Lead Investigator: Wataru Fukuokaya, The Jikei University School of Medicine
Title of Proposal Research: Association of serum magnesium levels with effectiveness of atezolizumab in advanced urothelial carcinoma
Vivli Data Request: 8052
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Magnesium is essential for activating immune cells in our bodies and magnesium deficiency, a condition in which the amount of magnesium in the blood is lower than normal, is shown to be associated with a worse response to cancer immunotherapy, a type of treatment that uses immune system in our body to fight cancer. Immunotherapy has been used for the treatment for cancer of the bladder, ureter, and renal pelvis that has spread to other parts of the body. However, the association between magnesium levels in the blood and treatment outcomes for patients with cancer of the bladder, ureter, and renal pelvis treated with immunotherapy remains unclear. Using the data from the clinical trials, it is possible to evaluate the association between magnesium levels in the blood and treatment outcome of patients with advanced cancer of the bladder, ureter, and renal pelvis treated with atezolizumab, a cancer immunotherapy that enhances the immune response against cancer. Given the possibility that magnesium deficiency is treatable and common in chemotherapy-treated patients with cancer of the bladder, ureter, and renal pelvis, the results of this study may improve their management.
Statistical Analysis Plan:
Each raw trial data will be processed to analysis-ready data before merging. Multiple imputation will be used to handle missing data in covariates. Descriptive statistics will show baseline characteristics. Survival distributions will be depicted using Kaplan-Meier curves. Hazard ratios and their corresponding 95% confidence intervals of baseline magnesium levels on treatment outcomes are calculated within multivariable Cox regression models adjusting covariates. To maintain the independence of the two studies, the trial (IMvigor210 vs. IMvigor211) will be incorporated into multivariable Cox regression models. The treatment-specificity of the association of interest will also be studied by testing the interaction terms within the multivariable Cox regression models. All statistical tests will be done using R statistics package.
Requested Studies:
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02302807
Sponsor ID: GO29294
A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02108652
Sponsor ID: GO29293 (Cohort 2)
Public Disclosures:
Fukuokaya, W., Akazawa, K. and Kimura, T., 2024. Association Between Serum Magnesium Levels and Outcomes of Atezolizumab in Patients With Metastatic Urothelial Carcinoma. Anticancer Research, 44(5), pp.2117-2123. Doi : 10.21873/anticanres.17017