bluuebunny/crossref_metadata_2025_split huggingface dataset:
The perception and emotional reaction to genetic test results in cancer patients in an immigrant enriched hospital.
Authors: Bhasin Pooja Gogia , Durana Theresa , Kyaw Nay Yee Wint , Natarajan Vijaya , Best Jacob , Wu Angela , Toom Sudhamshi , Xu Yiqing 
Published: June 2022

e24128 Background: Genetic testing detects hereditary cancer syndromes and guides prophylactic surgery, intensive surveillance and family member testing. Despite its surge in use, research studies exploring the cancer patient’s perception and emotional reactions of their genetic test result is sparing. We hypothesized that the patient’s perception may be influenced by their ethnicity, educational level and English speaking status. Methods: Cancer patients who had genetic testing performed in the last 10 years were consented to take a questionnaire survey. The correctness of understanding their genetic test results were studied and compared among various ethnic groups, education levels and first spoken languages. We also evaluated the patient’s emotional reaction towards the result. Results: The data for the first 100 patients were analyzed. The primary tumor sites were breast (n = 71), gynecological (n = 16), gastrointestinal (n = 7), genitourinary (n = 5) and lung (n = 1). Eighteen patients were mutation carriers. The correctness in understanding mutation status was 65.7%, 54.2%, 70% and 45.5% in African American, Asian, Caucasian and Hispanics respectively. The correctness was 60%, 64.5% and 66.67% in patients with education levels of grade school or below, high school, or college or higher respectively. None of the 3 patients who carried a mutation with education level of grade school or lower understood the implications of their mutations. Details of correctness in understanding in patients with and without mutation are provided in the table. The correctness was 61.72% and 63.15% in English speaking vs non-English speaking patients. Patients could recall pre-test counseling in 76% and posttest counseling in 67% of cases. Among mutation carriers, 22.2% had anxiety or stressful feelings about the test result, while in patients with no mutation, 20.7% had anxiety/depression. 67% patients carried out prophylactic surgery as recommended. Conclusions: The correctness of understanding their genetic test results across all ethnic groups, education levels and language was below 70%. Patients with education level below grade school encountered in the immigrant population need more attention. Improvement in communication and patient education is imperative in order to carry out recommendations. Structured emotional support to the patient should always complement genetic counseling and testing.[Table: see text]
The need for a personalized, comprehensive resource within the colorectal cancer community.
Authors: Newcomer Kim , Goodman Andrea , Fathi Negeen , Shoeb Abdullah 
Published: June 2022

e24139 Background: Colorectal cancer is the third-most commonly diagnosed cancer and the second-leading cause of cancer death in men and women combined in the United States. In efforts to manage the disease, patients and caregivers turn to a variety of tools and resources for financial assistance, information dissemination, emotional and peer support, and treatment planning, among other critical issues and needs they face. The Colorectal Cancer Alliance (the Alliance) is committed to providing patients and caregivers with a resource solution that encompasses all potential areas of need. Methods: A survey aimed at understanding needs, barriers, and quality improvement opportunity was disseminated via the Alliance's Blue Hope Nation community for two weeks and by email. One hundred sixty-seven colorectal cancer patients and forty caregivers of colorectal cancer patients completed the survey. Results: Patients and caregiver respondents alike report reliance on external tools and resources to manage disease and support information. Of the support methods, patient respondents reported using social media (46.11%); notebooks, journals, and planners (45.41%); online articles (44.91%); the Blue Hope Nation Facebook group (41.32%); cancer discussion boards (35.33%); and spiritual or religious advice (29.94%). Caregiver respondents reported relying on friends and family (57.5%); the Blue Hope Nation Facebook group (47.5%); healthcare websites (47.5%); the Alliance website (42.5%); and spiritual or religious advisors (37.5%). To minimize diagnosis-related stressors, patients reported they look for financial assistance, local peer support and groups, and mental health help. To provide more efficient care and limit stress, the community suggested the need for financial help, communication and support from other patients and caregivers, and informational resources. Conclusions: These survey results are consistent with other published learnings about patient and caregiver reliance on support tools and highlights the myriad resources that patients and caregivers currently use for managing colorectal cancer. The saturation of the market has compelled the Colorectal Cancer Alliance to create a one-stop-shop, personalized resource with tools to organize and effortlessly share customized information treatment plans, and other support mechanisms. Such patient and caregiver-directed resources may enable a better care experience and potentially lead to better physical and mental health outcomes for patients and their caregivers.
Decision making support for cancer patient's treatment strategy during the COVID-19 pandemic in Japan.
Authors: Yoshida Shiori , Sato Fumiko , Sasaki Konosuke , Sasaki Rie 
Published: June 2022

e24141 Background: During the COVID-19 pandemic, cancer patients became reluctant to come to the hospital, receive cancer treatment, and were willing to interrupt or postpone treatment due to concerns about infection. The purpose of this study was to discuss effective treatment strategy decision making support for cancer patients during the COVID-19 pandemic. Methods: An online survey was conducted on decision making support among nurses who worked at a cancer care hospital in Japan from May to July 2021. Results: Forty-nine facilities were asked to participate in the survey, and replies were received from 728 respondents; 185 (26.8%) were nurses engaged in the decision making. The most common treatment choice was postponement in 132 patients (73.3%). Nurses who “provided information on measures to prevent COVID-19 infection” were more likely to recognize that “the patient was satisfied with the treatment” (p < 0.05). Nurses who “listened to the patient's thoughts” were less likely to perceive that the patient was “not convinced and continued with the previous treatment” (p < 0.05). Nurses who “listened to the patient's intentions and thoughts after the decision was made,” “followed up on the patient's symptoms and changes in perceptions by telephone,” “followed up on the patient's symptoms and changes in perceptions by videophone”, and “assured the patient that they could take immediate action if symptoms worsened with the physician's permission” more often recognized that the patient “accepted the treatment recommended by the physician although they were not convinced” (p < 0.05). Conclusions: Effective treatment strategy decision making support for cancer patients during the COVID-19 pandemic includes lifestyle guidance for infection prevention, listening to identify the reasons behind patients’ choices, and telenursing for follow-up decision.
Psychological symptoms and quality of life in Chinese early-stage breast cancer patients throughout chemotherapy.
Authors: Lan Bo , Lv Dan , Yang Min , Sun Xiaoying , Zhang Li , Ma Fei 
Published: June 2022

e24145 Background: Breast cancer survivors with psychological problems have lower quality of life (QOL) and higher mortality than those without. It is important to monitor and manage their psychological status. The aim of this study was to examine the incidence and dynamic changes of anxiety/depression during postoperative adjuvant chemotherapy in Chinese breast cancer patients and to clarify the factors associated with anxiety/depression, the importance of family support, and the impact of anxiety/depression on QOL. Methods: In a prospective observational single-centre cohort study with early-stage breast cancer patients (n = 290), d epression and anxiety severity, QOL and social support were measured before chemotherapy, after 2 cycles of chemotherapy, and after the entire course of chemotherapy using the Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) and Chinese version of the Social Support Rating Scale (SSRS), respectively. Canonical correlations were applied to identify correlates between anxiety/depression and demographic and clinical variables. Paired t tests were used to analyse dynamic changes in QOL. Relationships between anxiety/depression and QOL were analysed using two-way repeated measures analysis of covariance (RMANCOVA). Results: Throughout the entire course of chemotherapy, the incidences of anxiety and depression were 35.2% and 44.1%, respectively. 31.4% of the patients had an increased risk for an anxiety disorder before chemotherapy, which decreased to 29.0% after 2 cycles of chemotherapy and slightly increased to 29.3% after completion of chemotherapy. 20.0% of patients had an increased risk of depression before chemotherapy, which shifted to 25.2% and 24.8% after 2 cycles and the entire course of chemotherapy, respectively. Through multivariable analysis, age (p = 0.042), surgical method (p = 0.009), social support (p = 0.001) and breast cancer family history (p = 0.045) were significantly associated with depression. No variables were significantly associated with anxiety. Patients with higher HADS depression/anxiety scores had lower FACT-B scores during chemotherapy (p < 0.001). Conclusions: We observed dynamic changes in depression, anxiety and QOL throughout adjuvant chemotherapy and the associated factors of depression and anxiety. These findings provide guidance for psychological monitoring and support during postoperative chemotherapy of breast cancer patients. Clinical trial information: NCT05055375. [Table: see text]
Erdafitinib in pediatric patients with advanced solid tumors with fibroblast growth factor receptor (FGFR) gene alterations: RAGNAR study pediatric cohort.
Authors: Witt Olaf , Geoerger Birgit , Dirksen Uta , Farouk Sait Sameer , Reardon David A. , Shih Kent C. , Diez Blanca D. , Monteiro Caran Eliana Maria , Karakawa Shuhei , Stuyckens Kim , Liao Huimin , Najmi Saltanat , Hammond Constance , Santiago-Walker Ademi E. , Sweiti Hussein 
Published: June 2022

TPS10058 Background: FGFR gene alterations have been observed in pediatric patients with cancers and represent potentially targetable genomic variants. Gliomas (high- and low-grade) and soft tissue sarcomas are among the pediatric solid tumors that may harbor FGFR alterations. Erdafitinib is a selective pan-FGFR inhibitor approved in patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR2/3 alterations. RAGNAR (NCT04083976) is an ongoing single-arm, open-label, phase 2 histology-agnostic study investigating the efficacy and safety of erdafitinib in patients with advanced solid tumors exhibiting FGFR alterations after failure of standard systemic therapies. Here we describe the pediatric study cohort. Methods: The pediatric cohort (n = 26, planned) includes patients (≥ 6- < 18 y) with advanced solid tumors (measurable disease per RECIST v.1.1 or RANO [brain tumors]) with FGFR mutations, gene fusions, or internal tandem duplication (patients with FGFR amplification are not eligible) identified via local test reports or central molecular testing. Eligible patients will have received ≥ 1 lines of prior systemic therapy, have exhausted or be unable to tolerate standard-of-care therapies, and have documented disease progression and measurable disease. In addition, up to 6 patients in this cohort will be allowed to be treatment naive. Children and adolescents will be treated with oral erdafitinib, allowing pharmacodynamically guided uptitration based on serum phosphate levels to maximize efficacy. Treatment will continue until progressive disease. The primary end point is overall response rate (ORR) assessed by an independent review committee. Secondary efficacy end points include ORR assessed by the investigator, duration of response, disease control rate, clinical benefit rate, progression-free survival, and overall survival. Other secondary end points are pharmacokinetic exposure parameters, incidence/severity of adverse events, and change from baseline in patient-reported health status. End-of-treatment visit will occur 30 days after the last dose of erdafitinib. A follow-up phase will continue until death, withdrawal of consent, loss to follow-up, or end of study. As of January 2022, 3 patients have been enrolled. Clinical trial information: NCT04083976.
CaboMain: A phase 2 study of cabozantinib as a maintenance agent in patients with ultra-high risk pediatric solid tumors.
Authors: Shah Nilay 
Published: June 2022

TPS10060 Background: Patients with relapsed or refractory pediatric solid tumors have one-year progression-free survival (PFS) <25% even if a remission is achieved [1-9]. Maintenance treatments may extend survival for these patients but have not been tested. Many tyrosine kinase inhibitors (TKIs) target oncogenic pathways active in pediatric cancers and are being evaluated in children with cancer. The multitargeted TKI cabozantinib inhibits MET, VEGFR, AXL, RET, ROS1, KIT, TRKB, FLT3, and TIE2. Preclinical studies and clinical use suggest that cabozantinib may be active against childhood cancers [10-20]. A pediatric Phase 1 study defined a dose of 40 mg/m2/day[21], currently used in an ongoing pediatric Phase 2 study for measurable relapsed/refractory solid tumors, NCT02867592. However, cabozantinib has not been tested as a maintenance agent against cancers in children. We hypothesize that cabozantinib, in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, can prevent recurrent tumor formation or induce a durable remission. Methods: Trial Design: Single arm, open-label, multisite investigator-initiated Phase 2 trial for patients with a “best response,” defined as no progression at least 28 days after end of prior therapy. Primary objective: Evaluate the effect of cabozantinib administered for up to 12 months on 1-year PFS. Statistical design and measure: Bayesian time-to-event optimal phase 2 design with a single interim analysis designed to detect 20% increase in PFS at 1 year with 80% power. Secondary objectives include 2- and 5-year PFS; 1-, 2-, and 5- year OS, duration of response, and safety and tolerability. Exploratory objectives include patient-reported outcomes, predictive biomarkers, PK and PD measurements. Treatment: Patients will take cabozantinib tablets on a continuous dosing schedule, partitioned into 28-day cycles, at an initial dose of 40 mg/m2/day (per dosing nomogram), for up to 365 days. Assessments are defined; radiographic assessment every 3 cycles. Dose modifications will be based on toxicities per protocol. Patients will continue on therapy until progression, toxicities not relieved by dose reduction, or end of planned therapy. Major eligibility criteria: Three strata: Neuroblastoma with residual disease at end of upfront therapy (“Best Response 1”, BR1) or after any relapse, n=36. Pediatric CNS tumors, defined in the protocol, n=30. Other pediatric solid tumors, as defined in the protocol, n=36. Patients must be ≥ 18 months and ≤40 years of age at enrollment, have completed prior therapy ≥ 4 weeks and ≤ 12 weeks prior to enrollment and demonstrate radiographic BR at time of enrollment. Measurable or evaluable disease is not required. Enrollment: Protocol is open to enrollment as of February 12, 2022. At time of abstract submission, we have not yet enrolled the first patient. Clinical trial information: NCT05135975.
Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial in progress).
Authors: Hamilton Erika P. , O'Sullivan Ciara Catherine Maria , Martin Miguel , Sohn Joohyuk , Tryfonidis Konstantinos , Santarpia Libero , Yang Shan , Dieras Veronique C 
Published: June 2022

TPS1108 Background: The current first-line (1L) standard of care (SOC) for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) is trastuzumab (T) plus pertuzumab (P) and a taxane. Despite advances in 1L SOC, most patients (pts) progress during maintenance therapy with T+P. Tucatinib is a tyrosine kinase inhibitor (TKI) approved in combination with T and capecitabine for adults with HER2+ MBC, with and without brain metastases (BM). In HER2CLIMB, the addition of tucatinib significantly prolonged progression-free survival (PFS) and overall survival (OS) in pts with HER2+ MBC and was well tolerated. Adding tucatinib also reduced the risk of disease progression or death in pts with untreated and/or active BM (Murthy et al. 2020, Curigliano et al. 2021). HER2CLIMB-05 investigates whether adding tucatinib to 1L SOC as maintenance therapy will extend PFS while maintaining quality of life (QOL). Methods: HER2CLIMB-05 (NCT05132582) is a phase 3, randomized, double-blind study evaluating tucatinib plus T+P as maintenance therapy for HER2+ MBC. Approximately 650 pts will be enrolled. Eligible pts will have advanced HER2+ disease, no progression on 4–8 cycles of prior 1L SOC, ECOG Performance Status of 0 or 1, and no or asymptomatic BM. Exclusion criteria include prior treatment with anti-HER2 and/or anti-epidermal growth factor receptor TKI (prior SOC for early BC is permitted) or inability to undergo contrast magnetic resonance imaging of the brain. Pts will be randomized 1:1 to receive either tucatinib or placebo twice daily, with T+P once every 21 days. Pts with HR+ disease may receive endocrine therapy. The primary endpoint is investigator-assessed PFS. Secondary endpoints include OS (key endpoint), time to deterioration of health-related QOL, central nervous system PFS, safety, and pharmacokinetic (PK) parameters. PFS and OS will be compared using a 2-sided stratified log-rank test between treatment groups. Time-to-event endpoints will be summarized using the Kaplan–Meier method. PK and safety data will be summarized using descriptive statistics. Enrollment is ongoing in the US, with additional sites planned. Clinical trial information: NCT05132582.
ARST2031: A study to compare early use of vinorelbine and maintenance therapy for patients with high risk rhabdomyosarcoma.
Authors: Allen-Rhoades Wendy A , Mascarenhas Leo , Xue Wei , Donaldson Sarah S. , Casey Dana , Shern John Frederick , Rudzinski Erin R. , Skapek Stephen , Rodeberg David A. , Lautz Timothy , Shenoy Archana , Maianski Irit , Yedururi Sireesha , Maxa Kim , Crompton Brian D. , Fricke Lindsey , Su Zhong , Harrison Douglas James , Venkatramani Rajkumar 
Published: June 2022

TPS11591 Background: Patients with high-risk rhabdomyosarcoma (HR-RMS) continue to have poor outcomes with 3-year event free survival (EFS) rates of 30% or less despite chemotherapy dose intensification on recent cooperative group RMS trials. Vinorelbine (VINO) has demonstrated clinical activity in RMS patients with relapsed/refractory disease and shown to provide a survival benefit when given with oral cyclophosphamide as maintenance chemotherapy for a select group of patients that achieved first complete remission. Methods: ARST2031 is a randomized Phase 3 trial with the primary aim to compare event-free survival (EFS) of patients with HR-RMS treated with vincristine, dactinomycin and cyclophosphamide (VAC) followed by maintenance with vinorelbine and oral cyclophosphamide (VINO-CPO) or vinorelbine, dactinomycin and cyclophosphamide (VINO-AC) followed by maintenance with VINO-CPO. Patients are stratified by histology and randomly assigned to VAC followed by VINO-CPO maintenance or VINO-AC followed by VINO-CPO maintenance. To be eligible, patients must be ≤ 50 years of age at the time of enrollment with newly diagnosed RMS except adult-type pleomorphic, based upon institutional histopathologic classification. All patients must have Stage 4 disease and patients diagnosed with embryonal RMS (ERMS) must be ≥ 10 years of age. Patients with malignant cytology in cerebrospinal fluid, intra-parenchymal brain metastases, or diffuse leptomeningeal disease are excluded. The study was activated on September 13, 2021 and is anticipated to enroll approximately 4 patients per month. The planned sample size is 100 patients, with approximately 50 patients randomized to each arm. Safety and feasibility of VINO-AC will be assessed in the first 8 patients prior to randomization. The study will have power of 0.8 to detect a hazard ratio of 0.61 (74 events in total) when the one-sided Type I error rate is 0.10, with 30 months of accrual and 2 years of follow-up. The hazard ratio of 0.61 was determined by assuming piecewise exponential distributions and specifying the 2-year EFS of 46% vs. 28% and long-term EFS of 32% vs. 16%, based on prior outcome data. Biospecimens will be collected and banked for future use. Clinical trial information: NCT04994132.
TTI-621-03: A phase I/II study of TTI-621 in combination with doxorubicin in patients with unresectable or metastatic high-grade leiomyosarcoma (LMS).
Authors: Chawla Sant P. , Kelly Ciara Marie , Gordon Erlinda Maria , Quon Doris V. , Moradkhani Ania , Chua-Alcala Victoria S. , Thompson Theresa M. , Scheuber Anita , Bruns Ingmar , Allgood Victoria E. , Movva Sujana 
Published: June 2022

TPS11593 Background: Doxorubicin is a standard of care agent for patients with advanced soft tissue sarcoma, with a response rate of around 15%, progression-free survival of 5-7 months and cumulative cardiac toxicity that limits its use. TTI-621 is a recombinant soluble fusion protein that combines the N-terminal portion of human SIRPα (the binding domain for CD47) with the Fc region of human IgG1, generating a decoy receptor for CD47 on the surface of tumor cells that both over-rides CD47-mediated inhibition of phagocytosis and provides a pro-phagocytic stimulation. Many solid tumors express high levels of CD47 which is associated with poor prognosis, thought to be the result of CD47-mediated inhibition of macrophage phagocytosis and escape of immune-mediated clearance. Interruption of the CD47-SIRPα signaling pathway using monoclonal antibodies to CD47 has shown anti-tumor activity in animal models and in some early clinical trials. The combination of doxorubicin with CD47-targeted antibodies results in enhanced anti-tumor activity and increased macrophage-mediated cell killing in animal models and macrophage-mediated phagocytosis of cancer cell lines in vitro, suggesting that combining TTI-621 with doxorubicin might be more effective than doxorubicin alone in tumor types that express CD47 and have high numbers of macrophages, such as LMS. Thus, a Phase 1/2 study was initiated to evaluate this combination in patients with advanced soft tissue sarcoma, including LMS. Methods: TTI-621-03 is a Phase 1/2, open-label study of TTI-621 in combination with doxorubicin in patients with anthracycline-naïve disease. The Phase 1 dose escalation evaluates doses of TTI-621 (0.2 to 2.0 mg/kg) in combination with doxorubicin at 75 mg/m2 in patients with high-grade soft tissue sarcomas. Expansion cohorts will evaluate TTI-621 (0.2 and 2.0 mg/kg) with doxorubicin in patients with LMS, with pathology confirmed at a central laboratory. The primary goals of this study are evaluation of safety of TTI-621 administered in combination with standard-of-care doxorubicin and to further evaluate clinical activity (ORR, PFS, OS), safety, PK and patient-reported quality of life in the LMS subpopulation. The dose escalation portion of the study has been completed without DLT. Enrollment to the expansion portion of the study is underway. Clinical trial information: NCT04996004.