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PURPOSEThe burden of cancer disproportionately affects low- and middle-income countries. Low 5-year survival figures for children with cancer in low-income countries are due to late presentation at diagnosis, treatment abandonment, absence of sophisticated multidisciplinary care, and lack of adequate resources. The reasons for late presentation are partly due to limited awareness of cancer symptoms, high treatment costs, and facility-level barriers to timely access to treatment. Given the systemic challenges, the regional need for palliative oncology care for children care is high. Despite the enormity of the need for palliative oncology for children with cancer in Africa, its level of development remains poor. This paper presents the evidence on the status of palliative oncology care for children in sub-Saharan Africa.METHODSThis review provides an overview of the current status of palliative oncology care for children in sub-Saharan Africa, using the WHO building blocks for health systems strengthening as reference points, before proposing a forward-looking prioritized agenda for its development.RESULTSWe noted that survival rates for children with cancer remain much poorer in Africa compared with developed countries and palliative oncology care resources are scant. Our results also show low coverage for palliative oncology care services for children, lack of a critical mass of health workers with the skills to deliver the care, a lack of robust documentation of the burden of cancer, widespread lack of access to essential controlled medicines, limited funding from government and limited coverage for palliative oncology care in most cancer control plans.CONCLUSIONThis review highlights priority areas for action that align to the WHO health system building blocks for strengthening health systems.

Recognizing the increase in cancer incidence globally and the need for effective cancer control interventions, several organizations, professional bodies, and international institutions have proposed strategies to improve treatment options and reduce mortality along with minimizing overall incidence. Despite these efforts, an estimated 9.6 million deaths in 2018 was attributed to this noncommunicable disease, making it the second leading cause of death worldwide. Left unchecked, this will further increase in scale, with an estimated 29.5 million new cases and 16.3 million deaths occurring worldwide in 2040. Although it is known and generally accepted that cancer services must include radiotherapy, such access is still very limited in many parts of the world, especially in low- and middle-income countries. After thorough review of the current status of radiotherapy including programs worldwide, as well as achievements and challenges at the global level, the International Atomic Energy Agency convened an international group of experts representing various radiation oncology societies to take a closer look into the current status of radiotherapy and provide a road map for future directions in this field. It was concluded that the plethora of global and regional initiatives would benefit further from the existence of a central framework, including an easily accessible repository through which better coordination can be done. Supporting this framework, a practical inventory of competencies needs to be made available on a global level emphasizing the knowledge, skills, and behavior required for a safe, sustainable, and professional practice for various settings. This white paper presents the current status of global radiotherapy and future directions for the community. It forms the basis for an action plan to be developed with professional societies worldwide.

PURPOSE Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields. METHODS We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records. RESULTS On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001). CONCLUSION Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process. [ABSTRACT FROM AUTHOR]

PURPOSE: Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions. METHODS: We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions. RESULTS: Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes. CONCLUSION: E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly. Digital technologies can improve consenting processes. We surveyed National Comprehensive Cancer Network member institutions about electronic consenting capabilities and experiences. Twenty-five (81%) completed the survey. Twenty (80%) had e-consent capabilities, mostly embedded in their electronic health record (14, 70%). One (5%) had e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and e-consenting. Obstacles included challenges procuring/maintaining hardware, content management, workflow integration, and patients' digital literacy. Successes included user satisfaction, workflow improvements, and better record-keeping. Only two had formally evaluated their e-consent processes. Further progress is needed to broadly realize e-consent's benefits. [ABSTRACT FROM AUTHOR]

PURPOSE Our institution participated in the Oncology Care Model, which required us to include many of the 13 elements of the National Academy of Medicine (NAM) care plan into care pathways for our patients. We optimized our existing chemotherapy consent process to meet this need and maximized completion. METHODS Our multidisciplinary committee developed a three-phase Plan-Do-Study-Act process in our breast cancer clinic: (1) update and educate providers on our paper chemotherapy form with multiple components of the NAM care plan including prognosis and treatment effects on quality of life; (2) piloted an electronic chemotherapy consent form to decrease the administrative burden; and (3) autopopulated fields within the electronic consent. We assessed feedback after cycle 1 and created a Pareto chart. The outcome measure was percent completion of chemotherapy consent documents. RESULTS Baseline monthly random chart audit of 40 patients revealed 20% of paper chemotherapy consent forms were completed in their entirety among patients. When we re-educated clinicians about the new paper consent containing the NAM elements, compliance rose to nearly 30%. A Pareto chart confirmed that content redundancy and wordiness were leading to under-completion. After creating and piloting the electronic consent, compliance increased to 90%. Finally, autopopulation with drop-down selections increased and sustained completion to 100%. CONCLUSION Incorporating regulatory requirements into an existing workflow using Plan-Do-Study-Act methodology can reduce administrative burden on clinicians. Additional use of innovative technology can further increase clinician compliance with regulatory requirements while delivering high-value quality care to patients with cancer. [ABSTRACT FROM AUTHOR]

PURPOSE: We previously implemented paper-based screening for health-related social resource needs (HRSN) in our gynecologic oncology clinic and found that 36% of patients who completed the screening reported HRSN. We identified two primary deficiencies with our process. First, only 52% of patients completed the screening. Second, 37% of patients with needs failed to indicate if they desired resource referral or not. Therefore, we conducted a quality improvement project to integrate screening and referral processes into the electronic medical record (EMR) and routine clinic workflow to achieve at least 90% screening compliance and 90% elicited referral preference. METHODS: A multidisciplinary team consisting of physicians, a health outcomes researcher, a computer programmer, project assistants, and the staff of a partner community organization designed and implemented an intervention that screened for HRSN online via the EMR patient platform or in person during visits. The primary outcome was the percentage of eligible patients who completed the HRSN screening (ie, reach). Outcomes were reviewed weekly, and feedback was provided to stakeholders monthly. Iterative changes were incorporated into five successive Plan-Do-Study-Act (PDSA) cycles completed from January 2021 to March 2023. RESULTS: Screening compliance increased from the baseline of 52% (paper-based) to 97% in PDSA 4. Completion via the online patient portal increased from 17% in prelaunch to 49% in PDSA 4. Of patients who reported needs, 100% had a documented referral preference. CONCLUSION: Compared with paper-based screening, an EMR-integrated HRSN screening and referral system significantly improved reach to patients at a gynecologic oncology clinic. Implementation efforts to expand to other ambulatory clinic settings are in process. [ABSTRACT FROM AUTHOR]

PURPOSE: Implementation science endeavors to facilitate the translation of evidence-based research into clinical routine. The clinical pharmacological/pharmaceutical care program evaluated in the randomized AMBORA trial on medication safety with oral antitumor therapeutics (OAT) optimizes care delivery and provides significant benefits for patients, treatment teams, and health care systems. Thus, we aimed to investigate the implementation of this care program within the AMBORA Competence and Consultation Center (AMBORA Center). METHODS: The AMBORA Center within a University Comprehensive Cancer Center offered several services (eg, patient consultations) and was evaluated according to the RE-AIM framework. This multicenter hybrid type III trial focused on implementation outcomes (eg, patient recruitment, referring units, evaluation of services) while concurrently investigating effectiveness (eg, side effects, medication errors). Quantitative and qualitative assessments were combined. RESULTS: The AMBORA Center conducted over 800 consultations with 420 patients in seven institutions. The primary end point of counseling 70% of patients treated with OAT was not reached. Patients were referred by 15 treatment units compared with 11 units in the AMBORA trial. On the basis of heterogeneous referral rates and characteristics across the institutions, barriers and facilitators of the implementation process were derived. Several survey results (eg, stakeholder interviews, online/paper-based questionnaires) reflected a high appreciation of services by patients and health care professionals. The severity of 60.1% (178 of 296) of detected side effects improved, and 86.3% (297 of 344) of medication errors were resolved. CONCLUSION: Despite not reaching the primary implementation outcome, the AMBORA Center included more treatment units and demonstrated patient benefit of the AMBORA care program by meeting all effectiveness outcomes. We outlined quantitative and qualitative implementation characteristics to enhance outreach and foster further dissemination of centers to optimize medication safety with OAT. The AMBORA Center to optimize medication safety with oral antitumor therapy: A hybrid type III trial. [ABSTRACT FROM AUTHOR]

PURPOSE: The specific aims of this paper are to (1) develop and operationalize an electronic health record (EHR) data quality framework, (2) apply the dimensions of the framework to the phenotype and treatment pathways of ductal carcinoma in situ (DCIS) using All of Us Research Program data, and (3) propose and apply a checklist to evaluate the application of the framework. METHODS: We developed a framework of five data quality dimensions (DQD; completeness, concordance, conformance, plausibility, and temporality). Participants signed a consent and Health Insurance Portability and Accountability Act authorization to share EHR data and responded to demographic questions in the Basics questionnaire. We evaluated the internal characteristics of the data and compared data with external benchmarks with descriptive and inferential statistics. We developed a DQD checklist to evaluate concept selection, internal verification, and external validity for each DQD. The Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) concept ID codes for DCIS were used to select a cohort of 2,209 females 18 years and older. RESULTS: Using the proposed DQD checklist criteria, (1) concepts were selected and internally verified for conformance; (2) concepts were selected and internally verified for completeness; (3) concepts were selected, internally verified, and externally validated for concordance; (4) concepts were selected, internally verified, and externally validated for plausibility; and (5) concepts were selected, internally verified, and externally validated for temporality. CONCLUSION: This assessment and evaluation provided insights into data quality for the DCIS phenotype using EHR data from the All of Us Research Program. The review demonstrates that salient clinical measures can be selected, applied, and operationalized within a conceptual framework and evaluated for fitness for use by applying a proposed checklist. A Data Quality Framework Applied to ductal carcinoma in situ EHR data. [ABSTRACT FROM AUTHOR]

This review paper analyzes the ethical implications of billing patients for electronic communication with physicians through electronic health records, a practice already adopted by medical institutions such as the Cleveland Clinic. The analysis assesses how billing aligns with pillars of medical ethics which include beneficence, respect for persons, and justice. Although billing may enhance communication, improve patient care, and alleviate physician burnout, concerns arise over potential consequences on patient autonomy, trust, and health care disparities. The review delves into the intricate balance of these ethical principles by first considering the potential benefits of incentivizing concise questions and improving physician workload management through billing. By reducing messages, this approach can potentially mitigate burnout and enhance care. It also acknowledges potential drawbacks such as deterring patients because of financial constraints and eroding trust in physicians and the medical team. It emphasizes the necessity of thoroughly examining all aspects of this intricate ethical dilemma to formulate a nuanced solution that protects patient well-being while respecting physicians. We propose a middle-ground approach involving nominal and transparent billing on the basis of the question's complexity, urgency, and level of expertise required in the response. Transparent billing policies, up-front communication of costs, and potential fee waivers on the basis of socioeconomic status can address equity concerns and maintain patient trust. Striking a balance between the potential benefits and drawbacks of billing for patient questions is crucial in maintaining ethical patient-physician interactions and equitable health care provision. The analysis underscores the importance of aligning online patient-physician communication with ethical principles within the evolving digital health care landscape. Billing for electronic patient-physician communications via #EHR is a novel phenomenon that intends in part to improve physician workload and mitigate burnout. Through the optic of the medical ethics pillars, the authors review the implications of this practice by considering the potential benefits and drawbacks in terms of beneficence, respect for persons, and justice. The analysis outlines a middle-ground approach involving nominal and transparent billing. [ABSTRACT FROM AUTHOR]

PURPOSE: Clinical oncology guidelines recommend addressing sexual and reproductive health (SRH) concerns in routine cancer care. However, limited training often hinders clinicians' ability to do so effectively. The objective of this study was to understand the state of current fellowship education on SRH (ie, sexual health, safe sex practices, and fertility) through conducting a national survey of US hematology/oncology fellowship program directors (PDs). METHODS: A survey was sent to all PDs of adult hematology/oncology fellowship programs in the United States via online link. PDs who did not complete the survey were sent up to four follow-up emails and a paper mailing. Descriptive statistics and McNemar tests were conducted. RESULTS: One hundred-fourteen PDs responded (65%). Fewer programs offered formal instruction on sexual health (49%) and safe sex practices (37%) compared with fertility (75%). Informal training in SRH relied heavily on direct clinical experience (73%-78% of programs), with other methods (eg, case-based approaches, webinars, and journal clubs) being less common. Lack of experts to provide instruction was the most commonly cited barrier to offering training in SRH, endorsed by 74% for sexual health, 68% for safe sex practices, and 54% for fertility; difficulty finding space within the curriculum (50%; 54%; and 43%, respectively) and a lack of training requirements were also commonly endorsed (57%; 60%; and 35%, respectively). Barriers were endorsed more commonly for sexual health topics than fertility. CONCLUSION: The results highlight the scarcity of training in SRH, particularly in sexual health, within hematology/oncology fellowship programs. The heavy reliance on informal instruction methods may lead to inconsistent and inadequate education. Efforts to integrate comprehensive training in SRH into fellowship programs are crucial to ensuring that such concerns are included in routine cancer care. 100 character summary: Survey of US hem/onc fellowship directors shows less than half offer formal training in sexual health. [ABSTRACT FROM AUTHOR]

PURPOSE: Selection of appropriate adjuvant therapy to ultimately reduce the risk of breast cancer (BC) recurrence is a challenge for medical oncologists. Several automated risk prediction models have been developed using retrospective clinical data and have evolved significantly over the years in terms of predictors of recurrence, data usage, and predictive techniques (statistical/machine learning [ML]). METHODS: Following PRISMA guidelines, we performed a systematic literature review of the aforementioned statistical and ML models published between January 2008 and December 2022 through searching five digital databases—PubMed, ScienceDirect, Scopus, Cochrane, and Web of Science. The comprehensive search yielded a total of 163 papers and after a screening process focusing on papers that dealt exclusively with statistical/ML methods, only 23 papers were deemed appropriate for further analysis. We benchmarked the studies on the basis of development, evaluation metrics, and validation strategy with an added emphasis on racial diversity of patients included in the studies. RESULTS: In total, 30.4% of the included studies use statistical techniques, while 69.6% are ML-based. Among these, traditional ML models (support vector machines, decision tree, logistic regression, and naïve Bayes) are the most frequently used (26.1%) along with deep learning (26.1%). Deep learning and ensemble learning provide the most accurate predictions (AUC = 0.94 each). CONCLUSION: ML-based prediction models exhibit outstanding performance, yet their practical applicability might be hindered by limited interpretability and reduced generalization. Moreover, predictive models for BC recurrence often focus on limited variables related to tumor, treatment, molecular, and clinical features. Imbalanced classes and the lack of open-source data sets impede model development and validation. Furthermore, existing models predominantly overlook African and Middle Eastern populations, as they are trained and validated mainly on Caucasian and Asian patients. We traced the advancement of breast cancer recurrence risk prediction models published between 2008 and 2022 in a systematic way that includes both statistical and artificial intelligence models. This review article serves as a guide for practitioners, offering valuable insights on how to effectively incorporate predictive tools into clinical practice. Moreover, it provides researchers with valuable feedback and recommendations to further improve and refine the predictive models. [ABSTRACT FROM AUTHOR]

PURPOSE: Increasing use of immune checkpoint inhibitors (ICIs) in routine cancer care will increase the incidence of immune-related adverse events (irAEs). Systems are needed to support remote monitoring for irAEs. Electronic patient-reported outcome (ePRO) symptom monitoring systems can help monitor and manage symptoms and side effects. We assessed the content and features of ePRO symptom monitoring systems for irAEs, and their feasibility, acceptability, and impact on patient outcomes and health care utilization. METHODS: A systematic literature search was conducted in May 2022 on MEDLINE, Embase, PsycINFO, and Cochrane Central Register of Controlled Trials. Quantitative and qualitative data relevant to the review questions were extracted and synthesized in tables. RESULTS: Seven papers describing five ePRO systems were included. All systems collected PROs between clinic visits. Two of five used validated symptom questionnaires, 3/5 provided prompts to complete questionnaires, 4/5 provided reminders to self-report, and 3/5 provided clinician alerts for severe/worsening side effects. Four of five provided coverage of ≥26/30 irAEs in the ASCO irAE guideline. Feasibility and acceptability were demonstrated with consent rates of 54%-100%, 17%-27% of questionnaires generating alerts, and adherence rates of 74%-75%. One paper showed a reduction in grade 3-4 irAEs, treatment discontinuation, clinic visit duration, and emergency department presentations, while another showed no difference in these outcomes or the rate of steroid use. CONCLUSION: There is preliminary evidence of the feasibility and acceptability of ePRO symptom monitoring for irAEs. However, further studies are needed to confirm the impact on ICI-specific outcomes, such as the frequency of grade 3-4 irAEs and duration of immunosuppression. Suggestions for the content and features of future ePRO systems for irAEs are provided. [ABSTRACT FROM AUTHOR]

PURPOSE: Real-world data (RWD) derived from electronic health records (EHRs) are often used to understand population-level relationships between patient characteristics and cancer outcomes. Machine learning (ML) methods enable researchers to extract characteristics from unstructured clinical notes, and represent a more cost-effective and scalable approach than manual expert abstraction. These extracted data are then used in epidemiologic or statistical models as if they were abstracted observations. Analytical results derived from extracted data in this way may differ from those given by abstracted data, and the magnitude of this difference is not directly informed by standard ML performance metrics. METHODS: In this paper, we define the task of postprediction inference, which is to recover similar estimation and inference from an ML-extracted variable that would be obtained from abstracting the variable. We consider fitting a Cox proportional hazards model that uses a binary ML-extracted variable as a covariate and evaluate four approaches for postprediction inference in this setting. The first two approaches only require the ML-predicted probability, while the latter two additionally require a labeled (human abstracted) validation data set. RESULTS: Our results for both simulated data and EHR-derived RWD from a national cohort demonstrate that we can improve inference from ML-extracted variables by leveraging a limited amount of labeled data. CONCLUSION: We describe and evaluate methods for fitting statistical models using ML-extracted variables subject to model error. We show that estimation and inference is generally valid when using extracted data from high-performing ML models. More complex methods that incorporate auxiliary labeled data provide further improvements. This paper develops novel methodology for using ML-extracted variables in statistical analyses. [ABSTRACT FROM AUTHOR]

PURPOSE: To evaluate natural language processing (NLP) methods to infer metastatic sites from radiology reports. METHODS: A set of 4,522 computed tomography (CT) reports of 550 patients with 14 types of cancer was used to fine-tune four clinical large language models (LLMs) for multilabel classification of metastatic sites. We also developed an NLP information extraction (IE) system (on the basis of named entity recognition, assertion status detection, and relation extraction) for comparison. Model performances were measured by F1 scores on test and three external validation sets. The best model was used to facilitate analysis of metastatic frequencies in a cohort study of 6,555 patients with 53,838 CT reports. RESULTS: The RadBERT, BioBERT, GatorTron-base, and GatorTron-medium LLMs achieved F1 scores of 0.84, 0.87, 0.89, and 0.91, respectively, on the test set. The IE system performed best, achieving an F1 score of 0.93. F1 scores of the IE system by individual cancer type ranged from 0.89 to 0.96. The IE system attained F1 scores of 0.89, 0.83, and 0.81, respectively, on external validation sets including additional cancer types, positron emission tomography-CT ,and magnetic resonance imaging scans, respectively. In our cohort study, we found that for colorectal cancer, liver-only metastases were higher in de novo stage IV versus recurrent patients (29.7% v 12.2%; P <.001). Conversely, lung-only metastases were more frequent in recurrent versus de novo stage IV patients (17.2% v 7.3%; P <.001). CONCLUSION: We developed an IE system that accurately infers metastatic sites in multiple primary cancers from radiology reports. It has explainable methods and performs better than some clinical LLMs. The inferred metastatic phenotypes could enhance cancer research databases and clinical trial matching, and identify potential patients for oligometastatic interventions. Ever thought of using NLP to extract sites of metastases from radiology reports? Read this paper. [ABSTRACT FROM AUTHOR]

PURPOSE: Real-world evidence (RWE)—derived from analysis of real-world data (RWD)—has the potential to guide personalized treatment decisions. However, because of potential confounding, generating valid RWE is challenging. This study demonstrates how to responsibly generate RWE for treatment decisions. We validate our approach by demonstrating that we can uncover an existing adjuvant chemotherapy (ACT) guideline for stage II and III colon cancer (CC)—which came about using both data from randomized controlled trials and expert consensus—solely using RWD. METHODS: Data from the population-based Netherlands Cancer Registry from a total of 27,056 patients with stage II and III CC who underwent curative surgery were analyzed to estimate the overall survival (OS) benefit of ACT. Focusing on 5-year OS, the benefit of ACT was estimated for each patient using G-computation methods by adjusting for patient and tumor characteristics and estimated propensity score. Subsequently, on the basis of these estimates, an ACT decision tree was constructed. RESULTS: The constructed decision tree corresponds to the current Dutch guideline: patients with stage III or stage II with T stage 4 should receive surgery and ACT, whereas patients with stage II with T stage 3 should only receive surgery. Interestingly, we do not find sufficient RWE to conclude against ACT for stage II with T stage 4 and microsatellite instability-high (MSI-H), a recent addition to the current guideline. CONCLUSION: RWE, if used carefully, can provide a valuable addition to our construction of evidence on clinical decision making and therefore ultimately affect treatment guidelines. Next to validating the ACT decisions advised in the current Dutch guideline, this paper suggests additional attention should be paid to MSI-H in future iterations of the guideline. This article demonstrates the value of real-world evidence in constructing a treatment guideline. [ABSTRACT FROM AUTHOR]

Radiomics, the science of extracting quantifiable data from routine medical images, is a powerful tool that has many potential applications in oncology. The Response Evaluation Criteria in Solid Tumors Working Group (RWG) held a workshop in May 2022, which brought together various stakeholders to discuss the potential role of radiomics in oncology drug development and clinical trials, particularly with respect to response assessment. This article summarizes the results of that workshop, reviewing radiomics for the practicing oncologist and highlighting the work that needs to be done to move forward the incorporation of radiomics into clinical trials. This paper by the RECIST Working Group outlines a path to realize the potential of radiomics as a precision biomarker. [ABSTRACT FROM AUTHOR]

Clinical genomic testing of patient germline, tumor tissue, or plasma cell-free DNA can enable a personalized approach to cancer management and treatment. In prostate cancer (PCa), broad genotyping tests are now widely used to identify germline and/or somatic alterations in BRCA2 and other DNA damage repair genes. Alterations in these genes can confer cancer sensitivity to poly (ADP-ribose) polymerase inhibitors, are linked with poor prognosis, and can have potential hereditary cancer implications for family members. However, there is huge variability in genomic tests and reporting standards, meaning that for successful implementation of testing in clinical practice, end users must carefully select the most appropriate test for a given patient and critically interpret the results. In this white paper, we outline key pre- and post-test considerations for choosing a genomic test and evaluating reported variants, specifically for patients with advanced PCa. Test choice must be based on clinical context and disease state, availability and suitability of tumor tissue, and the genes and regions that are covered by the test. We describe strategies to recognize false positives or negatives in test results, including frameworks to assess low tumor fraction, subclonal alterations, clonal hematopoiesis, and pathogenic versus nonpathogenic variants. We assume that improved understanding among health care professionals and researchers of the nuances associated with genomic testing will ultimately lead to optimal patient care and clinical decision making. This article provides a helpful framework for choosing and interpreting a genomic test in prostate cancer. [ABSTRACT FROM AUTHOR]

PURPOSE: The way late-onset toxicities are managed can affect trial outcomes and participant safety. Specifically, participants often might not have completed their entire follow-up period to observe any toxicities before new participants would be recruited. We conducted a methodological review of published early-phase dose-finding clinical trials that used designs accounting for partial and complete toxicity information, aiming to understand (1) how such designs were implemented and reported and (2) if sufficient information was provided to enable the replicability of trial results. METHODS: Until March 26, 2023, we identified 141 trials using the rolling 6 design, the time-to-event continuous reassessment method (TITE-CRM), the TITE-CRM with cycle information, the TITE Bayesian optimal interval design, the TITE cumulative cohort design, and the rapid enrollment design. Clinical settings, design parameters, practical considerations, and dose-limiting toxicity (DLT) information were extracted from these published trials. RESULTS: The TITE-CRM (61, 43.3%) and the rolling 6 design (76, 53.9%) were most frequently implemented in practice. Trials using the TITE-CRM had longer DLT assessment windows beyond the first cycle compared with the rolling 6 design (52.5% v 6.6%). Most trials implementing the TITE-CRM (91.8%, 56 of 61) failed to describe essential parameters in the protocols or the study result papers. Only five TITE-CRM trials (8.2%, 5 of 61) reported sufficient information to enable replication of the final analysis. CONCLUSION: When compared with trials using the rolling 6 design, those implementing the TITE-CRM design exhibited notable deficiencies in reporting essential details necessary for reproducibility. Inadequate reporting quality of advanced model-based trial designs hinders their credibility. We provide recommendations that can improve transparency, reproducibility, and accurate interpretation of the results for such designs. Evaluated late-onset toxicity-focussed dose-finding trials, recommending improved reporting practices [ABSTRACT FROM AUTHOR]

Paper describes our development of a web-based tool to make Medicare patient prices for cancer drugs known to their care teams. [ABSTRACT FROM AUTHOR]

PURPOSE: Although there are commonly accepted criteria of what defines quality of health care including cancer care, less is known about what defines quality of mHealth interventions in health care. The aim of this review was to identify how quality of mHealth interventions for cancer survivors is described and measured. METHODS: CINAHL, EmCare, JBI, Medline, SCOPUS, and ProQuest databases from January 2008 to January 2020 were searched. Review papers with search terms related to mobile devices, quality, and cancer relevant to adults with cancer were included. Interventions needed to consist of mHealth technologies, such as mobile applications or short message service, or wearable devices. Title and abstract screening, full-text screening, and data extraction were performed independently by two reviewers. Conflicts were resolved by a third reviewer. Reviews were evaluated for coverage of quality according to six metrics defined by the Institute of Medicine: patient-centeredness, equitability, safety, effectiveness, timeliness, and efficiency. Any additional quality items were recorded. A Measurement Tool to Assess systematic Reviews (AMSTAR) was used to rate the quality of the reviews included. RESULTS: The initial search yielded 766 papers with seven systematic reviews meeting the eligibility criteria. Four papers were of AMSTAR moderate quality, with three of low quality. The median number of quality metrics reported in a review was two (the range was 1-4). Efficacy and safety and timeliness and efficiency were most reported (n = 4), followed by usability (n = 3), equitability and access (n = 2), privacy and security (n = 2), and patient-centeredness (n = 2). CONCLUSION: There is great variability in how quality of mHealth interventions is defined with no reviews addressing all quality metrics. A comprehensive approach to measure quality of mHealth interventions is needed. Quality metrics of mHealth interventions for cancer survivors: variable and limited—standards needed [ABSTRACT FROM AUTHOR]

PURPOSE: Despite advances in molecular therapeutics, few anticancer agents achieve durable responses. Rational combinations using two or more anticancer drugs have the potential to achieve a synergistic effect and overcome drug resistance, enhancing antitumor efficacy. A publicly accessible biomedical literature search engine dedicated to this domain will facilitate knowledge discovery and reduce manual search and review. METHODS: We developed RetriLite, an information retrieval and extraction framework that leverages natural language processing and domain-specific knowledgebase to computationally identify highly relevant papers and extract key information. The modular architecture enables RetriLite to benefit from synergizing information retrieval and natural language processing techniques while remaining flexible to customization. We customized the application and created an informatics pipeline that strategically identifies papers that describe efficacy of using combination therapies in clinical or preclinical studies. RESULTS: In a small pilot study, RetriLite achieved an F 1 score of 0.93. A more extensive validation experiment was conducted to determine agents that have enhanced antitumor efficacy in vitro or in vivo with poly (ADP-ribose) polymerase inhibitors: 95.9% of the papers determined to be relevant by our application were true positive and the application's feature of distinguishing a clinical paper from a preclinical paper achieved an accuracy of 97.6%. Interobserver assessment was conducted, which resulted in a 100% concordance. The data derived from the informatics pipeline have also been made accessible to the public via a dedicated online search engine with an intuitive user interface. CONCLUSION: RetriLite is a framework that can be applied to establish domain-specific information retrieval and extraction systems. The extensive and high-quality metadata tags along with keyword highlighting facilitate information seekers to more effectively and efficiently discover knowledge in the combination therapy domain. [ABSTRACT FROM AUTHOR]

PURPOSE: This discussion paper outlines challenges and proposes solutions for successfully implementing prediction models that incorporate patient-reported outcomes (PROs) in cancer practice. METHODS: We organized a full-day multidisciplinary meeting of people with expertise in cancer care delivery, PRO collection, PRO use in prediction modeling, computing, implementation, and decision science. The discussions presented here focused on identifying challenges to the development, implementation and use of prediction models incorporating PROs, and suggesting possible solutions. RESULTS: Specific challenges and solutions were identified across three broad areas. (1) Understanding decision making and implementation: necessitating multidisciplinary collaboration in the early stages and throughout; early stakeholder engagement to define the decision problem and ensure acceptability of PROs in prediction; understanding patient/clinician interpretation of PRO predictions and uncertainty to optimize prediction impact; striving for model integration into existing electronic health records; and early regulatory alignment. (2) Recognizing the limitations to PRO collection and their impact on prediction: incorporating validated, clinically important PROs to maximize model generalizability and clinical engagement; and minimizing missing PRO data (resulting from both structural digital exclusion and time-varying factors) to avoid exacerbating existing inequalities. (3) Statistical and modeling challenges: incorporating statistical methods to address missing data; ensuring predictive modeling recognizes complex causal relationships; and considering temporal and geographic recalibration so that model predictions reflect the relevant population. CONCLUSION: Developing and implementing PRO-based prediction models in cancer care requires extensive multidisciplinary working from the earliest stages, recognition of implementation challenges because of PRO collection and model presentation, and robust statistical methods to manage missing data, causality, and calibration. Prediction models incorporating PROs should be viewed as complex interventions, with their development and impact assessment carried out to reflect this. Challenges and solutions to implementing patient-reported outcome–based predictive models in cancer. [ABSTRACT FROM AUTHOR]

PURPOSE Evidence supporting social media--based recruitment of cancer survivors is limited. This paper describes how we used Facebook during the COVID-19 pandemic to augment our recruitment of breast cancer survivors for our two-site telephone-based randomized clinical trial (RCT) at Dartmouth- Hitchcock Medical Center and the University of Alabama at Birmingham. METHODS Originally a two-site RCT of a telephone-delivered breast cancer survivorship intervention, we extended our clinic-based recruitment to Facebook. Participant characteristics, geographic reach, and baseline outcomes were compared across recruitment sources (ie, two clinics and Facebook) using descriptive statistics and effect sizes. RESULTS Enrollment rates (20%-29%) were comparable across recruitment sources. The 21-month Facebook marketing campaign accounted for 59% (n 5 179/303) of our total sample and had the greatest geographic reach, recruiting women from 24 states. The Facebook campaign reached a total of 51,787 unique individuals and cost $88.44 in US dollars (USD) per enrolled participant. Clinic samples had a greater proportion of women who were widowed (8% v 1%; P 5 .03) and Facebook had a higher proportion of women with a household income over $40,000 USD (83% v 71%; P 5 .02). There were no statistically significant differences between Facebook and the two clinics on baseline survey scores. CONCLUSION Augmenting traditional recruitment with Facebook increased our RCT's geographic and sociodemographic reach and supportedmeeting recruitment goals in a timely way. In the wake of the COVID-19 pandemic, cancer survivorship researchers should consider using social media as a recruitment strategy while weighing the advantages and potential biases introduced through such strategies. [ABSTRACT FROM AUTHOR]

PURPOSE: Patient portal technology offers important new opportunities to support person-centered clinician-patient communication. METHODS: Questionnaires relating to understanding of illness and treatment intent were sent quarterly via portal to all patients scheduled for follow-up in GI medical oncology clinics. For patients in selected clinics, items eliciting health-related values were added. Patient responses were available to all oncology team members in the electronic health record. Workflow and content of clinician-patient discussions about illness, treatment, and care goals stayed within clinicians' discretion. Feasibility (patient response rate), patient understanding, acceptability (three-item patient questionnaire), and efficacy (quality of clinician communication) were evaluated. RESULTS: From May 2021 through December 2022, a total of 12,233 questionnaires about illness/treatment understanding were sent to 6,325 patients (one to six per patient), with 97% response, including 9,358 with both open- and closed-ended responses. Fewer than 0.1% of patients indicated distress related to the questionnaire/process. Open-ended responses complemented closed-ended answers by revealing prognostic awareness and illness concerns. Of 48 patients approached to complete the full questionnaire including values items via portal, 15 first received and completed them in clinic (5 on iPad, 10 on paper), while 33 received and 27 (82%) completed the portal questionnaire. Patients found the portal process acceptable, and ratings of clinician communication were higher after clinic visits informed by patients' questionnaire responses (average prescore 6.8 v 5.9 post; P =.03). CONCLUSION: Almost all patients in this large GI cancer cohort responded via the portal about their understanding of illness and treatment goals. Eliciting their personal values by portal was also feasible, accepted by patients, and improved patient ratings of clinicians' communication. Portals represent a promising tool for scaling assessment of essential patient-reported elements of person-centered communication. Patient portals can help scale assessment of patient-reported elements of person-centered communication. [ABSTRACT FROM AUTHOR]

PURPOSE Cancer care guidelines recommend regular distress screening of patients, with approximately one in three patients with cancer experiencing significant distress. However, the implementation of such programs is variable and inconsistent. We sought to assess the feasibility of implementing a hybrid electronic and paper screening tool for distress in all patients coming to a large academic cancer center and an associated integrated network site. METHODS Patients at an academic cancer center (Stanford Cancer Center) and its associated integrated network site received either an electronic or on-paper modified Patient-Reported Outcomes Measurement Information System-Global Health questionnaire, to assess overall health and distress. We used the Reach, Effectiveness, Adoption, Implementation, and Maintenance implementation framework to test and report on the feasibility of using this questionnaire. Iterative workflow changes were made to implement the questionnaire throughout the healthcare system, including processes to integrate with existing electronic health records. RESULTS From June 2015 to December 2017, 53,954 questionnaires representing 26,242 patients were collected. Approximately 30% of the questionnaires were completed before the visit on an electronic patient portal. The number of patients meeting the positive screen threshold remained around 40% throughout the study period. Following assessment, there were 3,763 referrals to cancer supportive services. Of note, those with a positive screen were more likely to have a referral to supportive care (odds ratio, 6.4; 95% CI, 5.8 to 6.9; P < .0001). CONCLUSION The hybrid electronic and on-paper use of a commonly available patient-reported outcome tool, Patient-Reported Outcomes Measurement Information System-Global Health, as a large-scale distress screening method, is feasible at a large integrated cancer center. [ABSTRACT FROM AUTHOR]

PURPOSE: The Maine Cancer Genomics Initiative (MCGI) aimed to overcome patient- and provider-level barriers to using genomic tumor testing (GTT) in rural practices by providing genomic tumor boards (GTBs), clinician education, and access to comprehensive large-panel next-generation sequencing to all patients with cancer in Maine. This paper describes the successful implementation of the initiative and three key services made operative between 2016 and 2020. METHODS: A community-inclusive, hub-and-spoke approach was taken to implement the three program components: (1) a centralized GTB program; (2) a modular online education program, designed using an iterative approach with broad clinical stakeholders; and (3) GTT free of charge to clinicians and patients. Implementation timelines, participation metrics, and survey data were used to describe the rollout. RESULTS: The MCGI was launched over an 18-month period at all 19 oncology practices in the State. Seventy-nine physicians (66 medical oncologists, 5 gynecologic oncologists, 1 neuro-oncologist, and 7 pediatric oncologists) enrolled on the study, representing 100% of all practicing oncologists in Maine. Between July 2017 and September 2020, 1610 patients were enrolled. A total of 515 cases were discussed by 47 (73%) clinicians in 196 GTBs. Clinicians who participated in the GTBs enrolled significantly more patients on the study, stayed in Maine, and reported less time spent in clinical patient care. CONCLUSION: The MCGI was able to engage geographically and culturally disparate cancer care practices in a precision oncology program using a hub-and-spoke model. By facilitating access to GTT, structured education, and GTBs, we narrowed the gap in the implementation of precision oncology in one of the most rural states in the country. MCGI aimed to overcome patient- and provider-level barriers to GTT in rural practices by providing GTBs, clinician education, and access to large-panel NGS to all oncologists and their patients in Maine. [ABSTRACT FROM AUTHOR]

PURPOSE: Precision oncology mandates developing standardized common data models (CDMs) to facilitate analyses and enable clinical decision making. Expert-opinion–based precision oncology initiatives are epitomized in Molecular Tumor Boards (MTBs), which process large volumes of clinical-genomic data to match genotypes with molecularly guided therapies. METHODS: We used the Johns Hopkins University MTB as a use case and developed a precision oncology core data model (Precision-DM) to capture key clinical-genomic data elements. We leveraged existing CDMs, building upon the Minimal Common Oncology Data Elements model (mCODE). Our model was defined as a set of profiles with multiple data elements, focusing on next-generation sequencing and variant annotations. Most elements were mapped to terminologies or code sets and the Fast Healthcare Interoperability Resources (FHIR). We subsequently compared our Precision-DM with existing CDMs, including the National Cancer Institute's Genomic Data Commons (NCI GDC), mCODE, OSIRIS, the clinical Genome Data Model (cGDM), and the genomic CDM (gCDM). RESULTS: Precision-DM contained 16 profiles and 355 data elements. 39% of the elements derived values from selected terminologies or code sets, and 61% were mapped to FHIR. Although we used most elements contained in mCODE, we significantly expanded the profiles to include genomic annotations, resulting in a partial overlap of 50.7% between our core model and mCODE. Limited overlap was noted between Precision-DM and OSIRIS (33.2%), NCI GDC (21.4%), cGDM (9.3%), and gCDM (7.9%). Precision-DM covered most of the mCODE elements (87.7%), with less coverage for OSIRIS (35.8%), NCI GDC (11%), cGDM (26%) and gCDM (33.3%). CONCLUSION: Precision-DM supports clinical-genomic data standardization to support the MTB use case and may allow for harmonized data pulls across health care systems, academic institutions, and community medical centers. New paper led by @TaxiarchisB, @ValsamoA at @hopkinskimmel reports the development of Precision-DM, a #precision #oncology core data model that supports #clinical-#genomics data standardization and integration. [ABSTRACT FROM AUTHOR]

The article is a response to a letter sent by Kempf et al. regarding a publication on the automatic detection of distant metastasis mentions in radiology reports in Spanish. The authors acknowledge the interest in their paper and discuss the importance of context in determining the metastatic status of a tumor. They compare their machine learning-based model to a rule-based algorithm and highlight the limitations of rule-based methods in imaging reports in Spanish. The authors also provide performance metrics for their model and discuss the annotation process of the corpus used in their study. They express their commitment to improving their model and methodology and invite further collaboration and discussion with the research community. [Extracted from the article]

PURPOSE Comprehensive health care centers are increasingly popular as they offer inclusive health care services under one roof. Often, these centers are formed by merging previously separate clinics. However, there is a lack of systematic guidance on the interprofessional, and interteam and intrateam dynamics that may develop during such an organizational change process. Using team process literature, we identify a possible model to explain how merging into a comprehensive cancer center (CCC) might influence health care teams and their subsequent outcomes, including patient experience. METHODS We used a mixed-method research design. Qualitative data were collected via semistructured interviews from 20 health care professionals employed at a recently merged CCC. During the time frame the interviews were collected, quantitative data were collected from 50 patients receiving treatment at the cancer center through anonymous paper-pencil surveys. Qualitative interviews were analyzed using thematic analysis, on the basis of the input-process-output team dynamics framework. Descriptive statistics were calculated for patient experience data. Trends between data collections were identified. RESULTS On the basis of our qualitative analysis, we provide an input-process-output framework that documents positive and negative aspects of interteam and intrateam dynamics associated with the merger process. Additionally, a number of connections were found between health care professional perceptions and quality patient experiences (eg, merger impacts on interteam and patient communication). CONCLUSION Our findings and model may assist in future merging efforts. Future CCCs may use the proposed framework to better understand and visualize their postmerger progress, in particular from the aspects of interprofessional, and interteam and intrateam dynamics. [ABSTRACT FROM AUTHOR]

426 Background: Continued smoking after a cancer diagnosis is associated with poorer outcomes. Ontario Regional Cancer Centres are required to screen all new cancer patients for tobacco use and offer referrals for cessation support to patients using tobacco. At Princess Margaret Cancer Centre (Toronto, Canada), we leveraged an EMR change to Epic along with uptake in virtual care strategies from COVID-19, to improve both tobacco screening and referral rates for new patients. Methods: Following the EMR transition to Epic in June 2022, we piloted EMR and virtual care strategies from Jan 2023 to Mar 2024 to improve both tobacco screening and referral rates. Due to precautions during COVID-19, screening and referrals were completed using a hybrid pre-visit electronic tobacco use assessment questionnaire and in clinic paper-based referral system. Our interventions were co-developed by a team of hospital leadership, IT team members and clinicians. These included: 1) Collation of tobacco assessment data sources on Epic (Jan 2023); 2) Creation of an Epic referral inbox to track referrals (Aug 2023); 3) Assignment of electronic pre-visit tobacco assessments questionnaires to correct visit types (Sep 2023); 4) Creation of a half-day virtual nursing clinic to offer referrals for cessation support to patients initially declining support or those who were not offered using monthly reports from Epic (Nov 2023). Screening and referral rates were tracked monthly and quarterly during this period. Results: From Jan 2023 to March 2024, 15,063 new patients presented to our cancer centre. Baseline screening and referral rates before COVID-19 were 47% and 16%, respectively. Prior to this QI initiative, screening and referral rates were 18% and 1%, respectively. Post implementation, screening and referral rates improved to 42% and 25% (Table); rates of current tobacco use remained consistent from 12-16%. Collation of tobacco use assessments data on Epic had the greatest impact on improving screening rates from 18% to 39% (p<0.001), while the virtual nursing clinic helped to improve referral rates from 3% to 25% (p<0.001), with the greatest referral rate in Jan 2024 at 36%. Our virtual nursing clinic was feasible, where among patients contacted who initially declined or were not offered cessation support, 90% were contacted within 1-3 phone calls. Among patients contacted, 20% accepted a referral, while 41% of patients had already quit smoking by the time of contact. Conclusions: Both EMR and virtual care strategies helped to successfully improve both tobacco screening and referral rates for smoking cessation support; with the greatest impact from the collation of EMR data sources on tobacco use and development of a virtual nurse led clinic. Quarterly tobacco screening and referral rates. Jan-Mar 2023 Apr-Jun 2023 Jul-Sep 2023 Oct-Dec 2023 Jan-Mar 2024 Screening 33% 38% 39% 41% 42% Referrals 0% 1% 3% 20% 25% [ABSTRACT FROM AUTHOR]

361 Background: Cannabis use is rising among both the general and cancer populations. While the impact of cannabis on cancer care remains unclear, many patients who use cannabis report improvement in their cancer-related symptoms. However, little is known about the potential impact of cannabis on cancer development and treatment outcomes. Understanding patient beliefs about cannabis risks and their awareness of information about cannabis use may be important for future patient education. Here, we explored patient perceptions of harms and information-seeking habits on cannabis. Methods: Patients with cancer were recruited across outpatient ambulatory clinics at the Princess Margaret Cancer Centre (Toronto, Canada) through convenience sampling from July to August 2023. A one-time, paper-based, self-administered questionnaire was used to assess sociodemographic characteristics, perceptions of cannabis harms, and awareness of cannabis information. Multivariable regression analysis was used to identify factors associated with perceptions of cannabis use. Results: Among 243 participants, median age was 65 years, 45% reported lifetime cannabis use (12% were using cannabis at the time of survey), 50% were cigarette smokers, 62% were not employed full-time, and 77% spoke English as a primary language at home. Half (51%) of the participants reported being worried about the potential impacts of cannabis on their health. Current tobacco users (aOR=0.46 [0.19-1.07], p=0.07), primary English speakers at home (aOR=0.53 [0.28-1.01], p=0.06) and those not currently employed (aOR=0.57 [0.33-0.99], p=0.04) were less worried about the effect of cannabis on their health. Despite the perceived harms of cannabis, 84% of participants never sought cannabis-related information, while 40% wanted to know more about the influence of cannabis on cancer risk and treatment. Furthermore, Most (90%) participants reported never having discussed cannabis with their oncologists, but 93% felt it was important for healthcare providers to ask patients about cannabis use. Conclusions: Many patients with cancer are worried about the impact of cannabis on their health and want to know more about cannabis use in cancer care. Most patients report it is important for healthcare providers to have discussions about cannabis use. With the rising prevalence of cannabis use among patients with cancer, validated tools to assess cannabis use and cannabis-related educational resources specific to cancer risk and treatment outcomes should be explored to help address informational needs. [ABSTRACT FROM AUTHOR]

372 Background: Patients with cancer and their caregivers are at an increased risk of psychosocial distress that can negatively impact health outcomes and quality of life. Several organizations including NCCN, American College of Surgeons Commission on Cancer, and ASCO, recommend routine psychosocial distress screening and referral. However, many patients are not routinely screened for psychosocial distress, leading to missed intervention opportunities. The NCCN Distress Thermometer (NCCN DT) is the most commonly used self-reporting tool, but its use varies significantly due to differences in practice, workflows, and resources. This systematic review aims to capture elements of the workflow in screening and referral using the NCCN DT, with the goal of providing building block(s) for the implementation that can be adapted to different settings. Methods: A systematic review of full-text manuscripts published from 2013 was conducted using MEDLINE, EMBASE, and CINAHL. Studies describing implementation protocols were included. Systematic reviews and commentary articles were excluded. Additionally, studies conducted outside the US, non-English publications, and studies assessing associations of distress scores with disease burden were excluded. Attributes related to the implementation of screening and referral pathways were extracted. Results: From an initial screening to 1,219 articles, 12 studies were included in the final analysis. There was variation in the targeted populations, with three cancer centers implementing NCCN DT screening and referral protocols system-wide, while others focused on specific cancer types/ clinics. Screening was conducted by various personnel, including medical assistants, front-end staff, and nurse/ nursing assistants, with differences in screening frequency, and mode (paper, telephone, and tablet). Different referral workflows based on distress severity were adopted in multiple studies (n=4), with an array of referral services employed. Conclusions: The implementation of NCCN DT screening and referral pathways varies across the literature. While standardization is desirable, some variation is essential to accommodate the differing availability of resources and personnel for effective screening and referral. This review identifies foundational blocks and considerations for developing customized NCCN DT screening and referral protocols that align with specific needs and available resources of the practice. [ABSTRACT FROM AUTHOR]

355 Background: The cancer care system has struggled for decades to deliver meaningful post-tx survivorship care, relying on patient uptake of clinical guidelines for surveillance, and SCPs for health promotion and managing late effects. On paper, we know how to support survivors. However, there is a lack of "comprehensive guidance on patient-centered practices that specifically address how cancer patients experience their care or how to personalize survivorship so that it meets patients' unique needs" (Mead et al, 2020). Tofill this gap, we developed an evidence-based, community-delivered model for whole-person healing throughout acute and extended survivorship. Methods: We co-designed a new care model with 24 survivors, shaped by their lived experience & unmet needs. The pilot comprised: A) 2-day in-person retreat to evaluate healing modalities (incl. yoga, journaling, group discussion, nutrition coaching, songwriting); B) a 3-hour human-centered design workshop defining "thriving," mapping survivorship challenges/gaps & crafting an ideal care map; C) 8-12 weeks of facilitated organic social engagement with their retreat cohort. We conducted the intervention 3x (6/2003-3/2024) with 7-9 participants aged 29-60. Pre-intervention & 4-month post-intervention surveys measured QOL, symptoms & self-efficacy. Participants also did a qualitative survey post-intervention, sharing preferences & activity impact. Results: The model addresses cancer's proximal/distal psychological, emotional, physical & existential impacts. It builds a connected survivor community & drives long-term behavior change with group accountability. The intervention: A) reduced fears of recurrence & preoccupation with functional concerns & indicated positive changes in self-concept; B) improved social connectedness. 86% agreed/strongly agreed they felt seen & understood; 100% strongly agreed that they can implement 1+ new wellness/healing tool in daily life; 80% increase in confidence keeping emotional distress from interfering with life; 40% reduction in perception of cancer/Tx causing negative changes in self-concept; 60% increase in confidence keeping fatigue from interfering with life. Conclusions: A new model of post-treatment survivorship care is needed that aligns with oncology and primary care delivery, builds on the modern wellness movement, and is able to be sustained in daily life. Survivorship can be delivered in the community leveraging in-person/virtual retreats, workshops, apps and social networks. This intervention shows potential to transform survivorship care delivery & radically improve outcomes. [ABSTRACT FROM AUTHOR]

343 Background: The practice of clinical oncology includes diverse and complex clinical, interpersonal and ethical challenges that can lead to physical and/or emotional distress, including burnout (BO), compassion fatigue (CF), secondary traumatic stress (STS) or moral distress (MDS), which potentially impacts patient care and provider well-being. Surgical oncology presents additional stressors and challenges, yet little is known about CF, STS, and MDS in this population, and the greater body of literature in oncology is heterogenous.The aim of this paper is to review current literature regarding CF, MDS, and STS in clinical oncologists, with a focus on surgical oncologists. Methods: Searches of OVID Medline and Embase databases were performed, as well as relevant bibliographies to identify articles related to CF, STS and MDS in clinical and surgical oncologists. Descriptive analysis was completed on relevant articles to address common definitions, themes, and potential aggravating/protective factors. Results: 619 articles were retrieved, of which 196 underwent data extraction. Of these, 48 articles were related to CF, MDS, or STS in oncologists and 5 included surgical oncologists. There was no data specific to surgical oncologists. Definitions of the terms were inconsistent across the literature. Potential contributing factors for CF/STS/MDS are related to the work environment, time pressures, and poor communication skills. In contrast, self-care, supportive colleagues/supervisors, and experience appear to be protective. Conclusions: This study highlights a need for standardized definitions to accurately capture and explore each of these phenomena. Further research is needed to provide insight into the challenges faced by surgical oncologists and how to support them. [ABSTRACT FROM AUTHOR]

336 Background: Patients with gastrointestinal (GI) malignancies experience a high burden of disease-related symptoms and treatment side effects. We established an integrated GI oncology and palliative care (PC) clinic in which a PC physician is co-located with the oncology team and can provide timely response to patient distress and facilitate communication with the interdisciplinary palliative care team. Yet, even in the integrated clinic, patient symptoms were unreliably assessed, leading to missed opportunities to address patient suffering. Between October 2023 and January 2024 for patients seen in-person in the integrated clinic for oncology or PC visits, the median rate of symptom documentation was 45%. Emotional, financial, and spiritual distress documentation rates were lowest. We hypothesized that by implementing a systematic, comprehensive patient-reported symptom assessment tool, we could increase the detection and documentation of symptoms, and in turn, improve communication around patient distress and timely response to symptoms. Methods: We measured the rate of symptom documentation (primary outcome) and the use of a patient-reported symptom assessment tool for adults with GI cancers seen in-person in the integrated clinic in Spring 2024. Based on the Edmonton Symptom Assessment Scale (ESAS) and expert consensus, we determined which symptoms were most important to identify. Documentation rates were assessed via manual chart review of visit notes and flowsheet data. Prospective post-intervention data (March to May 2024) were compared to retrospective pre-intervention baseline data (October 2023 to January 2024). Interventions included modification of the ESAS to include GI oncology-specific symptoms, implementation of the tool in paper format to encourage patient-clinician communication, frequent staff education and feedback sessions, creation and dissemination of a resource guide for clinicians to respond to identified distress, and patient satisfaction surveys. Results: 126 patients were included in the study (31 pre-intervention and 95 post-intervention). During the post-intervention period, the median rate of symptom documentation increased from 45% to 83% and the median rate of ESAS survey completion increased from 9% to 68%. Documentation of financial and spiritual distress increased from 13% to 71%, for both, and documentation of emotional distress increased from 35% to 72%. On satisfaction surveys (N=20), most patients reported the tool was helpful in sharing their symptoms (70%), was easy to read and understand (100%), and that their clinician was engaged in addressing their symptoms (67%). Conclusions: The implementation of a patient-reported symptom assessment tool in an integrated GI oncology/PC clinic increased documentation of important symptoms, potentially increasing clinician awareness of patient distress. [ABSTRACT FROM AUTHOR]

166 Background: Health-related social needs (HRSNs) exacerbate inequities in cancer incidence, morbidity and mortality. To improve health equity, policymakers recommend systematic HRSN screening in oncology clinics. In preliminary studies, we found low rates (<10%) of HRSN screening in oncology. Building upon these findings and transdisciplinary expertise across four Implementation Science Centers in Cancer Control (ISC3), in the current study, we engaged oncology care teams in tailoring site-specific strategies to implement HRSN screening. Methods: Centers varied in collaborator engagement methods, including Context-Driven Co-Design (CD2), which aims to harmonize the intervention (i.e., HRSN screening), context (e.g., oncology clinic), and implementation strategies. First, site leads conducted semi-structured interviews with 8-10 care team members and clinic observations to identify current HRSN assessment processes and opportunities and barriers to systematic HRSN screening. Second, site leads engaged collaborators in one-on-one interviews or, when using CD2, in 3-4 iterative co-design workshops in which they used context assessment data and user-centered design activities (e.g., storyboarding) to prioritize contextual factors, identify necessary adaptations to HRSN screening, and co-design implementation strategies to address salient barriers. Centers met monthly to share knowledge and troubleshoot. Results: Most Centers' oncology clinics had established informal HRSN screening approaches. Across Centers, collaborators (e.g., providers, nurses, medical assistants, patients) identified similar opportunities (e.g., desire for a standardized approach to HRSN screening; well-functioning clinical teams and physical space). Common challenges included limited familiarity with HRSN screening and documentation tools; lack of standardized screening protocol; and limited awareness of HRSN screening's purpose. Implementation strategies included pencil-and-paper screening tools; clinic signage regarding HRSN screening's purpose; training and creation of standardized screening protocol; and a centralized resource for responding to HRSN with adjustment, assistance, alignment, and/or advocacy. Conclusions: Four ISC3 Centers developed multicomponent implementation plans tailored to their oncology clinic. Centers' varied approaches and timelines presented challenges and opportunities for cross-Center learning. Oncology clinics exhibited substantial overlap in opportunities and challenges in HRSN screening. Much of CD2's benefits were related to its collaborator-driven approach to implementation strategy development. Next steps include deploying implementation plans and assessing their impact on equitable reach and adoption of HRSN screening and response to identified needs. [ABSTRACT FROM AUTHOR]

PURPOSE: Accurate and efficient data collection is a challenge for quality improvement initiatives and clinical research. We describe the development of a custom electronic health record (EHR)–based registry to automatically extract structured Commission on Cancer axillary surgery-specific metrics from a custom synoptic note template included in the operative reports for patients with breast cancer undergoing surgery. METHODS: The smart functionality of our enterprise-based EHR system was leveraged to create a custom smart phrase to capture axillary surgery-specific variables. A multidisciplinary team developed structured data elements correlating to each axillary surgery-specific variable. These data elements were then included in a note template for the operative report. Each variable could be aggregated and converted into a single flat database through the EHR's reporting workbench and serve as a live, prospective registry for all users within the EHR. RESULTS: The final axillary surgery-specific note template in a synoptic format allowed for efficient and easy entry and automatic collection of breast cancer–specific metrics. From initial adoption in February 2021-December 2021, there were 1,254 patients who underwent breast surgery with axillary surgery. The operative notes allowed for automatic capture of metrics from 60.5% (n = 759) of patients. Data capture improved from 37.6% in the initial adoption period of 6 months to 86.2% in the last 5 months. CONCLUSION: We were able to demonstrate successful implementation of provider-driven structured data entry into EHR systems that permits automatic data capture. The end result is a custom synoptic note template and a real-time, prospective registry of breast cancer–specific Commission on Cancer metrics that are robust enough to use for quality improvement initiatives and clinical research. New @JCOCCI_ASCO paper on the implementation of a structured data entry system to collect axillary surgery specific metrics for #breast cancer patient demonstrates how existing #EHR systems can be used to improve documentation standards and surgical care. [ABSTRACT FROM AUTHOR]

PURPOSE: With deeper insight into precision medicine, more innovative oncology trial designs have been proposed to contribute to the characteristics of novel antitumor drugs. Bayesian information borrowing is an indispensable part of these designs, which shows great advantages in improving the efficiency of clinical trials. Bayesian methods provide an effective framework when incorporating information. However, the key point lies in how to choose an appropriate method for complex oncology clinical trials. METHODS: We divided the borrowing information scenarios into concurrent and nonconcurrent scenarios according to whether the data to be borrowed are observed at the same time as in the current trial or not. Then, we provided an overview of the methods in each scenario. Performance comparison of different methods is carried out with regard to the type I error and power. RESULTS: As demonstrated by the simulation results in each borrowing scenario, the Bayesian hierarchical model and its extensions are more appropriate for concurrent borrowing. The simulation results demonstrate that the Bayesian hierarchical model shows great advantages when the arms are homogeneous. However, such a method should be adopted with caution when heterogeneity exists. We recommend the other methods, considering heterogeneity. Borrow information from informative priors is more suggested for nonconcurrent borrowing scenarios. Multisource exchangeability models are more suitable for multiple historical trials, while meta-analytic-predictive prior should be carefully applied. CONCLUSION: Bayesian information borrowing is useful and can improve the efficiency of clinical trial designs. However, we should carefully choose an appropriate information borrowing method when facing a practical innovative oncology trial, as an appropriate method is essential to provide ideal design performance. Bayesian information borrowing is an indispensable part of innovative oncology trial designs which provides an effective framework when incorporating external information. The key point lies in how to choose an appropriate borrowing method. This paper divided the borrowing information scenarios into concurrent and non-concurrent scenarios according to whether the data to be borrowed are observed at the same time as in the current trial or not. Recommendations for the application scenarios are made based on extensive simulations. [ABSTRACT FROM AUTHOR]

PURPOSEKey to achieving better population-based outcomes for patients with lung cancer is the improvement of medical imaging and nuclear medicine infrastructure globally. This paper aims to outline why and spark relevant health systems strengthening.METHODSThe paper synthesizes the global lung cancer landscape, imaging referral guidelines (including resource-stratified ones), the reliance of TNM staging upon imaging, relevant multinational health technology assessments, and precisely how treatment selection and in turn patient outcomes hinge upon imaging findings. The final discussion presents data on current global gaps in both diagnostics (including imaging) and therapies and how, informed by such data, improved population-based outcomes are tangible through strategic planning.RESULTSImaging findings are central to appropriate lung cancer patient management and can variably lead to life-prolonging interventions and/or to life-enhancing palliative measures. Early-stage lung cancer can be treated with curative intent but, unfortunately, most patients with lung cancer still present at advanced stages and many patients lack access to both diagnostics and therapies. Furthermore, half of lung cancer cases occur in low- and middle-income countries. The role of medical imaging and nuclear medicine in lung cancer management, as outlined herein, may help inform strategic planning.CONCLUSIONLung cancer is the number one cancer killer worldwide. The essential role that medical imaging and nuclear medicine play in early diagnosis and disease staging cannot be overstated, pivotal in selecting the many patients for whom measurably improved outcomes are attainable. Prevention synergized with patient-centered, compassionate, high-quality lung cancer management provision mandate that strategic population-based planning, including universal health coverage strategies, should extend well beyond the scope of disease prevention to include both curative and noncurative treatment options for the millions afflicted with lung cancer.

PURPOSE There are numerous barriers to cancer clinical trial participation in the United States. This paper describes the approach and outcomes of The Leukemia & Lymphoma Society's Clinical Trial Support Center (CTSC), whose nurse navigators assist patients with a blood cancer and their oncologists by identifying all appropriate trials based on clinical data and patient preference, facilitating informed and shared decision making, and minimizing enrollment barriers. METHODS Data on patients served from October 2017 to October 2019 were analyzed using bivariate and multivariate analyses to determine demographic and clinical characteristics associated with enrollment. Reasons for nonenrollment were examined. RESULTS The CTSC opened 906 patient cases during this time frame. Among all US patients with a closed case (n 5 750), the clinical trial enrollment rate was 16.1%. Among those with a known enrollment outcome after a trial search (n5 537), the enrollment rate was 22.5%. Multivariate analysis controlling for variables significant in bivariate analyses (insurance, treatment status, Eastern Cooperative Oncology Group performance status, and urban or rural residence) revealed that patients with Medicaid were less likely to enroll than those with private or commercial insurance (adjusted odds ratio, 0.054; CI, 0.003 to 0.899), and patients in treatment ormaintenance were less likely to enroll than those relapsed or refractory tomost recent therapy (adjusted odds ratio, 0.312; CI, 0.139 to 0.702). Primary reasons for nonenrollment were preference for standard of care (66.3%) and patient passed away (16.1%). CONCLUSION The CTSC is an effective, replicable model for addressing multilevel barriers to clinical trial participation. The findings highlight the need to increase opportunities for trial participation sooner after diagnosis and among patients with Medicaid. [ABSTRACT FROM AUTHOR]

Quality improvement (QI) programs have rapidly grown in health care over recent years. Despite increasing evidence of successful QI initiatives resulting in improved outcomes, the adoption and implementation of QI programs remain a challenge worldwide. This paper briefly describes political and administrative barriers that impede the implementation of QI programs, including political and ideological factors, socioeconomic and educational barriers, and barriers related to data collection, privacy, and security. Key political and administrative barriers identified include resource limitations due to inadequate public funding, stringent laws, and change resistance. Potential solutions include support and commitment from regional and national authorities, consultation of all involved parties during QI program development, and financial incentives. The barrier of limited resources is starker among low- and middle-income countries (LMICs) compared with high-income countries (HICs) due to the absence of adequate infrastructure, personnel equipped with QI-oriented skills, and analytical technology. Solutions that have facilitated QI programs in some LMICs include outreach and collaboration with other health centers and established QI programs in HICs. The lack of QI-specific training and education in medical curricula challenges QI implementation but can be mitigated through the provision of QI promotion webinars, QI-specific project opportunities, and formalized QI training modules. Finally, barriers related to data collection, privacy, and security include laws hindering the availability of quality data, inefficient data collection and processes, and outdated clinical information systems. Access to high-quality data, organized record-keeping, and alignment of data collection processes will help alleviate these barriers to QI program implementation. The multidimensional nature of these barriers means that proposed solutions will require coordination from multiple stakeholders, government support, and leaders across multiple fields.

Discussion Using NGS, I RAF1 i gene fusion was recently described in eight soft-tissue sarcomas with various fusion partners including I PDZRN3 i , I SLMAP i , and I TMF1 i .[3] The tumors were found in different organs and usually displayed low-grade features. The advent of molecular pathology tools such as next-generation sequencing (NGS) has helped refine the classification of sarcomas and may help find new therapeutic targets.[1] Recently, a new group of soft-tissue sarcomas was described as harboring a distinct immunohistochemistry profile of S100 and CD34 coexpression and recurrent gene fusions involving I RAF1 i , I BRAF i , or I NTRK1 i / I 2 i .[2] In this paper, we report a case of recently described spindle cell tumor displaying a I QKI-RAF1 i gene fusion resistant to standard cytotoxic chemotherapy. [Extracted from the article]

PURPOSESerial patient-reported outcome (PRO) measurements in clinical practice are associated with a better quality of life and survival. Recording electronic PROs using smartphones is an efficient way to implement this. We aimed to assess the feasibility of the electronically filled Edmonton Symptom Assessment System (e-ESAS) scale in the lower-middle–income country (LMIC) setting.METHODSBaseline clinical features and conventional paper-based ESAS (p-ESAS) were collected in newly diagnosed patients with solid organ tumors. Text message link was sent to these patients for filling e-ESAS. ESAS was categorized into physical, psychological, and total symptom domains. Scores were divided into none to mild (0-3) and moderate to severe (4-10). Intraclass correlation coefficients (ICCs) were used to determine the correlation between p-ESAS and e-ESAS. Multivariable logistic regression was used to identify independent factors affecting symptom burden.RESULTSOf 1,160 participants who filled out p-ESAS, 595 completed both e-ESAS and p-ESAS questionnaires and were included in the final analysis. Moderate to severe physical, psychological, and total symptom scores were seen in 39.8%, 40%, and 39% of participants. Tiredness and anxiety were the most common physical and psychological symptoms, respectively. ICCs between the p-ESAS and e-ESAS varied between 0.75 and 0.9. Total symptom scores were independently predicted by metastatic disease (odds ratio [OR], 1.83; 95% CI, 1.26 to 2.67; P = .001) and a higher level of education (OR, 0.42; 95% CI, 0.25 to 0.72; P = .001).CONCLUSIONPaper-based and electronically filled ESASs have good intraobserver reliability across individual symptoms and domain scores in a representative cohort at a tertiary care institute in the LMIC. This may help us incorporate e-ESAS in routine clinical care in the real-world setting with financial, infrastructural, and manpower limitations.

PURPOSEThe COVID-19 pandemic significantly disrupted cancer care in Africa, further exposing major health disparities. This paper compares and contrasts the experiences of 15 clinicians in six different African cancer centers to highlight the positive aspects (silver linings) in an otherwise negative situation.METHODSData are from personal experience of the clinicians working at the six cancer centers blended with what is available in the literature.RESULTSThe impact of COVID-19 on cancer care appeared to vary not only across the continent but also over cancer centers. Different factors such as clinic location, services offered, available resources, and level of restrictions imposed because of COVID-19 were associated with these variations. Collectively, delays in treatment and limited access to cancer care were commonly reported in the different regions.CONCLUSIONThere is a lack of data on cancer patients with COVID-19 and online COVID-19 and cancer registries for Africa. Analysis of the available data, however, suggests a higher mortality rate for cancer patients with COVID-19 compared with those without cancer. Positive or silver linings coming out of the pandemic include the adoption of hypofractionated radiation therapy and teleoncology to enhance access to care while protecting patients and staff members. Increasing collaborations using online technology with oncology health professionals across the world are also being seen as a silver lining, with valuable sharing of experiences and expertise to improve care, enhance learning, and reduce disparities. Advanced information and communication technologies are seen as vital for such collaborations and could avail efforts in dealing with the ongoing pandemic and potential future crises.

PURPOSEThe COVID-19 pandemic has affected health care systems worldwide, resulting in critical shortages of essential items and materials. The available guidelines are of little use for cancer hospitals in low-income and low-middle–income countries. They have been designed for community hospitals serving in a centralized health care network. This study aimed to draft and field test a framework to establish a list of essential supplies that should be stockpiled for subsequent waves of the COVID-19 virus by a tertiary care cancer hospital in a low-middle–income country.MATERIALS AND METHODSA model was formulated using the consumption trends during the peak month of the first wave of COVID-19 infection to compile a list of essential materials and supplies. Furthermore, costing analyses were conducted to determine the financial benefits of stockpiling.RESULTSA proposed list of items to stockpile, including personal protective equipment, radiology supplies, laboratory reagents, medication, and oxygen, was shared with the hospital administration. However, the hospital administration only accepted the proposals for stockpiling personal protective equipment and oxygen.CONCLUSIONThis paper provides a framework and strategies that cancer hospitals and health care systems can modify and use as per individual, institutional requirements and specifications for stockpiling essential items during the COVID-19 or other similar pandemics.

PURPOSEChemotherapies are considered high-risk drugs for patient and staff safety. Considering the rising burden of cancer and the increasing use of chemotherapy drugs in low- and middle-income countries (LMICs), promoting continuous improvements in the safety and quality of practices in these settings is essential. This paper describes the development and proof of concept of a toolkit to audit chemotherapy handling practices in the health care facilities of LMICs.METHODSA steering committee defined the audit method and the toolkit content. Several checklists were developed to facilitate the audit and data collection. Items included in checklists were derived from key reference works on safe handling. Different tools were validated using Delphi surveys and expert reviews. Audits of pilot sites were performed to test the toolkit's applicability and relevance.RESULTSThe toolkit contains a 134-item global assessment tool for the different processes at each step of the medication pathway and three step-specific observation checklists to assess different health workers' practices during the prescription, preparation, and administration of chemotherapies. The toolkit also proposes using a surface-wipe sampling method to measure any cytotoxic contamination of the immediate environment. The toolkit was tested in three teaching hospitals in Africa.CONCLUSIONThe toolkit developed was successfully implemented in a variety of LMIC settings, providing a comprehensive evaluation of the quality and safety of the chemotherapy drug handling practices in participating health care facilities. This toolkit can help facilities in LMICs to implement a new approach to continuously improving the quality and safety of their practices and ultimately ensure patient and staff safety.

PURPOSEAuthorship is a proxy indicator of research capacity. Understanding the research capacity is imperative for developing population-specific cancer control strategies. This is particularly apropos for African nations, where mortality from cancer is projected to surpass that from infectious disease and the populations are critically under-represented in cancer and genomics studies. Here, we present an analysis and discussion of the patterns of authorship in Africa as they pertain to cancer genomics research across African countries.METHODSPubMed metadata of relevant cancer genomics peer-reviewed publications on African populations, published between January 1, 1990, and December 31, 2019, were retrieved and analyzed for patterns of authorship affiliation using R packages, RISmed, and Pubmed.mineR.RESULTSThe data showed that only 0.016% (n = 375) of cancer publications globally were on cancer genomics of African people. More than 50% of the first and last authors of these publications originated from the North African countries of Tunisia, Morocco, Egypt, and Algeria. South Africa (13.6% and 12.7%) and Nigeria (2.2% and 1.9%) were the Sub-Saharan African countries most represented by first and last authorship positions, respectively. The United States contributed 12.6% of first and last authored papers, and nearly 50% of all African countries had no contributing author for the publications we reviewed.CONCLUSIONThis study highlights and brings awareness to the paucity of cancer genomics research on African populations and by African authors and identifies a need for concerted efforts to encourage and enable more research in Africa, needed for achieving global equity in cancer outcomes.

PURPOSEGlioblastoma multiforme (GBM) has poor outcomes following surgery and radiation. Adjuvant temozolamide along with radiation therapy has been shown to improve survival. In this paper, we evaluate the cost-effectiveness of concomitant temozolamide with radiation and maintenance temozolamide for 6 months of treatment for GBM in India.MATERIALS AND METHODSWe used a Markov model to evaluate the lifetime costs and consequences of treating GBM with radiation alone versus radiation with adjuvant temozolamide. The model was calibrated using the published evidence from European Organisation for Research and Treatment of Cancer-NCIC trial on progression-free survival and overall survival to estimate the life years (LYs) and quality-adjusted LYs (QALYs). Cost of treatment and management of complications were estimated using the data from the National Health System Cost Database and Indian studies. Future cost and consequences were discounted at 3%. Incremental cost per QALY gained with temozolamide was estimated to assess cost effectiveness.RESULTSTemozolamide resulted in an increase of 0.59 (0.53-0.66) LY and 0.33 (0.29-0.40) QALY per person at an incremental cost of ₹75,120 in Indian national rupee (INR) (59,337-93,960). Overall, the use of temozolamide incurs an incremental cost of ₹212,020 INR (138,127-401,466) per QALY gained, which has a 4.7% probability to be cost-effective at 1-time per capita Gross Domestic Product (GDP) threshold. In case the current price of temozolamide could be decreased by 90%, the probability of its use for GBM being cost-effective increases to 80%.CONCLUSIONTemozolamide is not cost-effective for treatment of patients with GBM in India. This evidence should be used while framing guidelines for treatment and price regulation.

PURPOSEA group of international urology and medical oncology experts developed and completed a survey on prostate cancer (PCa) in developing countries. The results are reviewed and summarized, and recommendations on consensus statements for very low-, low-, and intermediate-risk PCa focused on developing countries were developed.METHODSA panel of experts developed more than 300 survey questions of which 66 questions concern the principal areas of interest of this paper: very low, low, and intermediate risk of PCa in developing countries. A larger panel of 99 international multidisciplinary cancer experts voted on these questions to create the recommendations for treatment and follow-up for very low-, low-, and intermediate-risk PCa in areas of limited resources discussed in this manuscript.RESULTSThe panel voted publicly but anonymously on the predefined questions. Each question was deemed consensus if 75% or more of the full panel had selected a particular answer. These answers are based on panelist opinion not a literature review or meta-analysis. For questions that refer to an area of limited resources, the recommendations consider cost-effectiveness and the possible therapies with easier and greater access. Each question had five to seven relevant answers including two nonanswers. The results were tabulated in real time.CONCLUSIONThe voting results and recommendations presented in this document can be used by physicians to support management for very low, low, and intermediate risk of PCa in areas of limited resources. Individual clinical decision making should be supported by available data; however, as guidelines for treatment for very low, low, and intermediate risk of PCa in developing countries have not been developed, this document will serve as a point of reference when confronted with this disease.