137 research outputs found
Overall Survival Endpoint in Oncology Clinical Trials: Addressing the Effect of Crossover - The Case of Pazopanib in Advanced Renal Cell Carcinoma
Objective: To identify the issues of using overall survival (OS) as a primary endpoint in the presence of crossover and the statistical analyses available to adjust for confounded OS due to crossover in oncology clinical trials. Methods: An indirect comparison was conducted between pazopanib and sunitinib in advanced renal cell carcinoma. Statistical adjustment methods were used to estimate the true comparative effectiveness of these treatments. Recently, a head-to-head trial comparing pazopanib and sunitinib was completed. This provided the opportunity to compare the OS treatment effect estimated for pazopanib versus sunitinib using indirect comparison and statistical adjustment techniques with that observed in the head-to-head trial. Results: Using a rank-preserving structural failure time model to adjust for crossover in the pazopanib registration trial, the indirect comparison of pazopanib versus sunitinib resulted in an OS hazard ratio (HR) of 0.97, while an unadjusted analysis resulted in an OS HR of 1.96. The head-to-head trial reported a final OS HR of 0.92 for pazopanib versus sunitinib. Conclusion: This case study supports the need to adjust for confounded OS due to crossover, which enables trials to meet ethical standards and provides decision makers with a more accurate estimate of treatment benefit
PCN200 Using A Weibull Parametric Model for Failure-Time Data to Assess Progression-Free Survival as A Surrogate Endpoint for Overall Survival in A Trial of Patients with Metastatic Renal Cell Carcinoma
Case Report: Long-Lasting Response in a Patient with Metastatic Renal Cell Cancer Receiving Antitumor Cytotoxic T Lymphocytes
Allogeneic Dendritic Cells Fused with Tumor Cells: Preclinical Results and Outcome of a Clinical Phase I/II Trial in Patients with Metastatic Renal Cell Carcinoma
Randomized Multicenter Phase II Trial of Subcutaneous Recombinant Human Interleukin-12 Versus Interferon-α2a for Patients with Advanced Renal Cell Carcinoma
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