Carrying out streamlined routine data analyses with reports for observational studies: introduction to a series of generic SAS® macros

Liu, Yuan; Nickleach, Dana; Zhang, Chao; Switchenko, Jeffrey M.; Kowalski, Jeanne

doi:10.12688/f1000research.16866.2

Cited by 51 publications

(35 citation statements)

References 14 publications

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“…A Cox regression model was carried out to associate the risk group with OS or PFS separately, and the multivariable model controlled for gender, checkpoint indication, number of previous treatments, RMH risk group, age, ECOG PS, race, number of metastatic sites, and histology. All analyses were done in SAS 9.4 and SAS macros developed by Winship Biostatistics and Bioinformatics Shared Resource [22] with significance level set at .05.…”

Section: Discussionmentioning

confidence: 99%

Combined Effect of Sarcopenia and Systemic Inflammation on Survival in Patients with Advanced Stage Cancer Treated with Immunotherapy

et al. 2019

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Background Sarcopenia and inflammation have been associated with poor survival in patients with cancer. We explored the combined effects of these variables on survival in patients with cancer treated with immunotherapy. Methods We performed a retrospective review of 90 patients enrolled on immunotherapy‐based phase I clinical trials at Emory University from 2009 to 2017. Baseline neutrophil‐to‐lymphocyte ratio, monocyte‐to‐lymphocyte ratio, and platelet‐to‐lymphocyte ratio (PLR) were used as surrogates of inflammation. The skeletal muscle index (SMI) was derived from the skeletal muscle density calculated from baseline abdominal computed tomography images. Optimal cutoffs for continuous inflammation biomarkers and SMI were determined by bias‐adjusted log‐rank test. A four‐level risk stratification was used to create low‐risk (PLR <242 and nonsarcopenic), intermediate‐risk (PLR <242 and sarcopenic), high‐risk (PLR ≥242 and nonsarcopenic), and very‐high‐risk (PLR ≥242 and sarcopenic) groups with subsequent association with survival. Results Most patients (59%) were male, and the most common cancers were melanoma (33%) and gastrointestinal (22%). Very high‐risk, high‐risk, and intermediate‐risk patients had significantly shorter overall survival (hazard ratio [HR], 8.46; 95% confidence interval [CI], 2.65–27.01; p < .001; HR, 5.32; CI, 1.96–14.43; p = .001; and HR, 4.01; CI, 1.66–9.68; p = .002, respectively) and progression‐free survival (HR, 12.29; CI, 5.15–29.32; p < .001; HR, 3.51; CI, 1.37–9.02; p = .009; and HR, 2.14; CI, 1.12–4.10; p = .022, respectively) compared with low‐risk patients. Conclusion Baseline sarcopenia and elevated inflammatory biomarkers may have a combined effect on decreasing survival in immunotherapy‐treated patients in phase I trials. These data may be immediately applicable for medical oncologists for the risk stratification of patients beginning immunotherapeutic agents. Implications for Practice Sarcopenia and inflammation have been associated with poor survival in patients with cancer, but it is unclear how to apply this information to patient care. The authors created a risk‐stratification system that combined sarcopenia and platelet‐to‐lymphocyte ratio as a marker of systemic inflammation. The presence of sarcopenia and systemic inflammation decreased progression‐free survival and overall survival in our cohort of 90 patients who received immunotherapy in phase I clinical trials. The data presented in this study may be immediately applicable for medical oncologists as a way to risk‐stratify patients who are beginning treatment with immunotherapy.

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Section: Discussionmentioning

confidence: 99%

Combined Effect of Sarcopenia and Systemic Inflammation on Survival in Patients with Advanced Stage Cancer Treated with Immunotherapy

et al. 2019

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“…Statistical analysis was conducted using SAS version 9.4 (SAS Institute, Cary, NC) as well as SAS macros or software developed at the Biostatistics and Bioinformatics at Winship Cancer Institute . Descriptive statistics for each variable were reported.…”

Section: Methodsmentioning

confidence: 99%

Trimodality Therapy in the Treatment of Stage III N2-Positive Non-Small Cell Lung Cancer: A National Cancer Database Analysis

et al. 2020

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Background Significant controversy remains regarding the care of patients with clinical stage III (N2‐positive) NSCLC. Although multimodality therapy is effective, the roles of surgery, chemotherapy, and radiotherapy are not fully defined and the optimal treatment approach is not firmly established. We analyzed outcomes and predictors associated with trimodality therapy (TT) in the National Cancer Database. Materials and Methods The NCDB was queried from 2004 to 2014 for patients with NSCLC diagnosed with stage III (N2) disease and treated with chemotherapy and radiation (CRT). Three cohorts of patients were studied: CRT only/no surgery (NS), CRT plus lobectomy (LT), and CRT plus pneumonectomy (PT). The univariate and multivariable analyses (MVA) were conducted using Cox proportional hazards model and log‐rank tests. Results A total of 29,754 patients were included in this analysis: NS 90.1%, LT 8.4%, and PT 1.5%. Patient characteristics: median age 66 years; male 56% and white 85%. Patients treated at academic centers were more likely to receive TT compared with those treated at community centers (odds ratio: 1.85 [1.53–2.23]; p < .001). On MVA, patients that received TT were associated with better survival than those that received only CRT (hazard ratio: 0.59 [0.55–0.62]; p < .001). The LT group was associated with significantly better survival than the PT and NS groups (median survival: 62.8 months vs. 51.8 months vs. 34.2 months, respectively). In patients with more than two nodes involved, PT was associated with worse survival than LT and NS (median survival: 51.4 months in LT and 39 months in NS vs. 37 months in PT). The 30‐day and 90‐day mortality rates were found to be significantly higher in PT patients than in LT. Conclusion TT was used in less than 10% of patients with stage III N2 disease, suggesting high degree of patient selection. In this selected group, TT was associated with favorable outcomes relative to CRT alone. Implications for Practice This analysis demonstrates that trimodality therapy could benefit a selected subset of patients with stage III (N2) disease. This plan should be considered as a treatment option following patient evaluation in a multidisciplinary setting in experienced medical centers with the needed expertise.

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“…Kaplan-Meier curves were generated to compare overall survival based on histological subtype. All analyses were done using SAS 9.4 (SAS Institute, Inc., Cary, North Carolina) and SAS macros developed by the Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute in Atlanta, Georgia 21…”

Section: Methodsmentioning

confidence: 99%

<p>Clinical outcomes of rare hepatocellular carcinoma variants compared to pure hepatocellular carcinoma</p>

Zakka

Jiang

Alese

et al. 2019

JHC

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Background HCC variants are rare primary hepatic tumors. The aim of this study is to compare clinical characteristics and outcomes of HCC variants with pure HCC. Methods Patients diagnosed between 2004 and 2013 with ICD-O-3 8180/3 and 8170/3-8175/3 were identified from the National Cancer Database. Univariate and multivariate survival analyses were conducted to analyze the association between histology and overall survival (OS). Results 80,280 patients were identified; pure HCC 78,461 (97.7%), fibrolamellar (FLHCC) 310 (0.4%), scirrhous 161 (0.2%), spindle cell 72 (0.1%), clear cell 487 (0.6%), pleomorphic 23 (0.0%), and combined HCC and cholangiocarcinoma (mixed HCC) 766 (1.0%). 76.7% were male and 72% Caucasian. Liver transplant was performed in 10.1% of pure HCC, 14.5% of mixed HCC, 16.2% of scirrhous, 6.9% of spindle cell, 8.8% of clear cell, 8.7% of pleomorphic, and 3.2% of FLHCC ( p <0.001). Pure HCC (10.6%) underwent surgical resection without transplant less often than variants except for scirrhous (9.9%) ( p <0.001). More than a third of patients in each histological type received chemotherapy. FLHCC had the best 5-year OS (38.7%), spindle cell and pleomorphic had the worst (9.6% and 13.0%). In multivariate analysis stratified by histology variants, chemotherapy was associated with improved OS in all histologies except for scirrhous and pleomorphic HCC. Conclusion HCC variants underwent surgical resection more often than pure HCC. FLHCC had the best 5-year OS. Liver transplant was commonly performed in HCC variants.

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Carrying out streamlined routine data analyses with reports for observational studies: introduction to a series of generic SAS® macros

Cited by 51 publications

References 14 publications

Combined Effect of Sarcopenia and Systemic Inflammation on Survival in Patients with Advanced Stage Cancer Treated with Immunotherapy

Combined Effect of Sarcopenia and Systemic Inflammation on Survival in Patients with Advanced Stage Cancer Treated with Immunotherapy

Trimodality Therapy in the Treatment of Stage III N2-Positive Non-Small Cell Lung Cancer: A National Cancer Database Analysis

<p>Clinical outcomes of rare hepatocellular carcinoma variants compared to pure hepatocellular carcinoma</p>

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