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The ADAURA study, which was unblinded in advance at the ASCO annual meeting in April 2020, became one of the most influential studies that year.
However, the emergence of a new treatment model is bound to be accompanied by controversy and troubles, especially after the ADJUVANT study obtained a negative OS result, academic controversy intensified.
Question 1: The primary end point of adjuvant therapy is DFS or OS?
Question 1: The primary end point of adjuvant therapy is DFS or OS? Question 1: The primary end point of adjuvant therapy is DFS or OS?There is no doubt that overall survival (OS) is the gold standard reflecting the survival benefit of patients because it is well-defined, objective and robust, easy to measure, easy to interpret, and unbiased in measurement.
The use of surrogate endpoints that reasonably predict clinical benefit in the early stages of clinical trials will speed up treatment evaluation and may reduce the cost of drug development.
For advanced lung cancer, the goal of treatment is to improve survival and/or quality of life by reducing cancer-related symptoms; for early stage lung cancer, the goal of treatment is to improve long-term survival, so OS is used as a criterion for adjuvant therapy It seems the most appropriate.
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Friends who are interested in this issue recommend reading this article: Analysis of OS benefit in the presence of cross over
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For regulatory agencies, OS is more recognized as the primary endpoint of postoperative adjuvant treatment; however, DFS is currently recognized by more and more clinicians as an early alternative endpoint of OS.
First, if DFS is long enough to enable more lung cancer patients to survive for more than 5 years and be cured, will we still be entangled with OS results?
Second, it takes 8 to 10 years to obtain mature OS results.
Nevertheless, it needs to be pointed out that DFS usually refers to the time from the start of randomization to the occurrence of tumor recurrence or death from any cause.
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ADJUVANT research design
ADJUVANT research design ADJUVANT research designADAURA research design
ADAURA Research DesignADAURA Research DesignThe author has the following guesses about the reasons for the different results in the end:
The author has the following guesses about the reasons for the different results in the end:First, prolonging the medication time may be related to a better prognosis.
Second, a negative result of one study does not mean that other studies will also have negative results.
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