June Meeting Research Articles

Biomarker testing and adjuvant osimertinib use in patients with resectable EGFR-mutated stage IB–IIIA NSCLC: Physician practices, therapy choice, and barriers among US oncologists.

e20007 Background: Epidermal Growth Factor Receptor mutations ( EGFRm) are commonly found in patients with resectable and metastatic non-small cell lung cancer (NSCLC). In December 2020, the FDA approved adjuvant osimertinib, for resectable EGFRm NSCLC, based on results of the ADAURA trial which showed significant survival benefit compared to placebo post-resection, further reinforcing need for biomarker testing in NSCLC. In light of publication of Aduara this study aims to understand US oncologists' biomarker testing practices and adjuvant osimertinib use in resectable EGFRm Stage IB–IIIA NSCLC. Methods: Questions related to biomarker testing and adjuvant therapy decision-making for resectable EGFRm Stage IB–IIIA NSCLC were presented to US-based oncologists/hematologists during live meetings in June and July 2023. In addition, questions related to impact of updated overall survival data from ADAURA trial on physicians’ reported treatment preferences were presented.Up to 108 participants responded to questions, though not all participants answered each question. Aggregate responses were summarized using descriptive statistics. Results: Among respondents, 52% identified as medical oncologists and 46% as hematological oncologists, 41% identified as being from an independent community practice and 75% indicated lung cancer was among the 3 solid tumors they most often treat. For patients with newly diagnosed resectable NSCLC patients, respondents indicated that genetic testing was performed before surgery on initial diagnostic biopsy sample (73%), after surgery (44%), and upon progression/relapse (31%). Commonly utilized diagnostic tools reported by respondents included NGS testing of tissue samples (87%), NGS liquid biopsy (42%), and IHC (31%). Barriers impacting molecular testing practices for resectable NSCLC included access to tissue for testing, cost to patient, disease stage, histology, tumor burden, patient age, patient fitness, and prior authorization or time to approval. Half (50%) of respondents reported prescribing adjuvant osimertinib monotherapy for patients with resectable EGFRm NSCLC in the past 6 months. After reviewing the updated ADAURA data, most (83%) respondents indicated they would prescribe adjuvant osimertinib immediately following surgery for resectable EGFRm NSCLC, and 56% would prescribe adjuvant osimertinib with or without adjuvant chemotherapy, 21% would prescribe adjuvant osimertinib with adjuvant chemotherapy, and 17% would prescribe adjuvant osimertinib only. Conclusions: Overall, nearly three-fourths of medical oncologist respondents prefer pre-operative genetic testing and regardless of test timing, when EGFRm identified > 80% will treat adjuvantly with osimertinib. Unfortunately, multiple barriers complicate this pursuit of evidence-based medicine.

Unification of Efforts to Improve Global Access to Cancer Therapeutics: Report From the 2022/2023 Access to Essential Cancer Medicines Stakeholder Summit.

There is an urgent need to improve access to cancer therapy globally. Several independent initiatives have been undertaken to improve access to cancer medicines, and additional new initiatives are in development. Improved sharing of experiences and increased collaboration are needed to achieve substantial improvements in global access to essential oncology medicines. The inaugural Access to Essential Cancer Medicines Stakeholder Meeting was organized by ASCO and convened at the June 2022 ASCO Annual Meeting in Chicago, IL, with two subsequent meetings, Union for International Cancer Control World Cancer Congress held in Geneva, Switzerland, in October 2022 and at the ASCO Annual Meeting in June of 2023. Invited stakeholders included representatives from cancer institutes, physicians, researchers, professional societies, the pharmaceutical industry, patient advocacy organizations, funders, cancer organizations and foundations, policy makers, and regulatory bodies. The session was moderated by ASCO. Past efforts and current and upcoming initiatives were initially discussed (2022), updates on progress were provided (2023), and broad agreement on resulting action steps was achieved with participants. Summit participants recognized that while much work was ongoing to enhance access to cancer therapeutics globally, communication and synergy across projects and organizations could be enhanced by providing a platform for collaboration and shared expertise. The summit resulted in new cross-stakeholder insights and planned collaboration addressing barriers to accessing cancer medications. Specific actions and timelines for implementation and reporting were established.

Advancements in Endometrial Cancer Research in 2023

Endometrial cancer is one of the most common gynaecological cancers in developed countries, and the incidence is rising significantly. The staging of this disease is evolving from anatomic staging and risk stratification to a more molecular-based stratification. Treatment of endometrial cancer is also evolving. Paclitaxel plus carboplatin is the standard first-line chemotherapy for endometrial cancer; however, there is new evidence that the combination of chemotherapy and immunotherapy has synergistic effects in the treatment of this disease. This article discusses the latest advancements in endometrial cancer research in 2023, including highlights from the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancers 2023 in March, the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June, the 24th European Gynaecological Oncology (ESGO) Congress in September and October, and the European Society for Medical Oncology (ESMO) Congress 2023 in October. The article highlights the unprecedented progression-free survival (PFS) data from two Phase III randomised controlled trials evaluating first-line immunotherapy in combination with chemotherapy in patients with advanced or recurrent endometrial cancer: RUBY with dostarlimab, and NRG-GY018 with pembrolizumab, which created a buzz at SGO 2023 in the spring, and stimulated discussion throughout the remainder of the year. The overall survival (OS) results, the clinically meaningful benefits regardless of mismatch repair status, and health-related quality of life (QOL) in these studies are also discussed. Further topics covered in this year-in-review article include the implications of the results from RUBY and NRG-GY018 on first-line treatment and recurrent settings, and the effect of adding a poly adenosine diphosphate ribose polymerase (PARP) inhibitor to immunotherapy–chemotherapy combinations in the Phase III trial, DUO-E. Disparities in endometrial cancer care, research on fertility-sparing, and the importance of the multidisciplinary team (MDT) in endometrial cancer management are also explored. Following the announcement of practice-changing findings from RUBY and NRG-GY018 in March, data presented and published throughout the remainder of 2023 show that research in endometrial cancer continues at a pace.

Effect of the Educational Game Tools on Early Childhoods in the Kindergarten

Empirically, the educational game tools have significant benefits in stimulating interest in early childhoods’ learning. It is because psychologically early childhoods tend to be in the age of playing. The present study aims to determine the effects of using the educational game tools on early childhoods’ learning in kindergarten level. In the present study, the researchers set forth a research question: What are the effect of using the educational game tools on early childhood and teacher at Kober Sartika Asih located in Mekarmulya, Pamarican, Ciamis? To gain the answer, the researchers employ a qualitative method under a descriptive study at which they conduct series of observation towards the early childhoods’ learning activities using the educational game tools during 4 meetings in June 2023. The results show that the educational game tools are the effective media to teach the early childhoods. Based on its usage, the educational game tools give the effects such as: increasing the early childhoods’ curiosity and enthusiasm when they are participating the learning process, providing a stimulus for the early childhoods to understand the learning material given, stimulating the early childhoods’ cognitive, physical-motor, language, social-emotional competencies, and increasing enthusiasm both for the teachers during teaching and the early childhoods during learning. In conclusion, there are some positive effects of using the educational game tools to teach to the early childhoods.

Abstract P1-11-05: Provider perceptions of DESTINY-Breast04, HER2-low directed treatment, and interstitial lung disease

Abstract Background: Human epidermal growth factor receptor 2 (HER2)-targeted therapies are an established treatment for patients with HER2-positive breast cancer, however, these therapies have not proven effective in the HER2-negative setting. Until recently, HER2 status was used to guide treatment decisions based on a binary classification of positive or negative. A new pathological category, HER2-low, has emerged as a subtype of interest within the breast cancer treatment landscape. HER2-low status is defined as a HER2 immunohistochemistry score of 1+ or 2+ and a negative in-situ hybridization result. DESTINY-Breast04 (DB04) was the first trial to evaluate a HER2-targeted agent within the metastatic HER2-low breast cancer setting. The anti-HER2 agent trastuzumab deruxtecan (T-DXd) demonstrated promising clinical activity in HER2-low expressing tumors. However, development of T-DXd-related interstitial lung disease (ILD) remains a concern when using this therapy. This survey-based study aimed to evaluate community oncologists’ perceptions of the DB04 data, HER2-low directed treatment, and management of ILD. Methods: U.S.-based oncologists (n=83) convened at two live meetings in June 2022 to review clinical updates presented at ASCO 2022. Participant characteristics and demographic data were collected via an online survey prior to the respective meetings. Perceptions/reactions to clinical updates were captured in real-time via electronic keypad. Data were summarized using descriptive statistics. Results: Among respondents, 83.1% identified as community providers, with an average experience of 20.7 years in practice. On average, participants reported that 88.2% of their time is allocated towards direct patient care, with roughly 18 patients seen per clinic day. Nearly half of respondents (49.4%) reported awareness of HER2-low as a distinct pathological category prior to the presentation of DB04 at ASCO 2022, however, less than 10% of respondents had previously used this sub-category to determine therapy. Increased T-DXd-related ILD, which occurred in 12% of trial participants, was cited as the greatest limitation of the DB04 trial by over one-third (37.3%) of respondents. After reviewing real-world evidence data of ILD incidence in metastatic breast cancer, nearly one-third (31%) of respondents reported that their observed ILD rates are less than DB04, but more (36%) said that ILD can be hard to quantify because patients are not always symptomatic. When asked if the ILD rate associated with T-DXd would limit their selection of this agent for their patients with breast cancer, approximately one-quarter (24.1%) of respondents indicated that they would reserve T-DXd use for patients without symptomatic pulmonary disease. However, the majority of respondents (60.2%) indicated that they would not limit their use of T-DXd based on ILD rates, with most (55.4%) opting for a risk-management approach involving increased monitoring for the development of ILD-related adverse events. Conclusions: Advancements in assay interpretation have made it possible to differentiate gradients of HER2 expression, creating a space for pathological sub-categories within a formerly binary paradigm. Among providers who reported awareness of HER2-low as a distinct pathological sub-category, few had used this as a benchmark to guide their treatment decisions prior to the presentation of DB04 at ASCO 2022. Newer anti-HER2 agents, such as T-DXd, provide a potential new standard of care for patients with HER2-low expressing tumors. Despite the concern of ILD rates associated with T-DXd use, the majority of providers do not view this as a limiting factor due to the ability to closely monitor patients for the development of adverse events coupled with appropriate provider/patient education. Citation Format: Brooke Leon, Robert Bone, Yolaine Jeune-Smith, Bruce Feinberg. Provider perceptions of DESTINY-Breast04, HER2-low directed treatment, and interstitial lung disease [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-11-05.

Actions of the ASHP Board of Directors - Meeting of June 11 and 14, 2022.

Journal Article Corrected proof Actions of the ASHP Board of Directors — Meeting of June 11 and 14, 2022 Get access American Journal of Health-System Pharmacy, zxad028, https://doi.org/10.1093/ajhp/zxad028 Published: 27 February 2023 Article history Corrected and typeset: 27 February 2023 Published: 27 February 2023

Towards green growth: Industry structure and energy transition in OECD countries

This paper is concerned with the impact on the global greenhouse effect issues and focus on comprehensive multi-indicator though analyze the relationship between CO2 emissions and real GDP, energy intensity, fraction of the renewable energy supply out of the total energy supply, and energy consumption from different sectors, including the agricultural, service, industrial and transport sectors. The panel data encompass all 37 Organization for Economic Co-operation and Development (OECD) member countries covering 20 years from 2000 to 2019 and divide into two subsamples, the first and second ten years, for comparison. The empirical results of all parameters track the sound progress of green growth trend in OECD countries in the second ten years (2010–2019). According to the OECD, green growth strategy had been acknowledged in OECD Ministerial Council Meeting in June 2009. Thus, the study divided into the first and second ten years with 2010 as the boundary to compare and the empirical result also indicates the green growth strategy in OECD countries have gradually matured in the last ten years. The implementation of the policy framework and measures includes pricing, removing perverse subsidies, ensuring the regulatory standards of energy efficiency, innovation, and infrastructure investments might also provide a reference and important information for energy policy makers.

Awards Presented at the 52nd Annual Meeting of the Behavior Genetics Association June 25 2022

Awards Presented at the 52nd Annual Meeting of the Behavior Genetics Association June 25 2022

Impact of pharmacy services on time to elexacaftor-tezacaftor-ivacaftor initiation.

BACKGROUND: The approval of elexacaftor-tezacaftor-ivacaftor (ELX/TEZ/IVA) expanded highly effective cystic fibrosis transmembrane receptor modulator therapy to approximately 90% of persons aged 12 years and older with cystic fibrosis. Clinical pharmacists and pharmacy technicians played a key role in planning for ELX/TEZ/IVA initiation prior to US Food and Drug Administration approval as well as initiating therapy after approval. OBJECTIVE: To evaluate the impact of pharmacy services on time to ELX/TEZ/IVA initiation. METHODS: A retrospective chart review evaluated 146 patients aged at least 12 years with cystic fibrosis qualifying for ELX/TEZ/IVA at a single health system between October 21, 2019, and April 1, 2020. RESULTS: Patients filling ELX/TEZ/IVA at an integrated health system specialty pharmacy (HSSP) vs an outside specialty pharmacy (SP) started on therapy an average of 10.8 days sooner (10.8 days ± 14.0 vs 21.6 days ± 18.8, respectively; P = 0.006). More patients filling at an HSSP received ELX/TEZ/IVA within 14 days of the prescription being written compared with outside SPs (82.0% vs 41.4%, respectively; P = 0.001). Before ELX/TEZ/IVA initiation, patients were hospitalized for a cystic fibrosis-related complication for an average of 6.26 days (range = 0-183) compared with 1.16 days (range = 0-91) after ELX/TEZ/IVA initiation. Lastly, an estimated $134,810 was saved in hospitalization dollars in the 105 patients that were able to fill ELX/TEZ/IVA at an HSSP by initiating the drug an average of 10.8 days sooner than outside SPs. CONCLUSIONS: The results of this study demonstrate the value of an integrated HSSP model. The ability to fill specialty medications at an integrated HSSP may optimize medication access, control costs, and improve patient outcomes for patients receiving care within a health system. DISCLOSURES: Dr Loucks has accepted payment for reviewing content of Lexicomp through Wolters Kluwer Consulting and for presenting and attending the American Society of Health System Pharmacists (ASHP) Summer Meeting in June 2022. Dr Loucks is also a Workgroup Chair for the ASHP Pharmacist Section of Specialty Pharmacy Practitioners - Section Advisory Group on Outcomes and Value. Dr Simonsen was a participant in the Vertex Pharmaceuticals Advisory Board in April 2019 and accepted payment for travel and expenses. The remaining authors have no conflicts of interest or financial interests to disclose. This work is in part supported by the Statistical Expertise and Network (StatNet) Award of Cystic Fibrosis Foundation.

June Meeting Report; "Can bees count?"

June Meeting Report; "Can bees count?"

Choosing Justice Over Abandonment Amidst Abundance

ABSTRACT This plenary presentation from the Society of Pastoral Theology Annual Meeting in June 2021 addresses the intersection of systemic racism, systemic poverty, ecological devastation, the war economy, and the false narrative of Christian Nationalism and puts forward a vision of justice that comes from listening to the needs and priorities of the 140 million poor and low-income Americans. Drawing lessons from the 1968 Poor People's Campaign, this paper suggests that poverty is not inevitable, not willed by God, nor an unfortunate accident, but the result of policy choices by political, religious, academic and health institutions. It argues that people of faith, pastoral theologians, practitioners have a role to play in building a moral movement to fully address inequality. Special attention is paid to the Poor People's Campaign: A National Call for Moral Revival and grassroots organizing in communities across the United States in the first quarter of the twenty-first century.

Actions of the ASHP Board of Directors - Meeting of June 5 and 7, 2021.

Actions of the ASHP Board of Directors - Meeting of June 5 and 7, 2021.

June Meeting Presentation Report: Julie Radford, Ecologist Bush Heritage " Seeds of Resilience" – planting for the future !

June Meeting Presentation Report: Julie Radford, Ecologist Bush Heritage " Seeds of Resilience" – planting for the future !

Improving Cancer Data Interoperability: The Promise of the Minimal Common Oncology Data Elements (mCODE) Initiative.

Because of expanding interoperability requirements, structured patient data are increasingly available in electronic health records. Many oncology data elements (eg, staging, biomarkers, documentation of adverse events and cancer outcomes) remain challenging. The Minimal Common Oncology Data Elements (mCODE) project is a consensus data standard created to facilitate transmission of data of patients with cancer. In 2018, mCODE was developed through a work group convened by ASCO, including oncologists, informaticians, researchers, and experts in terminologies and standards. The mCODE specification is organized by 6 high-level domains: patient, laboratory/vital, disease, genomics, treatment, and outcome. In total, 23 mCODE profiles are composed of 90 data elements. A conceptual model was published for public comment in January 2019 and, after additional refinement, the first public version of the mCODE (version 0.9.1) Fast Healthcare Interoperability Resources (FHIR) implementation guide (IG) was presented at the ASCO Annual Meeting in June 2019. The specification was approved for balloting by Health Level 7 International (HL7) in August 2019. mCODE passed the HL7 ballot in September 2019 with 86.5% approval. The mCODE IG authors worked with HL7 reviewers to resolve all negative comments, leading to a modest expansion in the number of data elements and tighter alignment with FHIR and other HL7 conventions. The mCODE version 1.0 FHIR IG Standard for Trial Use was formally published on March 18, 2020. The mCODE project has the potential to offer tremendous benefits to cancer care delivery and research by creating an infrastructure to better share patient data. mCODE is available free from www.mCODEinitiative.org. Pilot implementations are underway, and a robust community of stakeholders has been assembled across the oncology ecosystem.

ASHP delegates meet remotely to adopt forward-looking policies.

ASHP’s House of Delegates on June 9 officially approved 18 member-driven policies, bringing the year-to-date total to 37 approved policies and 1 ASHP statement addressing important pharmacy practice issues and codifying the profession’s stance on important social issues. The critical 2-day June meetings—the only ones at which delegates can amend policies—were for the first time conducted virtually this year because of the COVID-19 pandemic. The focus on social issues is embodied in ASHP Policy 2036 (Racial and Discriminatory Inequities), which recognizes the existence of racism, discrimination, and inequality in healthcare and society. The new policy asserts that racism and all forms of discrimination and injustice are intolerable and commits ASHP to fostering a just and inclusive healthcare system and society. Also new is ASHP Policy 2035 (Role of the Pharmacy Workforce in Violence Prevention), which recognizes that violence is a public health crisis and calls for the profession to get involved in and help lead violence-prevention initiatives in the workplace and the community.

Actions of the ASHP Board of Directors-Meeting of June 6 and 8, 2020.

Actions of the ASHP Board of Directors-Meeting of June 6 and 8, 2020.

Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery: ICI-RS 2019?

Polypropylene (PP) mesh has been used as a primary or adjuvant material for vaginal reconstruction for both stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades. Whether polypropylene is the optimal material for such indications has been called into question by clinicians, regulatory agencies and the public in several countries around the world. This paper is a report of presentations and subsequent discussion at the annual International Consultation on Incontinence Research Society (ICI-RS) Meeting in June 2019 in Bristol, UK on the proposal "Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery?" in which several of the salient issues were presented and discussed.

Perceptions of Community Hematologists/Oncologists on the Potential of Data Presented at ASH 2018 and ASCO 2019 to Alter the Standard of Care for Multiple Myeloma Treatment

Introduction There has been a remarkable growth of new therapies for multiple myeloma (MM) in the last 5 years with 5 new agents approved by the FDA. Daratumumab is a human anti-CD38 monoclonal antibody previously approved as a single agent in relapsed/refractory (RR) MM and as combination in relapsed MM. Selinexor represents a novel first-in-class selective inhibitor of nuclear export (SINE) XPO1 antagonist in RRMM. The perception of practicing community hematologists and oncologists (H/O) regarding new information presented at major scientific meetings has implications for all stakeholders including patients, practices, payers, manufacturers and distributors. We conducted market research with H/O to understand how MM data presented at ASH 2018 and ASCO 2019 might alter their treatment preferences. Methods Live meetings in February and June 2019 convened H/O with geographic representations from across the United States. The participants were shown data from selected oral and/or poster presentations from the 2018 ASH Annual Meeting or 2019 ASCO Annual Meeting and responded to questions regarding their perceptions of the data and its potential impact on current practice. The presentations used included the following: 1) MAIA: a phase III, randomized study in patients with transplant-ineligible newly diagnosed MM (NDMM) comparing daratumumab plus lenalidomide and dexamethasone (D-Rd) to lenalidomide and dexamethasone (Rd) alone (Facon T, et al. Blood. 2018;132[Suppl 1]:LBA-2); 2) CASSIOPEIA: a phase III, randomized study in patients with transplant-eligible NDMM comparing daratumumab plus bortezomib, thalidomide and dexamethasone (D-VTd) to bortezomib, thalidomide and dexamethasone (VTd) alone (Moreau P, et al. J Clin Oncol. 2019;37[15_suppl]:8003); and 3) STORM: a pivotal, phase II, single-arm study of selinexor and dexamethasone in patients with penta-refractory MM (Chari A, et al. Blood. 2018;132[Suppl 1]:598). Participants submitted their demographic responses via a web-based survey prior to the meetings and data impression responses via an audience response system at the live meetings. Results Among the 112 H/O who participated in these live market research programs on February 22-23 and June 21-22, 2019, 58% identified their primary specialty as hematology/oncology and 38% medical oncology. Only 27% of the 59 H/O at the February live meeting had attended the ASH 2018 in December 2018 and 43% of the 53 at the June live meeting had attended the ASCO 2019 in June 2019. The participants were mostly community-based physicians, 47% in private community and 48% in community practices owned by a hospital or academic center. 31% have been in practice for over 20 years, 39% for 11-20 years and 29% for 10 or fewer years. The majority of this group sees at least 16 patients per day and reported active MM as one of the three most common hematologic malignancies they manage. At the February 2019 live meeting, 79% of H/O in attendance indicated that, based on the results of the MAIA study, D-Rd is likely to become their standard of care for patients with NDMM who are ineligible for transplant. At the June 2019 live meeting, the majority of H/O in attendance indicated that bortezomib + lenalidomide + dexamethasone (VRd) was the regimen typically used for their transplant-eligible NDMM patients. After reviewing the data from the CASSIOPEIA study of D-VTd, 50% of H/O indicated that the results are practice-changing and will be widely adopted, but thalidomide will be substituted with lenalidomide (D-VRd). 65% of H/O who attended the February 2019 live meeting indicated that, if selinexor is approved by the FDA, they are very likely to consider it for their patients with RRMM. 76% of advisors indicated that selinexor's novel mechanism of action (MOA) is very clinically meaningful in MM. Qualitative data collected also denotes interest in seeing selinexor tested and moved to earlier lines of therapy akin to the development course followed by daratumumab. Conclusions The movement of daratumumab to the first-line setting was well received by the community H/O and their willingness to substitute IMiD drugs in the backbone regimen for transplant-eligible patients was notable. It is noteworthy that the interest in selinexor was high even prior to its FDA approval and especially driven by its novel MOA. Disclosures Gajra: Cardinal Health: Employment. Sweat:Cardinal Health: Employment. Jeune-Smith:Cardinal Health: Employment. Feinberg:Cardinal Health: Employment.

Actions of the ASHP Board of Directors-Meeting of June 8 and 11, 2019.

Actions of the ASHP Board of Directors-Meeting of June 8 and 11, 2019.

Taking a Deep Dive into the Emergent Theory of Change

The civic learning and democratic engagement (CLDE) emergent theory of change builds on the 2012 report A Crucible Moment, asking vital questions about higher education’s role in advancing CLDE. Though it can be difficult for practitioners to dive deep into such questions once the school year begins, if they do not continuously ask how their efforts contribute to a thriving democracy, they may miss opportunities for richer student experiences and collaborative efforts across their respective campuses. As a lead consulting institution for the National Association of Student Personnel Administrators, the University of North Carolina Greensboro decided to frame its cohort conversations around this theory of change and to apply the theory to initiatives and programs at institutions across the United States. This article expands upon the presentation the authors delivered at the Civic Learning and Democratic Engagement Meeting in June 2018 in Anaheim, California, centering on the transition from theory to practice.