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Center for Global Research Data

Surrogate Endpoints of Overall Survival in Non-Metastatic Renal Clear Cell Carcinoma

Lead Investigator: Susan Halabi, Duke University
Title of Proposal Research: Surrogate Endpoints of Overall Survival in Non-Metastatic Renal Clear Cell Carcinoma
Vivli Data Request: 4913
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Renal cell carcinoma (RCC) is a common malignancy in the United States, Europe and Japan, with more than 90% of all kidney tumors associated with RCC and it continues to have the highest mortality rate among the genitourinary cancers. Renal cell carcinoma continues to have the highest mortality rate of the genitourinary cancers. It is estimated that there will be approximately 64,000 newly diagnosed cases of RCC and 14,000 deaths from RCC in 2019. Worldwide, it is estimated that about 338,000 cases or RCC are diagnosed each year, resulting in 143,406 deaths in the US. About 75% of patients with clear cell are non-metastatic RCC (nRCC), and 70-80% will have a nephrectomy with curative intent, or surgical removal of the tumor. Until recently, the only treatment for patients at high risk for recurrence has been surgery followed by observation underscoring the need for other therapies. The FDA recently approved sunitinib for adjuvant treatment of high risk RCC patients following nephrectomy. However, overall survival (OS) data from S-TRAC is immature at this time and three other Phase III studies (adjuvant sunitinib/ sorafenib/ placebo, ASSURE), PROTECT (adjuvant pazopanib/placebo) and ATLAS failed to demonstrate an improvement in DFS or OS or had immature OS. Therefore, it is unclear at this time how widespread sunitinib use will be in this patient population. In particular, some physicians and patients may not consider it due to the lack of data to support an OS benefit. While OS remains the gold standard primary endpoint in phase III trials, is clearly defined, simple to measure, and translates into clinical benefit to patients, it has the disadvantages of requiring large trial sizes and an extended follow-up period, and hence a long study duration. Thus, it is not feasible to use OS as a primary endpoint in patients with nRCC. Considerable resources have been dedicated to developing prognostic models of clinical outcomes in mRCC patients. The literature on prognostic factors of OS is, however, limited. Understanding heterogeneity should lead to better risk stratification and tailored treatment strategies for nRCC.

Requested Studies:

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma (ASSURE)
Sponsor: National Cancer Institute (NCI)
Study ID: NCT00326898
Sponsor ID: NCI-2009-00534

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer (S-TRAC)
Sponsor: Pfizer
Study ID: NCT00375674

Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
Sponsor: Pfizer
Study ID: NCT01599754