bluuebunny/crossref_metadata_2025 huggingface dataset:
Everolimus combined with endocrine therapy in advanced HR-positive, HER2-negative Chinese breast cancer patients: A retrospective study.
Authors: Shen Xia-Bo , Li Guang-Liang , Zheng Ya-Bing , Chen Zhan-Hong , Cao Wen-Ming , Shao Xi-Ying , Wang Xiao-Jia
Published: June 2021

e13023

Background: The Food and Drug Administration (FDA) approves the combination of everolimus and exemestane for the treatment of advanced breast cancer patients who are hormone-receptor (HR) positive but human epidermal growth factor receptor-2 (HER2) negative. However, there is little real-world data on the everolimus in Chinese breast cancer patients. Endocrine therapy is the main treatment for advanced HR-positive, HER2-negative breast cancer patients which includes aromatase inhibitor (AI) or fulvestrant. Drug resistance and subsequent treatment after endocrine therapy are some of the most clinical concerns. CDK4/6 inhibitors and HDAC inhibitors are poorly available due to high price, and combined everolimus therapy can be a non-ignorable choice for advanced HR-positive, HER2-negative breast cancer patients. Methods: We retrospectively collected the treatment information of advanced breast cancer patients treated with everolimus from 2013 to 2020 in Zhejiang Cancer Hospital. Kaplan–Meier analysis and Cox regression methods were used to calculate and compare the progression-free survival (PFS). Results: The study finally enrolled 84 patients meeting the requirement, and patients were postmenopausal or premenopausal while received ovarian function suppression. And 54 patients were in the everolimus+AI group, 30 patients were in the everolimus+fulvestrant group. The median PFS in all 84 patients was 6.87 months, and the median overall survival (OS) was 28.87 months. The DCR in all 84 patients was 76.2%, and the most common grade 3-4 adverse event is stomatitis which is similar to other previous studies. Subgroup analyses were further performed based on everolimus combined with AI/fulvestrant. Patients were well-balanced in clinical characteristics in the two groups. Everolimus combined with fulvestrant group showed no superior to everolimus combined with AI group, 5.77 vs. 7.97 months (HR, 1.56; 95% CI, 0.92-2.65, P = 0.0735). Subgroup analyses showed everolimus combined with AI groups was superior to Everolimus combined with fulvestrant groups in some subgroups: postmenopausal group (HR, 0.50; 95% CI, 0.26-0.98); without bone metastasis group (HR, 0.22; 95% CI, 0.06-0.80); lung or pleura metastasis group (HR, 0.35; 95% CI, 0.16-0.77); visceral disease group (HR, 0.37; 95% CI, 0.20-0.69); previous therapy lines ≥ 4 group (HR, 0.44; 95% CI, 0.22-0.87). Conclusions: Everolimus combined with fulvestrant is not superior to everolimus combined with AI in HR-positive, HER2-negative breast cancer patients. For postmenopausal patients, patients without bone metastasis, and patients with visceral disease, everolimus combined with AI is a better choice.
Phase 1b study of H3B-6545 in combination with palbociclib in women with metastatic estrogen receptor–positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Authors: Johnston Stephen R. D. , Pluard Timothy J. , Wang Judy S. , Hamilton Erika P. , Juric Dejan , Scholz Catherine Rose , Hnitecki Elizabeth , Gao Lei , Cantagallo Lisa , Korpal Manav , Destenaves Benoit , Xiao Jianjun Alan , Zhang Zhaojie , Pipas J. Marc Marc , Yu Lihua , Sahmoud Tarek , Gualberto Antonio
Published: June 2021

e13025

Background: H3B-6545, a highly Selective ERα Covalent Antagonist (SERCA), inactivates both wild-type and mutant ERα by targeting cysteine 530 and enforcing a unique antagonist conformation. At the dose of 450 mg daily, H3B-6545 has a manageable safety profile and demonstrated preliminary single-agent antitumor activity in heavily pretreated ER+, HER2- mBC patients (Hamilton et al, San Antonio Breast Cancer Symposium, 2020). Methods: The study evaluates the safety, pharmacokinetics (PK), and efficacy of H3B-6545 in combination with palbociclib in patients with ER+, HER2- metastatic breast cancer (MBC). The escalation phase enrolls patients with 2 or more prior therapies in the metastatic setting. Up to one prior chemotherapy and up to one prior CDK4/6 inhibitor were allowed. Results: As of January 31, 2021, 10 patients were enrolled; 7 in Cohort 1 (H3B-6545 300 mg QD and palbociclib 100 mg QD) and 3 in Cohort 2 (H3B-6545 300 mg QD and palbociclib 125 mg QD). One patient in Cohort 1 was not evaluable for dose limiting toxicity (DLT) assessment and no DLT was observed in the 6 evaluable patients. One patient discontinued study treatment because of progression and no patients discontinued study treatment due to adverse events (AE). Grade 3 or 4 neutropenia and thrombocytopenia were observed in 4 patients and 1 patient, respectively. One patient had grade 3 hypercalcemia, generalized muscle weakness, hypophosphatemia, fall, and anemia and one patient had grade 3 lipase increase. Four patients had grade 1 bradycardia or sinus bradycardia (asymptomatic) 1 patient had grade 2 sinus bradycardia (symptomatic, no intervention required). Preliminary PK analysis suggested no clinically relevant drug-drug interactions between H3B-6545 and palbociclib, to be confirmed with data from additional cohorts. Recruitment is currently ongoing in Cohort 2. Updated results will be presented. Conclusions: H3B-6545, in combination with palbociclib, was well-tolerated. Clinical trial information: NCT04288089.
Improved survival supports primary endocrine therapy in patients with hormone receptor positive/ HER-2 negative metastatic breast cancer.
Authors: Shenk Robert , Cao Lifen , Bliggenstorfer Jonathan T. , Martin James Michael , Miller Megan E.
Published: June 2021

e13034

Background: Current ASCO guidelines recommend endocrine therapy as preferred primary treatment for hormone receptor positive (HR+) metastatic breast cancer (MBC). We assessed survival outcomes of HR+/HER2- MBC patients undergoing endocrine therapy with and without chemotherapy. Methods: The National Cancer Database was queried 2004-2016 for patients with de novo HR+/HER2- MBC. Exclusion criteria were treatment with surgery or radiation at the primary site and missing oncologic and follow up data. Overall survival was compared between systemic treatment groups using multivariable cox proportional hazards regression modes. Results: 19,317 patients met inclusion criteria, among whom 2,360 (12%) received no systemic therapy, 2,617 (14%) received chemotherapy only, 10,078 (52%) received endocrine therapy only and 4,262 (22%) received both chemotherapy and endocrine therapy. Patients treated with chemotherapy only more frequently had lung (38%, p<0.001) or liver (36%, p<0.001) metastasis while those undergoing endocrine therapy only presented primarily with bone metastasis (82%, p<0.001). Patients with multiple metastatic sites more often received endocrine therapy alone than combined therapy (44 vs. 25%, p<0.001). Median overall survival was similar after combination therapy and endocrine therapy, and poorest after chemotherapy alone (33.1 vs 31.4 vs 19.8 months, p<0.001). After controlling for patient, facility, and tumor characteristics, endocrine therapy alone provided superior survival benefit to chemotherapy only, though combination systemic therapy resulted in the greatest overall survival (p<0.001). Conclusions: Primary endocrine therapy provided significant survival benefit over chemotherapy alone for HR+/HER2- MBC. Though combination systemic therapy may be warranted in progressive disease, our results align with recommendations for endocrine therapy as first line treatment for HR+/HER2- MBC. [Table: see text]
Extracellular circular RNAs to promote the growth and metastasis of triple-negative breast cancer through remodeling the tumor immune microenvironment.
Authors: Yang Sujin , Tang Jinhai
Published: June 2021

e13047

Background: Triple-negative breast cancer (TNBC) has been confirmed to have a high degree of heterogeneity of breast cancer, which is more common in young women, with a high degree of malignancy, lack of effective clinical treatment and poor prognosis. Recently, many studies have also found that immune microenvironment (IME) can remarkablely affect the occurrence and metastasis of TNBC through exosome-mediated molecular transmission. Therefore, there is an urgent need to find new immune-related molecules as therapeutic targets and to predict the progress of TNBC and prognosis of treatment. Methods: Using RNA-sequencing and bioinformatics analysis, we found the differential-expressed circular RNAs (circRNAs) in exosomes from TNBC cell lines (BT549 and MDA-MB-231), non-TNBC cell lines (MCF-7 and MCF-10A) and tissues from breast cancer patients. Then, we used CIBERSORT and ESTIMATE algorithm to explore the tumor-infiltrating immune cells (TICs) or stromal components in IME, and identified the significant differential-expressed mRNAs in the immune cells between TNBC and non-TNBC samples. RT-qPCR was used to confirm the expression level of selected circRNAs and mRNAs in TNBC cell lines. Results: We profiled the circRNAs in the exosomes from TNBC cell lines and breast cancer patients by RNA sequencing and detected 27 significantly differentially-expressed circRNAs. After bioinformatic analysis and RT-qPCR, circRELB and circANXA1 were chose to further study. TICs and IME scores were found to associated with the survival and clinicopathological characteristics of TNBC patients and IME remodeling. Interestingly, 92 differentially-expressed genes were found to be enriched in the NF-kB signaling pathway and mTOR signaling pathway. Moreover, we identified 33 target genes of circRELB and circANXA1 by cross-analysis. Based on the predicted miRNAs and the corresponding mRNAs and circRNAs, we have established an IME-related circRNA-miRNA-mRNA network. Then, Kaplan-Meier plots showed the expression levels of certain targeted genes (PTEN, CCND1, IL6, CDKN1A, AKT1, TNF and WNT1) were connected to prognosis in TNBC metastasis patients. Conclusions: The expression levels of circRELB and circANXA1 was found significantly upregulated in exosomes from TNBC cell lines and tumor tissues from breast cancer patients. In addition, circRELB and circANXA1could affect the expression of downstream target genes by competing for endogenous RNA (ceRNAs), and ultimately promote the metastasis of TNBC and remodeling of IME. In summary, this study analyzes the mechanisms of exosome-contained circRNAs in TNBC and these targets from the IME-related circRNA-miRNA-mRNA network may be new potential prognostic biomarkers and immune treatment strategies to prevent the development and metastasis of TNBC.
Real-world clinical effectiveness of eribulin in metastatic breast cancer patients with visceral metastases in the United States.
Authors: Mougalian Sarah Schellhorn , Zhang Jingchuan , Kish Jonathan , Zettler Marjorie E. , Feinberg Bruce A.
Published: June 2021

e13058

Background: Eribulin mesylate was approved in the United States (US) in 2010 for the treatment of metastatic breast cancer (mBC) after at least two prior chemotherapeutic regimens, which should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Visceral metastases, including those to the lung and brain, have been identified as poor prognostic features for patients with mBC. The objective of this analysis was to assess the real-world clinical effectiveness of eribulin in mBC patients with visceral metastases when treated in accordance with the US label. Methods: Patients with mBC initiating eribulin consistent with the US label between 2011-2017 were identified through a retrospective, multi-site chart review study conducted in US oncology practices. De-identified, patient-level demographics, clinical characteristics, treatment patterns, and outcomes were entered into an electronic case report form by the patients’ treating physicians. Sites of metastases at initiation of eribulin were indicated by providers. Clinical outcomes assessed included best overall response to eribulin as recorded in the patient’s chart, progression-free survival (PFS), and overall survival (OS). The proportion of patients with either a complete or partial response as their best overall response was calculated. PFS and OS were calculated by the Kaplan-Meier method from the initiation of eribulin for all patients with visceral metastases and subsets reporting lung or brain metastases site, respectively. Results: The analysis included 470 patients with visceral metastases, including 342 with lung metastases and 22 with brain metastases at the time of eribulin initiation. Eribulin was third-line therapy for approximately three quarters of patients in these subgroups, and the remainder received eribulin in fourth line or later. Mean age was 59 years in general (59 and 54 years in those with lung and brain metastases, respectively). Over half of patients (53.6%) had either a complete or partial response to eribulin. Median PFS was estimated at 6.0 months, and median OS was estimated at 10.5 months. Results for the subgroups of patients with lung and brain metastases are shown in the table. Conclusions: The results of this retrospective analysis affirm clinical effectiveness of eribulin in mBC patients with visceral metastases, when used consistent with the US label.[Table: see text]
The prognostic value of cytoskeletal regulation and vesicle trafficking signaling pathway mutation in breast cancer.
Authors: Liu Haiyan , Huang Guanqun , Huang Tanxiao , Liu Ming , Liao Wenting , Yang Bo , Liu Yuanyuan , Chen Shifu
Published: June 2021

e13068

Background: Breast cancer (BC) is the most commonly diagnosed cancer in 2020, with an estimated 2.3 million new cases and the leading cause of cancer death in women. The cytoskeleton is a dynamic system of protein filaments that is regulated by dozens of proteins which are, in turn, regulated by phosphoinositides. Cytoskeletal regulation and vesicle trafficking (CRVT) signaling pathway is associated with many changes in the structure and movements of cells. Few studies addressing the association between genetic mutation of the CRVT pathway and the disease prognosis have been reported up to now. Here we investigate the genetic status of CRVT pathway as a biomarker for predicting overall survival (OS) and relapse-free survival (RFS) for breast cancer patients. Methods: We used cBioPortal platform to analyze a cohort of 10646 breast cancer samples. Mutations in 7 genes ( APC, BAP1, KEAP1, PAK1, PTEN, SRC, STAT3 ) are the most common indication in the CRVT signaling pathway. We define overall survival (OS) as the time between the procedure date when the tumor specimen was collected and the date of death or last follow-up visit. And we define relapse-free survival (RFS) as the time from surgical resection to relapse of disease. We estimated and compared the survival curves of these two groups using Kaplan-Meier method and log-rank tests. The statistical significance level was set to 5% ( p < 0.05). Results: Genomic alterations of the CRVT-indicator genes were found in 2582 (n = 2582/10646, 24.25%) samples with sorts of alterations identified including variants of non-synonymous mutations, splicing mutations, short in-frame insertion and deletion, short frame shift insertion and deletion, and copy number gain and loss. PTEN was most commonly altered (n = 2329), followed by PAK1 (n = 863), APC (n = 718), STAT3 (n = 341), KEAP1 (n = 317), BAP1(n = 292), and SRC (n = 278). Based on the result, patients were divided into the CRVT and non-CRVT group. The median OS of the CRVT group was 141.57 moth, which was significantly shorter than the OS of the non-CRVT group (log-rank test p= 0.000662). The median RFS of the CRVT group was 167.76 moth, which was also significantly shorter than the RFS of the non-CRVT group (log-rank test p= 0.0169). Conclusions: To the best of our knowledge, this study is the first investigation to evaluate the prognostic value of CRVT pathway mutation in patients with breast cancer. Our investigation shows that CRVT pathway mutation could significantly predict poor prognosis in breast cancer patients. The result of our analysis should be better confirmed with additional relevant research in the future using updated analyses.
Team huddle, education and infection screening as effective tools in continuing cancer care delivery during the peak of COVID-19 pandemic in 2020 in the Bronx, NY: Experience from a public teaching hospital.
Authors: Pathak Surabhi , Narurkar Roshni , Hasan Khan Mohammed , Jiang Bei , Soe May Nyein Chann , Muppidi Monica , Hwang Caroline
Published: June 2021

e13500

Background: COVID-19 pandemic has affected healthcare delivery, particularly in the hard-hit areas. During the peak of COVID-19 pandemic crisis in the New York city, our outpatient oncology infusion center, located within a public teaching hospital in the South Bronx remained active. We implemented twice daily team huddle, staff and patient education, and infection screening tools and modified treatment plans based on social, personal and disease related factors. We evaluate the effectiveness of the above strategies in timely delivery of critical oncological care. Methods: Patients treated from the March 1, 2020 to the May 8, 2020 were included. De-identified data from medical charts were analyzed using IBM SPSS Version 27.0. Bivariate logistic regression analysis was applied to identify factors associated with COVID-19. Results: In total, 170 patients were treated in 576 visits. Median age was 60.7 years, 44% Hispanic and 41% Black, median Charlson Comorbidity index (CCI) was 6.6. Fifty percent received cytotoxic chemotherapy, 44% targeted therapies and the remaining received immune-checkpoint inhibitors. Of the 170 patients, six developed severe COVID-19 requiring hospitalization. Their median age was 63 years with average of 10.5 days from infusion center visit to COVID-19 and median CCI score was 9, higher than the rest of the cohort. Two patients died, 3 made complete recovery, 1 enrolled in hospice. Two patients contracted mild COVID-19 managed in the outpatient setting. Diabetes mellitus was associated with severe COVID-19 [OR: 25.9 (95%CI: 1.3-519, p=0.03)]. Age, gender, type of cancer and oncological treatment, smoking, CCI, growth factor support, nursing home residence, statin use were not associated with risk of developing severe COVID-19 Conclusions: Cancer treatment in the outpatient setting using an approach focused on careful patient selection, infection prevention strategies and strong team communication is feasible and allows for continuity of critical oncological care. Receipt of cancer directed therapy was not associated with higher risk for infection compared to risks associated with community-based transmission.. In communities with high community-based transmission, careful selection of patients for oncological based treatment is paramount.
Impact of primary care providers (PCPs) on care receipt and satisfaction in adolescent and young adult (AYA) oncology patients.
Authors: Hess Eric , Parkes Amanda Marie
Published: June 2021

e13512

Background: While there has been ongoing work to define the role of primary care providers (PCPs) in adolescent and young adult (AYA) survivorship models, little has been done to understand the role of PCPs earlier in the care continuum. As PCP-shared models of care have been theorized to help address morbidity related to the physical and psychosocial effects of cancer and its treatment, there is a need to better understand the impact of PCPs on AYAs. Given this, we sought to study the influence of PCPs in the care of AYAs with cancer, comparing care receipt and satisfaction during treatment versus in survivorship. Methods: Electronic health record query identified adult AYA cancer patients 19-39 years with at least two visits at the University of Wisconsin from 3/30/2019-3/29/2020. Identified patients were sent an electronic survey to assess care team members and impact on care. Responses were categorized based on patient-reported presence of a PCP as part of their cancer care team. For the data analysis, all patients who did not self-identify as long-term survivors, defined as 5+ years since diagnosis, were defined as active patients. Given survey answers were not mandated for all questions, the denominator was unique for each question. Results: We found a minority of AYAs responding to our survey considered a PCP as part of their cancer care team (71/173, 41%). PCP presence led to improved satisfaction in all AYAs with addressing the impact of diagnosis/treatment on peer interactions and independence, with 67% (45/67) AYAs with a PCP very or some satisfied versus 55% (53/97) without a PCP. PCPs also decreased the likelihood that supportive care services weren’t received by patients due to a lack of knowledge of the services, seen in 64% (56/88) AYAs without a PCP versus 52% (32/62) with a PCP. As seen in table, there were several findings suggesting that PCP involvement in AYA care was more critical to active patients than long-term survivors, including supportive care service receipt and satisfaction with such services. Conclusions: Overall, we found PCP involvement on cancer care teams was important for AYAs defined as both active patients and long-term survivors. Despite this, less than half of all patients identified PCPs as part of their care team. Our data suggest PCP-shared models of cancer care may improve care utilization and satisfaction in AYAs and support efforts to incorporate PCPs as meaningful members of the care team throughout all phases of care. Survey responses based on PCP inclusion as cancer care team member and patient treatment status.[Table: see text]
Multi-site practice and physician travel burden by oncology specialty.
Authors: Frosch Zachary AK , Hicks-Courant Katherine , Bekelman Justin E. , Ko Emily Meichun , Kanter Genevieve P.
Published: June 2021

e13513

Background: Having physicians who practice at multiple sites may increase patients’ access to care, but also burden physicians Gynecologic oncologists (GO) are increasingly practicing at more sites across a larger geographic area, but the degree to which medical oncologists (MO), surgical oncologists (SO) or radiation oncologists (RO) are also doing so is unknown. Methods: We conducted a retrospective, observational study using data from the 2020 Physician Compare National Dataset. We included GO, MO, SO, RO, as determined by self-reported specialty. Practice sites with incomplete street addresses were excluded. For each specialty, we calculated the number of practice sites per physician, geographic practice dispersion (median driving distance required to go to each practice site), and temporal practice dispersion (median travel time required to go to each practice site). We used linear regression to compare the number of practice sites, geographic practice dispersion, and temporal practice dispersion by specialty. Results: The number of physicians, mean number of practice sites, along with geographic and temporal practice dispersion by specialty are shown in the table. MO practiced at a smaller number of practice sites compared to GO (p<0.001) and RO (p<0.001). Compared to MO, SO had a smaller geographic dispersion (median driving distance 22 miles vs. 38 miles, p=<0.001) and temporal practice dispersion (median driving time 27 minutes vs. 43 minutes, p<0.001), whereas RO had a larger geographic dispersion (median RO driving distance 58 minutes, p<0.001) and temporal practice dispersion (median RO driving time 63 minutes, p<0.001). Conclusions: Oncologic specialties vary in the number of practice sites and practice dispersion per oncologist. In particular, GO and RO practice at more sites than MO, with MO practices more geographically concentrated than RO practices. While SO practice at a similar number of practice sites compared to MO, their practices are the most geographically concentrated. While these practice patterns may represent increased patient access to specialty oncology care, the impact on quality of care and physician wellness is unknown.[Table: see text]
The impact of COVID-19 on oncologists: Experience from Egyptian physicians.
Authors: Omar Abeid Mohamed Athman , Ramadan Marwa , Khamis Yomna , Ismail Abdelsalam A.
Published: June 2021

e13514

Background: The unprecedented emergence of coronavirus disease (COVID-19) has disrupted the patients' and physicians' daily activities, including cancer care. However, little is known on how COVID-19 has impacted oncologists from low and middle-income countries. Methods: We conducted a cross-sectional survey among eighty-eight practicing oncologists in Alexandria governorate, Egypt. An electronic, anonymized self-reporting survey was distributed in February 2020 to collect information on occupational safety measures, the prevalence of COVID-19 among respondents, workload, and family support during the pandemic Results: Out of 88 contacted oncologists, 75% completed the survey (n=66). Nearly half (45%) of respondents were residents, 36% were specialists, and 18% were consultants. The mean age of respondents was 34.79 years (SD ±10.42). More than half of the respondents were not comfortable managing cancer patients during the pandemic (56%) and did not feel well-protected at the workplace (58%). However, most (79%) had managed a cancer patient with COVID-19 more than once. Furthermore, almost all participants (98%) have worked with an infected colleague. Nevertheless, to more than half (54%), it made no difference working with a colleague who was previously infected. Most physicians (79%) felt overwhelmed with workload than the pre-pandemic period. Despite being COVID-19 negative, nearly half reported their family members had reduced contact with them due to the fear of being infected. In contrast, 24% are now getting more family support, whereas 27% are experiencing the same contact level as before the COVID-19 era. Physicians lacking family support had a significantly higher burnout rate than those who had family support (p=0.038). However, the burnout rate was similar regardless of doctors' rank, or treating COVID-19 patients, or feeling protected at work. The majority of the participants (75%) had experienced COVID-19 like symptoms, and one third (n=21) were confirmed COVID-19 infected: residents - 52%, specialists - 33%, and consultants - 14%. Nevertheless, we found no association between the rank and being infected with COVID-19 (p=0.632). Most participants thought they were infected at the hospital (38% by patients; 24% by colleagues), and 14% by family members. However, there was no significant association between being infected and feeling protected at work (p=0.823). Most of the infected physicians (61%) received moral support from both the family and colleagues, and 33% received family support only. There was no association between burnout rate and being COVID-19 infected (p=0.719). Conclusions: One-third of the oncologists were COVID-19 positive. Besides, most oncologists feel overwhelmed with workload and experience more burnout than before the COVID-19 era, and it worsens if one lacks family support.
Efficacy of a clinical risk prediction tool to prioritize outreach for high-risk cancer patients.
Authors: Croyle Megan , Handley Nathan , Li Michael , Binder Adam F , Csik Valerie Pracilio
Published: June 2021

e13524

Background: Acute care utilization (ACU), including emergency department visits and hospitalizations, is common in patients with cancer. Prospectively identifying patients’ risk status may enable interventions to reduce ACU. We developed a REDUCE score (Reducing ED Utilization in the Cancer Experience for active oncology patients (defined as patients with an active cancer diagnosis in the last 12 months who had a Medical Oncology encounter in a 180-day period) to prospectively determine risk of ACU. The intended intervention was outreach to all high-risk patients. We evaluated the high risk group over an 11-month period (February through December 2020) to better characterize those who received outreach. Methods: Analysis of high-risk patients was conducted using a case-control method over two periods: February through June 2020 (Period 1) and July through December 2020 (Period 2) to account for a change in the type of outreach deployed. High risk was defined as REDUCE ≥2. High risk scores were stratified by those with REDUCE =2 and those with REDUCE >2. Control Group 1 consisted of high-risk patients with REDUCE =2 who did not receive outreach, and Control Group 2 included high-risk patients with REDUCE >2 who did not receive outreach. Case Group 1 consisted of high-risk patients with REDUCE =2 who had outreach, and Case Group 2 included patients with REDUCE >2 who had outreach. Average ACU per patient was compared across all groups over both periods. Descriptive statistics were applied. Results: Results are described in table 1. Average ACU per patient was higher in Periods 1 and 2 for both Case Groups, compared to both Control Groups. Over time, there was a trend in decreased ACU in the intervention group with stable to increasing ACU in the control groups. The proportion of patients who received outreach across both periods decreased in Case Group 1, but increased in Case Group 2. Conclusions: These findings suggest that patients who received outreach were at a higher risk of ACU. Further investigation revealed that there was not consistent prioritization of patients with the highest risk scores within the high-risk group for outreach. In addition to the REDUCE , ongoing efforts incorporate clinical judgment of the outreach team in assessing additional clinical risk factors to determine an intervention, which is meaningful. The REDUCE tool may provide value as an initial screening mechanism. Average ACU per patient by study group.[Table: see text]
Clinicians’ perspectives on strategies to improve cross-institutional collaboration and coordination of pancreatic cancer care for rural patients.
Authors: DePuccio Matthew , Kurien Natasha A , Sarna Angela , McAlearney Ann Scheck , Ejaz Aslam
Published: June 2021

e13532

Background: Rural pancreatic cancer patients often lack access to high-volume pancreatic cancer specialists. This lack of access can result in fragmented cancer care—when patients receive care at multiple institutions—and necessitates that specialists engage in cross-institutional collaboration. In the context of fragmented pancreatic cancer care, the strategies specialists use to facilitate collaboration across institutions are poorly understood. Methods: We conducted semi-structured interviews with cancer specialists (medical, surgical, and radiation oncologists) from a high-volume pancreas cancer center (n = 9) and rural community cancer centers (n = 11) to examine specialists’ coordination practices related to treating and co-managing pancreatic cancer patients across their respective institutions. Using qualitative methods, two of the co-authors independently coded the interview transcripts to identify themes related to cross-institutional coordination practices, noting improvement opportunities and facilitative strategies. Results: Cancer specialists described multiple practices to coordinate cross-institutional care including one-on-one phone calls and using a shared electronic medical record or secure email to exchange clinical notes. In recognizing the limitations of these practices, specialists acknowledged the need to develop and implement communication systems that could facilitate real-time discussions and information sharing between high-volume and rural specialists to coordinate diagnostic and treatment plans. Cross-institutional virtual tumor boards were viewed as a potentially useful approach to foster shared clinical decision-making and treatment plan development across institutions, but specialists perceived that logistical, institutional, and technological challenges could limit the use of this approach. Regardless, specialists indicated that cross-institutional virtual tumor boards could help disseminate treatment recommendations as well as identify barriers to care for mutually-shared rural cancer patients. Specialists also indicated that a dedicated patient navigator could help facilitate cross-institutional coordination by bridging communication between specialists while also assisting cancer patients with issues related to housing, transportation, scheduling, and treatment finances. Conclusions: It is important for cancer specialists treating rural cancer patients to have strategies that support efficient communication and decision-making. Cross-institutional virtual tumor boards and dedicated patient navigators are two such strategies that may help facilitate collaboration between high-volume and rural cancer specialists. Future research should examine the impact of these strategies on patients receiving cancer care at multiple institutions.
Results of a German survey among patients with gynecological malignancies during the COVID-19 pandemic.
Authors: Dimitrova Desislava , Armbrust Robert , Nasser Sara , Boz Seyma , Zocholl Dario , Fucaraccio Emelina , Kiechle Marion , Sehouli Jalid
Published: June 2021

e13533

Background: The COVID-19 pandemic has had an immense impact on health care systems und social life. Due to limited resources, a rearrangement in medical care has been necessary in many countries. Strict rules of social distancing and postponing of medical appointments has brought major changes. At the beginning of the COVID-19 pandemic, in March 2020, several studies reflecting patient perception of cancer care modification were performed. Currently, there are still limited data on patient perception concerning changes in cancer treatment, their willingness to receive a COVID-19 vaccine, and their acceptance of social life restrictions. We initiated a multicentre prospective anonymous survey among patients with gynecological cancer to gather information about the current therapy situation and the impact of their treatment and social life. We will report the first preliminary results of 108 patients. Methods: We performed a survey among patients with gynecological cancer, who received treatment or were in follow-up at Charité Campus Virchow Klinikum between October and December 2020. The paper form questionnaire included three sections in which social background, current disease status, and patient perception of the COVID-19 implications on cancer care and social life were evaluated. Results: We included 108 patients. The median age of the participants was 59. The majority of the participants had ovarian cancer (69.4 %) and 70 % were under current cancer treatment. Almost 65 % were willing to receive a COVID-19 vaccine. More than 50 % reported anxiety and fear during the last 2 weeks. Only 16.2 % were more afraid of a COVID-19 infection than their cancer disease. Despite uncertainty of the COVID-19 pandemic, most patients fear tumour progression more than a COVID-19 infection. The cancer treatment appointments were altered in a small number of patients (9.4 %). Testing of COVID-19 was performed in 73 % of the participants. The acceptance of social measures was high; 87 % keeping social distance and over 90 % wearing a mask. Conclusions: Despite major challenges in cancer care due to the COVID-19 pandemic for the majority of the patients, the access to cancer treatment was less affected and the acceptance of prevention measures was high. Anxiety and fear was experienced by more than 50 %. The psychological effects of the COVID-19 pandemic should be further explored. The survey underscores the high need of information regarding COVID-19 and cancer.
Joven y Fuerte (J&F): Multidisciplinary distance care program in Mexico for young women with breast cancer (YWBC) during the COVID-19 pandemic.
Authors: Labra Lucero , Guerra-Anlen Andrea , Galvez C. Lizette , Torres Juan , Fonseca Alan , Villarreal-Garza Cynthia , De Arrigunaga Jose Maria , Mesa-Chavez Fernanda , Espinosa Fernandez Jose R , Perez-Quintanilla Milagros , Bargallo-Rocha Enrique , Cabrera-Galeana Paula , Platas Alejandra , Mohar Betancourt Alejandro , Cruz-Ramos Marlid
Published: June 2021

e13536

Background: The COVID-19 Pandemic represents unprecedented new challenges for healthcare systems, care programs and especially for vulnerable populations like oncologic patients. The J&F Program, developed at the National Cancer Institute (INCan) in Mexico City, provides multidisciplinary care and navigation support for YWBC patients. During the first months of 2020, the whole mexican healthcare system, including the INCan and programs like J&F had to undergo structural adjustments to offer distance care attention (DCA) and face the Pandemic challenges. Methods: From March to September 2020, 196 patients received DCA (phone and video calls, text messages and virtual workshops), which addressed navigation, unmet psychological needs, psychoeducation, oncology and sexual support provided by different healthcare professionals (oncologists, psychologists, sexual specialists). Seventy agreed to participate in this study (intervention group, IG). Forty-three recently diagnosed breast cancer patients could not be contacted by the Program (control group, CG). The patients from the IG completed the emotional distress thermometer and were interviewed about stressors, coping strategies during the Pandemic, and satisfaction with the multidisciplinary support given by the J&F Program. We compared thestandard care given within the institutional facilities and the multidisciplinary support provided virtually by J&F Program for YWBC during the COVID-19 Pandemic regarding their perceived stressors and emotional distress. Results: The CG had more concerns about oncology treatments and their side effects (nausea p = 0.031, fever p = 0.007, anorexia p = 0.006) than the IG. Emotional distress was present in 77% and 86% in the IG and the CG respectively. The IG received significant navigation guidance and multidisciplinary support with the J&F Program’s DCA strategy during the Pandemic than the CG (p < 0.01 and p = 0.019). The J&F Program's psychological care significantly helped YWBC manage their distress (p = 0.001); 70% of the IG patients considered that the support given by the J&F Program dealt with the COVID-19 Pandemic challenges successfully (p < 0.01). Conclusions: DCA by theJ&F Program showed feasibility and benefit in the COVID-19 Pandemic context for YWBC. These findings suggest that multidisciplinary care could be preserved by combining care provision physically and virtually depending on patients' resources or unmet needs.
Early versus late patient discussions in multidisciplinary tumor boards: Quality time for quality care.
Authors: Ahmed Sharif , Kubicek Greg
Published: June 2021

e13539

Background: Multi-disciplinary tumor boards (MTB) are a way to generate quality patient care by allowing different specialties to provide insight into patient care. While the vast majority of hospital systems have MTB there are several aspects of how to run the most efficient MTB. The aim of this study was to determine if there was a difference in patients presented early versus late in MTB. Methods: At our institution we have disease specific weekly MTB. Patients are added to MTB based on order they are received (physicians or APN will send patient name to the disease specific nurse navigator). We recorded the time devoted to each patient and the number of providers that gave a comment or suggestion per patient. The time and number of comments were compared for patients presented at the start of MTB versus towards the end of MTB. Unpaired T test was used to compare time and comments. Results: We analyzed a total of 25 MTBs which corresponded to 241 patients. The median number of patients discussed per MTB was 9 (range 5 to 16). The median time spent per patient was 5.21 minutes and the median number of providers providing comments was 3 (range 1 to 9) with an average of 3.2. When analyzed by the first 8 patients versus the remainder, the median time spent was 6.1 minutes on the first 1-8 patients and 3.4 for > 8 (P < 0.0001). The mean number of comments was 3.4 for the first 1-8 patients and 2.4 for > 8 (P < 0.0001). Conclusions: We found that patients discussed towards the end of weekly MTB had less amount of time per devoted per patient and less discussion (as measured by number of providers supplying comments and suggestions). While the impact on long-term patient care is unclear we feel that this data is important in helping to ensure productive MTB discussions and avoid any arbitrary factor for reduced multidisciplinary insight. MTB should be cognitive of this time and attention biases.
Implementation and impact of a novel multidisciplinary immune-related adverse events tumor board for patients receiving immune checkpoint inhibitor therapy.
Authors: Boruah Abhilasha Pankaj , Demski Kathryn , Patil Pradnya Dinkar , Calabrese Cassandra , Funchain Pauline
Published: June 2021

e13541

Background: Given the often atypical and diverse presentations of immune-related adverse events, the utilization of an institutional multidisciplinary irAE tumor board is an effective strategy to deliver comprehensive, collaborative, and efficient care to patients experiencing these effects. We report the clinical impact of a multidisciplinary tumor board dedicated towards management of irAEs in patients receiving checkpoint inhibitor therapy. Methods: We completed a retrospective review of patients discussed during our multidisciplinary irAE tumor board at Cleveland Clinic Taussig Cancer Center. Pertinent data collection regarding malignancies, therapies, and reported irAEs was completed through the electronic medical system. Results: Between September 2017-January 2021, 96 patients were discussed in our institutional irAE tumor board. 48 males and 48 females were discussed with the most common primary malignancies being melanoma (53%, 51/96), lung neoplasms (25%, 24/96), and renal cell carcinoma (15%, 14/96). Of the therapies used by these patients, the most frequently associated checkpoint inhibitors were Nivolumab (41%, 39/96), Pembrolizumab (30%, 26/96), and Ipilumumab (17%, 16/96). irAEs affecting the gastrointestinal system such as colitis, hepatitis, and gastritis were most common among discussed patients (40%, 38/96), however several patients also exhibited irAEs targeting the neurological (12.5%, 12/96), rheumatologic (11%, 11/96), dermatologic (8%, 8/96), respiratory (8%, 8/96), and cardiac systems (4%, 4/96). The utilization of tumor board was documented in 41 patients’ notes (43%), with increased documentation over the past year (71%, 24/34), and 70 patients (73%) received a pertinent consult for management of their irAE post tumor board recommendations. Conclusions: Clinical utilization of irAE TB recommendations was high as evidenced by clinical documentation and consequent referrals. Increasing institutional awareness of tumor board over the past year was reflected in a proportionate rise in official documentation. irAE tumor board has the capacity to promote more effective cross-specialty collaboration during treatment of irAEs by both streamlining patient care discussions and encouraging cross-fertilization of therapeutic concepts between multiple subspecialties, and may ultimately increase quality of care for patients experiencing these toxicities.
The evaluation of a digital solution to improve the implementation of NCCN guidelines.
Authors: Prime Matthew Stewart , Guo Chaohui , Blanchard Francoise
Published: June 2021

e13542

Background: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) are the most commonly used guidelines in the US and globally, and aim to improve and facilitate quality, effective, efficient and accessible cancer care. The guidelines are constantly updated, as such, the number, scope, length and detail have continuously increased, which has placed challenges for clinicians to remain up to date. Solutions are highly needed to improve the usability and implementation of the NCCN Guidelines. The NAVIFY Guidelines application was developed to provide digitised NCCN Guidelines, to facilitate navigation, and to enable the real-time capture of clinical decisions, including reasons for deviation from guidelines. We assessed the usability and performance of the NAVIFY Guidelines application. Methods: A 60-minute remote, semi-structured interview and task-based user test was undertaken with 10 medical oncologists from diverse geographies (6 US, 2 UK, 2 Germany). No participants had prior experience with the digital solution. Participants tested the experience of using the NAVIFY Guidelines application on their computer by completing tasks for one of 3 tumor types (breast, lung or AML). Screen and audio activities were recorded via Zoom. At the end of the test, participants were asked to rate the performance of NAVIFY Guidelines and complete statements on a System Usability Scale (SUS) questionnaire. Results: NAVIFY Guidelines SUS score was on average 82.3 (80.8 – 84.0), classified as A score (i.e., excellent; NPS [net promoter score]: promoter level). Success ratings across all 6 tasks was 86%, as shown in Table1. The overall impression from participants was largely positive. "Ease of use" was the most salient theme followed by “logical structure” and the “value of being integrated with patient data”. Participants identified that the key value of NAVIFY Guidelines was improving communication between the care team and improving the documentation of guideline adherence. 3 participants saw the potential in teaching settings. Conclusions: NAVIFY Guidelines has been developed to support clinicians to apply the latest clinical recommendations, improve the documentation of decisions and to facilitate better communication between specialists, and with patients. Preliminary research has shown that NAVIFY Guidelines has excellent usability (score A) & high NPS. Overall NAVIFY Guidelines was perceived as easy to use, valuable to improve communication between care teams and helpful at easing documentation burdens.