Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Comparing four ways of measuring ‘treatment success’ in studies of kidney cancer

Date of summary: September 2019

Study number 1 (S-TRAC): NCT00375674

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Study start date: August 2007

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Study end date: September 2017

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Study number 2 (PROTECT): NCT01235962

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Study start date: November 2010

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Study end date: April 2019

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The full title of this abstract is: Impact of estimand selection on adjuvant treatment outcomes in renal cell carcinoma (RCC)

The study drugs sunitinib and pazopanib are both approved to treat people with advanced kidney cancer. Sunitinib, but not pazopanib, is approved to treat people at high risk of recurrent renal cell carcinoma after kidney surgery.

 

Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only two studies. The results of this study might be different from the results of other studies that the researchers look at.

 

More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did these studies look at?

  • Renal cell carcinoma (RCC for short) is the most common type of kidney cancer.
    • In some people with RCC, the cancer has spread within the kidneys but not to other parts of the body. This is known as locally advanced RCC.
    • People with RCC that has not spread beyond the kidneys can have their cancer removed by kidney surgery. This surgery is known as nephrectomy.
    • Some people are at high risk of RCC returning even after kidney surgery. If the cancer returns, it is known as recurrent RCC.
  • Sunitinib and pazopanib are treatments approved in Europe for use in people with advanced RCC.
    • Sunitinib and pazopanib are not approved in Europe for use in people at high risk for recurrent RCC after kidney surgery.
  • In the S-TRAC and PROTECT studies, researchers looked at the treatment effects of sunitinib or pazopanib in people at high risk for recurrent RCC after kidney surgery.
  • Researchers also looked at how to measure the success of these treatments.
    • Researchers can use different ways to measure treatment success. For example, they can measure how many people improved with treatment, how much (or how little) improvement people had, how quickly people improved, and how many people needed extra treatments.
    • Knowing how treatment success is measured is important. Researchers can use this information to design future studies, and it can affect decisions about treatment approval.
  • This summary describes 4 different ways to measure the success of treatment with sunitinib or pazopanib in people at high risk for recurrent RCC after kidney surgery.

Who took part in these studies?

What were the results of these studies?

  • How researchers measured treatment success did not matter in these studies.
    • When measured 4 different ways, treatment with sunitinib or pazopanib reduced risk by about the same percentage (19% to 24%).

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • These studies looked at 4 different ways of measuring the success of treatment in clinical studies for people at high risk of recurrent RCC after kidney surgery.
  • The researchers reported that it did not matter which of the 4 ways was used because risk reduction was similar with sunitinib or pazopanib.
  • The researchers noted that they should still pay close attention to how they measure treatment success in future studies.
  • Discussions among researchers, doctors and people living with RCC may also be important when deciding how to measure treatment effects in the future.

Who sponsored these studies?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
United States

The sponsors would like to thank all of the people who took part in these studies.

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