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In a group of palliative patients, venous thromboembolism (VTE) is a significant cause of death and reduction in quality of life. Current guidelines and scientific research on thromboprophylaxis most often refer to the population of oncology patients, who differ in many aspects from patients receiving palliative care. Thus, doctors working with patients undergoing palliative treatment have to face many problems related to safety and effectiveness of antithrombotic therapy in this type of care. In the case of chronically ill patients, diagnostic process may be somewhat difficult because the symptoms resulting from the underlying diseases can mask VTE symptoms. The aim of this article is to review the literature on symptoms and thromboprophylaxis in this group of patients. According to the latest guidelines of the American Society of Clinical Oncology (ASCO), it is not recommended to use VTE prophylaxis in outpatient oncology patients routinely, but it should be considered in high-risk patients who received a Khorana score of at least 2 before starting a new chemotherapy cycle. In patients diagnosed with VTE, in long-term prophylaxis lasting at least 6 months, due to greater effectiveness, it is recommended to use low-molecular-weight heparins, edoxaban, rivaroxaban or apixaban instead of vitamin K antagonists, which can be used if the previously mentioned drugs are unavailable. There are some studies which show that thromboprophylaxis may be beneficial for patients in palliative care. On the other hand, another studies’ results suggest that patients won’t gain any benefit from prevention. As our article shows it is very crucial to conduct scientific research on palliative patients and create clear guidelines for prophylaxis for this group of people. [ABSTRACT FROM AUTHOR]

Oncofertility is an extremely significant topic that is increasingly being discussed owing to increased evidence indicating that fertility preservation does not affect the treatment outcomes of patients with cancer but significantly contributes to preserving life quality. The effect of chemotherapy can range from minimal effects to complete ovarian atrophy. Limited data are available on the effects of monoclonal antibodies and targeted therapies on the ovaries and fertility. Temporary ovarian suppression by administering a gonadotropin-releasing hormone agonist (GnRHa) during chemotherapy decreases the gonadotoxic effect of chemotherapy, thereby diminishing the chance of developing premature ovarian insufficiency (POI). At present, the concomitant administration of GnRH analogs during chemotherapy is the only accepted pharmacological method for preserving ovarian function. Notably, most randomized studies on the effectiveness of luteinizing hormone-releasing hormone agonists during chemotherapy in preventing POI have been conducted in women with breast cancer, with a considerably small number of studies on patients with hematological malignancies. Furthermore, most randomized controlled trials on breast cancer have revealed a decrease in treatment-induced POI risk, regardless of the hormone receptor status. In addition, studies on hematological malignancies have yielded negative results; nevertheless, the findings must be interpreted with caution owing to numerous limitations. Current guidelines from the American Society of Clinical Oncology and ESMO Clinical Practice Guidelines recommend sperm, oocyte, and embryo cryopreservation as a standard practice and only offering GnRHa to patients when proven fertility preservation methods are not feasible. In this manuscript, we present a comprehensive literature overview on the application of ovarian suppression with GnRHa during chemotherapy in patients with cancer by addressing preclinical and clinical data, as well as future perspectives in this field that upcoming research should focus on. Graphic Abstract [ABSTRACT FROM AUTHOR]

At the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO), multiple research achievements in the field of colorectal cancer were announced. This article summarizes and interprets the research results related to colorectal cancer from the perspectives of local treatment progress, immunotherapy progress, targeted therapy, neoadjuvant therapy and surgery, and explores the hot spots, problems, and future directions of colorectal cancer treatment. [ABSTRACT FROM AUTHOR]

Context.--Quantitative imaging is a promising tool that is gaining wide use across several areas of pathology. Although there has been increasing adoption of morphologic and immunohistochemical analysis, the adoption of evaluation of fluorescence in situ hybridization (FISH) on formalin-fixed, paraffin-embedded tissue has been limited because of complexity and lack of practice guidelines. Objective.--To perform human epidermal growth factor receptor 2 (HER2) FISH validation in breast carcinoma in accordance with the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 guideline. Design.--Clinical validation of HER2 FISH was performed using the US Food and Drug Administration- approved dual-probe HER2 IQFISH (Dako, Carpinteria, California) with digital scanning performed on a PathFusion (Applied Spectral Imaging, Carlsbad, California) system. Validation parameters evaluated included z-stacking, classifier, accuracy, precision, software, and hardware settings. Finally, we evaluated the performance of digital enumeration on clinical samples in a real-world setting. Results.--The accuracy samples showed a final concordance of 95.3% to 100% across HER2 groups 1 to 5. During clinical implementation for HER2 groups 2, 3, and 4, we achieved a final concordance of 76% (95 of 125). Of these cases, only 8% (10 of 125) had discordances with clinical impact that could be identified algorithmically and triaged for manual review. Conclusions.--Digital FISH enumeration is a useful tool to improve the efficacy of HER2 FISH enumeration and capture genetic heterogeneity across HER2 signals. Excluding cases with high background or poor image quality and manual review of cases with ASCO/CAP group discordances can further improve the efficiency of digital HER2 FISH enumeration. [ABSTRACT FROM AUTHOR]

The role of immune checkpoint inhibitors for patients with gastroesophageal cancer with liver metastasis remains unclear. Our objective was to investigate whether immune checkpoint inhibitors are beneficial in patients with gastroesophageal cancer with liver metastasis. We searched PubMed, Embase, European Society for Medical Oncology, and American Society of Clinical Oncology meeting abstracts for phase 3 randomized clinical trials testing immune checkpoint inhibitors in metastatic/advanced gastroesophageal cancer from 2017 to 2023. Seven studies were included. Overall survival was similar among all patients (hazard ratio [HR] = 0.72 [95% confidence interval (CI) = 0.67 to 0.77], P  < .001), in patients without liver metastases (HR = 0.73 [95% CI = 0.67 to 0.81], P  < .001, I 2 = 0.0%), and in patients with liver metastases (HR = 0.74 [95% CI = 0.67 to 0.81], P  < .001, I 2 = 0.0%). Progression-free survival was also similar among all patients (HR = 0.63 [95% CI = 0.57 to 0.70], P  < .001), in patients without liver metastases (HR = 0.62 [95% CI = 0.51 to 0.76], P  < .001), and in patients with liver metastases (HR = 0.66 [95% CI = 0.57 to 0.76], P  < .001). Immune checkpoint inhibitors showed no difference in benefit in patients with gastroesophageal cancer, regardless of liver metastasis. Future studies could focus on deciphering the tumor microenvironment of liver metastasis as an area of translational research. [ABSTRACT FROM AUTHOR]

The article provides an updated guideline for managing cancer-related fatigue in adult survivors, emphasizing the need for comprehensive screening and evidence-based interventions. Topics include recommended therapies such as exercise, cognitive behavioral therapy, and mindfulness programs, the importance of individualized treatment plans, and recommendations against the use of certain medications like wakefulness agents and antidepressants.

The article outlines evidence-based guidelines for preventing and managing osteoradionecrosis in patients with head and neck cancer undergoing radiation therapy. Topics include radiation treatment planning to minimize osteoradionecrosis risk, the timing and frequency of dental evaluations for at-risk patients, and the use of systemic therapies or hyperbaric oxygen to reduce osteoradionecrosis incidence in high-risk individuals.

Background The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required to utilize evidence- and/or rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance. Methods A TACL task force reviewed the consortium's research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration to make expert consensus and evidence-based recommendations for modernizing, broadening, and codifying TACL-study washout periods while ensuring consistency with pediatric ethics, and federal regulations. TACL's screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment. Results Over a 19-year period, 42 (14.6% of all screened ineligible patients [n = 287]) patients were identified as excluded from TACL early phase studies exclusively because of not meeting washout criteria. An additional 6 (2.1%) did not meet washout and at least 1 other exclusion criterion. A new TACL washout guidance document was developed and then adopted for use. Where washout criteria were not eliminated, rationale- and/or evidenced-based criteria were established with citation. Conclusion In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale- and/or evidenced-based washout period standards largely following guidance from the NCI and ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence. [ABSTRACT FROM AUTHOR]

Information on several papers presented at the annual meeting of the American Society of Clinical Oncology held in 2024 in Chicago, Illinois is presented. Topics covered include the role of osimertinib in patients with non-small cell lung cancer harboring epidermal growth factor receptor mutations, treatment of oligometastatic colorectal cancer and treating esophageal cancer.

ASCO Standards are evidence-based standards to provide frameworks for best practices in cancer care, following the standards development process as outlined in the ASCO Standards Policies and Procedures Manual. ASCO Standards follow the ASCO Conflict of Interest Policy for Clinical Practice Guidelines. Standards and other guidance ("Guidance") provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by providers and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 (online only) for more. PURPOSE: To update the ASCO-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location. METHODS: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The standards presented here include clarification and expansion of existing standards to include home administration and other changes in processes of ordering, preparing, and administering antineoplastic therapy; the advent of immune effector cellular therapy; the importance of social determinants of health; fertility preservation; and pregnancy avoidance. In addition, the standards have added a fourth verification. STANDARDS: Standards are provided for which health care organizations and those involved in all aspects of patient care can safely deliver antineoplastic therapy, increase the quality of care, and reduce medical errors. Additional information is available at www.asco.org/standards and www.ons.org/onf. [ABSTRACT FROM AUTHOR]

The article discusses the integration of health equity into the American Society of Clinical Oncology (ASCO) guidelines, particularly focusing on the "Palliative Care for Patients with Cancer" guideline update. It emphasizes the need for comprehensive recommendations that address disparities in cancer care, which persist across various demographics despite ASCO's commitment to equitable treatment. It outlines the challenges faced by the Expert Panel during the guideline development process.

The article discusses the recent American Society of Clinical Oncology (ASCO) guidelines on germline genetic testing panels for patients with cancer. It emphasizes the importance of family history in selecting appropriate genes for testing, outlining when and how to use multigene panel testing. It also highlights the need for clinicians to navigate the complexities of testing various genes and the implications of variants of uncertain significance.

The article focuses on evidence-based recommendations for integrating palliative care into oncology, emphasizing its importance for patients with cancer, particularly those with advanced solid tumors and hematologic malignancies. It discusses the necessity of specialized palliative care teams and highlights the challenges faced by patients with hematologic malignancies, who often experience greater suffering and require comprehensive palliative services throughout their treatment.

The article explores the evolving role of inpatient oncology pharmacists. Topics discussed include a study commissioned by the American Society of Clinical Oncology in 2006 on the predicted shortage of oncologists through 2020, main areas in which challenges are possibly encountered with locum physicians in oncology practice, and opportunity provided by the era of locum physicians to oncology pharmacists.

Context.--: The American Society of Clinical Oncology/College of American Pathologists 2018 update of the human epidermal growth factor receptor 2 (HER2) testing guideline includes a fluorescence in situ hybridization (FISH) group with a HER2 to chromosome 17 centromere (CEP17) ratio less than 2.0 and HER2 copy number 6.0 or greater (group 3), which requires integrated review of HER2 immunohistochemistry (IHC). Objective.--: To assess the clinicopathologic features of group 3 patients and determine features associated with HER2-positive status after workup. Design.--: Cases submitted for HER2 FISH between January 2019 and June 2022 were identified, and relevant clinicopathologic information was obtained. Results.--: One hundred forty-two HER2 FISH cases (1.6%) were group 3. In 52 cases (36.6%) IHC was negative (0/1+), in 3 (2.8%) IHC was positive (3+), and in 86 (60.6%) IHC was 2+. Annotated IHC 2+ slides were recounted by a second reviewer in targeted areas, where 16 of 86 (18.6%) had a HER2:CEP17 ratio less than 2.0 and a HER2 copy number of 4.0 or greater to less than 6.0 (HER2 negative). After combined IHC/FISH review, 74 of 142 (52.1%) were classified as HER2 positive. HER2 copy number/cell was higher in HER2-positive compared with HER2-negative cases after the workup. The extent and intensity of staining in IHC 2+ cases did not correlate with the level of gene amplification. Twenty percent of HER2-positive patients achieved pathologic complete response. Conclusions.--: About half of group 3 cases were classified as HER2 positive after additional workup. Pathologic complete response rates in HER2-positive cases were lower than expected for group 1 (HER2:CEP17 ratio ≥2.0; HER2 copy number ≥4.0) patients. IHC-targeted FISH recounts may be redundant and may potentially lead to classification of some patients as HER2 negative, resulting in withholding of targeted therapy. [ABSTRACT FROM AUTHOR]

The article highlights the guidelines from the Anerican Society of Clinical Oncology (ASCO) for the systematic management of advanced hepatocellular carcinoma. Topics mentioned include the role of systematic therapy with immune checkpoint inhibitor in the peritransplant setting, the factors that need to consider when choosing between atezolizumab and bevacizumab or durvalumab and tremelimumab and the effectiveness of combined local and systemic therapy.

In this article, we report the breakthrough acquisitions for renal cell carcinoma (RCC) management presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The results from Keynote 564 showed an impressive overall survival (OS) advantage for pembrolizumab, in patients at higher risk of relapse after surgery and confirmed the benefit in terms of disease-free survival (DFS). Until now, pembrolizumab is the only immune checkpoint inhibitor (ICI) to prove a survival advantage. On the contrary, the results from CheckMate 914 trial showed the lack of benefit of adjuvant nivolumab. In the metastatic setting, the longer-term follow-up data of the CheckMate 9ER and CheckMate 214 trials reassessed the undoubtable role of ICI-based combination in first-line treatment, with a clear survival advantage in the subgroup of patients at intermediate/poor IMDC prognosis. No OS advantage was seen in favorable IMDC risk group patients. This 2024 ASCO Genitourinary Cancer Symposium laid the foundations for further knowledge development necessary for an increasingly personalized therapy for RCC patients. [ABSTRACT FROM AUTHOR]

Natural killer (NK) cell-based therapies have made great progress in treating both hematological and solid tumors. Their unique mechanism of action does not rely on antigen presentation to recognize and eliminate tumor cells, making them a promising approach for cancer immunotherapy. In this review, we present a comprehensive summary of the latest clinical data of the novel NK cell-based therapies from the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the potential of these advancements to revolutionize the treatment of hematologic malignancies and solid tumors. [ABSTRACT FROM AUTHOR]

Objective: The American Society of Clinical Oncology recommends all patients with high‐grade serous ovarian carcinoma (HGSC) undergo germline genetic testing. Genetic consultation rates in Ontario, Canada, only reached 13.3% in 2011. In 2016, PARP inhibitor maintenance therapy became available in Ontario for BRCA‐positive HGSC patients. Given expanding treatment options, we re‐examined genetic consultation rates among HGSC patients. Methods: This retrospective cohort study identified patients diagnosed with HGSC between 2012 and 2019 using population‐based administrative data from Ontario. Genetics consultations were identified using Ontario Health Insurance Plan billing codes. Consultation rates over time were analyzed using Cochran–Armitage trend test and segmental regression analysis. Multivariable analysis identified factors associated with attending genetics consultation. Results: This study included 4645 HGSC patients. The mean age was 64.2 years (±SD 12.3); 56.3% had stage 3–4 disease. Overall, approximately 35% attended genetics consultations. The genetic consultation rate per year increased significantly from 21.6% to 42.6% (P < 0.001). Shorter times between diagnosis and genetics consult were observed after PARP inhibitors became available (68.1 vs 34.1 weeks, P < 0.001). Patients treated at designated cancer centers (odds ratio [OR] 2.11, P < 0.001), diagnosed in later years (OR 1.33, P < 0.001), and from higher income groups (P < 0.05) were more likely to attend genetics consultation; older patients were less likely (OR 0.98, P < 0.001). After PARP inhibitors became available, consultation rates plateaued (P < 0.001). Conclusions: Between 2012 and 2019, genetic consultation rates improved significantly among HGSC patients; however, a large proportion of patients never attended consultation. Further exploration of barriers to care is warranted to improve consultation rates and ensure equitable access to care. Synopsis: Genetic consultation rates improved significantly among ovarian HGSC patients from 2012 to 2019; however, overall consultation rates remained suboptimal. Barriers to care persist despite publicly insured services. [ABSTRACT FROM AUTHOR]

The article focuses on the joint guidelines developed by the Society for Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO) regarding the use of integrative therapies to manage cancer-related symptoms. It provides evidence-based recommendations for complementary therapies, including acupuncture, mindfulness-based interventions, yoga, and t'ai chi, aimed at alleviating pain, anxiety, depression, and fatigue associated with cancer treatment.

Cancer is a disease that mostly affects older adults and because of the aging of the population, the number of older adults diagnosed with cancer will increase significantly around the world. With increasing age, more older adults are living with frailty, and this may impact the tolerability of cancer treatments. International guidelines, such as the American Society for Clinical Oncology geriatric oncology guideline, recommend a geriatric assessment and management for all older adults with cancer to support the treatment decision-making process as well as develop a plan for supportive care interventions to support the older adults during cancer treatments. While there is clinical trial evidence to support a geriatric assessment and management for older adults receiving chemotherapy, there is less evidence to support a geriatric assessment for older adults starting immunotherapy. There are increasing numbers of new immunotherapies and targeted therapies available for older adults with cancer but often few older adults have been included in the clinical trials, leaving less evidence for clinicians to guide treatment decisions. In this current opinion, we review the current evidence on the use of a geriatric assessment and management in the context of immunotherapy and targeted therapy. We review how a geriatric assessment could support older adults making treatment decisions for immunotherapy, review how geriatric assessment parameters are linked with outcomes and provide guidance on how geriatric assessment can guide the supportive care plan during immunotherapy treatment. [ABSTRACT FROM AUTHOR]

The article discusses the highlights of the American Society of Clinical Oncology annual meeting in May-June 2024. Topics covered include results showing darolutamide efficacy in nonmetastatic castration-resistant prostate cancer (nmCRPC), and patient-reported outcomes' (PRO) affirmation of efficacy data from EV-302 trial in urothelial cancer. Also noted is the absence of quality of life (QOL) impact in treatment suspension of enzalutamide on nonmetastatic hormone-sensitive prostate cancer.

The article provides information on common clinical situations encountered by oncologists caring for patients with advanced non-small cell lung cancer (NSCLC). Topics discussed include how to approach a newly diagnosed patient with metastatic NSCLC who has high PD-L1 expression but their molecular profile is pending, how to manage patients who have progressed on chemotherapy regardless of line of therapy, and what they recommend to a newly diagnosed patient with EGFR-positive metastatic NSCLC.

The article addresses some of the key questions that clinicians may have as they implement the guideline recommendations by the American society of Clinical Oncology (ASCO). These include recommendations that clinicians can give to patients regarding immunization against infection, the best time to vaccinate, and common safety concerns regarding vaccines in people with cancer.

Summary: Background: Immune checkpoint inhibitors (ICIs) are effective oncologic agents which frequently cause immune‐related adverse events (irAEs) which can impact multiple organ systems. Onco‐Gastroenterology is a novel and emerging subspecialty within gastroenterology focused on cancer treatment‐related complications. Gastroenterologists must be prepared to identify and manage diverse immune‐mediated toxicities including enterocolitis, hepatitis, pancreatitis and other ICI‐induced toxicities. Aim: To provide a narrative review of the epidemiology, diagnostic evaluation and management of checkpoint inhibitor‐induced gastrointestinal and hepatic toxicities. Methods: We searched Cochrane and PubMed databases for articles published through August 2023. Results: Gastrointestinal and hepatic irAEs include most commonly enterocolitis and hepatitis, but also pancreatitis, oesophagitis, gastritis, motility disorders (gastroparesis) and other rarer toxicities. Guidelines from the National Comprehensive Cancer Network, American Society of Clinical Oncology and European Society for Medical Oncology, in combination with emerging cohort and clinical trial data, offer strategies for management of ICI toxicities. Evaluation of irAEs severity by formal classification and clinical stability, and a thorough workup for alternative etiologies which may clinically mimic irAEs underlie initial management. Treatments include corticosteroids, biologics and other immunosuppressive agents plus supportive care; decisions on dosing, timing and choice of steroid adjuncts and potential for subsequent checkpoint inhibitor dosing are nuanced and toxicity‐specific. Conclusions: Expanding clinical trial and cohort data have clarified the epidemiology and clinical characteristics of gastrointestinal, pancreatic and hepatic toxicities of ICIs. Guidelines, though valuable, remain based principally on retrospective cohort data. Quality prospective, controlled studies may refine algorithms for treatment and potential immunotherapy rechallenge. [ABSTRACT FROM AUTHOR]

Multigene prognostic genomic assays have become indispensable in managing early breast cancer (EBC), offering crucial information for risk stratification and guiding adjuvant treatment strategies in conjunction with traditional clinicopathological parameters. The American Society of Clinical Oncology (ASCO) guidelines endorse these assays, though some clinical contexts still lack definitive recommendations. The dynamic landscape of EBC management demands further refinement and optimization of genomic assays to streamline their incorporation into clinical practice. The breast cancer community is poised at the brink of transformative advances in enhancing the clinical utility of genomic assays, aiming to significantly improve the precision and effectiveness of both diagnosis and treatment for women with EBC. This article methodically examines the testing methodologies, clinical validity and utility, costs, diagnostic frameworks, and methodologies of the established genomic tests, including the Oncotype Dx Breast Recurrence Score®, MammaPrint, Prosigna®, EndoPredict®, and Breast Cancer Index (BCI). Among these tests, Prosigna and EndoPredict® have at present been validated only on a prognostic level, while Oncotype Dx, MammaPrint, and BCI hold both a prognostic and predictive role. Oncologists and pathologists engaged in the management of EBC will find in this review a thorough comparison of available genomic assays, as well as strategies to optimize the utilization of the information derived from them. [ABSTRACT FROM AUTHOR]

@JCO_ASCO guideline on #cannabis in cancer with @JCOOP_ASCO companion Q&A addressing key clinical questions [ABSTRACT FROM AUTHOR]

The article highlights the 2024 American Society of Clinical Oncology Genitourinary Cancers (ASCO-GU) Symposium, focusing on recent advancements in genitourinary cancer treatment. Topics discussed include disappointing outcomes of adjuvant nivolumab trials in kidney cancer, promising results from adjuvant pembrolizumab trials, and updates on treatments for bladder cancer, particularly the efficacy of nadofaragene firadenovec in BCG-unresponsive non-muscle-invasive bladder cancer.

Objectives A combination of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) is the current standard of care for HER2 evaluation in breast cancer. Here, we investigate the potential clinical utility of next-generation sequencing (NGS)–derived HER2/ERBB2 copy number (CN) data for predicting HER2 status as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Methods In total, 294 locally recurrent and metastatic breast cancers previously tested by targeted hybrid capture–based NGS and by HER2 IHC/FISH were included. Analyses focused on the ERBB2 median log2 ratios and start-end genomic coordinates from NGS, average HER2 CN and HER2/ CEP17 ratios from FISH, and the HER2 IHC scores. We also determined a more stringent log2 ratio cutoff to predict HER2-positive status with 100% specificity. Results Sixty-four (22%) cases were HER2 positive and 230 (78%) were HER2 negative by ASCO/CAP guidelines. The ERBB2 median log2 ratios from NGS strongly correlated with HER2 status by IHC/FISH (area under receiver operator characteristic curve = 0.951). ERBB2 log2 ratio more than 1.7 was 100% specific for HER2-positive results by IHC/FISH. Start and end genomic coordinates for regions of gain near ERBB2 by NGS also predicted HER2 status. Conclusions Copy number data from our NGS panel strongly correlate with HER2 status. Using a stringent cutoff, ERBB2 log2 ratio accurately predicts HER2 positivity with high specificity. The NGS CN assessment may have utility in determining HER2 status in certain clinical settings. [ABSTRACT FROM AUTHOR]

PURPOSE Little data exist regarding approaches to support oncology professionals who deliver cancer care for underserved populations. In response, ASCO developed the Serving the Underserved Task Force to learn from and support oncology professionals serving underserved populations. METHODS The Task Force developed a 28-question survey to assess oncology professionals' experiences and strategies to support their work caring for underserved populations. The survey was deployed via an online link to 600 oncology professionals and assessed respondent and patient demographic characteristics, clinic-based processes to coordinate health-related social services, and strategies for professional society support and engagement.We used chi-square tests to evaluate whether there were associations between percent full-time equivalent (FTE) effort serving underserved populations (<50% FTE v ≥50% FTE) with responses. RESULTS Of 462 respondents who completed the survey (77% response rate), 79 (17.1%) were Asian; 30 (6.5%) Black; 43 (9.3%) Hispanic or Latino/Latina; and 277 (60%) White. The majority (n = 366, 79.2%) had amedical doctor degree (MD). A total of 174 (37.7%) had <25% FTE, 151 (32.7%) had 25%-50% FTE, and 121 (26.2%) had ≥50% FTE effort serving underserved populations. Most best guessed patients' sociodemographic characteristics (n = 388; 84%), while 42 (9.2%) used data collected by the clinic. Social workers coordinated most health-related social services. However, in clinical settings with high proportions of underserved patients, there was greater reliance on nonclinical personnel, such as navigators (odds ratio [OR], 2.15 [95% CI, 1.07 to 4.33]) or no individual (OR, 2.55 [95% CI, 1.14 to 5.72]) for addressing mental health needs and greater reliance on physicians or advance practice practitioners (OR, 2.54 [95% CI, 1.11 to 5.81]) or no individual (OR, 1.91 [95% CI, 1.09 to 3.35]) for addressing childcare or eldercare needs compared with social workers. Prioritization of solutions, which did not differ by FTE effort serving underserved populations, included a return-on-investment model to support personnel, integrated health-related social needs screening, and collaboration with the professional society on advocacy and policy. CONCLUSION The findings highlight crucial strategies that professional societies can implement to support oncology clinicians serving underserved populations with cancer. [ABSTRACT FROM AUTHOR]

Introduction: Neck mass is the most common presentation of human papillomavirus-related (HPV-related) oropharyngeal squamous cell carcinoma (OPSCC). Recently, circulating tumor HPV-DNA (ctHPVDNA) assays have been developed to detect active OPSCC. This pilot study investigates the diagnostic accuracy of ctHPVDNA in establishing HPV status for known vs. unknown OPSCC presenting as a neck mass. Methods: A single-institution pilot study was conducted on all patients with OPSCC presenting as a neck mass between 2021 and 2022. The diagnostic accuracy of ctHPVDNA was compared to that of standard diagnostic procedures used to obtain HPV status according to the American Society of Clinical Oncology (ASCO) guideline for squamous cell carcinoma of unknown primary (SCCUP). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ctHPVDNA were calculated. Results: A total of 27 patients were included; 70.4% were current or former smokers, 48.1% (N = 13) had identifiable primaries, and 51.9% (N = 14) had SCCUP. Four patients with known primaries required operative direct laryngoscopy with biopsy (DLB) to establish HPV status. Two patients with SCCUP underwent diagnostic transoral robotic surgery (TORS) to establish HPV status and localize the primary. Twelve patients underwent therapeutic TORS and neck dissection. The gold standard for HPV status was based on final histopathologic p16 or HPV in situ hybridization (ISH) staining during workup/treatment. ctHPVDNA had 95.8% sensitivity, 100% specificity, 100% PPV, and 75% NPV in predicting HPVpositive OPSCC in the whole sample. Binary logistic regression model using ctHPVDNA results to predict HPV-positive OPSCC was significant (-2 log likelihood = 5.55, χ² = 8.70, p <.01, Nagelkerke's R squared = .67). Among patients with identifiable primaries, all patients had HPV-positive tumors on final pathology, and ctHPVDNA was positive in 100%. In the unknown primary patients, ctHPVDNA had 90.9% sensitivity, 100% specificity, 100% PPV, and 75% NPV. Discussion: ctHPVDNA demonstrated good diagnostic accuracy for both known and unknown primaries. Incorporation of ctHPVDNA into the diagnostic algorithm for SCCUP may reduce the need for multiple procedures to establish HPV status. [ABSTRACT FROM AUTHOR]

Hematological indicators of chronic systemic inflammation are significant biomarkers for gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs). We performed a systematic review and meta‐analysis to assess the impact of certain factors on the overall survival (OS), progression‐free survival (PFS), and disease‐free survival (DFS) of patients with GEP‐NENs. These factors include the neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR), lymphocyte/monocyte ratio (LMR), and C‐reactive protein (CRP) levels. After searching the Medline, Embase, and Cochrane Library databases from January 1, 2000 to October 20, 2022 and the American Society of Clinical Oncology conference proceedings from January 1, 2017, hazard ratios (HRs) and 95% confidence intervals (CIs) were extracted. Subgroup analyses were conducted to identify the origins of heterogeneity and examine the impact of factor grouping. The effects of the cut‐off values and sample size were assessed by meta‐regression. The results revealed that higher NLRs, PLRs, and CRP levels were associated with shorter OS (HR = 2.09, 95% CI = 1.55–2.8; HR = 1.79, 95% CI = 1.40–2.28; and HR = 2.88, 95% CI = 2.09–3.95, respectively; all p < 0.001). Higher NLRs and lower LMRs were associated with shorter DFS (HR = 3.34, 95% CI = 2.11–5.29 and HR = 2.71, 95% CI = 2.27–3.24, respectively; both p < 0.001). Higher PLRs and CRP levels were correlated with shorter PFS (HR = 3.48, 95% CI = 1.34–9.03, p = 0.01 and HR = 3.14, 95% CI = 1.63–6.08, p = 0.001). As demonstrated in the research, hematological indicators of systemic inflammation are promising biomarkers for GEP‐NEN assessment. [ABSTRACT FROM AUTHOR]

Background: Establishing a new head and neck cancer (HNC) treatment center requires multidisciplinary team management and expertise. To our knowledge, there are no clear recommendations or guidelines in the literature for the commencement of HNC radiation therapy (RT) at a new cancer center. We propose a novel framework outlining the necessary components required to set‐up a new radiation therapy HNC treatment. Methods: We reviewed the infrastructure and methodology in the commencement of HNC radiation therapy in our cancer care center and invited several external, experienced metropolitan head and neck radiation oncologists to develop a novel consensus guideline that may be used by new RT centers to treat HNC. Recommendations were presented to our internal and external staff specialists using a survey questionnaire with ratings utilized to determine consensus using pre‐defined thresholds as per the American Society of Clinical Oncology Guidelines Methodology Manual. Conclusion: This consensus recommendation aims to improve RT utilization whilst advocating for optimal patient outcomes by presenting a framework for new radiation therapy centers ready to step up and manage the treatment of head and neck cancer patients. We propose these evidence‐based consensus guidelines endorsed by external HNC radiation oncologists. [ABSTRACT FROM AUTHOR]

The article presents questions and answers related to germline testing in patients with breast cancer including patients that are appropriate for testing for genes beyond BRCA1/2, the appropriate gene panel, and how clinical oncologists can connect to patients with professionals qualified to counsel patients regarding germline mutations.

Objective: This study aimed to evaluate mesothelin (MSLN) expression and determine its clinical significance and correlation with human epidermal growth factor receptor 2 (HER2) expression in gynecological carcinosarcoma. Methods: We retrospectively evaluated patients with uterine carcinosarcoma (UCS) and ovarian carcinosarcoma (OCS) who underwent surgery between 1997 and 2019. Immunohistochemical staining of formalin-fixed, paraffin-embedded specimens for MSLN (clone SP74) and HER2 (clone 4A5) was also performed. MSLN was scored using the H-score and 4-tired scoring system (0-3+). MSLN positivity was defined as any positive cell at any intensity, while high MSLN expression was defined as an intensity of =2+ in =30% of tumor cells. HER2 expression was scored according to modified 2018 American Society of Clinical Oncology/College of American Pathologists criteria. Results: A total of 128 patients were recruited, including 119 with UCS and 9 with OCS. All cases in UCS exhibited MSLN positivity, and 33.9% showed high-MSLN expression. Clinicopathological characteristics were not significantly associated with high or low-MSLN expression. However, the high-MSLN group showed more prolonged overall survival (OS) than the low-MSLN group (not assessed vs. 36.8 months; hazard ratio=0.48, 95% confidence interval=0.26-0.89, p=0.016). HER2-high patients had higher MSLN expression than HER2- negative patients. In high-MSLN and low-MSLN expression groups, HER2 status did not affect OS. OCS showed 100% MSLN positivity, with 66.6% high-MSLN. Conclusion: MSLN expression is widely observed in gynecological carcinosarcomas. Moreover, high-MSLN expression is a favorable prognostic factor for UCS. MSLN could be a promising therapeutic target for UCS, even in the era of anti-HER2 therapy. [ABSTRACT FROM AUTHOR]

Objectives: To characterise the restrictiveness of eligibility criteria in contemporary renal cell carcinoma (RCC) trials, using recommendations from the American Society of Clinical Oncology (ASCO)‐Friends of Cancer Research (FCR) initiative. Methods: vPhase I–III trials assessing systemic therapies in patients with RCC starting between 30 June 2012 and 30 June 2022 were identified. Eligibility criteria regarding brain metastases, prior or concurrent malignancies, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and human immunodeficiency virus (HIV) infection were identified and stratified into three groups: exclusion, conditional inclusion, and not reported. Descriptive statistics were used to determine the frequency of eligibility criteria. Fisher's exact test or chi‐square test were used to calculate their associations with certain trial characteristics. Results: A total of 423 RCC trials were initially identified of which 112 (26.5%) had sufficient accessible information. Exclusion of patients with HIV infection, HBV/HCV infection, brain metastases, and prior or concurrent malignancies were reported in 74.1%, 53.6%, 33.0%, and 8.0% of trials, respectively. In the context of HIV and HBV/HCV infection, patients were largely excluded from trials evaluating immunotherapy (94.4% and 77.8%, respectively). In addition, brain metastases were excluded in trials assessing targeted therapy (36.4%), combined therapy (33.3%), and immunotherapy (22.2%). Exclusion of patients with prior or concurrent malignancies was less frequently reported, accounting for 9.1%, 8.3%, and 5.6% targeted therapy, combined therapy and immunotherapy trials, respectively. Conclusion: A substantial proportion of RCC trials utilise restrictive eligibility criteria, excluding patients with fairly prevalent comorbidities. Implementing the ASCO‐FCR recommendations will ensure resulting data are more inclusive and aligned with patient populations in the real‐world. [ABSTRACT FROM AUTHOR]

Neoadjuvant immunotherapy has emerged as a prominent research focus recently. For potentially operable patients, neoadjuvant therapy serves as a primary method to reduce tumor load and facilitate surgical interventions. We retrieved articles from PubMed, Embase, Cochrane Library, American Society of Clinical Oncology, and European Society of Medical Oncology websites from inception to December 2023. Statistical analyses were performed using the R software. Primary outcomes assessed included major pathological response (MPR), pathological complete response (pCR), and treatment-related adverse events (trAEs). 29 studies encompassing 1163 patients were included. The MPR rate of neoadjuvant combination immunotherapy was 38% (95% confidence interval [CI]: 25%–52%), and the pCR rate was 33% (95%CI: 25%–42%). These values were significantly higher than those obtained with single agent immunotherapy (p < 0.001). The pooled incidence of overall trAEs was 83% (95%CI: 73%–92%), and grade (G) 3–4 trAEs was 22% (95%CI: 15%–29%), both significantly higher than those observed with single agent immunotherapy (p < 0.05). This study demonstrated the efficacy of neoadjuvant combination immunotherapy. Given that the majority of the included trials were phase II with small sample sizes, further multicenter phase III randomized controlled trials should be conducted to validate the findings of the review. [ABSTRACT FROM AUTHOR]

This Medical News article is an interview about JAMA Network highlights from the American Society of Clinical Oncology's annual meeting, hosted by Nora Disis, MD, editor in chief of JAMA Oncology and a JAMA deputy editor. [ABSTRACT FROM AUTHOR]

Background/Purpose: The American Society of Clinical Oncology has called for an increased priority to improve cancer care for sexual and gender minority (SGM) populations because of heightened risk of receiving disparate treatment and having suboptimal experiences, including perceived discrimination. We demonstrate how integrating trauma‐informed care (TIC) principles across the cancer continuum is a key strategy to improving care delivery and outcomes among SGM populations. Method: This empirically informed perspective expands on the concepts generated through the American Society of Clinical Oncology position statement and uses the Substance Abuse and Mental Health Services Association's "Four Rs" Toward Trauma Informed Care: Realize, Recognize, Response, and Resist Traumatization. Results: Recommendations for each component of TIC include: (1) Realize: Implement SGM cultural humility training, including modules on SGM‐specific trauma, discrimination, harassment, and violence; (2) Recognize: Routinely screen for emotional distress using methods to ensure privacy, and/or normalize mental health screenings to cancer patients; (3) Respond: Create and widely disseminate policies and patients' rights that prohibit discrimination and ensure access to gender‐neutral clinical environments; and (4) Resist Traumatization: Establish and respond to quality metrics (e.g., standardized patients, patient satisfaction surveys) that are informed by a community advisory board with the purpose of ensuring and maintaining quality care. Conclusions and Implications: Integrating TIC principles into cancer care for SGM populations is crucial to address disparities in treatment and clinical outcomes. Our recommendations offer practical approaches for oncology teams to implement TIC care and ensure equitable and inclusive cancer care for patients and their families. This perspective highlights the urgent need to integrate trauma‐informed care principles into cancer care for sexual and gender minority populations. By implementing the proposed recommendations, oncology care teams can address disparities and enhance outcomes, ensuring equitable and inclusive cancer care for all patients and their families. [ABSTRACT FROM AUTHOR]

The article focuses on ASCO's commitment to addressing the impact of climate change on cancer, emphasizing specific actions guided by its mission pillars of research, education, and quality. Topics include ASCO's endorsement of climate change as a public health crisis, its support for evidence-based policies to reduce the health burden from climate change, and its collaboration with the Medical Society Consortium on Climate and Health.

Background: Cancer anorexia-cachexia syndrome (CAS) is a multifactorial condition that is highly prevalent in advanced cancer patients and associated with significant reduction in functional performance, reduction in quality of life, and increased mortality. Currently, no medications are approved for this indication. Recently, the American Society of Clinical Oncology (ASCO) released a rapid recommendation suggesting that low-dose olanzapine once daily may be used to treat cancer cachexia. Many questions still exist on how to use olanzapine for this indication in clinical practice. The objective of this review is to identify existing knowledge on the use of olanzapine for CAS. Methods: A comprehensive search was conducted to identify the primary literature that involved olanzapine for anorexia and cachexia in cancer patients between 2000 and 2023. Results: Seven articles were identified and are discussed here, including two randomized double-blinded placebo-controlled studies, one randomized comparative study, two prospective open-label studies, one retrospective chart review, and one case report. Conclusions: Low dose olanzapine (2.5–5 mg once daily) may be useful in the treatment of CAS for increasing appetite, reducing nausea and vomiting, and promoting weight gain. Further large-scale multi-center randomized placebo-controlled studies will be needed to investigate the impact of olanzapine on weight change in CAS patients. [ABSTRACT FROM AUTHOR]

Background: Neoadjuvant combination immunotherapy is changing the treatment landscape for patients with cancer. Exploring the incidence of immune-related adverse events (irAEs) in relation to this novel approach may provide valuable insights for future clinical investigations. Methods: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed, Embase, Cochrane Library, American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO) websites were searched for all relevant literature from their inception to November 24, 2023. We then extracted the required data from the included studies and used the R software to analyze the pooled incidence of irAEs. Subgroup analyses examined the pooled incidence of irAEs according to cancer and combination types using a random-effects model. Results: Sixteen studies involving 501 patients were included in the metaanalysis. Considering the heterogeneity of the study design, we analyzed the randomized controlled studies (RCTs) and the single-arm studies separately. In RCTs, the incidence of any-grade irAEs was 95.0% (95% confidence interval [CI] 87.3-99.3) and that of grade ≥3 irAEs was 24.0% (95% CI 13.7-36.0). In single-arm studies, the incidence of any-grade irAEs was 89.4% (95% CI 75.0-98.0) and grade ≥3 irAEs was 20.3% (95% CI 8.7-35.2). In both RCTs and single arms, the most common any-grade irAEs were rash and fatigue, while the most common grade ≥3 irAEs was abnormal liver function and colitis. Due to irAEs, 9.4% of patients in RCTs and 6.9% of patients in single-arm studies did not complete the prescribed neoadjuvant treatment cycle. Conclusion: This study comprehensively summarized the incidence of irAEs in neoadjuvant combination immunotherapy. The occurrence of irAEs varies depending on the cancer and combination types. Our meta-analysis provides clinicians with essential guidance for the management of patients with cancer. [ABSTRACT FROM AUTHOR]

T rastuzumab deruxtecan (T-DXd) is an antibody–drug conjugate widely used in human epidermal growth factor receptor 2 (HER2)- positive metastatic breast cancer (MBC), based on the results of the DESTINY-Breast 01, 02 and 03 studies. The data show the efficacy of T-DXd in HER2-low (defined as HER2 expression of 1+, 2+ and ISH [in situ hybridization]-) breast cancer. The DESTINY-Breast04 trial, a randomized trial comparing T-DXd with the treatment of physician’s choice (TPC) in pretreated MBC with low HER2 expression, showed higher efficacy for T-DXd than for TPC. Because of its landmark results, the DESTINY-Breast04 trial was simultaneously published in the New England Journal of Medicine when presented at the 2022 American Society of Clinical Oncology Annual Meeting. T-DXd is now being used for HER2-low-expressing breast cancer as the second-line treatment and beyond. The DESTINY-Breast06 trial, which evaluated the efficacy of T-DXd as the first-line treatment, has completed the enrolment and is awaiting results. This article reviews the findings on T-DXd in advanced recurrent breast cancer with low HER2 expression. [ABSTRACT FROM AUTHOR]