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Amy Pierre, MSN, ANP-BC, of Flatiron Health and Memorial Sloan Kettering Cancer Center, considers takeaways from a program targeting minority accrual to oncology trials and a study evaluating minority representation in precision oncology trials.

With coverage from The ASCO Post, Lisa Kottschade, APRN, MSN, CNP, of Mayo Clinic, reviews data on immune therapy after surgery, the combination of the anti–LAG-3 antibody relatlimab and nivolumab, and a 6.5-year update of combination nivolumab and ipilimumab.

Following coverage from The ASCO Post, Emily Lemke, DNP, AGPCNP-BC, AOCNP®, of Medical College of Wisconsin Cancer Center, comments on an adjuvant trial of a checkpoint inhibitor for clear cell renal cell carcinoma (RCC), real-world data comparing first-line platinum regimens for patients with metastatic urothelial carcinoma, and combination regimens for RCC.

The treatment landscape of hepatocellular cancer has changed significantly within the past few years. At JADPRO Live Virtual 2020, Bridget O’Brien, DNP, APRN, FNP-BC, AOCNP®, provided an overview of developments in hepatocellular cancer treatment and clinical pearls for how advanced practitioners can manage common adverse events.

During JADPRO Live Virtual 2020, Ravi Krishnadasan, MD, FACP, provided an overview of the terminology of hemolysis, laboratory tests used in the diagnosis of hemolytic anemias, and appropriate indications for treatment of the various hemolytic anemias.

At JADPRO Live Virtual 2020, Lisa Kottschade, APRN, MSN, CNP, highlighted considerations for advanced practitioners on the recognition and monitoring of rare and life-threatening immune-related adverse events (irAEs), as well as strategies for managing patients who have corticosteroid-refractory irAEs.

Toxicologic Pathology is the official journal of the Society of Toxicologic Pathology (STP), the British Society of Toxicological Pathology (BSTP), and the European Society of Toxicologic Pathology (ESTP). Toxicologic Pathology publishes articles related to topics in various aspects of toxicologic pathology such as anatomic pathology, clinical pathology, experimental pathology, and biomarker research. Publications include society-endorsed Best Practice/Position and Points to Consider publications and ESTP Expert Workshop articles that are relevant to toxicologic pathology and scientific regulatory processes, Opinion articles under the banner of the STP Toxicologic Pathology Forum, Original Articles, Review Articles (unsolicited/contributed, mini, and invited), Brief Communications, Letters to the Editor, Meeting Reports, and Book Reviews. This article provides details on the various publication categories in Toxicologic Pathology and will serve as a reference for authors and readers.

At the 2020 SOHO Annual Meeting, Alex F. Herrera, MD, of City of Hope, discussed the integration of novel agents into the management of patients with relapsed or refractory Hodgkin lymphoma. Kelly Valla, PharmD, BCOP, of Winship Cancer Institute of Emory University, discusses insights from this session for advanced practitioners.

While regulatory requirements for carcinogenicity testing of chemicals vary according to product sector and regulatory jurisdiction, the standard approach starts with a battery of genotoxicity tests (which include mutagenicity assays). If any of the in vivo genotoxicity tests are positive, a lifetime rodent cancer bioassay may be requested, but under most chemical regulations (except plant protection, biocides, pharmaceuticals), this is rare. The decision to conduct further testing based on genotoxicity test outcomes creates a regulatory gap for the identification of non-genotoxic carcinogens (NGTxC). With the objective of addressing this gap, in 2016, the Organization of Economic Cooperation and Development (OECD) established an expert group to develop an integrated approach to the testing and assessment (IATA) of NGTxC. Through that work, a definition of NGTxC in a regulatory context was agreed. Using the adverse outcome pathway (AOP) concept, various cancer models were developed, and overarching mechanisms and modes of action were identified. After further refining and structuring with respect to the common hallmarks of cancer and knowing that NGTxC act through a large variety of specific mechanisms, with cell proliferation commonly being a unifying element, it became evident that a panel of tests covering multiple biological traits will be needed to populate the IATA. Consequently, in addition to literature and database investigation, the OECD opened a call for relevant assays in 2018 to receive suggestions. Here, we report on the definition of NGTxC, on the development of the overarching NGTxC IATA, and on the development of ranking parameters to evaluate the assays. Ultimately the intent is to select the best scoring assays for integration in an NGTxC IATA to better identify carcinogens and reduce public health hazards. Electronic supplementary material The online version of this article (10.1007/s00204-020-02784-5) contains supplementary material, which is available to authorized users.

This JADPRO Live session tested attendees’ knowledge on biomarkers and their use in determining targeted therapy for certain tumor types, key assays used to measure common biomarkers, and guideline-endorsed biomarker testing recommendations.

At JADPRO Live 2019, Leslie A. Swanson, ARNP, and Kathleen Boyle, PA-C, reviewed guideline-concordant molecular testing and therapy in patients with metastatic colorectal cancer (mCRC), the clinical significance of emerging data for existing and novel agents used to treat mCRC, and the management of adverse events associated with mCRC therapies.

At JADPRO Live 2019, Joshua Bauml, MD, and Christina Knepley, CRNP, discussed how to devise treatment plans for patients with metastatic non–small cell lung cancer, including using biomarkers to guide treatment selection, understanding clinical data supporting the use of targeted and immune checkpoint inhibitor therapies, and managing adverse events.

Colleen Lewis, MSN, ANP-BC, AOCNP®, and R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, presented on the new world of tumor-agnostic treatment approaches, including those aimed at managing patients with tumors that have high microsatellite instability (MSI-H) or neurotrophic receptor tyrosine kinase (NTRK) fusions. Learn about the clinical trial designs that enable development of these novel therapies, and discover how testing methodologies support precision medicine advances.

In the last decade, adverse outcome pathways have been introduced in the fields of toxicology and risk assessment of chemicals as pragmatic tools with broad application potential. While their use in the pharmaceutical and cosmetics sectors has been well documented, their application in the food area remains largely unexplored. In this respect, an expert group of the International Life Sciences Institute Europe has recently explored the use of adverse outcome pathways in the safety evaluation of food additives. A key activity was the organization of a workshop, gathering delegates from the regulatory, industrial and academic areas, to discuss the potentials and challenges related to the application of adverse outcome pathways in the safety assessment of food additives. The present paper describes the outcome of this workshop followed by a number of critical considerations and perspectives defined by the International Life Sciences Institute Europe expert group.

This article highlights preclinical and clinical studies in the field of wasting disorders that were presented at the 12th Cachexia Conference held in Berlin, Germany, in December 2019. Herein, we summarize the biological and clinical significance of different strategies including antibodies that target Fn14, Spsb 1, SAA1 treatment, ZIP14, a MuRF1 inhibitor, and new diagnostic tools like T‐cell communication targets and cut‐offs for the detection of skeletal muscle wasting. Of particular interest were the transplantation of mesenchymal stromal cells and muscle stem cell communication. Importantly, one presentation discussed the effect of metal ion transporter ZIP14 loss that reduces cancer‐induced cachexia. The potential of anti‐ZIP14 antibodies and zinc chelation as anti‐cachexia therapy may require testing in patients with cancer cachexia. Large clinical studies were presented such as RePOWER (observational study of patients with primary mitochondrial myopathy), MMPOWER (treatment with elamipretide in patients with primary mitochondrial myopathy), and ACT‐ONE as well as new mouse models like the KPP mouse. Promising treatments include rapamycin analogue treatment, anamorelin, elanapril, glucocorticoids, SAA1, antibodies that target Fn14, and a MuRF1 inhibitor. Clinical studies investigated novel approaches, including the role of exercise. It remains a fact, however, that effective treatments for cachexia and wasting disorders are urgently needed in order to improve patients' quality of life and their survival.

Lay Summary: Competition often occurs among diverse parasites within a single host, but control efforts could change its strength. We examined how the interplay between competition and control could shape the evolution of parasite traits like drug resistance and disease severity.

Myotonic dystrophy type 1 (DM1) and myotonic dystrophy type 2 (DM2) are multisystem, genetic disorders caused by repeat expansions on chromosome 19 (DM1) and chromosome 3 (DM2). Although the effects of DM on the skeletal, cardiac, and smooth muscles, as well as the endocrine and central nervous systems, can be disabling, there are no disease-modifying therapies for the disorder. Following a process established by the US Food and Drug Administration (FDA) in 2012 known as the Patient-Focused Drug Development (PFDD) Initiative, Myotonic (formerly the Myotonic Dystrophy Foundation) has been conducting patient- and caregiver-inclusive sessions to explore disease burden as defined by patients and caregivers, and what affected individuals want most from potential new therapies. In September 2017, at Myotonic’s annual conference, a session titled “Bringing the Patient Voice to CNS-Targeting Drug Development in Myotonic Dystrophy” attracted some 350 members of the DM community. During the session, patients and caregivers described CNS disease symptoms, their impact on quality of life, and potential CNS-related targets that they considered important for drug development consideration. These included fatigue and daytime sleepiness; dysregulated sleep; cognitive deficits such as “brain fog,” memory and focus impairment, learning and attention difficulties, and time management challenges; emotional/psychological/behavioral difficulties, including impulsivity, apathy, antisocial behavior, personality changes, and depression; social difficulties, including disconnection, lack of awareness, and feelings of isolation; and general anxieties about the future and potential loss of independence. Improvements in memory and lessening of “brain fog” were considered particularly important.

The purpose of this article is to draw the attention of specialists in the field of social sciences to a unique collection of documents at Moscow’s Institute of social psychology (1917–1924) created by V.M. Khvostov — a legislative science expert, philosopher, sociologist, who set himself the task of separating sociology and making it a specialized scientific discipline. The only work to date devoted to the Institute was an article written by its employee L.A. Byzov in 1923 (published in 2011), where he speaks about the history of the Institute, its development, achievements and failures from the point of view of a person who knows the situation from the inside. This makes it invaluable in terms of studying the history of the Institute of social psychology, in this work in particular, which provides more detailed information about the activities of V.M. Khvostov, the Institute’s employees and specialists involved in its work. These people were actually performing a scientific feat, creating a new direction in the field of social sciences, working in the extremely difficult conditions of the post-revolutionary era. The content and completeness of those of the Institute’s protocols which found their way into our hands, them currently being stored in the archives of the European University in St. Petersburg, are worthy of a full-fledged scientific publication that could write another page in the history of Russian sociology.

The XV. Banff conference for allograft pathology was held in conjunction with the annual meeting of the American Society for Histocompatibility and Immunogenetics in Pittsburgh, PA (USA) and focused on refining recent updates to the classification, advances from the Banff working groups, and standardization of molecular diagnostics. This report on kidney transplant pathology details clarifications and refinements to the criteria for chronic active (CA) T cell–mediated rejection (TCMR), borderline, and antibody‐mediated rejection (ABMR). The main focus of kidney sessions was on how to address biopsies meeting criteria for CA TCMR plus borderline or acute TCMR. Recent studies on the clinical impact of borderline infiltrates were also presented to clarify whether the threshold for interstitial inflammation in diagnosis of borderline should be i0 or i1. Sessions on ABMR focused on biopsies showing microvascular inflammation in the absence of C4d staining or detectable donor‐specific antibodies; the potential value of molecular diagnostics in such cases and recommendations for use of the latter in the setting of solid organ transplantation are presented in the accompanying meeting report. Finally, several speakers discussed the capabilities of artificial intelligence and the potential for use of machine learning algorithms in diagnosis and personalized therapeutics in solid organ transplantation., This report focuses on the clarification of the criteria for chronic active T cell–mediated rejection and antibody‐mediated rejection and the optimization of the inflammation threshold for the diagnosis of borderline for acute T cell–mediated rejection, and discusses the potential to use machine learning in diagnostics and personalized therapeutics in solid organ transplantation.

Background Artificial Intelligence (AI) platforms, increasingly deployed in public health, utilize robust data systems as a critical component for health emergency preparedness. Yet, Africa faces numerous challenges in the availability, analyses, and use of data to inform health decision-making. Countries have limited access to their population data. Those with access, struggle to utilize these data for program improvements. Owing to the rapid growth of mobile phone ownership and use in the region, Africa is poised to leverage AI technologies to increase the adoption, access and use of data for health. To discuss and propose solutions for responsible development and adoption of innovations like AI in Africa, a virtual workshop was organized from the 21st to 24th June, 2021. This report highlights critical policy dimensions of strengthening digital health ecosystems by high-level policymakers, technical experts, academia, public and private sector partners. Method The four days’ workshop focused on nine sessions, with each session focusing on three themes. Discussions during the sessions concentrated on public and private sectors, the academia and multilateral organizations’ deployment of AI. These discussions expanded participants’ understanding of AI, the opportunities and challenges that exist during adoption, including the future of AI for health in the African region. Approximately 250 participants attended the workshop, including countries representatives from ministries of Health, Information and Technology, Developmental Organizations, Private Sector, Academia and Research Institutions among others. Results The workshop resolved that governments and relevant stakeholders should collaborate to ensure that AI and digital health receive critical attention. Government ownership and leadership were identified as critical for sustainable financing and effective scale-up of AI-enabled applications in Africa. Thus, government is to ensure that key recommendations from the workshop are implemented to improve health sector development in Africa. Conclusions The AI workshop was a good forum to deliberate important issues regarding AI for health in the African context. It was concluded that there is a need to focus on vital priorities in deploying AI in Africa: Data protection, privacy and sharing protocols; training and creating platforms for researchers; funding and business models; developing frameworks for assessing and implementing AI; organizing forums and conferences on AI; and instituting regulations, governance and ethical guidelines for AI. There is a need to adopt a health systems approach in planning for AI to reduce inefficiencies, redundancies while increasing effectiveness in the use of AI. Thus, robust collaborations and partnerships among governments and various stakeholders were identified as key.

The 43rd meeting of the Reference Material Committee of ISO, ISO/REMCO, that was scheduled to take place in Milan, Italy, from 30 June to 3 July 2020 with Accredia, the Italian accreditation body and INRIM, the Italian Metrology Institute as the hosts, was cancelled due to the COVID-19 pandemic. This report shares the details of the important decision that was taken by the ISO Technical Management Board (TMB) in December 2020 to transform ISO/REMCO into an ISO technical committee, ISO/TC 334, Reference materials. The background that led to the decision is provided as well as the implications of the decision for the future of the development of guidance for the production and use of reference materials. The report also gives an update on the progress with the work program of the committee during the past year and the strategy for the future work of the committee.

At the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting, William Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, described the clinical implications of measuring minimal residual disease. Lisa Nodzon, PhD, ARNP, AOCNP®, of Moffitt Cancer Center, summarizes the key points for advanced practitioners.

Sheeba Cantanelli, MPAS, PA-C, of UT Southwestern Medical Center, Simmons Comprehensive Cancer Center, discusses results from studies evaluating adjuvant therapy with a PARP inhibitor in BRCA-mutated HER2-negative metastatic breast cancer; immunotherapy in the treatment of early-stage triple-negative breast cancer; adjuvant capecitabine after neoadjuvant chemotherapy in triple-negative breast cancer; the addition of palbociclib to fulvestrant in HR-positive, HER2-negative advanced breast cancer; and the impact of vitamin D levels on outcomes. Reporting is provided by The ASCO Post.

Elizabeth S. Waxman, RN, MSN, AOCN®, ANP-BC, of MD Anderson Cancer Center, reviews important research in thoracic cancers presented at the 2021 ASCO Annual Meeting, including atezolizumab in early-stage lung cancer, the addition of doublet chemotherapy to doublet immunotherapy in advanced-stage NSCLC, the first-in-class KRAS G12C inhibitor sotorasib, and the combination of amivantamab and lazertinib. Coverage provided by The ASCO Post.

With conference reporting provided by The ASCO Post, Amber B. Koehler, PA-C, MS, of Mayo Clinic, evaluates data on BTK inhibitors; fixed-duration, first-line treatment with ibrutinib plus venetoclax; and a novel oral BCL2 antagonist for patients with CLL. P. Andrew Allred, MS, PA-C, of Banner MD Anderson Cancer Center, reviews data on a front-line therapy for patients with Ph+ acute lymphoblastic leukemia and brexucabtagene autoleucel, an anti-CD19 CAR T-cell therapy. Donna Catamero, ANP-BC, OCN®, CCRC, of Mount Sinai Hospital, reflects on findings on a BCMA-directed CAR T-cell therapy and a bispecific monoclonal antibody for patients with multiple myeloma.

Nina N. Grenon, DNP, AGCNP-BC, AOCN®, of Dana-Farber Cancer Institute, evaluates data on single and dual immunotherapy for advanced esophageal squamous cell carcinoma; maintenance therapy for metastatic colorectal cancer; a HER2-targeted therapy for colorectal cancer; adjuvant therapy for resected esophageal cancer and gastroesophageal junction cancer; and standard of care for patients with advanced biliary tract cancer.

Josh Epworth, ARNP, of University of Washington Medical Center, considers the findings of three important abstracts from the 2021 ASCO Annual Meeting and reflects on how advanced practitioners can improve access and care for their patients with cancer. Meeting coverage is provided by The ASCO Post.

Abby Fuoto, DNP, ANP-BC, AOCNP®, ACHPN, of University of Arizona Cancer Center, considers the implications of a novel monoclonal antibody for nasopharyngeal cancer, and Mee-young Lee, MSN, ANP-BC, of Monter Cancer Center, Northwell, discusses the design of a basket trial for tumors with HER2 amplification or overexpression. Meeting coverage is provided by The ASCO Post.

Laura Doherty, FNP-BC, AOCNP®, of Women & Infants Hospital of Rhode Island/Brown University, interprets data on adjuvant chemotherapy for locally advanced cervical cancer, bevacizumab for advanced ovarian cancer, a new treatment option for platinum-resistant ovarian cancer patients, and side effects that long-term ovarian cancer survivors experience. Reporting by The ASCO Post.

Morgane C. Diven, PharmD, BCOP, of Phoenix VA Health Care System, evaluates research on an investigational radiolabeled small molecule, combination therapy in the treatment of de novo metastatic prostate cancer, and a CYP17-lyase inhibitor in metastatic hormone-sensitive prostate cancer. Coverage provided by The ASCO Post.