American Society Of Clinical Oncology Research Articles

Systemic Anticancer Therapy and Overall Survival in Patients With Very Advanced Solid Tumors.

Two prominent organizations, the American Society of Clinical Oncology and the National Quality Forum (NQF), have developed a cancer quality metric aimed at reducing systemic anticancer therapy administration at the end of life. This metric, NQF 0210 (patients receiving chemotherapy in the last 14 days of life), has been critiqued for focusing only on care for decedents and not including the broader population of patients who may benefit from treatment. To evaluate whether the overall population of patients with metastatic cancer receiving care at practices with higher rates of oncologic therapy for very advanced disease experience longer survival. This nationwide population-based cohort study used Flatiron Health, a deidentified electronic health record database of patients diagnosed with metastatic or advanced disease, to identify adult patients (aged ≥18 years) with 1 of 6 common cancers (breast cancer, colorectal cancer, non-small cell lung cancer [NSCLC], pancreatic cancer, renal cell carcinoma, and urothelial cancer) treated at health care practices from 2015 to 2019. Practices were stratified into quintiles based on retrospectively measured rates of NQF 0210, and overall survival was compared by disease type among all patients treated in each practice quintile from time of metastatic diagnosis using multivariable Cox proportional hazard models with a Bonferroni correction for multiple comparisons. Data were analyzed from July 2021 to July 2023. Practice-level NQF 0210 quintiles. Overall survival. Of 78 446 patients (mean [SD] age, 67.3 [11.1] years; 52.2% female) across 144 practices, the most common cancer types were NSCLC (34 201 patients [43.6%]) and colorectal cancer (15 804 patients [20.1%]). Practice-level NQF 0210 rates varied from 10.9% (quintile 1) to 32.3% (quintile 5) for NSCLC and 6.8% (quintile 1) to 28.4% (quintile 5) for colorectal cancer. No statistically significant differences in survival were observed between patients treated at the highest and the lowest NQF 0210 quintiles. Compared with patients seen at practices in the lowest NQF 0210 quintiles, the hazard ratio for death among patients seen at the highest quintiles varied from 0.74 (95% CI, 0.55-0.99) for those with renal cell carcinoma to 1.41 (95% CI, 0.98-2.02) for those with urothelial cancer. These differences were not statistically significant after applying the Bonferroni-adjusted critical P = .008. In this cohort study, patients with metastatic or advanced cancer treated at practices with higher NQF 0210 rates did not have improved survival. Future efforts should focus on helping oncologists identify when additional therapy is futile, developing goals of care communication skills, and aligning payment incentives with improved end-of-life care.

Racial differences in familiarity, interest, and use of integrative medicine among patients with breast cancer.

Integrative medicine (IM) has received the American Society of Clinical Oncology's endorsement for managing cancer treatment-related side effects. Little is known about racial differences in familiarity, interest, and use of IM among patients with breast cancer. Patients with breast cancer enrolled in the Chicago Multiethnic Epidemiologic Breast Cancer Cohort were surveyed regarding familiarity, interest, and use of acupuncture, massage, meditation, music therapy, and yoga. Familiarity and interest, measured by a 5-point Likert scale, was modeled using proportional odds. Use was self-reported, and modeled using binary logistic regression. Of 1,300 respondents (71.4% White and 21.9% Black), Black patients were less likely than White patients to be familiar with acupuncture (aOR 0.60, 95% CI 0.41-0.87); there were no racial differences in familiarity with massage, meditation, music therapy, and yoga. While there were no differences in interest in acupuncture between Black and White patients (aOR 1.12, 95% CI 0.76-1.65), Black patients were more interested in massage (aOR 1.86, 95% CI 1.25-2.77), meditation (aOR 2.03, 95% CI 1.37-3.00), music therapy (aOR 2.68, 95% CI 1.80-3.99), and yoga (aOR 2.10, 95% CI 1.41-3.12). Black patients were less likely than White patients to have used acupuncture (aOR 0.49, 95% CI 0.29-0.84); but there were no racial differences in use of massage, meditation, music therapy, and yoga. Black patients expressed more interest in IM than their White counterparts; there were no racial differences in IM use, except lower acupuncture use among Black patients. A breast program focused on equity should provide access to these services for patients with breast cancer.

A Comparison of Additional Benefit Assessment Methods for Time-to-Event Endpoints Using Hazard Ratio Point Estimates or Confidence Interval Limits by Means of a Simulation Study.

For time-to-event endpoints, three additional benefit assessment methods have been developed aiming at an unbiased knowledge about the magnitude of clinical benefit of newly approved treatments. The American Society of Clinical Oncology (ASCO) defines a continuous score using the hazard ratio point estimate (HR-PE). The European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) developed methods with an ordinal outcome using lower and upper limits of the 95% HR confidence interval (HR-CI), respectively. We describe all three frameworks for additional benefit assessment aiming at a fair comparison across different stakeholders. Furthermore, we determine which ASCO score is consistent with which ESMO/IQWiG category. In a comprehensive simulation study with different failure time distributions and treatment effects, we compare all methods using Spearman's correlation and descriptive measures. For determination of ASCO values consistent with categories of ESMO/IQWiG, maximizing weighted Cohen's Kappa approach was used. Our research depicts a high positive relationship between ASCO/IQWiG and a low positive relationship between ASCO/ESMO. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 corresponds to ESMO categories. Using ASCO values of 21 and 38 as cutoffs represents IQWiG categories. We investigated the statistical aspects of the methods and hence implemented slightly reduced versions of all methods. IQWiG and ASCO are more conservative than ESMO, which often awards the maximal category independent of the true effect and is at risk of overcompensating with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and underpowered/overpowered studies influence all methods in some degree. Nevertheless, ESMO is the most liberal one. For the additional benefit assessment, the American Society of Clinical Oncology (ASCO) uses the hazard ratio point estimate (HR-PE) for their continuous score. In contrast, the European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) use the lower and upper 95% HR confidence interval (HR-CI) to specific thresholds, respectively. ESMO generously assigns maximal scores, while IQWiG is more conservative.This research provides the first comparison between IQWiG and ASCO and describes all three frameworks for additional benefit assessment aiming for a fair comparison across different stakeholders. Furthermore, thresholds for ASCO consistent with ESMO and IQWiG categories are determined, enabling a comparison of the methods in practice in a fair manner.IQWiG and ASCO are the more conservative methods, while ESMO awards high percentages of maximal categories, especially with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and under/-overpowered studies influence all methods. Nevertheless, ESMO is the most liberal one. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 correspond to the categories of ESMO. Using ASCO values of 21 and 38 as cutoffs represents categories of IQWiG.

Abstract PO1-11-10: Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients

Abstract There is a steep linear increase in patients surviving a cancer diagnosis. Clinical solutions that address the high prevalence of cancer-related treatment effects (CRTE) are urgently needed. A stark example of this need is the dearth of screening and treatment programs for cancer related cognitive impairment (CRCI) (colloquially called “chemo-brain”). Up to 75% of cancer patients report neurocognitive changes that leave patients unable to cope with the expectations of employers, colleagues, families, and friends. The prevalence of neurological disorders is 275% higher among adult cancer patients, when compared to an adult cancer-free population. For many adolescent and young adult cancer patients, the onset of CRCI occurs during "cognitive prime time"; a time when individuals are pursuing education, careers, and raising families. To address a gap in CRTE we have implemented a virtual multi-disciplinary intervention to measure and treat CRCI. Our CRCI intervention follows National Comprehensive Cancer Network and American Society of Clinical Oncology (ASCO) guidelines for CRCI. These guidelines indicate a multi-disciplinary approach with emphasis on increasing physical activity levels, cognitive-behavioral therapy, memory adaptive training, mood management, and sleep optimization. Our approach also follows recent ASCO guidelines for nutrition counseling. Our CRCI program utilizes medical oncologists, physician assistants, mental health therapists, registered dietitians, and occupational therapists. A nationally validated patient reported outcome (PRO) measurement, analysis, and reporting platform informs clinical treatment pathways, monitors patient progress, guides clinical decision making, and improves patient/provider communication. Using health status measures for CRCI, and following American Cancer Society and ASCO guidelines, patients are risk-stratified into three personalized cancer survivor care pathways: 1) low-complexity patients; 2) medium-complexity patients; and 3) high-complexity patients. Low-complexity patients baseline PROs score in the normal range, medium-complexity patients are those who score below the norm (moderate to large effect size difference from normal), and high-complexity patients are those who score well below the norm (greater than larger effect size difference from normal). Low-complexity patients are enrolled into a self-management and continuation of care program. Medium-complexity patients are enrolled into a shared care program. High-complexity patients are enrolled into an acute care program. All three clinical pathways include continued risk-factor vital-sign surveillance. Nearly 100% (99%) of patients who enroll in our primary cancer survivor care program complete our PRO baseline (N=80). From a convenient sample of breast cancer patients (N=42), provisional results of patient-specific segmentation analyses reveal a nearly perfect bell-shaped curve, with 51% of the population classified within the definition of medium-complexity and even split of outliers (high-complexity 24% and low-complexity 24%). Additionally, of all patients in our primary cancer survivor care program who completed at least three measurement time points for health status measures of cognitive impartment (N=38), 92% had a positive experience, 71% had a clinically significant improvement in cognitive health, 21% had a no change in cognitive status, and only 8% had a decline in cognitive health. If these data, and PRO implementation approach hold true, this program could be scaled to national and international cancer survivor population suffering from CRCI. Citation Format: John Librett, Mark Kosinski, Gregory Litton. Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-10.

Abstract PO1-10-07: A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Metastatic Breast Cancer: Primary Results of a Prospective Intervention Trial

Abstract Background: Tumor genomic testing (TGT) has become standard-of-care for all patients with metastatic breast cancer (MBC). American Society of Clinical Oncology (ASCO) and American College of Medical Genetics (ACMG) guidelines for patient education prior to TGT are not widely followed. We have previously demonstrated disparities in general genomic knowledge across race and income. The purpose of this study was to develop a concise (3-4 minute) video for patient education prior to TGT and evaluate the video’s impact in a prospective interventional trial. We report the results of the primary endpoint of the MBC cohort (ClinicalTrials.gov NCT05215769). Methods: We previously published our internal quality improvement cycle involving provider surveys, patient focus groups, and adult learning theory-based content development for TGT educational videos. An animated video incorporating culturally diverse images available in English and Spanish was created to be applicable to any cancer type, with MBC-specific content included for patients with breast cancer. A total of 150 participants were enrolled at a single tertiary academic institution, of whom 53 were diagnosed with MBC. Participants completed validated survey instruments immediately prior to video viewing (T1), immediately post-viewing (T2) and 60-90 days later, after TGT results were documented (T3). Instruments included: 1) 10-question objective genomic knowledge/understanding (GKU); 2) 10-question video message-specific knowledge/recall (VMSK); 3) 11-question Trust in Physician/Provider (TIPP); 4) attitudes regarding TGT. The primary objective was to assess change in VMSK between T1 and T2 and a cohort of 50 participants provided 90% power to detect an effect size of 0.47 from pre- to post-video using two-sided Wilcoxon signed-rank test with alpha of 0.05. Associations of VMSK, GKU, and TIPP with categorical demographic variables were explored with Kruskal-Wallis test. Results: From April 2022 to May2023, a total of 150 participants were enrolled (MBC n=53, lung cancer n=38, metastatic cancer of any type n=59). The MBC cohort analysis is presented. The MBC cohort had a median age of 59; all were female; majority Caucasian (48/53, 91%); most were married/in domestic partnership (35/53, 66%). For the primary endpoint, there was a significant increase in video message-specific knowledge (Wilcoxon signed rank p< 0.0001) but there was no significant change in general genomic knowledge (p=0.89) or trust in provider (p=0.59). Improvement of video message-specific knowledge was consistent across demographic groups, including age, income, and education. Of the 10-questions in the VMSK survey, results for four questions significantly improved after viewing the video, including questions informing the likelihood of TGT impact on treatment decision, incidental germline findings, and cost of testing (Table 1). Baseline genomic knowledge was significantly associated with income (nominal p=0.028), with higher income associated with higher baseline knowledge. Conclusions: A concise, 3-4 minute, broadly applicable video incorporating culturally diverse images administered prior to TGT significantly improved video message-specific knowledge across all demographic groups. Ongoing work includes analysis of additional cohorts (lung, any type) and evaluation in community oncology setting with a goal to provide a paradigm to efficiently educate and empower patients while addressing ASCO/ACMG guidelines within the flow of clinical practice. Table 1. Response to video message-specific questions before versus after tumor genomic testing educational video intervention Citation Format: Daniel Stover, Deloris Veney, Lai Wei, Amanda Toland, Carolyn Presley, Tasleem Padamsee, Clara Lee, Heather Hampel, William Irvin, Jawad Francis, Michael Bishop, Shelly Hovick, Leigha Senter. A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Metastatic Breast Cancer: Primary Results of a Prospective Intervention Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-10-07.

Abstract PO5-16-06: Prophylactic Neurokinin-1 Receptor Antagonist Use Pre- and Post- Choosing Wisely Initiative among Women with Breast Cancer

Abstract Objective: In April 2012, the American Society of Clinical Oncology (ASCO) issued recommendations as a part of the Choosing Wisely (CW) campaign with the aim to identify the areas of low-value utilization. One of the CW recommendations is not to use expensive antiemetics, specifically Neurokinin-1 Receptor Antagonist (NK1-RA) for patients initiating low or moderate emetic risk chemotherapy. The purpose of this study was to determine the impact of CW on prophylactic NK1-RA use among women with breast cancer. Methods: Using Optum’s de-identified Clinformatics® Data Mart Database for 2010 to 2018, a retrospective cohort study was conducted for women aged ≥18 years with breast cancer with at least one newly initiated claim for low/minimal/moderate emetic risk chemotherapy (n = 25,549). All approved antiemetics - aprepitant, fosaprepitant, rolapitant, and netupitant/palonosetron) were included. An interrupted time series using a segmented regression model was used to assess the effect of CW on the prophylactic NK1-RA use. Results: The prophylactic use of NK1-RAs among patients with breast cancer receiving low/minimal/moderate emetic risk chemotherapy decreased from 11.1% pre-CW to 7.7% post-CW. Segmented regression analysis showed that there was a significant increase of 0.11 per 100 patients per quarter in the use of prophylactic NK1-RAs prior to CW recommendation. However, immediately after the CW (occurred in Q42013), there was a significant decline in prophylactic NK1-RA use by 1.03 per 100 patients in Q22014. For the time after intervention, there was a significant decline in NK1-RA use by 0.37 per 100 patients per quarter in the post-CW period compared to the pre-CW period (p< 0.05). Conclusion: This study highlights a significant but modest decline in the inappropriate use of prophylactic NK1-RAs after the implementation of CW antiemetic recommendation. Continued statewide or local educational efforts for dissemination of CW recommendations are needed to facilitate appropriate prophylactic use of NK1-RAs. Table. Adjusted* Interrupted Time Series Segmented Regression Analysis of Prophylactic NK1-RA use among women with breast cancer before and after the Choosing Wisely initiative *Adjusted for insurance, health plan type, age, comorbidity, and emetic risk Citation Format: Shweta Kamat, Britny Brown, Steven Cohen, Ami Vyas. Prophylactic Neurokinin-1 Receptor Antagonist Use Pre- and Post- Choosing Wisely Initiative among Women with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-16-06.

Authorship characteristics of hematology and oncology education chapters: A comprehensive analysis

IntroductionAchieving diversity and equity in healthcare, especially within academic and clinical spheres, poses significant challenges. This study aims to evaluate gender representation, geographical diversity among authors, and disclosure of conflicts of interest (COIs) in educational materials published by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH). Materials and methodsWe conducted a comprehensive cross-sectional analysis covering all volumes of ASCO and ASH educational chapters from 2012 to 2022 and 2000 to 2022, respectively. Author data were extracted from the official websites of ASCO and ASH educational books, focusing on names, affiliations, countries of practice, COIs, and publication titles/subjects. ResultsAnalysis of 2796 articles revealed significant trends in gender representation. Women comprised 44 % of first authors and 38 % of last authors in ASCO educational books, and 39 % of first authors and 39% of last authors in ASH educational books. Notably, there was a marked increase in female first and last authors over time across both ASCO and ASH publications (p < 0.001). Geographical diversity showed disparities, with the majority of authors affiliated with US institutions (72 % of first and last authors). International authors were less represented, with Canada, the UK, and Italy prominent among articles featuring international women authors. A substantial portion of analyzed articles disclosed COIs, mainly research funding, honoraria, and travel expenses. DiscussionOur findings suggest a notable rise in female authorship, potentially reflecting efforts by ASH and ASCO to promote diversity. International authorship remained stable, while COIs were prevalent, primarily involving research funding. Addressing the need for greater international engagement and improving COI reporting quality are crucial to promote inclusivity and transparency in academic publications.

Barriers to Clinical Trial Implementation Among Community Care Centers

While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol. To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment. This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)-ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents. To determine participation trends among health care practices in oncology-focused research, identify barriers to clinical trial implementation and operation, and establish unmet needs for cancer clinics interested in trial participation, a 34-question survey was designed. Survey questions were defined within 3 categories: cancer center demographic characteristics, clinical trial characteristics, and referral practices. The survey was distributed through email and was open from June 20 through October 5, 2022. Participation in and barriers to conducting oncology trials in different community oncology settings. The survey was distributed to 100 cancer centers, with completion by 58 centers (58%) across 25 states. Fifty-two centers (88%) reported that they conduct therapeutic clinical trials, of which 33 (63%) were from urban settings, 11 (21%) were from suburban settings, and 8 (15%) were from rural settings. Only 25% of rural practices (2 of 8) offered phase 1 trials, compared with 67% of urban practices (22 of 33) (P = .01). Respondents noted challenges in conducting research, including patient recruitment (27 respondents [52%]), limited staffing (27 [52%]), and nonrelevant trials for their patient population (25 [48%]). Among sites not offering therapeutic trials, barriers to research conduct included limited infrastructure, funding, and staffing. Most centers (46 of 58 [79%]) referred patients to outside centers for clinical trial enrollment, particularly in the context of late-stage disease and/or disease progression. Only 17 of these sites (37%) had established protocols for patient follow-up subsequent to outside referral. In this national survey study of barriers to clinical trial implementation, most sites offered therapeutic trials, but there were significant disparities in trial availability across care settings. Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities. These results identify crucial unmet needs for oncology clinics to effectively offer clinical trials to patients seeking care.

Critical importance of correctly defining and reporting secondary endpoints when assessing the ethics of research biopsies.

This article reviews the implementation challenges to the American Society of Clinical Oncology's ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the incentive structure that encourages inclusion of biopsies. Principles of research stewardship require that the clinical trials community correctly articulate the scientific goals of any research biopsies, especially those that are required for the patient to enroll on a trial and receive an investigational agent. Furthermore, it is important to sufficiently justify the characterization of secondary (as distinguished from exploratory) endpoints, protect the interest of research participants, and report accurate and complete information to ClinicalTrials.gov and the published literature.

Opportunities for Expanding the Integration of Palliative Care in Oncology Care.

Patients with cancer and their families comprise a significant population served by palliative care. Close collaboration between oncology clinicians and palliative care teams has demonstrated improved patient-centered care, especially when this care is integrated early in the course of the disease. The American Society of Clinical Oncology recently released their updated clinical practice guidelines for palliative care in oncology, which provide new opportunities for collaboration to expand the scope of care.

Review article: Contemporary management of gastrointestinal, pancreatic and hepatic toxicities of immune checkpoint inhibitors.

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. To provide a narrative review of the epidemiology, diagnostic evaluation and management of checkpoint inhibitor-induced gastrointestinal and hepatic toxicities. We searched Cochrane and PubMed databases for articles published through August 2023. 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. 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 SY08-01: Does exercise or fitness deter cancer progression after diagnosis

Abstract SY08-01: Does exercise or fitness deter cancer progression after diagnosis

Characteristics of Triple Negative Subtype Breast Cancer in Dr. Hasan Sadikin General Hospital for 5 Years (2019-2023): An Observational Study

Background: Triple-negative breast cancer has a percentage of 15% to 20% in breast cancer patients at the time of first diagnosis. Guidelines from St. Gallen guidelines, the American Society of Clinical Oncology, and the American College of Pathology state that triple-negative breast cancer is breast cancer with ER and PR expression &lt;1%. As an aggressive subtype, outcomes are poor when compared with hormone receptor-positive. Methods: This research is an observational study. The research subjects in this study were triple-negative breast cancer patients in Dr. Hasan Sadikin General Hospital, Surgical Oncology division, West Java, Indonesia, from October 2018 - November 2023. There were 702 research subjects who would be studied. Characteristics of triple-negative breast cancer were taken from medical records. Results: The results showed that the average age of the subjects was 47 years. Based on histology, the most common was Invasive Carcinoma of no special type (86.75%), followed by Invasive lobular carcinoma (7.26%), medullary carcinoma (1.7%), micropapillary carcinoma (0.99%), metaplastic carcinoma (2.36%) and the least amount is Pleomorphic invasive lobular carcinoma (0.71%). The side of the breast affected is not significant, and the highest grade is 3. The involvement of lymph node metastases is due to aggressive tumor subtypes and lymphovascular invasion. Lymphovascular invasion is known to be a negative prognostic factor. It is a late stage for metastasis and local recurrence. Conclusion: Triple-negative breast cancer is breast cancer that has histopathological heterogeneity; most of the tumors are grade 3 and have significant metastases in regional lymph nodes. There is no significant relationship between grading and regional lymph node metastases. there is a significant relationship between lymphovascular invasion and regional lymph nodes metastases.

Human papillomavirus circulating tumor DNA: a diagnostic tool in squamous cell carcinoma of unknown primary-a pilot study.

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. 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. 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 HPV-positive 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. 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.

Seeking American Society of Clinical Oncology‐Quality Oncology Practice Initiative (ASCO‐QOPI) certification in a northern New England rural health system and cancer care network

AbstractIn 2006 following several years of preliminary study, the American Society of Clinical Oncology (ASCO) launched the Quality Oncology Practice Initiative (QOPI). This cancer‐focused quality initiative evolved considerably over the next decade‐and‐a‐half and is expanding globally. QOPI is undoubtedly the leading standard‐bearer for quality cancer care and contemporary medical oncology practice. The program garners attention and respect among federal programs, private insurers, and medical oncology practices across the nation. The MaineHealth Cancer Care Network (MHCCN) has undergone expansive growth since 2017. The network provides cancer care to more than 70% of the cases in Maine in a largely rural health system in Northern New England. In fall 2020, the MHCCN QOPI project leadership, following collaborative discussions with the ASCO‐QOPI team, elected to proceed with a health system–cancer network‐wide QOPI certification. Key themes emerged over the course of our two‐year journey including: (1) Developing a highly interprofessional team committed to the project; (2) Capitalizing on a single electronic medical record for data transmission to CancerLinQ; (3) Prior experience, especially policy development, in other cancer‐focused accreditation programs across the network; and (4) Building consensus through quarterly stakeholder meetings and awarding Continuing Medical Education (CME) and American Board of Medical Specialists (ABMS) Maintenance of Certification (MOC) credits to oncologists. All participants demonstrated a genuine spirit to work together to achieve certification. We report our successful journey seeking ASCO‐QOPI certification across our network, which to our knowledge is the first‐of‐its‐kind endeavor.

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 15.

In this latest update we discuss real-world evidence (RWE) guidance from the leading oncology professional societies, the American Society of Clinical Oncology and the European Society for Medical Oncology, and the PRINCIPLED practical guide on the design and analysis of causal RWE studies.

Abstract 7391: Beyond traditional staining: A virtual-IHC digital assay for HER2 score prediction from routine H&amp;E images

Abstract Background: In breast cancer diagnostics, the accurate assessment of HER2 status is essential for treatment stratification. Conventionally, HER2 immunohistochemistry (IHC) scoring necessitates specialized staining protocols, which are resource- and time-intensive. This study presents a virtual IHC (vIHC) digital assay to predict HER2 scores directly from hematoxylin and eosin (H&amp;E) stained images, which are routinely acquired for all specimens. This methodology aims to accelerate standard practices by reducing the need for additional IHC staining, thereby decreasing laboratory workload, costs, and turnaround time. It also presents an opportunity to screen a wider array of samples promptly, potentially identifying candidates for HER2-targeted therapy that might otherwise be delayed or overlooked. Methods: Serially sectioned breast core needle biopsy samples were stained with H&amp;E and HER2-IHC following Leica-Bond staining protocols. Stained slides were imaged using the Hologic GeniusTM Digital Diagnostics System with Research Use Only software for Whole Slide Imaging. From this initial image dataset, 240 regions of interest (ROIs) were manually selected in order to create a dataset that uniformly covers: (i) all HER2-IHC scores (0-3), (ii) a wide range of HER2 stain intensities, and (iii) expression patterns. The IHC scores were assigned to each selected ROI by a pathology expert, following the scoring recommendations of ASCO/CAP American Society of Clinical Oncology and College of American Pathologists, with the caveat that ductal carcinoma in situ was also given a score for the purpose of training the model. These ROIs were then extracted from the images of the serially sectioned H&amp;E-stained slides using Reveal Bio’s proprietary co-registration digital assay. A predictive digital assay was developed at Reveal Biosciences to classify the 240 H&amp;E-stained breast tissue ROIs into four HER2 IHC score categories: 0, 1, 2, and 3. For model evaluation, cross-validation was performed 10 times by randomly splitting the dataset of H&amp;E ROIs into 80% for training MIL and 20% for testing the model, followed by averaging the performance metrics across the 10 dataset splits. The performance metrics included classification accuracy, precision, recall, and F1 scores for each HER2 score category. Results: The vIHC digital assay for predicting the HER2 scores directly from H&amp;E stained breast tissue images achieved the average classification accuracy of 93% across the four HER2 score categories on the test set of ROIs. This performance demonstrates that the model is capable of successfully distinguishing between the HER2 score categories directly from H&amp;E images without the need for IHC staining. The results suggest that the vIHC digital assay could be a reliable and cost-effective tool for preliminary breast cancer screening, providing a valuable adjunct to traditional histopathological analysis. Citation Format: Misagh Naderi, Nikola Mitic, Nikola Spasic, Djordje Cikic, Kristen Ruf, Nikolaus Wagner, Igor Mihajlovic, Sinisa Todorovic, Ray Jenoski, Sid Mayer, Michael Quick, Claire Weston. Beyond traditional staining: A virtual-IHC digital assay for HER2 score prediction from routine H&amp;E images [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 7391.

Updates in BRAF V600E-Mutated Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer worldwide, and the second leading cause of cancer death. Approximately one in five patients with CRC present with metastatic disease at diagnosis. The BRAF V600E mutation occurs in 8–12% of patients with metastatic colorectal cancer (mCRC), and is characterised by an aggressive clinical course and poor prognosis. This article is based on a webinar discussion in March 2024, between two experts in gastrointestinal cancers, Chiara Cremolini, University of Pisa, Italy; and Julien Taieb, Georges Pompidou European Hospital, Université Paris-Cité, France, both of whom have a wealth of experience and expertise in the clinical management of CRC. The experts described the most important recent advances in the treatment of BRAF V600E-mutated mCRC, including data presented at the European Society for Medical Oncology (ESMO) Congress in October 2023, and the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium in January 2024. Cremolini and Taieb gave valuable insights into topics such as the aggressive nature of BRAF V600E-mutated mCRC, and how this impacts choice of treatment, patient outcomes, and quality of life, as well as the importance of early testing and monitoring. The experts also discussed how the BRAF V600E mutation impacts treatment response and outcomes in patients with microsatellite unstable (microsatellite instability [MSI]) versus microsatellite stable (MSS) tumours, and recent key clinical trials in BRAF V600E-mutated mCRC. The importance of surgery in the multidisciplinary management of patients with BRAF V600E-mutated mCRC, BRAF as a prognostic marker in resected CRC, and real-world studies in this field were also explored. Finally, Cremolini and Taieb described what the future of the management of patients with BRAF V600E-mutated mCRC might look like, and which advancements in research they would like to see.

National Survey of Oncologists' Knowledge, Attitudes, and Practice Behaviors: Caring for Cancer Patients Experiencing Incarceration.

Cancer is the leading cause of illness-related death in state prisons in the United States. The experiences of physicians providing oncological care to individuals experiencing incarceration are underexplored. The study aims were to evaluate knowledge, attitudes, and practices of oncologists caring for cancer patients who are incarcerated. An online survey was distributed to a random sample of 150 oncologists from the American Society of Clinical Oncology and the American Society for Radiation Oncology from July 2020 to December 2021. Statistical analyses included two proportion Z-test, Fisher's exact test, Kruskal-Wallis test, and Cramer's V to estimate factors associated with attitudes and barriers to care. Of the 55 respondents (36.7% response rate), 21 were medical oncologists and 34 were radiation oncologists. Academic center oncologists were more likely to report caring for incarcerated patients than community or private practice oncologists (p = .04). Most (53%) incorrectly reported "heart disease" as the leading cause of death, as opposed to "cancer" (15% identified correctly). Oncologists practicing at both academic and community centers were more likely to report care coordination barriers than oncologists at academic or community centers (p < .01). We identified potential barriers in caring for incarcerated cancer patients. Future studies should explore ways to improve care coordination between oncology teams and prisons.

Significance of PD-L1 in Metastatic Urothelial Carcinoma Treated With Immune Checkpoint Inhibitors

Immune checkpoint inhibitors (ICIs) have broadened the metastatic urothelial carcinoma (mUC) therapeutic scenario. The association of programmed death ligand 1 (PD-L1) with response and survival in patients treated with ICIs is still controversial. To evaluate the association of PD-L1 with response rate and overall survival among patients with mUC treated with ICIs. PubMed, Embase, American Society of Clinical Oncology and European Society for Medical Oncology Meeting Libraries, and Web of Science were searched up to December 10, 2023. Two authors independently screened the studies. Included studies were randomized and nonrandomized clinical trials enrolling patients with mUC receiving ICIs with available overall survival (OS), progression-free survival (PFS), or overall response rate (ORR) data, separated between patients with PD-L1-positive and -negative tumors. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was followed. Two reviewers independently extracted data. Fixed- or random-effects models were used depending on the heterogeneity among the studies. Primary outcomes were odds ratios (ORs) for ORR and hazard ratios (HRs) for OS, comparing patients with PD-L1-positive tumors and patients with PD-L1-negative tumors. Secondary outcomes were the PFS HR between patients with PD-L1-positive and -negative tumors and OS HR between ICI arms and non-ICI arms of only randomized clinical trials. A total of 14 studies were selected, comprising 5271 patients treated with ICIs (2625 patients had PD-L1-positive tumors). The ORR was 13.8% to 78.6% in patients with PD-L1-positive tumors and 5.1% to 63.2% in patients with PD-L1-negative tumors, with an association between PD-L1 status and ORR favoring patients with PD-L1-positive tumors (OR, 1.94; 95% CI, 1.47-2.56; P < .001). Median OS ranged from 8.4 to 24.1 months in patients with PD-L1-positive tumors and from 6.0 to 19.1 months in patients with PD-L1-negative tumors. The pooled HR showed a significant reduction for patients with PD-L1-positive tumors compared with those with PD-L1-negative tumors in the risk of death (HR, 0.71; 95% CI, 0.57-0.89; P = .003) and risk of progression (HR, 0.55; 95% CI, 0.44-0.69; P < .001) when ICIs were administered. PD-L1 is not likely to be a predictive biomarker of ICI response. This systematic review and meta-analysis suggests that PD-L1 expression is associated with improved ORR, OS, and PFS for patients with mUC who receive ICIs, but it is unlikely to be useful as a predictive biomarker. Developing predictive biomarkers is essential to select patients most likely to benefit from ICIs and avoid toxic effects and financial burden with these agents.