Confirmed Cancer Diagnosis Research Articles

Emergency department use before cancer diagnosis in Ontario, Canada: a population-based study.

Although suspicions of cancer may be raised in patients who visit the emergency department, little is known about emergency department use before a cancer diagnosis. We sought to describe emergency department use among patients in Ontario within the 90 days before confirmed cancer diagnosis and to evaluate factors associated with this emergency department use. We conducted a retrospective, population-based study of patients aged 18 years or older who had a confirmed cancer diagnosis in Ontario from 2014 to 2021 using linked administrative databases. The primary outcome was any emergency department visit within 90 days before the cancer diagnosis date. We used multivariable logistic regression to evaluate factors associated with emergency department use, such as demographics (e.g., age, sex, rurality, Ontario Health region, indicators of marginalization), comorbidities, previous emergency department visits and hospital admissions, continuity of primary care, type of cancer, and year of cancer diagnosis. We included 651 071 patients with cancer. Of these, 229 683 (35.3%) had an emergency department visit within 90 days before diagnosis, 51.4% of whom were admitted to hospital from the emergency department. Factors associated with increased odds of emergency department use before cancer diagnosis included rurality (odds ratio [OR] 1.15, 95% confidence interval [CI] 1.13-1.17), residence in northern Ontario (North East region OR 1.14, 95% CI 1.10-1.17 and North West region OR 1.27, 95% CI 1.21-1.32, v. Toronto region), and living in the most marginalized areas (material resources OR 1.37, 95% CI 1.35-1.40 and housing OR 1.09, 95% CI 1.06-1.11, v. least marginalized quintile). We observed significant variation in emergency department use by cancer type, with high odds of emergency department use among patients with intracranial, pancreatic, liver or gallbladder, or thoracic cancer. Emergency department use is common before cancer diagnosis, with about one-third of patients with cancer in Ontario using the emergency department before diagnosis. Understanding why patients visit the emergency department before cancer diagnosis is important, particularly for patients who live in rural or marginalized areas, or those who have specific cancer types.

Oral health-related quality of life among oropharyngeal cancer survivors

ObjectivesThe incidence of oropharyngeal cancer continues to rise in the United States, yet studies on the quality of life (QoL) of oropharyngeal cancer patients are limited. The objective of this pilot study was to assess the impact of oral health on the QoL in oropharyngeal cancer survivors. Materials and MethodsOropharyngeal cancer survivors with a confirmed cancer diagnosis from 1996 to 2016 were sampled from the Utah Cancer Registry. The Oral Health Impact Profile-14 (OHIP-14) questionnaire was administrated between January and May of 2019. The impact of oral health on QoL was evaluated using simple linear regression (β-coefficient). ResultsAmong the 260 oropharyngeal cancer survivors, the majority were male (84.6 %) and ≥ 60 years of age at the time of cancer diagnosis (74.0 %). The most frequently reported symptoms of OHIP-14 were discomfort while eating any foods (19.2 %) and worsening sense of taste (16.0 %). The overall OHIP-14 mean score was 13.3. Significantly worse OHIP-14 scores were observed for females (β = 12.85, p = 0.01), chemotherapy recipients (β = 6.60, p = 0.02), and past smokers (β = 5.25, p = 0.04). Better OHIP-14 scores (better oral QoL) were observed in patients with distant cancer stage (β = −7.66, p = 0.01), higher income (β = −2.50, p = 0.05), and older age at cancer diagnosis (β = −0.35, p = 0.03). ConclusionThe oral health-related quality of life scores observed in this pilot study suggest a need for improvement in patient symptom management over time.

Financial Toxicity Screening Preferences in Patients With Breast Cancer.

Financial toxicity is an important issue in cancer that affects quality of life and treatment adherence. Screening can identify patients at risk but consensus on appropriate timing or methods is lacking. We sent an anonymous survey to e-mail subscribers of a nationwide breast cancer-specific philanthropic organization in July 2023 asking about financial toxicity screening preferences. Frequencies, percentages, and medians were calculated for categorical and continuous variables. Of 5,774 potential participants, 738 respondents with a confirmed cancer diagnosis participated (12.7% response rate). Participants were 93% female (n = 690), had a median age of 50 years (IQR, 44-57), were 57% non-Hispanic White (n = 418), 20% Black/African-American (n = 149), 9.2% Hispanic (n = 68). 93% confirmed a breast cancer diagnosis (n = 689), and 54% were currently undergoing treatment (n = 400). Most indicated not being asked about financial stressors by (58%, n = 425) and not receiving assistance from their care team (68%, n = 498). Most preferred for providers to reach out regarding financial needs (83%, n = 615). Most wished for these discussions to take place early (when first diagnosed [45%, n = 334] or when treatment selected [37%, n = 275]) and to be asked frequently (each appointment [42%, n = 312] or once per month [36%, n = 268]). Participants felt most comfortable discussing financial needs with a social worker or patient/financial navigator (92%, n = 679), in person (75%, n = 553), or via telephone (65%, n = 479). Patients in this sample primarily consisting of women with breast cancer desired financial screening to occur early, often, and to be initiated by their providers. Patient preferences can inform optimal implementation of financial toxicity screening practices. Continued work refining best practices for financial toxicity screening should incorporate these patient preferences.

Identification of tumor-marker gangliosides for early cancer detection: A multi-platform approach.

e17551 Background: Tumor-marker gangliosides (TMGs) have enormous potential for early-stage cancer detection as diagnostic biomarkers despite being relatively understudied in this context. AOA Dx is focused on the analytical development of three separate platforms for the quantitation of TMGs in human serum. The development of these platforms for TMG quantitation may allow for the identification of diagnostic signatures for early-stage cancer detection. Methods: First, we are developing a pipeline of antibody-based assays to target TMGs. To aid in development of multiple immunoassays, we collected specificity and affinity data on commercial and proprietary antibodies targeting TMGs using glycoarrays. We are also currently using two immune-based platforms to target TMGs. We have developed an enzyme-linked immunosorbent assay (ELISA) and we have implemented high-performance thin-layer chromatography (HPTLC) to detect individual and total gangliosides. Additionally, we are applying both targeted and untargeted mass spectrometry to human serum from confirmed cancer diagnoses. Results: The specificity and affinity data from the glycoarrays confirm that our TMG antibodies have negligible cross-reactivity and are suitable for diagnostic platform development. Additionally, our developed ELISA allows for the quantification of TMGs in diverse and complex matrices including human serum and plasma, cell lines, and exosomes. HPTLC also detects individual and total gangliosides in each of these matrices, which allows for high-throughput analysis for TMG quantitation. Finally, the application of both targeted and untargeted mass spectrometry has identified multiple TMGs characterized by unique lipid tails. Notably, MS analysis shows that the serum of melanoma and ovarian cancer patients exhibited significantly increased levels of several ganglioside species compared to age-matched healthy serum, further highlighting the potential of TMGs as a promising avenue for cancer diagnosis. Further experiments will focus on refining all platforms. We will also expand the demographic representation of our human serum sample cohort to confirm the initial findings from our mass spectrometry experiments and continue to use this platform to identify additional TMGs of interest. Conclusions: AOA Dx is advancing the development of a multi-platform approach for the detection of TMGs. Our objective is the identification of a diagnostic disease signature for early-stage cancer detection. The validation of this type of diagnostic panel would allow for expedited diagnosis and treatment of cancers currently diagnosed at late stages, ultimately reducing healthcare costs and increasing survival rates. Future research will aim to validate these biomarkers in independent prospective studies.

Inpatient outcomes of patients with new solid tumors admitted to a comprehensive cancer center.

e23056 Background: Hospitalized cancer patients demonstrate multiple challenges including management of acute illnesses, establishment of the cancer diagnosis, creation of a goal concordant care plan, and post-hospital disposition. Yet, there has been limited research regarding characteristics and outcomes of new to hospital oncology patients. Methods: We performed a retrospective chart review of patients with suspicion or confirmed solid tumor cancer diagnosis who were admitted without an established MD Anderson Cancer Center oncologist. We assessed length of stay, ICU utilization, 30-day readmission rate, inpatient mortality, and discharge disposition. We compared the results to our group’s established oncology patients. Statistical analysis was performed using Chi-squared testing. Results: Between November 2022 and January 2023, 201 unique new patients were reviewed out of 1635 admissions. Of those 103 (51.2%) were males, median age of 60 (range: 22-79), White including Hispanics 118 (59%), African Americans 46 (23%), others 33 (18%). Of the study population, 88 (43.8%) did not have a confirmed cancer diagnosis, of which we established a cancer diagnosis in 68 (77.3%) and ruled out cancer in 8 (4%). Of the 113 (56.2%) diagnosed at outside facilities, 63 (55.8%) were treatment naive and 22 (19.4%) had their cancer diagnosis revised. Of 175 patients which had staging information, 150 (85.7%) were stage 4. During the index admission, 45 (22.4%) patients had cancer-directed therapy. The average and geometric mean length of stay (days) for new patients was 12.1 and 8.8, respectively, compared to the established group of 8.2 and 6.1 (p < 0.001). Inpatient mortality was higher in new patients (10.5% vs 6.8%, p < 0.001) and they were more likely to be referred to hospice services (17.4% vs 8.3%, p < 0.001). Furthermore, hospice referral was higher in the unestablished, previously treated group compared to treatment naive patients (28% vs 13.9%, p = 0.003), however inpatient mortality was similar (12% vs 9.9%, p = 0.63). ICU stay, 30-day readmission rate, discharge to home vs placement were similar in new and established patients (Table 1). Conclusions: Admitted new oncology patients typically present with advanced disease and had longer length of stay, mortality rates, and hospice referrals compared to established patients. Further research is needed to identify and improve care barriers to new inpatients, focusing on improving workflow process and timely goal concordant care discussions. [Table: see text]

The impact of socioeconomic status on gastrointestinal cancer care delivery in southeast Texas.

e15579 Background: Gastrointestinal (GI) cancers are a leading cause of cancer deaths in the US with an estimated 1,038,410 new cases and a 30.4% mortality rate in 2023. Disparities in cancer care are well documented and result from several variables, including socioeconomic status (SES), behavioral, and biological factors. We conducted a retrospective population-based cohort study aimed to investigate the relationship between various socioeconomic factors and delays in cancer treatment initiation, emphasizing the impact of gender, race, age, and geographical distance on the time to treatment initiation (TTI). Methods: We identified patients with colorectal, hepatobiliary, small intestinal, and gastroesophageal cancers, who received their cancer diagnosis and initiated treatment at Baptist Hospitals of Southeast Texas in Beaumont, Texas between January 2012, and December 2017. SES data, including age, sex, race, geographical distribution, insurance status, cancer staging, and treatment were collected. Logistic regression was performed to determine risk association by calculating odds ratios with 95% confidence intervals, as well as p-values to determine significance. The primary outcomes of interest were the overall survival (OS) rate, and TTI defined as the time interval between the confirmed cancer diagnosis and initiating the first treatment modality. Results: A total of 517 GI cancer patients were included in this study, with 359 comprising a cohort of patients with colorectal cancer. The majority of patients included were ; caucasians(%) males (%).. African American patients were significantly more likely to receive delayed treatment, Odds Ratio (OR): 5.89, 95% confidence interval (CI) 4.02-8.62, especially compared to the odds for similar Caucasian patients (OR: 0.16, CI: 0.11-0.23). When compared to younger counterparts, patients above the age of 80 were found to have poorer odds of prolonged survival (OR: 2.91, CI: 1.80-4.72). Patients who lived 30 miles away or further from our hospital had longer TTI compared to those living within 30 miles radius (OR: 1.85, CI: 1.19-2.87), a risk which remained significant within the colorectal cancer cohort (OR: 2.20, CI: 1.29-3.74). Patients with Medicare insurance showed longer TTI (OR: 1.50, CI: 1.01-2.23), and decreased OS (OR: 1.79, CI: 1.05-3.06)). No statistically significant difference was observed based on gender. Conclusions: Age, geographical location, and racial SES variables contribute to the disparities in GI cancer care in our community. Addressing these disparities and implementing targeted interventions to mitigate the impact of socioeconomic barriers is imperative to ensure equitable access to timely and effective cancer care, ultimately leading to improved patient outcomes and cancer survival rates.

Optimizing resource allocation: Cost-effectiveness of specified D-dimer cut-offs in cancer patients with suspected venous thromboembolism

An accurate diagnosis of venous thromboembolism (VTE) is crucial, given the potential for high mortality in undetected cases. Strategic D-dimer testing may aid in identifying low-risk patients, preventing overdiagnosis and reducing imaging costs. We conducted a retrospective, comparative analysis to assess the potential cost savings that could be achieved by adopting different approaches to determine the most effective D-dimer cut-off value in cancer patients with suspected VTE, compared to the commonly used rule-out cut-off level of 0.5 mg/L. The study included 526 patients (median age 65, IQR 55–75) with a confirmed cancer diagnosis who underwent D-dimer testing. Among these patients, the VTE prevalence was 29% (n = 152). Each diagnostic strategy's sensitivity, specificity, negative likelihood ratio (NLR), as well as positive likelihood ratio (PLR), and the proportion of patients exhibiting a negative D-dimer test result, were calculated. The diagnostic strategy that demonstrated the best balance between specificity, sensitivity, NLR, and PLR, utilized an inverse age-specific cut-off level for D-dimer [0.5 + (66-age) × 0.01 mg/L]. This method yielded a PLR of 2.9 at a very low NLR for the exclusion of VTE. We observed a significant cost reduction of 4.6% and 1.0% for PE and DVT, respectively. The utilization of an age-adjusted cut-off [patient’s age × 0.01 mg/L] resulted in the highest cost savings, reaching 8.1% for PE and 3.4% for DVT. Using specified D-dimer cut-offs in the diagnosis of VTE could improve economics, considering the limited occurrence of confirmed cases among patients with suspected VTE.Graphical In the context of accurate diagnosis of VTE, strategic D-dimer testing helps identify low-risk patients, preventing overdiagnosis and reducing imaging costs. In our retrospective study, the diagnostic strategy that demonstrated the best balance between specificity, sensitivity, and best PLR, utilized an inverse age-specific cut-off level for D-dimer. We observed a significant cost reduction of 4.6% for PE and 1% for DVT. Abbreviations: CTPA, computed tomography pulmonary angiography; CUS, compression ultrasound; DVT, deep vein thrombosis; PE, pulmonary embolism; VTE, venous thromboembolism.

Abstract 3891: Early real-world experience with repeat multi-cancer early detection (MCED) testing

Abstract Background: An MCED test (Galleri®, GRAIL, LLC, Menlo Park, CA) has been in clinical use since April 2021. We previously reported the results of screening the first ~53,000 individuals in the US with this test from real-world (RW) practice. Here, we report the RW experience with repeated MCED testing in ~5800 individuals. Methods: This MCED test analyzes targeted methylation in cell-free DNA and uses machine learning to detect a Cancer Signal (CS) and determine its Cancer Signal Origin (CSO). We analyzed results returned through August 2023 for those with a “No Cancer Signal Detected” (NCSD) result in Year 1 and an additional consecutive test. We excluded tests from clinical studies and sites that limited data sharing. Systematic collection of outcomes was attempted for all cases with a “CS detected” (CSD) result and continues via a quality assurance (QA) program. Results: In this RW cohort, a second test was ordered in 5794 individuals (58% male, average age=61.3 y, range: 24.0-89.0 and 42% female, average age=60.5 y, range: 23.0-89.0). Median interval between blood draws was 12.9 months, and 81% (4693/5794) were tested 10-18 months after the initial test. Among the 5794, 26 received a CSD result in the second test, of which 20 were within 10-18 months, corresponding to a CSD rate (CSDR) of 0.45% (95% CI 0.31%-0.66%; 26/5794). The CSDR was slightly higher in males (0.50% [0.32%-0.81%; 17/3367]) vs females (0.37% [0.2-0.7%; 9/2427]) and was lower than the Year 1 CSDR of 0.95% (95% CI 0.87-1.0; 510/53,744). The top CSOs reported during second tests were: Lymphoid, Head & Neck, Bladder and Urothelial, Colon & Rectum, Anus. Among the 26 CSD cases, the QA program confirmed 12 clinical outcomes (8 with a cancer diagnosis, 4 with no cancer diagnosis), and 14 cases are still under investigation or without outcomes at this time. Among 8 cases with a confirmed cancer diagnosis, accuracy of the 1st CSO prediction was 100%, and diagnoses reflected invasive cancers across multiple cancer types including anus, colon, head & neck, urothelial tract, ovary, and lymphomas. Staging information was available in 5 cases, including 4 stage I cancers (4/5, 80%; anus, head & neck, lymphoma, bladder) and one stage IV cancer (ovary). Conclusions: A subset of individuals who returned for MCED testing had cancers detected, including cancers without recommended screening, underscoring the potential value of annual screening with this MCED test. There may be systematic differences in this limited population of individuals who returned for repeat screening, reducing the signal detection rate through potential early adopter bias. Clinical data return was incomplete, and confirmed 8 cancers, including 4 stage I cancers. All cancers were found at the predicted CSO, demonstrating the clinical utility of this unique test feature that directs diagnostic work up. Citation Format: Richard Abrams, Rita Shaknovich, Jordan Lipton, Matthew McMillin, Adam Schneider, Matthew Margolis, Xinyi Hou, Yoobin Oh, Victoria Le, Earl Hubbell, Roger Jiang, Jeffrey M. Venstrom, Ora K. Gordon. Early real-world experience with repeat multi-cancer early detection (MCED) testing [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3891.

Abstract 2447: Identification of tumor marker gangliosides for early cancer detection: A mass spectrometry approach

Abstract Tumor-marker gangliosides (TMGs) have enormous potential for early-stage cancer detection as diagnostic biomarkers despite being relatively understudied in this context. AOA Dx is focused on the development of a mass spectrometry platform for the quantitation of TMGs in human serum, particularly disialogangliosides GD2 and GD3. The development of a mass spectrometry platform for TMG quantitation may allow for the identification of diagnostic signatures for early-stage cancer detection. Briefly, we monitored fragment moieties characteristic of gangliosides in an untargeted fashion by mass spectrometry. We then identified those differentially altered in cancerous groups compared to normal, and subsequently performed targeted MRM analysis. Through these investigations, we have identified multiple TMGs, specifically multiple types of GD2 and GD3 species characterized by unique lipid tails across different cancer types in human serum from confirmed cancer diagnoses. Other ganglioside classes including GMs and relatively understudied GTs were also identified in this study. Notably, the serum of melanoma and ovarian cancer patients exhibited significantly increased levels of several ganglioside species compared to age-matched healthy serum, highlighting the potential of TMGs as a promising avenue for cancer diagnosis. Further experiments will focus on refining this mass spectrometry method and expand demographic representation to confirm our initial findings and identify additional TMGs of interest. In addition, we intend to apply immune-based platforms such as thin-layer chromatography and ELISA, which have already shown promising results in the detection and quantitation of these compounds. Taken together, AOA Dx is advancing the development of a high-throughput mass spectrometry platform designed for the detection of TMGs, with a primary focus on GD2 and GD3. Our objective is the identification of a diagnostic disease signature for early-stage cancer detection. The validation of this type of diagnostic panel would allow for expedited diagnosis and treatment of cancers currently diagnosed at late stages, ultimately reducing healthcare costs and increasing survival rates. Future research will aim to validate these biomarkers in independent prospective studies. Citation Format: Rachel Culp-Hill, Collin Hill, Adele Blackler, William Ricketts. Identification of tumor marker gangliosides for early cancer detection: A mass spectrometry approach [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2447.

Next-generation sequencing-based liquid biopsy may be used for detection of residual disease and cancer recurrence monitoring in dogs.

The purpose of this study was to evaluate the performance of a next-generation sequencing-based liquid biopsy test for cancer monitoring in dogs. Pre- and postoperative blood samples were collected from dogs with confirmed cancer diagnoses originally enrolled in the CANcer Detection in Dogs (CANDiD) study. A subset of dogs also had longitudinal blood samples collected for recurrence monitoring. All cancer-diagnosed patients had a preoperative blood sample in which a cancer signal was detected and had at least 1 postoperative sample collected. Clinical data were used to assign a clinical disease status for each follow-up visit. Following excisional surgery, in the absence of clinical residual disease at the postoperative visit, patients with Cancer Signal Detected results at that visit were 1.94 times as likely (95% CI, 1.21 to 3.12; P = .013) to have clinical recurrence within 6 months compared to patients with Cancer Signal Not Detected results. In the subset of patients with longitudinal liquid biopsy samples that had clinical recurrence documented during the study period, 82% (9/11; 95% CI, 48% to 97%) had Cancer Signal Detected in blood prior to or concomitant with clinical recurrence; in the 6 patients where molecular recurrence was detected prior to clinical recurrence, the median lead time was 168 days (range, 47 to 238). Next-generation sequencing-based liquid biopsy is a noninvasive tool that may offer utility as an adjunct to current standard-of-care clinical assessment for cancer monitoring; further studies are needed to confirm diagnostic accuracy in a larger population.

Diagnostic Delay in Pediatric Cancer; Causes and Effect on Survival Rates

Background Currently, timely diagnosis immediately followed by effective treatment is an essential approach for control of the public health burden due to childhood cancers. Our aim was to ascertain the median lag time till diagnosis, and treatment of pediatric patients with malignancy and to determine factors influencing the delayed diagnosis and relate delay times to diagnosis with overall and event free survival rates. Methods A cross sectional prospective study including children and adolescents with confirmed cancer diagnosis was conducted in Pediatric Hematology –Oncology Unit of Ain Shams University Children's Hospital, Egypt. A predesigned questionnaire was structured to collect data from parents or legal guardians of patients diagnosed with cancer about demographic and cancer characteristics the latter included presenting symptoms, type, site, risk, modalities of diagnosis, time to diagnose, treatment with calculation of event free survival and overall survival times. Results The study enrolled 115 children and adolescents with cancer during the period from August 2020 to May 2021. Misdiagnosis was initially recorded in 16 (13.9%) patients. Median total diagnostic delay or Lag Time (LT) for all patients was 53 days. Patients’ gender, age and socioeconomic status did not affect the median total delay, whereas residency, misdiagnosis, presence of health insurance, tumor location and presence of metastasis significantly influenced the total diagnostic delay. There was no significant correlation between overall and event free survival rates and total diagnostic delay. Conclusion Delayed diagnosis of solid malignant neoplasms except Wilms tumor, needs more attention to health care providers awareness especially in rural regions.

Accuracy of a clinical decision support system in identifying patients at risk of cancer in primary care.

1562 Background: 85% of patients diagnosed with cancer are symptomatic at presentation. Yet a delay in diagnosis (e.g. missing a presentation) can result in late stage detection and poorer outcomes. Clinical decision support systems (CDSS) have been used in other fields to calculate risk and support standardization of care. However, little has been reported about successful implementation of CDSS with determining cancer risk. C the Signs is a CDSS which uses artificial intelligence, mapped with the latest evidence and guidance, to assist healthcare professionals in identifying patients at risk of cancer and determining the most appropriate pathway for diagnosis. The aim of this study is to assess the accuracy of C the Signs in a real-world setting. Methods: A retrospective observational study was conducted in the National Health Service in England utilizing all patients risk assessed for cancer through the Electronic Healthcare Record (EHR) integrated C the Signs platform between 1st January 2021 and 31st August 2022. A total of 118,677 patients were risk assessed. All patients were followed up for 6 months post risk assessment to determine outcome. A sub-analysis was performed on the patients who were flagged at risk of cancer through C the Signs and subsequently diagnosed with cancer to establish the CDSS’s cancer origin accuracy (the ability for the system to accurately predict which cancer the patient is at risk of). Results: 7,295 patients were diagnosed with cancer within 6 months of a C the Signs risk assessment. 7,056 patients were successfully identified at risk of cancer by the CDSS with a sensitivity of 96.7%. There were 103,168 false positives with a specificity of 7.37%. Of the 8,453 patients who were identified as not at risk of cancer using the CDSS, 239 had a confirmed cancer diagnosis within 6 months of risk assessment (with a negative predictive value 97.2%). The cancer origin accuracy of C the Signs was 85.6% across all cancers. Conclusions: A cancer CDSS like C the Signs can be used to accurately identify patients at risk of cancer. More research is needed to understand the specificity and false positive rate, and the impact of identifying these patients with non-cancer disease.

Cancer survival (SURVCANCER BRAZIL): Analysis of 132,621 cases from 19 hospital-based registries in southernmost Brazilian state comparing public and private insurance.

6632 Background: Brazilian data for cancer survival are scarce. Therefore, we aimed to describe the 5-year overall survival (OS) of individuals with public and private insurance from Rio Grande do Sul/RS (Brazil) diagnosed with the 17 most incident tumors in the country. Methods: Data from 19 of the 27 hospital-based cancer registries from RS were integrated with the Brazilian Information System data. Individuals with confirmed cancer diagnoses between 2005-2017 were included. Passive follow-up time was calculated as the difference between diagnosis and death (from any cause) or censure date. Survival was estimated by Kaplan-Meier method. Comparison between the survival of individuals assisted by public or private insurance was evaluated using hazard ratios (HR) estimated by multivariate Frailty and Cox regression models with adjustments for age, sex, and economic status. Results: 5-year OS was higher for patients with private health insurance for 13 of the 17 cancers studied. Conclusions: The survival trends among cancer patients assisted by public and private health insurance systems reveal vast differences that may be likely attributable to differences in access to early diagnosis and optimum treatment. We hope our results will help government officials understand that ongoing cancer survival surveillance is an indispensable source of information and a key policy tool for public health decisions. [Table: see text]

Real-world performance of a multi-cancer early detection test based on integrative analysis of cell-free DNA whole-methylome sequencing.

10521 Background: Early detection and diagnosis is key to reducing cancer-related mortality. We developed a blood-based multi-cancer early detection test, called THEMIS, using multimodal analysis of plasma cell-free DNA (cfDNA) methylation, fragmentation, and copy number alteration features by whole-methylome sequencing (WMS). The real-world performance of THEMIS was investigated with a prospective cohort of high-risk populations and the preliminary results were reported here. Methods: A total of 1,374 adults over 65 y with additional cancer risk factors for five common cancers (colorectal, esophageal, liver, lung, or stomach cancer) were recruited in the city of Wuxi, Jiangsu province, China. Additional risk factors included fecal occult blood, smoking history, H. pylori infection, HBV infection, and serum protein biomarkers. Participants had no known cancer diagnosis at the time of administration. Blood samples were collected and subject to low-pass WMS assay (~2X) and cancer probability was predicted by the THEMIS model, which was developed and locked in previous studies. Participants predicted as cancer positive by THEMIS were followed up until positive cancer diagnosis in a clinic or one year after receiving the test report, whichever was earlier. Results: At a fixed cutoff rendering 99% training specificity, THEMIS predicted 58 (4.15%) positive cases, among whom 19 participants consented to and completed follow-up. Ten participants received confirmed cancer diagnosis within the follow-up period, including five lung cancers, three liver cancers, one esophageal cancer, and one colorectal cancer. These results yielded a positive predictive value (PPV) of 52.6%. Those who declined follow-up upon a positive THEMIS report were predicted with digestive tract cancers, which need gastrointestinal endoscope for diagnostic confirmation. Conclusions: The nonivasive blood-based THEMIS test demonstrated promising performance and patient compliance for clinical utility to detect cancer early and improve patient outcome. Given that clinical follow-ups were only conducted with a subset of participants, future investigations of the precise real-world performance of THEMIS are needed with more complete patient follow-up.

Health Data Sharing Perspectives of Patients Receiving Care in CancerLinQ-Participating Oncology Practices.

CancerLinQ seeks to use data sharing technology to improve quality of care, improve health outcomes, and advance evidence-based research. Understanding the experiences and concerns of patients is vital to ensure its trustworthiness and success. In a survey of 1,200 patients receiving care in four CancerLinQ-participating practices, we evaluated awareness and attitudes regarding participation in data sharing. Of 684 surveys received (response rate 57%), 678 confirmed cancer diagnosis and constituted the analytic sample; 54% were female, and 70% were 60 years and older; 84% were White. Half (52%) were aware of the existence of nationwide databases focused on patients with cancer before the survey. A minority (27%) indicated that their doctors or staff had informed them about such databases, 61% of whom indicated that doctors or staff had explained how to opt out of data sharing. Members of racial/ethnic minority groups were less likely to be comfortable with research (88% v 95%; P = .002) or quality improvement uses (91% v 95%; P = .03) of shared data. Most respondents desired to know how their health information was used (70%), especially those of minority race/ethnicity (78% v 67% of non-Hispanic White respondents; P = .01). Under half (45%) felt that electronic health information was sufficiently protected by current law, and most (74%) favored an official body for data governance and oversight with representation of patients (72%) and physicians (94%). Minority race/ethnicity was associated with increased concern about data sharing (odds ratio [OR], 2.92; P < .001). Women were less concerned about data sharing than men (OR, 0.61; P = .001), and higher trust in oncologist was negatively associated with concern (OR, 0.75; P = .03). Engaging patients and respecting their perspectives is essential as systems like CancerLinQ evolve.

Malignancy in Ataxia Telangiectasia (A-T)

RationaleAtaxia telangiectasia (A-T) is an autosomal recessive DNA repair disorder caused by biallelic mutations in the ATM gene. Clinical features include immunodeficiency, neurodegeneration and cancer predisposition. About 25% of A-T patients will develop early onset malignancies, which are difficult to treat given hypersensitivity to radiation and radiomimetic drugs. Cancer is a leading cause of death in A-T patients. MethodsWe queried the Johns Hopkins A-T Clinical Center database for patients with a confirmed cancer diagnosis. A total of 76 out of 505 patients seen at the clinic from 1995 to the present were identified. Patients were characterized by demographics, age at cancer diagnosis, A-T phenotype (classic versus atypical), ATM mutation, type of malignancy, cancer therapy, therapy modifications, therapy-associated toxicity, and two-year event free survival. ResultsWe found 56 hematologic malignancies with an average cancer diagnosis age of 14.1 years. Among patients < 18 years of age, hematological malignancies were predominant (91%), whereas among patients >18 years old, solid tumors were common (61%). 34 (60.7%) cases were non-Hodgkin lymphoma, 15 (26.7%) leukemias with T cell predominance, and 7 (12.5%) Hodgkin's lymphomas. There were 24 solid tumors in 22 patients, with an average cancer diagnosis age of 25.3 years; 9 (38%) gastrointestinal, 7 (29%) skin, 3 (13%) breast, 2 (8%) thyroid, and 1 each lung, gynecologic and parotid cancer. We found that 76% of our malignancy cohort died of cancer or therapy complications. ConclusionsWe characterized cancers in the world's largest A-T cohort with the future goal of providing improved malignancy screening and developing research protocols for standardized treatment.

Abstract 3377: Liquid biopsy analysis reveals orthologs of actionable human cancer variants in dogs

Abstract Genotype-matched therapeutics have become widely adopted in the management of human cancers and can be guided by testing tumor tissue or cell-free DNA from plasma. OncoKB (Oncology Knowledge Base) is the first FDA-recognized database that contains information about these targetable somatic variants and corresponding therapeutic agents, including levels of evidence. Many of the human OncoKB variants have orthologs in the canine genome. This study was conducted to determine the feasibility of detecting these orthologs in dogs using liquid biopsy. This study involved two cohorts: The first was a cohort of 619 client-owned dogs with a variety of cancer diagnoses across all disease stages enrolled in a clinical validation study for a liquid biopsy test (herein the “research cohort”). All dogs had pre-treatment plasma samples collected at enrollment, and a subset of dogs also had matched tumor tissue collected. The second cohort comprised 457 client-owned dogs that had testing as part of the clinical deployment of the above-mentioned liquid biopsy test (herein the “clinical cohort”); 31% of these dogs had samples submitted as an aid in diagnosis (for dogs in which cancer was suspected clinically), and 69% had samples submitted for screening (in dogs with no a priori suspicion of cancer). Blood samples (and tumor samples, when available) were subjected to DNA extraction, proprietary library preparation, and next-generation sequencing. Sequencing data were analyzed using an internally developed bioinformatics pipeline to detect genomic alterations associated with the presence of cancer. Only canine orthologs of variants in the OncoKB database were evaluated in this study. Variants were called if they were observed in plasma at an allele frequency of at least 0.5%, with at least 6 unique supporting reads. Variants identified from plasma were subsequently genotyped in tissue without additional variant-level filtering. Analysis of plasma identified canine orthologs of OncoKB variants in ~8% of dogs in the research cohort, and ~4% of dogs in the clinical cohort. The higher percentage observed in the research cohort is likely due to the higher percentage of patients with confirmed cancer diagnosis. In the patients with an OncoKB ortholog in the research cohort, the dog had a cancer type that matched the human indication for the detected variant in 15% of cases. Of dogs in which an ortholog was identified in plasma, 44% had matched tumor tissue; and the variant observed in plasma was confirmed in tissue in &amp;gt;50% of these subjects. This study demonstrates the feasibility of detecting canine orthologs of targetable human cancer somatic variants in the blood of dogs using next-generation sequencing. Although it is currently unclear how human databases can be used to inform targeted treatment decisions in dogs, these findings may have relevance for comparative oncology studies and future precision therapeutics development for both species. Citation Format: Daniel S. Grosu, Ilya Chorny, Kristina M. Kruglyak, John A. Tynan, Susan C. Hicks, Todd A. Cohen, Allison L. O'Kell, Jill M. Rafalko, Jason Chibuk, Angela L. McCleary-Wheeler, Andi Flory, Dana W. Tsui. Liquid biopsy analysis reveals orthologs of actionable human cancer variants in dogs [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 3377.

Pharmacokinetics and Comparative Bioavailability of Test or Reference Capecitabine and Discrepant Pharmacokinetics Among Various Tumors in Chinese Solid Cancer Patients.

The main objective of this study was to compare the pharmacokinetic (PK) bioequivalence of two capecitabine tablets and explore the different PK profiles of various tumors in Chinese patients with cancer. All 76 patients with a confirmed cancer diagnosis were included in this study. A single dose of 2000mg of test or reference capecitabine (Xeloda, Hoffmann-La Roche) was orally administered postprandially. After 24hours of washout, the patients were administered the test or the reference capecitabine alternately. PK samples were taken at the time of predose up to 6hours postdose. Bioequivalence evaluation was performed using the geometric mean ratios of peak concentration in plasma (Cmax) , area under the concentration-time curve from time 0 to 6 h (AUC0-t) , and area under the concentration-time curve from time 0 to infinity (AUC0-∞ ) for capecitabine and 5-fluorouracil (5-FU). In this study, 90% confidence intervals of test/reference mean ratios of Cmax , AUC0-t , AUC0-∞ of capecitabine and 5-FU were in the range of 80%-125%. Both the test and reference capecitabine regimens were well tolerated in this study. Furthermore, we found that patients with esophageal-gastrointestinal cancers had higher exposure to capecitabine and a shorter time to Cmax (Tmax) than those with breast cancer. In conclusion, a single oral dose of 2000mg of test capecitabine tablets after postprandial administration was bioequivalent to the reference drug.

Cannabis in Cancer Survivors Who Report High Impact Chronic Pain: Findings from a 1500+ Patient Survey.

Chronic pain in cancer survivors negatively impacts quality of life. This study sought to investigate the relationship between high-impact chronic pain (HICP) -- defined as chronic pain that limits life or work activities on most days or every day in the past 3 months -- and cannabis in cancer survivors. An electronic survey was developed in conjunction with the National Cancer Institute Comprehensive Cancer Centers in the United States. This survey was distributed to cancer survivors within a multi-site, single institution setting. The survey response rate was 23.0% (2304/10,000); 72.7% of these patients (1676/2304) did in fact have a confirmed cancer diagnosis. Among these cancer survivors, 16.5% (unweighted 278/1676) had HICP, and 12.4% (208/1676) reported cannabis use since their cancer diagnosis. The prevalence of past 30-day cannabis use was 12.3% (206/1676). Compared to cancer survivors without pain, those with HICP were more likely to believe in the benefits of cannabis (unweighted 92.1% vs. 74.7%; age-adjusted odds ratio [OR] = 3.1; 95% CI: 1.9-5.1) and less likely to believe in its risks (unweighted 48.2% vs. 58.4%; age-adjusted OR = 0.6; 95% CI: 0.4-0.7). Cancer survivors with HICP have a higher prevalence of cannabis use compared to those patients without pain. More research is needed to advance pain and symptom management among cancer survivors and to identify clinical scenarios in which benefit is greater than potential harm.

Income Change One Year after Confirmed Cancer Diagnosis and Its Associated Factors in Japanese Patients

The number of patients who survive for a long time after cancer diagnosis is rapidly increasing; however, such patients experience major problems such as returning to work and changes in their income. This study aimed to determine the extent of income changes of cancer patients during the first year after cancer diagnosis and identify the influencing factors. From November 2019 through January 2020, we conducted a multicenter, self-administered anonymous survey of cancer patients in Kagawa Prefecture, Japan. The number of questionnaires collected was 483 (recovery rate 60.4%), and the number of participants who met the inclusion criteria was 72. Mean year-on-year income level one year since cancer diagnosis was 66% (SD: 32%; median: 70%). Cancer stage (p = 0.016), employment status at diagnosis (p = 0.006), and continued employment at the same workplace (p = 0.001) were associated with income change. Findings from this study showed that cancer patients lost one-thirds of their income one year after their diagnosis. It was related to the stage of their illness, employment status, and continued employment at their workplace just before the diagnosis. Employers should provide cancer patients with the support they need to keep them employed.