Computational protocol: Surgical Management of the Primary Tumor in Stage IV Colorectal Cancer: A Confirmatory Retrospective Cohort Study

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Protocol publication

[…] The primary end point of this study was to determine relationship between SRPT and overall survival (OS). Survival was estimated by using the Kaplan-Meier method. Survival distribution of subgroups was compared by the Log Rank test.Charlson comorbidity index was used in this confirmatory study to defined major comorbid illness . A multivariate analysis was performed to determine the prognostic significance of SRPT in patients with stage IV CRC in relation to other clinico-pathological variables. The Cox proportional hazard model was used and the hazard ratio (HR) and its 95% CI were estimated. Following variables were examined with respect to their prognostic significance:Interventions: Resection of primary tumor, metastasectomy, use of chemotherapy with or without biologics , second line therapy, third line therapy, and radiation therapy; clinical & demographic variables: age (<65 vs. ≥65), gender, major comorbid illness (as per Charlson comorbidity index), secondary cancer, Eastern Cooperative Oncology Group performance status [ECOG PS] (<2 vs. ≥2), cancer center, and smoking; laboratory values: albumin (≥36 vs. <36 g/l), bilirubin (≥26 vs. <26 um/l), alkaline phosphatase (≥120 vs. <120 U/l), sodium level (≤135 mEq/l vs. >135 mEq/l), serum creatinine (≥120 vs. <120 um/l), blood urea nitrogen (BUN) (≥8 vs. <8 mm/l), hemoglobin (≥120 vs. <120 g/l), white blood cell (WBC) (≥11 vs. <11 x 109/l), platelet count (≥450 vs. <450 x109/l), and carcinoembryonic antigen (CEA) (≥6 vs. <6 ug/l); disease characteristics: site (colon vs. rectal), grade (3 vs. <3), symptomatic disease, extra-hepatic metastases, and stage (stage IVa vs. stage IVb disease). For the Cox proportional hazard model, log-log survival curves were used to assess the proportional hazards assumption.All variables that were significant on univariate analysis with P<0.05, were examined in multivariate models. The likelihood ratio test and t test were used to determine if a variable correlates with survival in the model. Test for interaction was performed for SRPT and the other variables that were correlated with survival. In addition, secondary analyses were performed in subgroups of patients with asymptomatic disease, or patients who did not have metastasectomy. A two-sided P-value of <0.05 was considered to be statistically significant. For missing data imputation technique was used. All patients were followed till June 2014 when the data entry was closed. The SPSS version 22 was used for statistical analysis (SPSS Inc. Chicago, IL). […]

Pipeline specifications

Software tools (PS)2, SPSS
Applications Miscellaneous, Protein structure analysis
Organisms Homo sapiens