The National Cancer Database Conforms to the Standardized Framework for Registry and Data Quality.

BACKGROUND: Standardization of procedures for data abstraction by cancer registries is fundamental for cancer surveillance, clinical and policy decision-making, hospital benchmarking, and research efforts. The objective of the current study was to evaluate adherence to the four components (completeness, comparability, timeliness, and validity) defined by Bray and Parkin that determine registries' ability to carry out these activities to the hospital-based National Cancer Database (NCDB). METHODS: Tbis study used data from U.S. Cancer Statistics, the official federal cancer statistics and joint effort between the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), which includes data from National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology, and End Results (SEER) to evaluate NCDB completeness between 2016 and 2020. The study evaluated comparability of case identification and coding procedures. It used Commission on Cancer (CoC) standards from 2022 to assess timeliness and validity. RESULTS: Completeness was demonstrated with a total of 6,828,507 cases identified within the NCDB, representing 73.7% of all cancer cases nationwide. Comparability was followed using standardized and international guidelines on coding and classification procedures. For timeliness, hospital compliance with timely data submission was 92.7%. Validity criteria for re-abstracting, recording, and reliability procedures across hospitals demonstrated 94.2% compliance. Additionally, data validity was shown by a 99.1% compliance with histologic verification standards, a 93.6% assessment of pathologic synoptic reporting, and a 99.1% internal consistency of staff credentials. CONCLUSION: The NCDB is characterized by a high level of case completeness and comparability with uniform standards for data collection, and by hospitals with high compliance, timely data submission, and high rates of compliance with validity standards for registry and data quality evaluation.

Impact of the COVID-19 Pandemic on Lung Cancer Screening Processes in a Northeast Tertiary Health Care Network.

ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic disrupted health care systems, including implementation of lung cancer screening programs. The impact and recovery from this disruption on screening processes is not well appreciated. Herein, the radiology database of a Northeast tertiary health care network was reviewed before and during the pandemic (2013-2022). In the 3 months before the pandemic, an average of 77.3 lung cancer screening with computed tomography scans (LCS-CT) were performed per month. The average dropped to 23.3 between April and June of 2020, whereas COVID-19 hospitalizations peaked at 1604. By July, average hospitalizations dropped to 50, and LCS-CTs rose to >110 per month for the remaining year. LCS-CTs did not decline during COVID-19 surges in December of 2021 and 2022. The LCS-CT performance grew by 4.5% in 2020, 69.6% in 2021, and 27.0% in 2022, exceeding projected growth by 722 examinations. This resiliency indicates a potentially smaller impact of COVID-19 on lung cancer diagnoses than initially feared.

The Representation of Surgery in Oncology Clinical Trials: 2001 to 2022.

BACKGROUND: Surgery is a mainstay of cancer care. Since the advancement of cancer treatment occurs through clinical trials, it is critical to investigate the degree and nature of representation of surgery in oncological clinical trials. METHODS: This observational analysis used publicly available data from clinicaltrials.gov to investigate non-industry-funded oncological clinical trials in the United States between 2012 and 2022. RESULTS: From 2012 to 2022, 1,861 (15.7%) of the 11,843 registered oncologic clinical trials were surgical. There was a 43.2% increase in proportional surgical trials and an 18.9% increase in oncology trials over the last two decades. Surgery+diagnostic-technique trials increased from 5.14 to 12.6% (P < 0.001, 95%CI [- 0.097, - 0.052]), surgery+radiation trials increased from 5.24 to 8.1% (P = 0.004, 95%CI [- 0.047, - 0.0088]), surgery+systemic-therapy trials decreased from 34.5 to 29.2% (P = 0.003, 95%CI [0.018, 0.088]), surgery+supportive-therapy trials increased from 8.0 to 11.3% (P = 0.004, 95%CI [- 0.056, - 0.01]) and 'surgery-as-the-variable' trials decreased from 12.0 to 3.5% (P < 0.001, 95%CI[0.065, 0.1]). Systemic therapy with biologics increased from 38.1 to 53.9% (P < 0.001, 95%CI [- 0.22, - 0.091]). Surgery-vs.-no-surgery trials increased from 16.8 to 37.3% (P = 0.001, 95%CI [- 0.32, - 0.078]). CONCLUSION: Surgical oncology trials increased by 43.2% over the last 10 years. The focus of clinical trials is changing to the encouragement of innovation in more diagnostic and less invasive techniques, and targeted therapies.

Evaluation of the Impact of the COVID-19 Pandemic on Reliability of Cancer Surveillance Data in the National Cancer Database.

PURPOSE: This study evaluated the reliability of cancer cases reported to the National Cancer Database (NCDB) during 2020, the first year of the COVID-19 pandemic. METHODS: Total number of cancer cases reported to the NCDB between January 2018 and December 2020 were calculated for all cancers and 21 selected cancer sites. The additive outlier method was used to identify structural breaks in trends compared with previous years. The difference between expected (estimated using the vector autoregressive method) and observed number of cases diagnosed in 2020 was estimated using generalized estimating equation under assumptions of the Poisson distribution for count data. Interrupted time series analysis was used to compare changes in the number of records processed by registrars each month of 2020. All models accounted for seasonality, regional variation, and random error. RESULTS: There was a statistically significant decrease (structural break) in the number of cases diagnosed in April 2020, with no recovery in number of cases during subsequent months, leading to a 12.4% deficit in the number of cases diagnosed during the first year of the pandemic. While the number of cancer records initiated by cancer registrars also decreased, the number of records marked completed increased during the first months of the pandemic. CONCLUSION: There was a significant deficit in the number of cancer diagnoses in 2020 that was not due to cancer registrars' inability to extract data during the pandemic. Future studies can use NCDB data to evaluate the impact of the pandemic on cancer care and outcomes.

Association Between Metastatic Pattern and Prognosis in Stage IV Gastric Cancer: Potential for Stage Classification Reform.

PURPOSE: This study aims to clarify the association between metastatic pattern and prognosis in stage IV gastric cancer, with a focus on patients presenting with metastases limited to nonregional lymph nodes. METHODS: In this retrospective cohort study, the National Cancer Database was used to identify patients ≥ 18 years of age diagnosed with stage IV gastric cancer between 2016 and 2019. Patients were stratified according to pattern of metastatic disease at diagnosis: nonregional lymph nodes only ("stage IV-nodal"), single systemic organ ("stage IV-single organ"), or multiple organs ("stage IV-multi-organ"). Survival was assessed by Kaplan-Meier curves and multivariable Cox models in unadjusted and propensity score-matched samples. RESULTS: Overall, 15,050 patients were identified, including 1,349 (8.7%) stage IV-nodal patients. Most patients in each group received chemotherapy [68.6% of stage IV-nodal patients, 65.2% of stage IV-single organ patients, and 63.5% of stage IV-multi-organ patients (p = 0.003)]. Stage IV-nodal patients exhibited better median survival (10.5 months, 95% CI 9.7-11.9, p < 0.001) than single organ (8.0, 95% CI 7.6-8.2) and multi-organ (5.7, 95% CI 5.4-6.0) patients. In the multivariable Cox model, stage IV-nodal patients also exhibited better survival (HR 0.79, 95% CI 0.73-0.85, p < 0.001) than single organ (reference) and multi-organ (HR 1.27, 95% CI 1.22-1.33, p < 0.001) patients. CONCLUSIONS: Nearly 9% of clinical stage IV gastric cancer patients have their distant disease confined to nonregional lymph nodes. These patients were managed similarly to other stage IV patients but experienced a better prognosis, suggesting opportunities to introduce M1 staging subclassifications.

Twenty-Five Years of Cancer Follow-Up; Is the Data Worth the Effort?

BACKGROUND: Substantial resources are dedicated to long-term follow-up within cancer registries; however, the completeness of these data is poorly characterized. Our objectives were to quantify long-term cancer follow-up data completeness and the effort required to collect these data using the National Cancer Database (NCDB). METHODS: To quantify data completeness, patients diagnosed with cancer in 1989 were identified in the NCDB and loss to follow-up rates were assessed for 25 years after diagnosis. To quantify data collection effort, patients diagnosed from 1989 to 2014 who were alive and eligible for follow-up in 2014 were identified and the effort to perform patient follow-up was obtained via a survey of tumor registrars. The effort to perform follow-up beyond various intervals after diagnosis was calculated. RESULTS: In total, 484,201 patients at 958 hospitals were diagnosed with cancer in 1989. After 5 years, 6.5% of patients were lost to follow-up (13.1% of living patients), 50.3% were deceased, and 43.2% had ongoing follow-up. After 15 years, 22.9% were lost to follow-up (68.7% of living patients), 66.7% were deceased, and 10.5% had ongoing follow-up. By 25 years, loss to follow-up increased to 28.6% (93.7% of living patients), 69.5% were deceased, and 1.9% had ongoing follow-up. In 2014, 522,838 h were spent performing follow-up for 2,091,353 patients at 1456 hospitals who were >15 years from their initial cancer diagnosis. CONCLUSIONS: While 5-year follow-up is excellent in the NCDB, loss to follow-up increases over time. The impact of curtailing data collection is under investigation and follow-up duration requirements will be re-evaluated.

Evaluating information loss in the National Cancer Database from cases lost to follow-up.

BACKGROUND AND OBJECTIVES: Cancer registries must focus on data capture which returns value while reducing resource burden with minimal loss of data. Identifying the optimum length of follow-up data collection for patients with cancer achieves this goal. METHODS: A two-step analysis using entropy calculations to assess information gain for each follow-up year, and second-order differences to compare survival outcomes between the defined follow-up periods and lifetime follow-up. A total of 391 567 adult cases, deidentified in the National Cancer Database and diagnosed in 1989. Comparisons examined a subset of 61 908 lung cancer cases, 48 387 colon and rectal cancer cases, and 64 134 breast cancer cases in adults. A total of 4133 pediatric cases were diagnosed in 1989 examining 1065 leukemia cases and 494 lymphoma cases. RESULTS: Annual increases in information gain fell below 1% after 16 years of follow-up for adult cases and 9 years for pediatric cases. Comparison of second-order differences showed 62% of the comparisons were similar between 15 years and lifetime follow-up when examining restricted mean survival time. In addition, 90% of the comparisons were statistically similar when comparing hazard ratios. CONCLUSIONS: Survival analysis using 15 years postdiagnosis follow-up showed minimal differences in information gain compared to lifetime follow-up.

Where the Other Half Dies: Analysis of Mortalities Occurring More Than 30 Days After Complex Cancer Surgery.

BACKGROUND: Nearly half of operative mortalities occur outside the traditionally studied 30-day period after surgery. To identify additional opportunities to improve surgical safety, the circumstances of deaths occurring 31-90 days after complex cancer surgery are analyzed. PATIENTS AND METHODS: Patients aged ≥ 65 years who died within 90 days of complex cancer surgery for nonmetastatic cancer were analyzed in the Surveillance, Epidemiology, and End Results (SEER)-Medicare and the Connecticut Tumor Registry (CTR) databases. RESULTS: Of the 36,114 patients undergoing complex cancer surgery from 2004 to 2013 in SEER-Medicare, 1367 (3.8%) died within 31-90 days ("late mortalities"). Seventy-eight percent of late mortalities were readmitted prior to death. The highest proportion of late mortalities occurred during a readmission (49%), and 11% were never discharged from their index admission. Cause of death (COD) was largely attributed to the malignancy itself (56%), which is unlikely to be the underlying cause. Of the noncancer COD, cardiac causes were most frequent (34%), followed by pulmonary causes (18%). Death was rarely attributed to thromboembolic disease (< 1%). The CTR provided location of death, which was most commonly in a hospital (65%) or nursing facility (20%); death at home was rare (6%). CONCLUSIONS: The vast majority of patients dying between 31 and 90 days of surgery were admitted to a hospital or nursing facility at the time of their death after initially being discharged, and few patients died at home. Greater clarity in death documentation is needed to identify specific opportunities to rescue patients from fatal complications arising in the later postoperative period.

Results of COVID-minimal Surgical Pathway During Surge-phase of COVID-19 Pandemic.

OBJECTIVE: The outcomes of patients treated on the COVID-minimal pathway were evaluated during a period of surging COVID-19 hospital admissions, to determine the safety of continuing to perform urgent operations during the pandemic. SUMMARY OF BACKGROUND DATA: Crucial treatments were delayed for many patients during the COVID-19 pandemic, over concerns for hospital-acquired COVID-19 infections. To protect cancer patients whose survival depended on timely surgery, a "COVID-minimal pathway" was created. METHODS: Patients who underwent a surgical procedure on the pathway between April and May 2020 were evaluated. The "COVID-minimal surgical pathway" consisted of: (A) evolving best-practices in COVID-19 transmission-reduction, (B) screening patients and staff, (C) preoperative COVID-19 patient testing, (D) isolating pathway patients from COVID-19 patients. Patient status through 2 weeks from discharge was determined as a reflection of hospital-acquired COVID-19 infections. RESULTS: After implementation, pathway screening processes excluded 7 COVID-19-positive people from interacting with pathway (4 staff and 3 patients). Overall, 122 patients underwent 125 procedures on pathway, yielding 83 admissions (42 outpatient procedures). The median age was 64 (56-79) and 57% of patients were female. The most common surgical indications were cancer affecting the uterus, genitourinary tract, colon, lung or head and neck. The median length of admission was 3 days (1-6). Repeat COVID-19 testing performed on 27 patients (all negative), including 9 patients evaluated in an emergency room and 8 readmitted patients. In the postoperative period, no patient developed a COVID-19 infection. CONCLUSIONS: A COVID-minimal pathway comprised of physical space modifications and operational changes may allow urgent cancer treatment to safely continue during the COVID-19 pandemic, even during the surge-phase.

Quality Versus Quantity: The Potential Impact of Public Reporting of Hospital Safety for Complex Cancer Surgery.

OBJECTIVE: To estimate the potential mortality reduction if patients chose the safest hospitals for complex cancer surgery. BACKGROUND: Mortality after complex oncologic surgery is highly variable across hospitals, and directing patients away from unsafe hospitals could potentially improve survivorship. Hospital quality measures are becoming increasingly accessible at a time when patients are more engaged in choosing providers. It is currently unclear what information to share with patients to maximally capitalize on patient-centered realignment. METHODS: The National Cancer Database was queried for adults undergoing 5 complex cancer surgeries (pulmonary lobectomy, pneumonectomy, esophagectomy, gastrectomy, and colectomy) for a primary cancer between 2008 and 2012. Risk-standardized mortality rate (RSMR) methodology, currently used by Medicare-based hospital rating systems, was used to classify hospitals as "safest" and "least safe" by procedure. Patients were modeled moving from "least safe" to "safest" hospitals and the potential number of lives saved through patient realignment determined. As surgical volume has historically been used to distinguish safe hospitals, comparisons were made to models moving patients from low-volume to high-volume hospitals. RESULTS: A total of 292,040 patients were analyzed. In an optimally modeled scenario, realignment using RSMR would result in a greater number of lives saved (3592 vs 2161, P < 0.01) and require only 15 patients to change hospitals to save a life, compared to 78 patients using volume models (P < 0.01). CONCLUSIONS: Public reporting of hospital safety, specifically based on RSMR instead of volume, has the potential to lead to meaningful reductions in surgical mortality after complex cancer surgery, even in the setting of a modest patient realignment.

Why Travel for Complex Cancer Surgery? Americans React to 'Brand-Sharing' Between Specialty Cancer Hospitals and Their Affiliates.

INTRODUCTION: Leading cancer hospitals have increasingly shared their 'brand' with smaller hospitals through affiliations. Because each brand evokes a distinct reputation for the care provided, 'brand-sharing' has the potential to impact the public's ability to differentiate the safety and quality within hospital networks. The general public was surveyed to determine the perceived similarities and differences in the safety and quality of complex cancer surgery performed at top cancer hospitals and their smaller affiliate hospitals. METHODS: A national, web-based KnowledgePanel (GfK) survey of American adults was conducted. Respondents were asked about their beliefs regarding the quality and safety of complex cancer surgery at a large, top-ranked cancer hospital and a smaller, local hospital, both in the presence and absence of an affiliation between the hospitals. RESULTS: A total of 1010 surveys were completed (58.1% response rate). Overall, 85% of respondents felt 'motivated' to travel an hour for complex surgery at a larger hospital specializing in cancer, over a smaller local hospital. However, if the smaller hospital was affiliated with a top-ranked cancer hospital, 31% of the motivated respondents changed their preference to the smaller hospital. When asked to compare leading cancer hospitals and their smaller affiliates, 47% of respondents felt that surgical safety, 66% felt guideline compliance, and 53% felt cure rates would be the same at both hospitals. CONCLUSIONS: Approximately half of surveyed Americans did not distinguish the quality and safety of surgical care at top-ranked cancer hospitals from their smaller affiliates, potentially decreasing their motivation to travel to top centers for complex surgical care.

The Significance of Upfront Knowledge of N2 Disease in Non-small Cell Lung Cancer.

BACKGROUND: Previous literature suggests that patients with non-small cell lung cancer (NSCLC) and unsuspected N2 disease (cN0, pN2) represent a distinct subgroup associated with improved overall survival compared to patients with N2 disease identified prior to resection (cN2, pN2). METHODS: Retrospective analysis of the National Cancer Database of patients from 2004 to 2011 with cN0 and cN2 status found to be pathologic stage III-N2 NSCLC after surgical resection. Comparison of 5-year survival of patients with unsuspected N2 disease versus those with known N2 disease after surgical resection using Kaplan-Meier analysis was made. The independent effect of unsuspected N2 disease on mortality was analyzed using multivariate analysis. RESULTS: A total of 3271 patients with pathologic stage III-N2 NSCLC underwent curative intent surgical resection with or without adjuvant chemotherapy or chemotherapy and radiation. Unsuspected N2 disease was identified in 48% of patients. Patients with unsuspected N2 disease were more likely to have T1 tumors (37 vs. 32%, p < 0.001). Unsuspected N2 disease did not impact 5-year overall survival compared with known N2 when adjuvant therapy was utilized (40 vs. 37%, p = 0.167). Multivariate analysis identified older age, higher comorbidity score, and treatment with surgery alone as independent risk factors for mortality. The presence of unsuspected N2 disease was not significant in this model. CONCLUSIONS: The findings of this study suggest that unsuspected N2 disease is associated with equivalent 5-year survival compared to cN2 disease when adjuvant therapy is employed. These results support the use of adjuvant chemotherapy and radiation therapy when confronted with unsuspected N2 disease after surgical resection for stage IIIA-NSCLC.