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Re: HyGro post# 512758

Saturday, 09/10/2022 5:26:35 PM

Saturday, September 10, 2022 5:26:35 PM

Post# of 822874
That is correct—OS is the gold standard.

Anyone can research to verify that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.

“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”

“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”

“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”

Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.

Quite simply:

You cannot mistake
the dead for the living.
That is why OS is the
gold standard.
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