bluuebunny/crossref_metadata_2025_split huggingface dataset:
Australian real-world outcomes of ribociclib and aromatase inhibitor in hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): Results from Kisqali Access Registry for Metastatic breast cancer in Australia (KARMA) collected alongside a medicine access program.
Authors: Wong Vanessa , de Boer Richard , Baron-Hay Sally E. , Blum Robert helmut , Forster Benjamin Carl , Chua Susan Li Ling , Cuff Katharine , Green Michael , Lim Elgene , Mok Kelly , Nott Louise M. , Nottage Michelle K. , Tafreshi Ali , Tsoi Daphne T. F. , Yeo Belinda , Gibbs Peter , Lok Sheau Wen 
Published: June 2021

e13018 Background: International guidelines recommend a combination of CDK4/6 inhibitor and endocrine therapy (ET) as first line treatment for HR+, HER2- MBC. Results from MONALEESA-2 demonstrate improved progression free survival (PFS) with ribociclib (CDK4/6 inhibitor) and ET as compared to ET alone. Prior to Australia’s Pharmaceutical Benefits Scheme funding, ̃800 patients participated in the ribociclib Medicine Access Program (MAP) from May 2017 to June 2018. Methods: KARMA is a secondary data use, non-interventional study of Australian patients who received first line treatment with ribociclib and aromatase inhibitor (AI), obtained via a MAP, for HR+, HER2- MBC. The aim was to capture comprehensive patient and treatment data to reflect real world practice and outcomes. Direct comparisons were made with the ribociclib/letrozole cohort in MONALEESA-2 given that the eligibility criteria were similar for both studies. Results: Data from 160 patients at 17 sites was analysed with a median follow up of 36.5 months. Baseline characteristics are shown in the table. 63 of 160 (39%) patients remain on ribociclib/AI at time of analysis. 58% of patients had at least 1 dose reduction, with the majority (77%) requiring only a single dose reduction. The most common reasons for dose reductions were neutropenia (68%) and abnormal liver enzymes (17%). 16 of 160 (10%) discontinued treatment due to toxicity, including 1 patient with QTc prolongation > 600ms. There were no deaths due to toxicity. Median duration of treatment and PFS were 24.5 (95% CI 17.8-33.3) and 36.3 months (95% CI 29.9- NR) respectively, compared to 20.2 and 25.3 months in MONALEESA-2. Landmark PFS was 76% at 12 months, 67% at 18 months and 64% at 24 months. Conclusions: This is the first real world study of ribociclib and AI developed alongside a MAP. The combination treatment was well tolerated with similar rates of dose reductions (58% in both) and treatment discontinuation due to toxicity (10% vs 8%) when compared to MONALEESA-2. This real-world cohort achieved a superior PFS, potentially explained in part by a younger population with more favourable baseline disease characteristics, including fewer disease sites and higher rates of bone only metastases. It is encouraging to see drug tolerability and efficacy replicated in real world patients.[Table: see text]
Impact of COVID19 pandemic on the hospitalization burden of cancer patients: Results of a quasi-experimental study.
Authors: Sanchez Juan Cristobal , Nuñez García Beatriz , Ruano Alberto , Blanco Mariola , Cantos Sanchez de Ibarguren Blanca , Mendez Miriam , Ramos-Vegue Arturo Jose , Morito Ana Maria , Aguado Ramon , Provencio-Pulla Mariano 
Published: June 2021

e13527 Background: The SARS-CoV-2 (COVID19) pandemic has had a huge impact on health care, leading to the declaration of a “state of alarm” in many countries. This situation has possibly conditioned the care of cancer patients, compromising hospitalization resources due to healthcare restraints. We aim to analyze the impact of the COVID19 pandemic on the hospitalization of cancer patients during the “state of alarm” in an Academic Hospital in Madrid, considered one of the most affected regions in the World during the first wave of the pandemic in Europe. Methods: Quasi-experimental study with similar controls collected in the same period of the previous year from cancer patients admitted to the Medical Oncology (MO) department of the Puerta de Hierro University Hospital in Madrid. Patients were selected from diagnoses coded by the ICD-10 obtained from discharge reports in the Admission Department. Cancer and viral pneumonia codes (excluding influenza) were analyzed. Admission to Internal Medicine (IM) department was also explored to describe hospitalization due to COVID19 pneumonia. We defined two groups: pandemic (03/14/20 - 06/20/20) and control (pre-pandemic) (03/14/19 - 06/20/19). Results: 74 cancer patients were admitted to MO department in 2020, while 162 admissions were recorded for the equivalent period in 2019 (- 54%). No differences were observed related to sex and age. In 2020, emergency and programmed admissions decreased by the same proportion, and no difference in mortality was observed. Admissions for all neoplasms decreased, but with higher magnitude in breast cancer. Viral pneumonia (no influenza) in cancer patients were mostly admitted to IM (96%) rather than MO department. 79 cases were identified in 2020, 22 in 2019 (p < 0.001), with a non-significant increase in mortality in patients with pneumonia: 25,3% in 2020 and 13,6% in 2019. Conclusions: The COVID 19 pandemic seriously impacted cancer hospitalization care, decreasing admissions to the MO department in half compared to the equivalent period. We observed a reduction in admissions through all neoplasias. Admissions due to viral pneumonia in cancer patients increased 3.5 times, mostly admitted to IM changing the dynamics of cancer hospitalization burden and compromising resources. A non-significant increase in mortality from viral pneumonia was observed. The analysis of hospitalizations through administrative data can allow better management of resources and facilitate rapid decision-making in a pandemic situation yet to be resolved.[Table: see text]
Trends in modifiable behaviorally related cancers: Who is affected the most?
Authors: Chan John , Caesar Michelle Ann P. , Chan Chloe , Richardson Michael , Kapp Daniel Stuart , Francoeur Alex Andrea , Liao Cheng-I 
Published: June 2021

e13531 Background: To examine trends in modifiable behaviorally related cancers among racial groups in the United States. Methods: Data were obtained from the United States Cancer Statistics (USCS) database for all cancers diagnosed between 2001 and 2017. Alcohol-associated cancers, HPV-associated, obesity-associated, physical inactivity-associated, and tobacco-associated were defined using ICD-O-3 site codes. SEER*Stat 8.3.8 and Joinpoint regression program 4.8.0.1 were used to calculate the trends of associated cancers expressed per 100,000. Results: In women, the incidence of all cancers has decreased significantly or remain unchanged for all racial groups in 2017, with the exception of an increase of HPV related cancers in white women (APC = 0.77%, p < 0.001), obesity related cancers in Hispanic women (APC = 0.46%, p < 0.001), and postmenopausal breast cancer in Black and Asian women (APC 0.78%, 1.06%, p < 0.001). The incidence of alcohol, tobacco, obesity, and physical inactivity associated cancer decreased significantly in men for all racial groups in 2017. HPV related cancers increased annually by 3.13% (p < 0.001) in White men and 0.90% in Asian men (p = 0.022). The highest decrease in modifiable factors associated with cancers was in physical inactivity related cancers in black men from the west (APC = -3.79, p < 0.001). The intersection of black race and U.S. region had the highest decreases in all cancers except obesity-related cancers where the intersection of Asian race and Midwest region had the highest decrease. Conclusions: In women, most modifiable factors associated with cancer are decreasing except in obesity related cancers and physical inactivity/obesity related postmenopausal breast cancer. In men, these rates of cancer are decreasing for all racial groups except HPV related cancers in White and Asian men.
Patient quality criteria for a multidisciplinary integrated care pathway for von Hippel-Lindau syndrome.
Authors: Giles Rachel H. , Dreijerink Koen , van Leeuwaarde Rachel , Wolters Wendy , Zandee Wouter , Zondervan Patricia , Links Thera P. ,   Dutch VHL Working Group
Published: June 2021

e13534 Background: The objective was to establish a comprehensive set of patient-driven recommendations for specialists and allied healthcare professionals for the care of individuals with the multiple neoplasia syndrome von Hippel-Lindau (VHL). VHL patients require multiple surgeries during the course of their lifetimes, due to cysts and tumors in various organs including the kidney, brain, eye, spine, pancreas, adrenal glands, and broad ligament/epididymis. Screening and care from multiple specialists form the backbone of their care, yet this is rarely coordinated in an optimal manner. Methods: The Dutch VHL patient organization (Belangenvereniging VHL) initiated this process, and approached specialists and expert patients for input. Using components of consensus methodology, a 20-member multidisciplinary panel produced an integrated care pathway relating to the provision of care for VHL patients by patients, medical specialists, specialist nurses and allied healthcare professionals. Items were developed by 3 rounds of email correspondence in which the basis was formed for a consensus meeting which constituted the third round of review. The fourth and final round was an email review of the consensus output. Results: The panel agreed on recommendations for the optimal quality of care for VHL patients, in the form of a decision tree, which is supervised by a nurse specialist as a main contact point. These items were grouped under categories of "Diagnosis" and "Patient Pathway" and included recommendations on training, communication, and quality assessment as well as specific items related to VHL diagnosis clinics, non-academic treatment clinics, and follow-up survivor groups. The Netherlands has 3 official Expert Reference Centers for VHL care (Groningen, Utrecht, Nijmegen), and the patient organization and allied specialists are planning to publish this protocol, while implementing its practice in those 3 sites. Conclusions: Medical specialists (internists, endocrinologists, urologists, neurosurgeons, ophthalmologists, geneticists, etc) and specialist nurses play a vital role alongside allied healthcare professionals to provide care to people with VHL and their families. Yet VHL patients and their families are the experts most acquainted with their own unmet needs. We present a set of standards and consensus recommendations from the patient perspective for the roles for these practitioners to provide optimal VHL care. These recommendations could form the basis for facilitated development of comprehensive integrated pathways for any pleiotropic neoplasia syndrome, and represent best-practice collaboration between patient organizations and national expertise centers to provide value-based healthcare.
Distress screening for patients with a history of cancer during the COVID-19 pandemic.
Authors: Worster Brooke , Waldman Lauren , Garber Gregory D. , Dahal Subecha , Binder Adam F , Csik Valerie Pracilio , Handley Nathan , Gentsch Alexandra , Rising Kristin , Trachtenberg Olivia , Lopez Ana Maria 
Published: June 2021

e13537 Background: Although a diagnosis of cancer is widely accepted as resulting in significant levels of distress, distress itself cannot be considered benign and screening for distress is considered a best practice metric for patients receiving oncological care. Endorsed by NCCN, the Distress Thermometer (DT) considers a cutoff score of 4 or greater to identify patient with clinically relevant levels of distress. We hypothesized that the COVID-19 pandemic would manifest with higher levels of stress and anxiety in most persons by compounding the distress experienced by patients with a diagnosis of cancer. Methods: Patients with a new diagnosis of cancer underwent distress screening with the DT prior to a clinical appointment at a NCI-designated academic cancer center. Patients who scored 4 or higher were discussed at an Interprofessional Supportive Medicine patient conference or referred to oncology social work for appropriate evaluation and therapeutic care. By mid-March 2020, the SKCC catchment area was under a public health emergency with limited access to non-essential healthcare; therefore, we present data from 1/1-3/15/20 (pre-pandemic), 3/16-6/7/20 (pandemic peak with 2000+ daily cases in late April and peak daily deaths 300+ in May), and 6/8-8/30/20 (daily cases generally less than 700 except for occasional levels of 1000-in July and daily deaths less than 40 daily). Results: In the pre-pandemic time period, 60% of patients assessed reported a score of 4 or higher. During the subsequent periods—the first pandemic peak and the first post-pandemic period—the incidence of an elevated distress screen (4 or higher) was relatively stable at about 30%. Conclusions: Contrary to expectations, the DT screen identified less patient distress during the pandemic compared to pre-pandemic. Our results may be due to multiple factors—changes in processes and procedures to prioritize DT screening as pandemic risk became more apparent; an increased use of telemedicine; and the compounding of new, non-cancer related stressors resulting in the greater resiliency noted in disaster psychology. For example, during the first pandemic peak when the majority of patients were seen via telemedicine, the opportunity afforded by telemedicine for safety and decreased risk for COVID-19 infection may have reduced the overall distress experience. In addition, the compounding of stressors—the diagnosis of cancer, the risk of the pandemic, and its economic and financial stressors—may have influenced distress perception. Future work incorporating multiple distress assessment points may help better understand the impact of the layers of stress experienced by persons with cancer.[Table: see text]
Oncology clinical research landscape in Middle East and North Africa (MENA) region: Challenges and proposed solutions.
Authors: Sameh Kareem , Khalife Natasha 
Published: June 2021

e13567 Background: Similar to other regions of the world, cancer incidence in Middle East and North Africa (MENA) is rising, which has been attributed to increased life expectancy and adoption of western lifestyle habits. Conducting clinical trials in the region is important to assess efficacy and safety of oncology medications in the specific population (response to drugs can be impacted by genetics, demographics and lifestyle factors). Although the MENA comprises around 5% of the global population, the region only participates in approximately 3% of clinical trials worldwide. It is important to understand the challenges in conducting trials in MENA and identify strategies to overcome these in order to facilitate advances in clinical research in the region. Methods: A literature review was conducted (via e.g. PubMed and ClinicalTrials.gov) to understand the current oncology clinical research landscape in MENA (from Jan 2015-Dec 2020), with the aim of identifying key challenges and potential strategies to overcome these. Results: Conduct of oncology clinical trials (phases 1-4) has risen in recent years in MENA, from 47 trials in 2015 to 53 trials in 2020. Despite the presence of various research-favourable factors in MENA (large patient pool, high demand for medication, lower clinical trial operational costs, compliance with ICH-GCP standards), the region still falls behind other countries in clinical research. Key factors identified as challenges in conducting clinical trials in MENA include the research infrastructure and patient awareness/understanding of research. We propose the following strategies to support the advancement of clinical research in the region: (1) Enhance research infrastructure through bolstering national clinical research networks and supporting collaboration between healthcare institutes, academia and the pharma industry; (2) Diversify methods of patient engagement (e.g. patient advisory groups and social media networks) and provide education on pros/cons of participating in research to raise awareness and improve trial participation rates; and (3) Improve availability of comprehensive oncology registries to enhance understanding of disease burden and support clinical research. Conclusions: The conduct of oncology clinical trials in MENA is increasing, yet the region is still under-represented in the global clinical trial market, despite its significant potential. The advancement of clinical research in the region will require a multi-level approach, involving collaboration between multiple stakeholders including the pharma industry, regulators, government, and healthcare professionals.
A prospective study of an AI-based breast cancer screening solution for resource-constrained settings.
Authors: Bansal Richa , Aggarwal Bharat , Krishnan Lakshmi 
Published: June 2021

e13586 Background: Screening mammography is often found to have low sensitivity in women with high density breast tissues. Alternate modalities of breast USG and MRI require high-quality expensive equipment making the regular screening with these modalities less affordable and accessible, particularly in resource-constrained settings This study evaluates the clinical performance of an AI-based test (Thermalytix) that uses machine learning on breast thermal images which could potentially be a low-cost solution for breast screening in low- and middle-income countries (LMICs). Methods: The prospective comparative study conducted from December 2018 to January 2020 evaluated the performance of Thermalytix in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography. Further investigations were recommended for participants who were reported as positive on either test. Sensitivity and specificity of Thermalytix were evaluated across age-groups, menopausal status, and breast densities. Results: Among the 687 women recruited for the study, 459 women who satisfied the inclusion criteria were included in the analysis. 168 women had ACR categories ‘c’ or ‘d’ dense breasts, of which 37 women had an inconclusive mammography report (BI-RADS 0). Overall, 21 women were detected with breast cancer in the study. Thermalytix demonstrated an overall sensitivity of 95.2% (95% CI, 76.1-99·9) and a specificity of 88.6% (95% CI, 85.2-91.4). Among women with dense breast tissue (n=168), Thermalytix showed a sensitivity of 100% (95% CI, 69.2-100) and a specificity of 81.7% (95% CI, 74.7-87.4). In women with ACR categories ‘c’ and ‘d’ dense breasts, mammography reported 22% of them as inconclusive (BI-RAD 0), while in the same sub-set of the population Thermalytix demonstrated a sensitivity of 100%. Conclusions: The AI-based Thermalytix demonstrated high sensitivity and specificity in the study cohort. It also fared well in women younger than 50 years and pre-menopausal women where routine mammography screening yields low sensitivity. Overall, this study introduces Thermalytix, a promising radiation-free, automated, and privacy-aware test that can supplement mammography for routine screening of women, especially in women with dense breast tissue, and has the potential to influence the clinical practice in LMICs by making breast cancer screening portable and affordable. Performance of Thermalytix and mammography in women with high breast densities (ACR categories ‘c’ and ‘d’ breasts). Clinical trial information: NCT04688086. [Table: see text]
Cancer Care during Covid-19: A multi-institutional qualitative study on physician and patient perspectives on telemedicine.
Authors: Wong Bonnie O. , Aslakson Rebecca , Holdsworth Laura M , Siden Rachel , Tabor Holly , Verano Mae-Richelle , Schapira Lidia 
Published: June 2021

e13611 Background: The COVID19 pandemic has had significant effects on cancer care, including disruptions or delays to screening, diagnosis, treatment, and follow-up for cancer patients as well as shifts from in-person visits to telemedicine to allow for continued access to care. Methods: We conducted semi-structured in-depth interviews with fifty radiation oncologists, medical oncologists, surgical oncologists, and cancer patients or their caregivers. These physicians and patients were recruited from four different hospitals in varying geographic regions and of varying practice settings. Interviews were conducted between October 2020 and May 2021. Interviews were transcribed, then thematically coded to consensus by three researchers. Results: The COVID19 pandemic shifted cancer care from in-person visits towards telemedicine. Providers recognized the necessity and benefit of telemedicine in increasing access to care, but were generally dissatisfied with use of telemedicine. These reasons included: (1) difficulty conducting physical exam maneuvers and assessing patient status; (2) technological failures, exacerbating barriers to care; (3) absence of “connection” with patients; (4) decreased access to interdisciplinary care teams. Patient perspectives on telemedicine were similarly varied, but were overall positive. Patients appreciated the convenience of accessing telemedicine at home, particularly for those who travel long distances or have difficulty traveling. Patients cited challenges similar to their physicians: technological difficulties and the loss of human connection usually conveyed through touch and physical presence. Conclusions: Telemedicine has been a key tool to allow for continued access to care and may continue to be a visit modality after the pandemic subsides. However, telemedicine poses numerous challenges for both physicians and patients and creative solutions to allow for “human connection” via telemedicine should be sought. Further evaluation is needed to determine the effect of telemedicine on quality of care.