Kaplan-Meier estimators were calculated for each group and were compared by using the log-rank test. There are numerous publications regarding the use of SBRT for primary HCC.7,11,12,23,24 Some have focused on local tumor control rate as a primary end point, so long-term survival data are not reported. Data that guide selection of optimal local ablative therapy for the management localized hepatocellular carcinoma (HCC) are lacking. Table 1. National Cancer Data Base - Data Dictionary PUF 2016 Search form Search About Data Items Organ - Sites Tools Getting Started - A User's Guide Revisions FAQs National Cancer Data Base - Data Dictionary PUF … -,Bold" 6AQI NACOR Participant User File (PUF) Dates of Service 2017 - 2019 Data Dictionary | Variable ID Variable Label Data Type Variable Description Permitted values / … Variable Attributes Variable Name: IssuerID Variable Definition: NCDB data are used to analyze and track patients with malignant neoplastic diseases, their treatments and outcomes. Observations: The NCDB is one of the largest cancer registries in the world and has rapidly become one of the most commonly used data resources to study the care of cancer in the United States. All calculations were performed with SAS software, version 9.4 (SAS Institute, Cary, NC). process, or were generated by CCIIO for use in data processing (i.e., system-generated). We obtained data from the NCDB Participant User Files (PUF). The survival rates reported in our analysis with RFA and SBRT are comparable with those in the published literature.7,8,11,12,22 The largest published SBRT experience for stage I and II HCC by Wahl et al22 reported 1- and 2-year OS of 74.1% and 46.3% for 63 patients, respectively. Careful review of the individual definitions in the respective AJCC manuals is necessary before combining or comparing data across two or more AJCC editions. Clinicopathological and treatment-related data extracted included tumor histology (fibrolamellar or not), pT stage (), pN stage, tumor size, single or multiple tumors, vascular invasion, surgical margin status, type of cancer-directed surgical treatment applied, and the administration of … We were unable to distinguish between patients with a solitary lesion with vascular invasion and multifocal tumors (all < 5 cm) in our analysis because the NCDB groups these together under T2 disease. Baseline patient characteristics are listed in Table 1. JCO Oncology Practice The application period for the next version of the PUF, which will contain data for cases diagnosed in 2004-2015, will open late Summer 2017. cancer.gov. All relationships are considered compensated. The following represents disclosure information provided by authors of this manuscript. To construct the propensity-score– and time-to-treatment–matched model of OS, patients treated with SBRT were matched 1:2 to patients treated by RFA on propensity score and time since diagnosis to treatment by using a greedy, nearest neighbor matching algorithm, with maximum allowed differences of ± 2% for propensity scores and ± 14 days for time since diagnosis to treatment. Overall survival was compared by using propensity score–weighted and propensity score–matched analyses based on patient-, facility-, and tumor-level characteristics. National Cancer Data Base Participant User File (PUF) Data Dictionary, version PUF In addition to the observed treatment effect, sensitivity analysis also incorporated hypothetical information regarding the survival effect and differential exposure of the unmeasured confounding factor to calculate the true treatment effect that would have been observed if the unmeasured confounding factor were removed. Inverse probability–weighted analysis yielded similar results. Listen to the podcast by Dr Covey at ascopubs.org/jco/podcasts, Conception and design: Devalkumar J. Rajyaguru, Andrew J. Borgert, Collection and assembly of data: Devalkumar J. Rajyaguru, Andrew J. Borgert, Angela L. Smith, Reggie M. Thomes, Data analysis and interpretation: Devalkumar J. Rajyaguru, Andrew J. Borgert, Patrick D. Conway, Thorvardur R. Halfdanarson, Mark J. Truty, A. Nicholas Kurup, Ronald S. Go, Final approval of manuscript: All authors, Accountable for all aspects of the work: All authors. The NCDB PUF is a Health Insurance Portability and Accountability Act (HIPAA) compliant data file. 4 0 obj Use of radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) for nonsurgically managed stage I and II hepatocellular carcinoma over time in the unmatched study population from the National Cancer Center Database, 2004-2013. 2 0 obj Fig A1. On the basis of the propensity score, a stabilized inverse probability of treatment weight was calculated.18 IPTWs were truncated at the 5th and 95th percentiles. The SA-PUF is available for plan year 2014, plan year 2015, plan year 2016, and plan year 2017. Additionally, the NCDB provides a reference list of recent abstracts and publications DOI: 10.1200/JCO.2017.75.3228 Journal of Clinical Oncology - The propensity score model of receipt of SBRT was constructed via stepwise variable selection into a multivariable logistic regression model. (Review either the table that automatically was created for you at the end of the NCDB Export process or review the Cross Tab of Population being sent to NCDB determine this information.) 2. x���MK�@�} ��,��I�̙/��*^�p!.b���6��q�w��E1��)�"!�I�3��8���K=�pzZ��X�_�gx(&m��걨>ޚ�^,�u\�����)v�.�66��3�̦�'�J,�#��l:��`���� ��lR�YqI0X�^�R��f���Z�.Ww��`���wWy�pǏP�ʳ����y7S�ⶫ�fz=�RX����DŽ���/�2�!+�O��VcФP�e=�l�K�/�YHk ’�g$1nF���bݎ��N���t�Xʗݏ���p0��k�?���. Table 2. Overall, 3,684 (92.6%) and 296 (7.4%) nonsurgically managed patients with stage I or II HCC received RFA or SBRT, respectively. In addition, we performed exploratory analyses to determine the effectiveness of RFA and SBRT in clinically relevant patient subsets. IPTW analysis revealed similar results (Fig 3; Appendix Table A3 [online only]). Methods: Patients diagnosed with SPN between 1998 and 2012 were identified from the National Cancer Data Base (NCDB) (n=389). Tumor-level variables included TNM stage, tumor size, year of diagnosis (2004-2008 v 2009-2013), and alpha-fetoprotein status. In addition, our exploratory analyses showed that treatment effect was consistent across all the subgroups, as well as in those with small tumor size (Appendix Fig A5, online only). NCDB PUF Data Dictionary The current release of the NCDB PUF is documented in this on-line data dictionary and includes: overview documentation describing the PUFs, detailed documentation of the specific items included in the PUFs, and a list of investigators who have participated in testing phases of the PUF. We focused on OS, but several other aspects of treatment selection such as toxicity, cost, location of tumor, and the patient’s ability to undergo invasive procedures such as RFA should be considered when dealing with unresectable localized HCC. 2017 CFS Public Use File (PUF) SAS File [148.1 MB] CSV File [118.8 MB] Appendix A - Data Dictionary [<1.0 MB] PUF User's Guide [<1.0 MB] PUF FAQ's [<1.0 MB] Related Information. Advertisers, Journal of Clinical Oncology We investigated how this missingness can bias results in breast cancer studies including patients treated with neoadjuvant chemotherapy (NAC). By using de-identified data exempt from oversight by the institutional review board, we performed a retrospective analysis using the NCDB. Overview of the Rate PUF The Centers for Medicare & Medicaid Services (CMS) Center for Consumer Information and Insurance Oversight (CCIIO) is releasing the State-Based Marketplace (SBM) PUF in order to improve the transparency and increase access to the SBM data. Stage-specific overall survival (OS) with radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) in propensity-matched patients with nonsurgically managed stage I or II hepatocellular carcinoma. published online before print The incidence of hepatocellular carcinoma (HCC) has steadily increased over recent decades.1,2 Mortality as a result of HCC mirrors this trend, which makes it the third leading cause of cancer death worldwide.3,4 In localized disease, cure can be achieved with surgical resection or transplantation; however, the majority of patients are not candidates for surgery and are instead treated with local ablative therapies,5,6 including radiofrequency ablation (RFA), microwave ablation, cryoablation, and stereotactic body radiation therapy (SBRT). A comparison of breast, colorectal, lung, and prostate cancers reported to the National Cancer Data Base and the Surveillance, Epidemiology, and End Results Program. JCO Global Oncology 1 0 obj The primary objective of this study was to compare overall survival (OS) of nonsurgically managed patients with clinical stage I or II HCC treated with RFA with OS of those treated with SBRT. This data item was added to the 2015 PUF (data released in Fall 2017), and does not appear in prior versions of the PUF data. This report also represents the first sizeable assessment of the comparative effectiveness of RFA versus SBRT with OS as a primary end point. We attempted to address this by conducting a sensitivity analysis to assess the potential effect of underlying advanced fibrosis/cirrhosis. Rigorous prospective randomized studies are needed to accurately define the role of SBRT and optimize patient selection in this population. Data represent approximately 70 % of all newly diagnosed cancer cases nationwide annually. Cancer. We believe that improved local control rates achieved with SBRT for large tumors do not necessarily translate into superior survival, and future studies should focus on more clinically relevant end points such as survival when examining the comparative effectiveness among local ablative therapies. The Centers for Medicare & Medicaid Services (CMS) Center for Consumer Information and Insurance Oversight (CCIIO) is committed to increasing transparency in the Health Insurance Exchange. An announcement will be made on this page when the NCDB has set the dates for the There is no standard mechanism to recode AJCC items from one edition to another. Background: Solid pseudopapillary neoplasm (SPN) of the pancreas is a rare tumor which predominantly occurs in young female. The combination of underlying patient characteristics (poor functional status, chronic liver disease) and the likelihood of disease progression in untreated liver cancer results in disappointing OS rates after SBRT of 21% to 69%.25 Methodologic concerns, such as relatively small sample size, selection bias, and intrinsic heterogeneity of the tumor have been advocated to explain this wide variation in survival. The CoC reserves the right to modify or update this Data Dictionary … Search . Patients who received SBRT were older (≥ 71 years), more frequently white compared to nonwhite/non African American, and had fewer comorbid conditions. Methods We obtained data from the NCDB Participant-User File (PUF; NCDB). This data dictionary describes the variables contained in the SA-PUF. Most patients in our study received < 50 Gy of radiation over three to five fractions. This data dictionary describes the variables contained in the Quality-PUF. Implications for studies that use the National Cancer Data Base. endobj RFA, radiofrequency ablation; SBRT, stereotactic body radiotherapy. Enter the Hospital Code 4. A secondary objective was to determine the effectiveness of RFA and SBRT in clinically relevant patient subsets. *Note that there are four places to insert filenames and location: lines 138, 268, 288, 1018. Selected variables (data elements) relating to fatal and injury collisions for the collisions from 1999 to the most recent available data. 16. Within the matched patient group, we assessed heterogeneity of treatment effects with tests of interaction and subgroup analyses that explored the effect of age, sex, clinical T stage, tumor size, tumor grade, Charlson-Deyo comorbidity score, and facility type. In the propensity-score– and time-to-treatment–matched Cox proportional hazard regression analysis, RFA was associated with a significant OS benefit (hazard ratio [HR], 0.67; 95% CI, 0.55 to 0.81; P < .001); the 5-year OS was 29.8% (95% CI, 24.5% to 35.3%) in the RFA group versus 19.3% (95% CI, 13.5% to 25.9%) in the SBRT group (P < .001). CASE KEY. Fig A5. We conducted an observational study to compare the effectiveness of RFA versus SBRT in nonsurgically managed patients with stage I or II HCC. NCDB Analytic Stage Group Collaborative Stage Data Collection System CS Site Specific Factors 1-25 CS Version Number CS Extension CS TS/Ext Eval Lymph-vascular … This data dictionary describes the variables contained in the Plan-PUF file for each SBM. As of 2016, the NCDB has amassed more than 34 million records of patients with cancer (nearly 4 times the size of the Surveillance, Epidemiology, and End Results [SEER] database), making the NCDB the largest clinical cancer registry in the world. 2. Each record relates to the coverage at the issuer level. 6. Patient-level variables included age at diagnosis, sex, race, insurance status, median household income according to patient ZIP code, percentage of persons with less than a high school education within the patient’s census tract of residence, and Charlson-Deyo comorbidity score (truncated by the NCDB into score categories of 0, 1, and ≥ 2).17 Facility-level variables included type of facility (as assigned by the CoC), distance from patient area of residence to treatment facility, case volume in quartiles, and geographic region. I = Immediate Family Member, Inst = My Institution. Specific variables and definitions can be found elsewhere. Table A1. January 12, 2018. 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