurements of psychosocial research in cancer to address major shortcomings in this field. The questionnaire includes demographic characteristics, perceived risk of breast cancer, and questions regarding spiritual and GLHC. Differences in patient demographics (including race), perceived risk, and multivariate testing was performed. Results: When asked to rank their chances of developing breast cancer in their lifetime, Caucasian participants were statistically more likely to respond with a higher perceived risk than African American participants (p = 0.01). Caucasian participants were more likely to respond with a higher perceived risk score when asked to compare their chances of developing breast cancer to that of the average woman their age (p = < 0.001). Linear regressions correlating perceived risk, degree of GLHC and race did not show any statistical significance. Multivariate analyses only showed race was a statistically significant predictor of any of the perceived risk variables. Our study showed that Caucasian participants were more likely to have a lower GLHC score than their African American counterparts and were more likely to perceive a higher risk of developing breast cancer. GLHC was not statistically significantly associated with any of the 4 perceived risk measures (p > 0.05 for all). Conclusions: Overall, there was not a statistically significant relationship between GLHC scores and perceived risk. Further larger-scale studies will be needed to further characterize these findings.
Trial in progress: A phase I trial of dual EZH 1/2 inhibitor valemetostat tosylate (DS-3201b) in pediatric, adolescent, and young adult patients with malignant solid tumors.
Authors: Arakawa Ayumu , Ozawa Hitoshi , Hirakawa Akihiro , Sadachi Ryo , Hoshina Yukari , Tomatsuri Sawako , Saito Yoshimasa , Ando Reiko Makihara , Terashima Keita , Nakamura Kenichi , Ogawa Chitose 
Published: June 2022

TPS10059 Background: Enhancer of zeste homolog enzymes (EZH1 and EZH2) form parts of the polycomb repressive complex 2 and regulate gene expression by catalyzing the tri-methylation of lysine 27 residue of histone H3. SMARCB1/INI1 is one of the core components of the SWI/SNF chromatin remodeling complex, with the loss of SMARCB1/INI1 causing the oncogenic activation of EZH2 and EZH1. The inhibition of EZH2 or both EZH2 and EZH1 can be effective against various hematological malignancies and SMARCB1/INI1-deficient solid tumors. Valemetostat tosylate (DS-3201b; valemetostat) is a potential first-in-class dual inhibitor of EZH1 and EZH2 that targets epigenetic regulations by inhibiting both EZH1 and EZH2 enzymes. A phase 2 single-arm study showed that valemetostat demonstrated promising response rates in Japanese patients with relapsed or refractory adult T-cell leukemia/lymphoma (Yoshimitsu M et al., presented at ASH Annual Meeting, 2021). Tumors characterized by SMARCB1/INI1 deficiency (a SWI/SNF mutation), such as malignant rhabdoid tumors, epithelioid sarcoma, or synovial sarcoma are quite frequently observed during childhood and adolescence, among whom valemetostat is expected to show antitumor effects. Methods: This open-label multi-center phase I trial evaluates the safety and efficacy of valemetostat in pediatric, adolescent, and young adult patients with refractory/relapsed solid tumors. The inclusion criteria are relapsed, refractory, or progressive metastatic disease; >3 and <19 years of age during the dose escalation cohort and < 29 years of age in the expanded cohort; performance status of >50 (assessed by Karnofsky Performance score in patients >16 years old, and Lansky Performance score in patients <15 years old); and adequate organ function. Valemetostat is administered orally once a day without interruption. Three dose levels (150, 200, and 250 mg/1.7 m2) are assessed using a 3+3 design during the dose escalation cohort. After determining the recommended phase 2 dose (RP2D) during dose escalation cohort, up to 30 patients will be further enrolled, and the safety and efficacy data of valemetostat are determined in the expanded cohort. The primary endpoint is the incidence of dose limiting toxicity, whereas the secondary endpoints include safety, pharmacokinetics, overall response rate, progression-free survival. The overall response rate of the tumors with SMARCB1/INI1 deficiency or SWI/SNF mutation is also evaluated as a secondary endpoint. Exploratory endpoint includes overall survival. Enrollment into this trial began in March 2020, and enrollment into the dose escalation cohort was completed. Enrollment into the expanded cohort began in November 2021. Clinical Trial Information: jRCT2031190268.
A multicenter, open-label, phase 2 study of odetiglucan (IMPRIME PGG) and pembrolizumab in patients with metastatic breast cancer (mBCA) who have progressed through prior hormonal therapy.
Authors: Stopeck Alison , Gargano Michele Anne , Niles Nick , Rathmann Blaine , Chisamore Michael Jon , Bose Nandita , Iglesias Jose Luis 
Published: June 2022

TPS1115 Background: Hormone receptor (HR) positive/ human epidermal growth factor receptor 2-negative (Her2-) breast cancer is generally considered ‘immunologically cold’ in comparison to TNBC or Her2+ breast cancer. Keynote-028 results showed a modest ORR of 12% to anti-PD1 antibody, pembrolizumab (PEM) in previously treated HR+/ HER2-/programmed death ligand 1-positive (PD-L1-positive) advanced breast cancer patients (pts). With limited options available, there is significant unmet need to expand clinical benefit from ICI. Odetiglucan, a novel beta glucan, acts as a pathogen-associated molecular pattern (PAMP) that drives a cascade of immune activating events. It repolarizes the immunosuppressive microenvironment, activates the maturation of antigen presenting cells and significantly enhances efficacy of ICI therapy in preclinical tumor models. In a Ph2 trial (IMPRIME 1) of odetiglucan + PEM in 44 pts with heavily pretreated metastatic TNBC, an ORR=15.9%, DCR=54.5%, mDOR=12.7mo, mPFS=2.86 mo, 12 mo OS rate=57.6%, and mOS=16.4 mo were observed. Clinical benefit was particularly evident in a subset of pts, mTNBC “converters” (12/44 pts) who were originally diagnosed with ER/PR+ disease and progressed through endocrine therapies +/- CDK4/6 inhibitors. In these 12 pts, an ORR=50%, DCR=83%, mDOR=11.2, mPFS=5.6 mo, 12-mo OS rate=64.8%, and mOS=17.4 mo were observed. Methods: Odetiglucan + PEM is now being explored in pts with hormone-resistant metastatic breast cancer (MBC). This is a phase 2, Simon’s 2-Stage study of MBC pts who have progressed through prior hormonal therapy with >1 CDK4/6 inhibitor. Pts will receive odetiglucan 4 mg/kg/wk + PEM 200 mg Q3wk. Stage 1 will enroll 23 pts. If >4 pts have an objective response after 12 wks of treatment, the study will proceed to Stage 2 enrolling an additional 24 pts (N=47). Rejection of the null hypothesis requires >10 objective responses. Main eligibility criteria include: MBC having failed prior hormonal therapy with >1 CDK4/6 inhibitor, <2 chemotherapies, serum ABA ≥20 µg/mL, and no prior ICI exposure. Primary endpoint is ORR (RECIST v1.1); secondary endpoints are PFS, OS, DCR, DoR, and safety. Exploratory objectives assess impact of the treatment combination on immune activating events in peripheral blood and tumor biopsies, and correlate tumor microenvironmental changes with clinical benefit Select subpopulations may be explored. Point estimates with 95% confidence intervals (CIs) of ORR and DCR will be computed. Medians, first, and third quartiles with 95% CI will be estimated using Kaplan-Meier method for other secondary endpoints. Safety parameters will be summarized. The trial is sponsored by HiberCell, Inc. in collaboration with Merck & Co. ̃25 US sites will participate. Clinical trial information: NCT05159778.
Phase 1b/2 study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (SGNLVA-002, trial in progress).
Authors: Meisel Jane Lowe , Pluard Timothy J. , Vinayak Shaveta , Stringer-Reasor Erica Michelle , Brown-Glaberman Ursa , Dillon Patrick Michael , Basho Reva K , Varadarajan Ramya , O'Shaughnessy Joyce , Han Hyo S. , Sinha Rajni , Fox Jenny R. , Villanueva Rafael , Chen Lin Chi , Wu Sheng , Li Hong , Tran Sinhan , Manso Luis 
Published: June 2022

TPS1127 Background: Patients with metastatic triple-negative breast cancer (mTNBC) have a poor prognosis. Treatment combinations of anti-programmed death ligand 1 (anti–PD-L1) agents with chemotherapy have shown promise in mTNBC. LV is an investigational antibody–drug conjugate directed to LIV-1, a protein highly expressed on breast cancer cells, via a humanized IgG1 monoclonal antibody conjugated to monomethyl auristatin E (MMAE) by a protease-cleavable linker. LIV-1–mediated delivery of MMAE disrupts microtubules and induces cell cycle arrest and apoptosis. LV has also been shown to drive immunogenic cell death (ICD) to elicit an immune response. LV + pembrolizumab may result in synergistic activity through LV-induced ICD, creating a microenvironment favorable for enhanced anti–PD-L1 activity. Preliminary results show LV delivered once every 3 weeks (Q3W) + pembrolizumab was tolerable with encouraging antitumor activity in patients with mTNBC (Han 2019). Additionally, interim results of weekly LV monotherapy at doses up to 1.5 mg/kg were clinically active and generally well tolerated (Tsai 2021). Based on pharmacokinetic and pharmacodynamic modeling and simulation analysis, an intermittent LV + pembrolizumab dosing regimen is being evaluated to further enhance efficacy and improve the tolerability profile. Due to an unmet medical need for patients with mTNBC who are PD-L1 low or negative, Part D will focus on this patient population. Methods: SGNLVA-002 (NCT03310957) is an ongoing global single-arm, open-label phase 1b/2 study of LV + pembrolizumab as 1L therapy for patients with unresectable locally advanced/mTNBC. Part D is currently enrolling ̃40 patients. Eligible patients must have advanced disease with no prior cytotoxic/anti–PD-L1 treatment, PD-L1 combined positive score < 10, measurable disease per RECIST v1.1 and an ECOG score ≤1. Patients with Grade ≥2 pre-existing neuropathy or active central nervous system metastases are not permitted. Patients will receive LV at 1.5 mg/kg on Days 1 and 8 plus pembrolizumab 200 mg on Day 1 Q3W. The primary objectives are to evaluate the safety/tolerability and objective response rate of LV + pembrolizumab. Secondary objectives include duration of response, disease control rate, progression-free survival, and overall survival. Safety and efficacy endpoints will be summarized with descriptive statistics. Global enrollment is ongoing in the US, EU, and Asia. Clinical trial information: NCT03310957.
Take charge during treatment: A planned exercise protocol to evaluate disparities and cardiovascular outcomes in Black and White patients with breast cancer undergoing treatment.
Authors: Hidde Mary , Beyer Andreas M , Beyer Kirsten M. M. , Durand Matthew J , Phillips Shane A , Grigoriadis Georgios , Jankowski Courtney , Berendt Madeline , Canales Bethany , Norwood Toro Laura , Kong Amanda L. , Hoskins Kent , Brown Sherry-Ann , Gutterman David , Stolley Melinda 
Published: June 2022

TPS12138 Background : Cardiotoxicity is a significant challenge associated with common first-line breast cancer (BC) chemotherapy (CTx) treatments including anthracyclines (AC) and targeted therapies, such as anti-Her-2 therapy. For targeted therapies, cardiac complications typically resolve once treatment is completed or stopped. For ACs, treatment may lead to permanent long term cardiac damage, and elevated risk for major adverse cardiovascular events (MACE). Black/African American (B/AA) women are at higher risk for AC-based cardiotoxicity compared to Non-Hispanic White (NHW) women. To date, most efforts have targeted managing and defining mechanisms of large vessels and cardiac damage. However, impaired microvascular function, a powerful but clinically underused predictor of future MACE, may also be implicated. Extensive evidence shows that exercise interventions reduce systemic inflammation and possibly MACE. However, few cardio-oncology studies have utilized exercise to mitigate cardiotoxicity, and none have quantified microvascular endothelial function. A further gap in cardio-oncology research is a paucity of studies focused on understanding and addressing disparities. This research project aims to 1) test the feasibility and efficacy of an exercise intervention designed to mitigate the effects of CTx, Take Charge during Treatment (TCT) and 2) examine the influence of socio-ecological factors on endothelial function in response to an exercise intervention. Methods: B/AA (n=50) and NHW (n=50) women diagnosed with non-metastatic BC, scheduled to receive AC and/or anti-HER-2 therapy, will be recruited and randomized to participate in the TCT intervention or usual care (NCT05223322). TCT is a virtual exercise coaching program with weekly coaching sessions, six of which include supervised exercise. Assessments to assess socio-ecologic and vascular outcomes are presented in the Table. Assessments will be completed prior to treatment (T1), after treatment completion (18-24 weeks, T2), and 12-months post treatment (T3). Clinical trial information: NCT05223322. [Table: see text]
Episodic future thinking: A behavioral intervention to promote weight loss in breast cancer survivors.
Authors: Sukumar Jasmine S , Vaughn Jennifer , Stein Jeffrey , Schnell Patrick , Sudheendra Preeti Khetarpal , Pariser Ashley , Gatti-Mays Margaret Elena , Williams Nicole Olivia , Cherian Mathew Amprayil , Stover Daniel G. , Wesolowski Robert , Ramaswamy Bhuvaneswari , Lustberg Maryam B. , Sardesai Sagar D. 
Published: June 2022

TPS12139 Background: Obesity at diagnosis is associated with an increase in breast cancer (BC) specific mortality. Behavioral interventions targeting obesity-related health choices offer a scalable approach to improve patient engagement in the community. Episodic Future Thinking (EFT) is a novel remotely delivered behavioral intervention which engages the science of prospection where participants mentally simulate positive, detailed, and personal events that can occur in the future. EFT targets a key behavioral economic measure – Delay Discounting (DD). As DD rate rises, an individual devalues future outcomes to a greater degree and has a higher bias for immediate gratification. EFT can decrease DD in obese patients, leading to improved diet quality and weight loss. However, valuation of the future may impact cancer survivors differently. Herein, we propose the first randomized Phase II trial evaluating adherence and changes in DD and body weight with 12-week remotely delivered EFT vs control in overweight or obese BC survivors. Methods: Eligible patients have a history of DCIS or stage 1 to 3 BC, BMI > 25 kg/m2, have completed surgery, radiation, and chemotherapy, and are motivated to lose weight. They are randomized 1:1 to a 12-week EFT intervention or control (Episodic Recent Thinking; ERT). ERT is a validated control in which patients imagine events in the recent past. Randomization will be stratified by baseline DD rate. There is an optional 12 week follow up period where patients can continue to receive EFT or ERT cues. DD will be measured at baseline and every 4 weeks for 24 weeks. The primary endpoint is adherence, measured by percentage of thrice daily smartphone prompts participants open and attend to during the 12-week trial. Secondary endpoints are changes in body weight and DD rate at 12 and 24 weeks and change in PROs (PROMIS scales), insulin resistance (HOMA-IR), hs-CRP, and diet quality (HEI 2015) at 12 weeks from baseline. With 20 subjects per arm, the study has 80% power to detect deviation of 14 points from a target adherence rate of 80% using a 1 sample t-test. The primary endpoint is evaluable for all subjects, regardless of drop-out. Secondary endpoints will be evaluated using a linear mixed effects model. Hypothesis tests and confidence intervals will be two-sided at 5% significance/95% confidence level. Since trial activation in November 2021, 9 of the planned 46 patients are enrolled. Accrual is closely integrated with the dedicated Ohio State University Comprehensive Cancer Center Survivorship Program. This work is supported by the Alliance Cancer Control Program Pilot Award (5UG1CA189823-08). Clinical trial information: NCT05012176.
Preventive effect of goshajinkigan against peripheral neuropathy induced by paclitaxel-containing chemotherapy: An open-label, randomized, phase II study.
Authors: Nakamura Naoki , Kato Yuka , Makimoto Go , Ninomiya Kiichiro , Harada Daijiro , Ninomiya Takashi , Oze Isao , Kubo Toshio , Fujii Masanori , Ichihara Eiki , Ohashi Kadoaki , Kozuki Toshiyuki , Hotta Katsuyuki , Tabata Masahiro , Kiura Katsuyuki 
Published: June 2022

TPS12141 Background: Paclitaxel is a taxane agent that has been used as a standard treatment for various malignancies. However, taxanes, such as paclitaxel, unfortunately cause a high frequency of chemotherapy-induced peripheral neuropathy (CIPN) as a result of axonal damage (All grade; 70%) (Clin Cancer Res.1996), CIPN worsens patients’ QOL and then lead to poor treatment compliance. Furthermore, there is no evidence for the prevention of CIPN. Goshajinkigan (GJG) is one of the Kampo medicine and it is approved in Japan for the treatment of numbness and has been commonly used for diabetic peripheral neuropathy. In addition, a non-clinical study has also shown the preventive effect of GJG against CIPN induced by paclitaxel (Molecular pain. 2014). To investigate if GJG indeed has a preventive effect for severe CIPN in patients receiving chemotherapy including paclitaxel, we started a two-arm randomized trial of GJG vs physician’s choice of treatment for patients. Methods: Patients have to meet the followings: pathologically diagnosed with malignant tumor (regardless of cancer type) and scheduled to receive ≥4 courses of chemotherapy including carboplatin and paclitaxel (paclitaxel ≥150mg/m2 every 3-4 weeks) as initial chemotherapy; age ≥20yrs; Performance Status of 0 or 1. The primary endpoint is set as a proportion of ≥G2 CIPN by CTCAE ver.5.0 by the end of 4 courses of chemotherapy. With stratification by cancer type and age, patients will be randomized centrally to receive GJG at the same time as chemotherapy (A), or to receive the physician’s choice of treatment for pts if ≥G2 CIPN occurs without prophylaxis (B). Assuming that the incidence of ≥G2 CIPN would be 50% without prophylaxis and 20% with GJG prophylaxis, and assuming an 80% completion rate of four paclitaxel courses, the required sample size is 66 patients (1-β: 0.75, α: 0.1). The secondary endpoint includes time to the onset of CIPN G2, incidence rate and severity of CIPN at the end of each course, relative dose intensity of paclitaxel, adverse events other than CIPN. Enrollment began in 2022, and will be complete by 2025. Clinical trial information: 061210047.