Palis, Bryan E.

BACKGROUND: The National Cancer Database (NCDB) captures 73.7% of newly diagnosed cancers in the USs and underpins thousands of outcomes studies informing oncologic practice. To remain relevant amid rapid therapeutic and policy changes, the NCDB has undergone substantial structural and variable-level revisions. We characterized major updates during the past decade and their implications for research. STUDY DESIGN: We performed a narrative review of annual NCDB data dictionary revisions, American College of Surgeons bulletins, and internal program updates in collaboration with NCDB leadership. Structural modifications, variable additions, and policy changes affecting data capture, follow-up, staging, and accessibility were systematically summarized. RESULTS: The NCDB now includes data from 1,413 Commission on Cancer–accredited hospitals and more than 55 million records. Since 2020, the Rapid Cancer Reporting System enables near–real-time monthly submissions. Embargo periods were reduced from 5 to 3 years for survival data and 2 years for other variables, increasing analytic timeliness. Follow-up was limited to 15 years beginning January 1, 2022. Variable refinements include continuous tumor size in millimeters (since 2016), separation of tumor grade into clinical, pathologic, and posttherapy fields (since 2018), phased radiation treatment reporting (since 2018), and American Joint Committee on Cancer eighth edition staging implementation in January 2018 with nineth edition rollout ongoing. New data elements include Medicaid expansion status (2020), COVID-19 variables (2020 to 2021; 12.4% reduction in cases in 2020), smoking status (2023), and planned programmed death-ligand 1 reporting for non–small cell lung cancer beginning in 2025. CONCLUSIONS: The NCDB has evolved toward more granular, contemporary, and policy-relevant data capture while maintaining broad national coverage. Investigators must account for staging transitions, variable maturation, follow-up limits, and registry-specific biases to ensure valid interpretation of NCDB-based research.

3520 Background: Recent analyses highlight nonhierarchical outcomes using the 8 th Edition AJCC staging system for CC. For instance, the 5-year survival rate for stages I and IIIa patients (pts) closely align. Additionally, tumor deposits (TDs) have been established as significant prognostic indicators. The AJCCCCEP commissioned this study to develop an updated pathological staging system for CC focused specifically on pts without distant metastasis (M0), while retaining the existing stage IV classification. Methods: Individual patient data (IPD) from pts diagnosed with cc (2010- 2017) in the NCDB were divided into training (70%) and internal validation (30%) datasets. External validation used IPD from clinical trials. The primary endpoint was overall survival (OS). Risk classification development for M0 pts incorporated ungrouped data on pathologic T categories, the number of involved regional lymph nodes (LN+), and TD counts. Recursive partitioning and regression tree analyses were applied to construct hierarchical staging levels. Pre-specified criteria required survival probabilities to be consecutive and show clear separations using Kaplan-Meier (KM) estimates with pairwise log-rank test P of < 0.005 for the training and < 0.05 for validation analyses. Results: Data from 281,997 pts (median age 67 years, 50% male, 81% white, 55% T3, 19% T4, 44% N+, 26% M+, and 11% with ≥1 TD) were analyzed, with a median follow-up of 7.3 years. The updated staging system (Table) met pre-specified criteria, with all observed pairwise P < 0.0001 in the development and internal validation sets. KM OS curves displayed a hierarchical separation across all sub-levels after the 1 st year of diagnosis. Consistent results were seen in pts treated with adjuvant chemotherapy in 4 trials (all pair-wise P < 0.0001). Conclusions: The proposed pathological staging system for M0 pts fulfills pre-specified criteria for hierarchical risk stratification, validated both internally and externally, and provides an evidence-based update. Pending review process, the AJCCCCEP will recommend that these changes be made to the Version 9 staging protocol for colon cancer to improve prognostication for CC pts. Stage T, # of LN+, # of TD M % of pts 1y OS (CI), % 3y OS (CI), % 5y OS (CI), % I T1, 0, 0 0 5 96 (95-97) 91 (90-92) 84 (83-86) IIa T2, 0, 0 0 10 95 (94-95) 88 (88-89) 80 (79-81) IIb T1, 0, 1+T1, 1+, 0T2, 0, 1+T2, 1-4, 0T3, 0, 0 0 27 93 (92-93) 84 (84-85) 75 (75-76) IIIa T1, 1+, 1+T2, 1-4, 1+T2, 5+, 0T3, 0, 1+T3, 1-4, 0 0 14 92 (91-92) 80 (80-81) 71 (70-72) IIIb T2, 5+, 1+T3, 1-4, 1+T3, 5+, 0T4a, 0-4, 0T4b, 0-2, 0 0 13 86 (86-87) 69 (68-70) 58 (57-59) IIIc T3, 5+, 1+T4a, 0-4, 1+T4a, 5+, anyT4b, 0-2, 1+T4b, 3+, any 0 5 78 (77-80) 53 (51-54) 40 (38-41) IVa Any 1a 19 59 (58-60) 28 (28-29) 17 (16-18) IVb Any 1b 7 43 (42-44) 14 (13-14) 6 (6-7) CI: 95% confidence internal; Peritoneum involvement data were not available before 2018 in NCDB. Thus, IVa/b were based on 7 th Edition.

The National Cancer Database (NCDB) collects data from approximately 1,500 Commission on Cancer (CoC) facilities and represent 73.7% of newly diagnosed cancers nationwide. The American College of Surgeons Cancer Program developed it first annual report from the NCDB 2021 participant user file reporting new observations and recent trends of cancer diagnoses, patient demographics, and treatments as well as an in-depth report on treatment and outcomes in breast, pancreas, and colon cancers. Of the 1,328,131 cancers diagnosed in 2021 at 1,281 reporting CoC hospitals, one-fifth continue to be female breast cancer. In 2021, the NCDB’s 5 most common adult cancers were breast, prostate, lung, colon, and melanoma and varied by patient sex. Use of neoadjuvant systemic therapy increased in recent years in pancreas, breast, and urinary bladder cancer, although a slight decrease in pancreas and breast cancer was observed in 2021. Breast cancer has high survival rates, especially in lower-stage disease and estrogen receptor-positive/human epidermal growth factor receptor 2-negative disease. There is increase in neoadjuvant systemic therapy use, especially in human epidermal growth factor receptor 2-positive disease and estrogen receptor-negative disease. Colon cancer presents most commonly as stage III or II with a primary in the cecum or ascending colon in 38.9%. The majority are microsatellite instability stable, Kirsten rat sarcoma viral oncogene homologue normal, and CEA positive. Survival is most dependent on stage but also associated with microsatellite instability stability, abnormal Kirsten rat sarcoma viral oncogene homologue, and positive CEA. Pancreatic cancer presents with stage IV disease in nearly half, although an increase in stage I disease is seen. The most common location is pancreatic head. Survival is relatively low and most dependent on stage.

256 Background: Current staging for colon cancer utilizing the American Joint Committee on Cancer TNM framework stratifies disease into groups according to how advanced the disease is and provides important standardized, individual prognostic information. Ideally, staging systems should exhibit hierarchical logic, with increasing stage reflecting worse prognosis. We sought to evaluate hierarchy within the 8th edition AJCC staging system for colon cancer. Methods: All patients with primary colon (including rectosigmoid) cancer diagnosed 2010-2017 were identified from the National Cancer Database (NCDB). Patients were only included if they carried a histologic diagnosis of invasive primary (non-recurrent) cancer, underwent radical surgery, and had complete pathologic staging data (T, N, M category data). Patients with missing follow-up data were excluded. Kaplan-Meier curves were used to assess overall survival by AJCC 8th edition pathologic summary stage group to determine whether staging was hierarchical for colon cancer. Multivariable modeling and log likelihood ratio test was then used to identify relative contributions of T and N variables to overall survival. Results: Among 270,584 colon cancer patients, pathologic staging was noted to be hierarchical by T category alone and by N category alone. However, summary staging was non-hierarchical in both instances. Multivariable modeling confirmed the AJCC non-hierarchy issue (colon HRs: 1, 1.54, 2.62, 2.60, 1.02, 2.15, and 4.38 for stage 1 as reference, 2a, 2b, 2c, 3a, 3b, 3c respectively). Multivariable modeling demonstrated that high T category (T4a, T4b) conferred the greatest risk of mortality based on hazard ratio (T4a HR 2.76, T4b HR 3.04), while high T category as well as high N category (N2a, N2b) contributed substantially to the survival model based on z-score. Further modeling assessing the predictive power of T and N category with respect to overall survival demonstrated that T category more strongly predicted overall survival than N category in colon cancer (likelihood chi-square test statistic pT:7009 vs pN:3586). Conclusions: Hierarchy in survival based on AJCC summary stage was not observed for patients with stage II-III colon cancer resulting in a paradoxical better observed survival with some stage III cancer subgroups compared to stage II cancer subgroups. High T category appears to more significantly impact survival than N category for patients with N0-N1 disease, while high N category appears more important for patients with T1-3 disease. Future revisions of the AJCC staging system should account for the differential impact of T and N category identified herein to more accurately confer prognostic information.