bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mindfulness based stress reduction (MBSR) to improve cardiovascular (CV) function and psychosocial outcomes in breast cancer survivors.
Authors: Blaes Anne Hudson , Jewett Patricia , Nijjar Prabhjot , Everson-Rose Susan 
Published: June 2021

e24058 Background: Breast cancer survivors on aromatase inhibitors (AIs) can develop endothelial dysfunction, a measure of increased CV risk. Stress modifying techniques such as MBSR may improve CV function and quality of life (QOL). We present data of a pilot study assessing the impact of MBSR on endothelial dysfunction and psychosocial outcomes. Methods: 31 women with locally advanced breast cancer and taking an AI were randomized 1:1 to 8 weekly MBSR classes or wait-list control. Subjects with tobacco use, known hypertension or hyperlipidemia were excluded. Participants completed surveys and vascular testing at baseline and 10 weeks. With the COVID-19 pandemic, MBSR classes were held on a virtual platform. Endothelial function was measured using the Endo-PAT2000 system; reductions in EndoPAT ratio (<1.6) are indicative of worsening endothelial function and increased CV risk. Questionnaires included the CDC’s 4-item Healthy Days Core Module (HRQOL), Patient Health Questionnaire (PHQ)-8 for depression, the Perceived Stress Scale, and the Generalized Anxiety Disorder Scale (GAD-7). Functional test markers were compared between groups using t-tests. Results: Baseline mean age was 59 years, body mass index was 28.4 kg/m2, mean systolic blood pressure was 128.1 mmHg and cholesterol was 226.9 mg/dL. These measures did not differ between groups. Baseline EndoPAT ratio (0.60) and follow up (0.52) were low in all participants. As statewide COVID-19 cases spiked, 3/31 participants did not return for a second assessment, and for another 5 participants, one EndoPAT ratio measurement was not interpretable. Both groups showed a decline in EndoPat ratio pre-to-post, but the decline among MBSR participants (all of whom completed the intervention) was five times less than that observed among controls [Table]. Groups did not differ on QOL or psychosocial outcomes. Conclusions: Breast cancer survivors on AIs have endothelial dysfunction, a measure of increased CV risk. Stress reduction techniques, using virtual platforms, are feasible and acceptable to this patient population, and may help improve endothelial function. Further research and longer follow up is warranted in understanding the long-term impact of these interventions on CV risk and psychosocial well-being. [Table: see text]
Incidence of neutropenia in breast cancer patients with administration of mecapegfilgrastim.
Authors: Fu Peifen , Wang Yongsheng , Li Yongqing , Yao Yumin , Li Huiping , Shi Yanxia , Yu Zhiyong , Song Lihua , Zhang Guifang , Ren Zhangxia , Cheng Gang , Ding Lifang , Yan Jun , Zhang Jing , Bie Jun , Yuan Chao , Wang Zhanggui , Ma Jun 
Published: June 2021

e24070 Background: Neutropenia is the frequently observed adverse events for breast cancer patients under chemotherapy. Prophylactic administration of mecapegfilgrastim could reduce the incidence of grade 3/4 neutropenia/febril neutropenia(FN). The effectiveness of mecapegfilgrastim in breast cancer patients and different subgroups were explored. Methods: Patients with breast cancer and tolerable of mecapegfilgrastim were prospectively enrolled in a real-world study. All the patients received mecapegfilgrastim prophylacticly at least in chemotherapy cycle one. The incidence of grade 3/4 neutropenia/febril neutropenia in all patients and subgroups were presented. Results: 322 eligible patients were enrolled. The median age was fifty one years. The ECOG performace score was 0 – 1. In total, 752 chemothrapy cycles were conducted. Grade 3/4 neutropenia occurred in 44 (5.9 %) cycles, grade 4 neutropenia occurred in 16 (2.1 %) cycles. FN were reported in 4 (1.2 %) patients. The incidence of grade 3/4 neutropenia were stratificated by age group (≥65, ＜65), chemotherapy history, radiotherapy history, baseline absolute white blood cell count (≥4.0 ×109/L, ＜4.0 ×109/L), baseline absolute neutrophil count (≥2.0 ×109/L, ＜2.0 ×109/L), baseline hemoglobin level (≥110 g/L, ＜110 g/L) and chemotherapy regimens (High risk of FN, intermediate risk of FN). The results showed that patients with baseline hemoglobin of ≥110 g/L and ＜110 g/L had grade 3/4 neutropenia of 5% and 14.8 % respectively (P = 0.017). Patients treated with high FN risk chemotherapy and intermediate FN risk chemotherapy had grade 3/4 neutropenia of 0.9 % and 8.9 % respectively (P = 0.003). No significant difference of incidence of grade 3/4 neutropenia between other subgroups were found. Patients treated with cyclophosphamide and epirubicin (AC, classified as intermediate risk of FN by investigator) had grade 3/4 neutropenia of 15.4 %; Patients treated with cyclophosphamide, docetaxel and epirubicin (TAC, classified as high risk of FN by investigator) had grade 3/4 neutropenia of 14.3 %; Patients treated with docetaxel monotherapy (classified as intermediate risk of FN by investigator) had grade 3/4 neutropenia of 4.9 %. Conclusions: Prophylactic administration of mecapegfilgratim reduced the incidence of grade 3/4 neutropenia/febril neutropenia. Baseline hemoglobin level and specific chemotherapy regimen could be a useful prognostic facots for neutropenic events after administered mecapegfilgrastim.
Outcomes of radiotherapy combined with systemic therapy for stage IV NSCLC: A real-world study.
Authors: Jia Hongyuan , Lv Jiahua , Liang Long 
Published: June 2021

e24084 Background: Although systemic therapy is standard treatment for stage IV NSCLC, radiation therapy can also play an important role. In the practice of our institute, radiotherapy to local diseases has been extensively used. In this study, we observed and analyzed the outcomes of systemic therapy combined with radiotherapy in stage IV non-small cell lung cancer. Methods: Patients with stage IV non-small cell lung cancer treated with combination of systemic therapy and radiotherapy were enrolled in this study. Radiotherapy was delivered using sIMRT or VMAT technique with CBCT image guidance. SBRT or hypofractionated radiation was used according to lesion site and patients general condition. For patients with driving gene mutations TKIs were used, and for these without chemotherapy of cisplatin/carboplatin plus paclitaxel or pemetrexed was given. Results: From 2016 to 2018, 105 patients were included in this study. Sites mostly irradiated included pulmonary lesions or mediastinal lymph nodes(48%), intracranial metastatic lesions(33%), bone metastatic lesions (20%). 42% of all patients received one course of radiotherapy to a single lesion site and others received multiple courses of radiation to different sites. Median follow-up was 39.1 months. Median OS for whole cohort was 18.6 months. In subgroup analysis, the survival of TKIs+radiotherapy group as significantly better than that of chemotherapy+radiotherapy group (median OS: 35.2 months vs 11.1 months, p < 0.001). The survival of patients with oligometastasis was also significantly better than these with extensive diseases( median OS 25.3 months vs 7.9 months, p < 0.001). The local control rate of irradiated sites was 82%. The incidence of ≥Grade 2 radiation esophagitis and pneumonitis were 33.2% and 24.2% for thoracic radiotherapy. Conclusions: Radiotherapy combined with systemic therapy is feasible and well tolerated for stage IV NSCLC, especially for patients with driving gene mutations and oligometastasis. It needs to be further confirmed by large randomized controlled clinical studies.
Perceptions of cancer patients and their caregivers regarding COVID-19 pandemic in Ethiopia.
Authors: Woldemariam Aynalem Abraha , Berbyuk Lindström Nataliya , Andersson Rune , Addissie Adamu 
Published: June 2021

e24116 Background: Limited research is available about COVID 19 pandemic in Ethiopia in general and in relation to cancer care in particular. Ethiopia reported the first COVID-19 in March, 2020. The number of cases is increasing, putting much pressure on oncology care. This study examines what the Ethiopian cancer patients and their caregivers knew about COVID 19 after the initial stages of the pandemic. It also assesses the information needs, psychological experiences as well as the impact of pandemic on oncologist-patient-caregiver communication and treatment process. Methods: A cross-sectional study was conducted among 200 participants (100 cancer patients and 100 caregivers) at the initial stage of pandemic (May 1 - June 30, 2020) at Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. Data was collected using a pre-tested, structured questionnaire to assess knowledge and perceptions on COVID-19. Ethics approval was obtained from the Ethical Review Board of TASH (04/14/2015) and the Ethical Review Board of Western Sweden (DNR 520-18). Results: The results indicate that though both cancer patients and their caregivers show a high awareness of and knowledge about COVID 19, they need more information about the risks specific to cancer patients. The respondents are also concerned about the risks of pandemic outbreak in Ethiopia and its impact on availability of cancer care treatments in the country. The respondents report experiencing psychological concerns in relation to the pandemic. The higher educated patients and caregivers report being more concerned than the lower educated respondents. Delays in appointments and therapy are the main concerns in relation to cancer care. Further, both patients and caregivers experience that the restrictions on the number of caregivers present during interactions with oncologists negatively influence communication, resulting in relatives being excluded and patients experiencing loneliness and lack of support. Conclusions: Getting a better insight into knowledge and awareness of COVID-19 among cancer patients and their caregivers is essential for managing the effects of pandemic in cancer care. To our knowledge, there was no similar study in Ethiopia. The results of the study contribute to insights into patient and caregiver awareness of COVID 19, essential for adoption of health care protective practices, providing information and managing oncologist-patient-caregiver communication.
Phase 1 expansion trial of the LSD1 inhibitor seclidemstat (SP-2577) with and without topotecan and cyclophosphamide (TC) in patients (pts) with relapsed or refractory Ewing sarcoma (ES) and select sarcomas.
Authors: Reed Damon R. , Chawla Sant P. , Setty Bhuvana , Mascarenhas Leo , Meyers Paul A. , Metts Jonathan , Harrison Douglas James , Lessnick Stephen L. , Crompton Brian D. , Loeb David , Stenehjem David D. , Wages David S. , Santiesteban Daniela Y. , Mirza Nadeem Q. , DuBois Steven G. 
Published: June 2021

TPS11577 Background: Several sarcomas possess chromosomal translocations in FET family members ( FUS, EWSR1, and TAF15) responsible for cancer development. Sarcomas caused by FET family gene rearrangements include ES, desmoplastic round cell small tumors (DSRCT), myxoid liposarcoma (ML), and several others. Lysine specific demethylase 1 (LSD1) is a critical protein for sarcoma development and progression through its colocalization and/or association with several FET family oncogenic transcription factors. This suggests that pharmacologic inhibition of LSD1 may be a therapeutic strategy. Seclidemstat (SP-2577, Salarius Pharmaceuticals) is an oral, first-in-class, small molecule with reversible, noncompetitive inhibition of LSD1 (IC50: 25–50 nM). In vitro and in vivo data demonstrate seclidemstat, or analogs, modulate EWS/ETS transcriptional activity, down-regulating oncogene expression and up-regulating tumor-suppressor gene expression, leading to significant tumor growth inhibition in ES mouse xenograft studies. Seclidemstat has shown in in vitro ES cell lines near additivity efficacy when added to TC. In in vitro studies of other FET-translocated sarcomas, including ML (FUS/DDIT3 fusion) and clear cell sarcoma (EWS/ATF1 fusion), seclidemstat showed anti-proliferative activity. In an ongoing Phase 1 trial investigating single agent seclidemstat in advanced solid tumors (NCT03895684), three pts with metastatic FET-translocated sarcomas had a median progression-free survival of 5.7 months (range: 4.3–7.2) with a best response of stable disease despite having a median of 5 (range: 1–7) prior therapies. Methods: This dose expansion Phase 1 study (NCT03600649) assesses seclidemstat at 900 mg PO BID, the recommended Phase 2 dose, in two expansion cohorts: a single agent expansion in select sarcoma pts (n = 30) and a safety lead-in dose escalation and expansion (n = 24) of seclidemstat combined with TC in pts with ES. Pts must be ≥12 years old, have ECOG performance status of 0 or 1, with a life expectancy > 4 months. In the select sarcoma cohort, pts must have ML (n = 15) or other sarcomas with FET family translocations (n = 15) including DSRCT. One to 3 prior lines of therapy are allowed. In the ES combination cohort, up to 2 lines of prior therapy are allowed. Primary objective is safety/tolerability and secondary objective is efficacy. The trial is currently recruiting across 8 locations in the United States. Clinical trial information: NCT03600649.
Olanzapine or dexamethasone, with 5-HT3 receptor antagonist and NK-1 receptor antagonist, to prevent nausea and vomiting induced by cisplatin-based doublet chemotherapy: A non-inferiority, prospective, multi-centered, randomized, controlled, phase III clinical trial.
Authors: Liu Zhigang , Zhou Yuling , Yang Shuang , Feng Wei-neng , Chen Ming-Yuan , Zou Xiong , Han Guang , Tang Jie , Zou Guorong , He Yu-Xiang , Zhang Lemeng , Cui Lei , Chen Hualin , Li Guo , Jiang Shan , Gao Jin , Xiao Lin , Zhang Qun , Yi Wei , Huang Chenghui 
Published: June 2021

TPS12133 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common side effect of cancer treatments, and dexamethasone offers an advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects are diverse including moderate to severe insomnia, hyperglycemia, dyspepsia and so on, which are gathering increasing concerns. What’s more, dexamethasone is not applicable to all cancer patients. The incidence of diabetes mellitus varies in different cancer which can reach up to 55.3%, and dexamethasone might not be a proper anti-emesis choice for them. Besides, dexamethasone delivery is always on debating when patients are receiving immunotherapy. However, all anti-emesis regimen recommended in guidelines are dexamethasone based. Alternative anti-emesis regimen are required. Studies have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Thus, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: the non-inferiority role of applying olanzapine to prevent CINV instead of dexamethasone. Methods: This clinical trial started on February 3, 2020 is being conducted in 23 centres. All patients eligible are chemotherapy naïve and plan to receive cisplatin-containing regimen. Based on a 70% complete remission rate of previous study, to demonstrate a non-inferiority margin of 10%, 548 patients are required for two arms with the consideration of 5% of drop out and lost to follow-up (80% power,α = 0.05). Study design: Enrolled patients are randomized 1:1 into 2 arms to receive olanzapine or dexamethasone combined with 5-HT3 receptor antagonist (palonosetron, granisetron or ondansetron) and NK-1 receptor antagonist (aprepitant or fosaprepitant) from the first day of chemotherapy. Olanzapine (5mg) is delivered orally per night from day 1 to day 4. Dexamethasone (12 mg) is given orally or intravenously within 30 minutes before cisplatin administrated on day 1; on day 2-4, the orally or intravenously given dose of dexamethasone is 8 mg. The primary endpoint is complete remission rate of vomiting during the whole observation period (0-120 hours from the starting of first course chemotherapy delivery). The secondary endpoints are complete remission rate of vomiting during 25-120 hours from the starting of first course chemotherapy delivery and no nausea rate during the whole observation period. Besides, side effects will be recorded according protocol. Clinical trial information: NCT04437017.
Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): An open-label, phase 2 trial.
Authors: Maeng Chi Hoon , Kim Bo-Hyung , Chon Jinmann , Kang Won Sub , Kang Kyounglan , Woo Mihye , Hong Il Ki , Lee Junhee , Lee Kil Yeon 
Published: June 2021

TPS12134 Background: Cancer Cachexia (CC) is a multi-factorial process characterized by progressive weight loss, muscle mass and fat tissue wasting, and adversely affecting the quality of life and survival in patients with advanced stage of cancer. CC has a complex and multi-factorial pathophysiology, and there is no established standard treatment. Once it occurs, it is often irreversible and also difficult to suppress the its progression with any single treatment modality. We are conducting an open-label, parallel, randomized phase 2 trial to investigate the effect on preventing or alleviating cancer cachexia and safety of a multi-modal intervention including anti-inflammation, omega-3-fatty acids, nutritional supplement with counselling, physical exercise, psychiatric intervention as well as bojungikki-tang, which mediates immune-modulation and reverse inflammation-related chronic consumptive wasting condition as a complementary and alternative medicine compared to patients receiving best supportive care. Methods: Eligible criteria included patients with recurrent or metastatic gastrointestinal (gastric, colorectal and pancreaticobiliary) as well as lung cancer undergoing active palliative chemotherapy. Patients who have already developed refractory cachexia (ie, low performance status, difficult to take medications orally or visit the hospital to exercise) are excluded. Patients are randomized into experimental arm (Multi-modal intervention care: MIC) versus control arm (Conventional Palliative Care, CPC). MIC are comprised of 1) daily oral medications; ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day, and 2) clinical interventions; weekly physical exercise (60 minutes per visit), psychiatric assessment on every other week, and nutritional counselling total four times during the study period. CPC included basic nutritional counselling for two times provided by National Health Insurance Service, and megestrol acetate as needed (ie, anorexia ≥ Grade 2). All interventions were provided during 12 weeks per subject. Co-primary outcomes are change of total lean body mass and handgrip strength from the baseline. Secondary outcomes included change of fat mass and total body mass, lean body mass, Functional Assessment of Anorexia/Cachexia Treatment (FAACT) score, quality of life assessed by EORTC QLQ-C30, Spleen Qi Deficiency questionnaire (SQDQ), and overall survival. Total 112 patients will be assigned in the two arms (56 in each group). We have started the study in October 2020. At the time of submission, 26 patients were enrolled. Planned period of enrollment is 18 months. Clinical trial information: Clinical Research information Service, CRIS (KCT0004967). Clinical trial information: KCT0004967.
Primary care oncology model (PCOM): Implementation of a model integrating primary and oncology care for patients taking oral anticancer agents.
Authors: Mackler Emily R. , Farris Karen B. , Gatwood Katie S. , Rizvi-Toner Amna , Wallace Alex , Dashputre Ankur , Rajpurohit Abhijeet , Farley Joel , Gatwood Justin 
Published: June 2021

TPS1587 Background: Non-adherence to oral anticancer agents (OAA) has been reported among 30% of individuals. Often, individuals with cancer are not just managing their new OAA but also medications to treat multiple chronic conditions (MCC). Multiple factors contribute to the extent patients on OAAs and MCC medications adhere to therapy. The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and MCC through care coordination between pharmacists. Methods: Design. This is a multi-center prospective single arm pilot study at two academic medical centers in Michigan and Tennessee. Subjects. Ninety participants will be recruited, 60 from site 1 and 30 from site 2. Inclusion criteria are: adults > 18 years, diagnosed with and initiating oral treatment for chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma, diagnoses of at least 2 chronic conditions, where one is type 2 diabetes, hypertension, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, hyperlipidemia, or chronic obstructive pulmonary disease, taking at least two chronic medications, and able to provide electronic consent. Exclusion criteria are: inability to speak English, and diagnosis of type 1 diabetes or HIV. Intervention. Participants will complete two Patient Reported Outcome Measures (PROMs) for their OAA that will be reviewed by the oncology pharmacist, with follow-up to the care team if needed. Participants will be scheduled for a Comprehensive Medication Review with a primary care pharmacist for up to two visits for their chronic medications. The intervention over 2 months, and the oncology and primary care pharmacists communicate via electronic health record about medications, symptoms, and disease control. Outcomes. The primary endpoints are (a) dose-adjusted adherence by proportion days covered (PDC) for the OAA and (b) PDC for chronic condition medications, assessed using 6 months of prescription claims. Data will be collected from patients using REDCap surveys and abstracted data will be entered into REDCap. Implementation by pharmacists and patient acceptability will be examined. Analysis. The association of OAA and chronic medication adherence (PDC) will be examined via correlation. Participant demographics,clinical characteristics, and the symptom experience from the PROM will be described. Using CMR results, medication problems, recommendations, and changes will be provided. Program implementation will be assessed and patient perceptions obtained from post-CMR interviews. A joint display for the quantitative and qualitative data for feasibility, appropriateness, and acceptability from pharmacists will be completed. Results: Screening and recruitment has begun. Clinical trial information: NCT04595851 and NCT04663100.