The impact of the California state lockdown during the COVID-19 pandemic on management of patients with pancreatic ductal adenocarcinoma.

BACKGROUND AND OBJECTIVES: The SARS-COVID-19 pandemic significantly limited healthcare access. We sought to evaluate whether California's lockdown in March 2020 affected staging and time to treatment of pancreatic ductal adenocarcinoma (PDAC). We hypothesized that patients diagnosed after the lockdown would have longer time to treatment and higher stage at presentation. METHODS: We retrospectively identified and categorized 1294 patients presenting to five University of California healthcare systems with a new diagnosis of PDAC into "pre-lockdown" and "post-lockdown" groups based on timing of pathologic diagnosis. RESULTS: In the 12 months pre-lockdown, 835 patients were diagnosed with PDAC, and 459 patients in the 6 months post-lockdown. Demographics, staging, and treatment type were similar between eras. There was a decreased male:female ratio post- versus pre-lockdown (0.97 vs. 1.25; p = 0.03). Time from symptom onset to first treatment was significantly increased among females post-lockdown (p = 0.001). However, overall time from diagnosis to first treatment was shorter in the post-lockdown era (median 23 vs. 26 days, p < 0.001). CONCLUSIONS: The COVID-19 lockdown did not significantly delay initial presentation, diagnosis, or treatment of newly diagnosed PDAC patients. Time from diagnosis to first treatment was shorter post-lockdown. Reduced healthcare utilization for minor complaints and increased telehealth utilization may have contributed.

Electronic Coding for Abnormal Fecal Immunochemical Test Is Associated With Increased Colonoscopy Completion.

INTRODUCTION: We examined the utility of the International Classification of Disease, Tenth Revision (ICD-10) code, R19.5, for a positive or abnormal fecal immunochemical test (FIT) and its association with colonoscopy completion. METHODS: We identified all patients in a safety-net health system who underwent FITs from January 1, 2020, to August 31, 2021, and extracted the FIT date, FIT result, and ICD-10 code (R19.5) and colonoscopy procedures for each patient. RESULTS: FIT-positive patients who had an R19.5 designation within 90 days (n = 383) were significantly more likely than all other FIT-positive patients (n = 273) to complete a colonoscopy within 6 months (40.9% vs 16.8%, P <0.001). DISCUSSION: We found that less than two-thirds of patients had an ICD-10 code designated in their chart within 30 days of an abnormal FIT. When coding occurred in a timely manner, patients were more likely to complete their colonoscopy within 6 months.

Effect of Mailed Fecal Immunochemical Test Outreach for Patients Newly Eligible for Colorectal Cancer Screening.

INTRODUCTION: Limited data exists on the effectiveness of organized outreach campaigns on CRC screening completion for patients who are newly eligible for such screening. METHODS: We conducted an analysis of an existing clinical trial dataset of a publicly funded safety-net health system serving low-income populations. RESULTS: A total of 619 patients aged 50-51 received the outreach intervention and 3108 patients aged greater than 51 years old who had no prior history of FIT testing similarly received the outreach intervention. Patients newly eligible for FIT were more likely to complete a FIT test compared with older patients who had yet to complete a FIT test (58.3% vs 40.5%, p < 0.001). CONCLUSION: Patients who are newly eligible for colorectal cancer screening are more likely to respond to outreach interventions than older patients without a prior history of FIT, indicating newly eligible patients across diverse populations may benefit from targeted outreach intervention.

Durability of FIT Screening After Cessation of a Screening Outreach Intervention.

INTRODUCTION: Organized outreach to increase CRC screening using mailed FIT tests has been shown to be effective, but durable changes to screening behavior after cessation of screening is not known. METHODS: In this study, after cessation of funding for an organized cancer screening outreach program, we evaluated whether adherence to screening remained elevated. Patients aged 50-75 years eligible for CRC screening from eight safety net clinics were randomly assigned to outreach intervention vs usual care alone in 2016 to 2018; the primary outcome analyzed was the difference in the cumulative proportion of completed FIT screening between study assignments 1 year after study cessation. RESULTS: Despite higher rates of FIT screening for patients who were randomly assigned to the outreach intervention, FIT completion was not significantly different between the group that received the outreach services versus the usual care group (28.3% vs 29.8%, p = 0.158). CONCLUSION: Outreach campaigns and their activities must be sustained to maintain improved rates of screening participation.

Characteristics and Growth Rate of Lung Metastases in Patients With Primary Gastrointestinal Malignancies and Lung-dominant Metastatic Disease: A Retrospective Cohort Analysis.

INTRODUCTION: There are no formal guidelines for the management of patients with primary gastrointestinal (GI) cancers who have lung-exclusive or lung-predominant metastases. We performed a retrospective analysis to evaluate host and tumor characteristics of this patient population, model patterns and rates of growth, and describe treatment approaches. MATERIALS AND METHODS: Eligible patients had a GI cancer with either synchronous or metachronous lung metastases but no other visceral or peritoneal sites of involvement. In addition to collecting detailed patient-specific and tumor-specific information, all imaging studies (computed tomography±positron emission tomography scans) were reviewed by an independent radiologist. Up to 5 lung metastases were tracked through each patient's clinical course. Growth rate was estimated using a linear mixed model analysis. RESULTS: Forty patients met eligibility criteria (18 pancreatic, 15 colorectal, 6 hepatobiliary, 1 gastroesophageal; synchronous vs. metachronous, 13 and 27, respectively). Median time from original cancer diagnosis to onset of metachronous lung lesions was 16 months. Interval from first appearance of lung metastases to treatment initiation was 6.2 months. Average growth rate of the largest lesion was 0.21 mm/mo (95% confidence interval, 0.12-0.30), with substantial intrapatient and interpatient variability. Sixty percent of patients underwent locoregional interventions in addition to or in lieu of systemic therapy for their lung metastases. Median survival of the entire study cohort from first appearance of lung metastases was 54 months. CONCLUSIONS: Lung metastases from primary GI cancers have a variable but overall indolent natural history and are generally associated with prolonged survival outcomes. Further efforts to define patterns of growth of lung metastases, informed by size, number, and clinical/molecular features, are needed to guide appropriate timing and selection of therapy as well as surveillance strategies.

Rapid Improvement in Gemcitabine-associated Thrombotic Microangiopathy After a Single Dose of Eculizumab: Case Report and Review of the Literature.

We present here the case of a 39-year-old man with metastatic pancreatic carcinoma receiving chemotherapy with the combination of gemcitabine and nab-paclitaxel as part of a clinical trial. Despite an impressive response to therapy, he ultimately developed profound anasarca, renal insufficiency, progressive cytopenias, and malignant hypertension 6 months into his treatment course. The diagnosis of gemcitabine-associated thrombotic microangiopathy (G-TMA) was made based on renal biopsy, and receipt of the anti-C5 monoclonal antibody eculizumab proved successful at reversing his deteriorating clinical course and improving his laboratory parameters. This case illustrates the importance of recognizing this rare but serious complication, and highlights one potential therapeutic option that can be used in the appropriate clinical context.

Blockchain-Authenticated Sharing of Genomic and Clinical Outcomes Data of Patients With Cancer: A Prospective Cohort Study.

BACKGROUND: Efficiently sharing health data produced during standard care could dramatically accelerate progress in cancer treatments, but various barriers make this difficult. Not sharing these data to ensure patient privacy is at the cost of little to no learning from real-world data produced during cancer care. Furthermore, recent research has demonstrated a willingness of patients with cancer to share their treatment experiences to fuel research, despite potential risks to privacy. OBJECTIVE: The objective of this study was to design, pilot, and release a decentralized, scalable, efficient, economical, and secure strategy for the dissemination of deidentified clinical and genomic data with a focus on late-stage cancer. METHODS: We created and piloted a blockchain-authenticated system to enable secure sharing of deidentified patient data derived from standard of care imaging, genomic testing, and electronic health records (EHRs), called the Cancer Gene Trust (CGT). We prospectively consented and collected data for a pilot cohort (N=18), which we uploaded to the CGT. EHR data were extracted from both a hospital cancer registry and a common data model (CDM) format to identify optimal data extraction and dissemination practices. Specifically, we scored and compared the level of completeness between two EHR data extraction formats against the gold standard source documentation for patients with available data (n=17). RESULTS: Although the total completeness scores were greater for the registry reports than those for the CDM, this difference was not statistically significant. We did find that some specific data fields, such as histology site, were better captured using the registry reports, which can be used to improve the continually adapting CDM. In terms of the overall pilot study, we found that CGT enables rapid integration of real-world data of patients with cancer in a more clinically useful time frame. We also developed an open-source Web application to allow users to seamlessly search, browse, explore, and download CGT data. CONCLUSIONS: Our pilot demonstrates the willingness of patients with cancer to participate in data sharing and how blockchain-enabled structures can maintain relationships between individual data elements while preserving patient privacy, empowering findings by third-party researchers and clinicians. We demonstrate the feasibility of CGT as a framework to share health data trapped in silos to further cancer research. Further studies to optimize data representation, stream, and integrity are required.