CUA CS on Role of Adjuvant therapy after nephrectomy 2018

Question 1

what was Assure trial and what were the results?

Answer 1

Sunitinib vs sorafenib vs placebo post Nx for T1b or greater disease. No difference in OS or DFS in ITT or subgroup analysis of higher stage and grade disease. very high rate of discontinuation of tx due to toxicity

Question 2

describe S-TRAC. What were the findings of S-TRAC trial?

Answer 2

Sunitinib vs placebo in high risk locoregional disease. no difference in OS or DFS. tx discontinuation due to side effects high, DFS was improved in high risk patients unlike ASSURE

Question 3

What was PROTECT trial?

Answer 3

Pazopanib 600mg vs 800mg vs placebo, no improvement in OS, improved DFS with higher dose pazopanib.

Question 4

What did the metanalysis of ASSURE, S-TRAC and PROTECT trial show regarding OS and DFS?

Answer 4

No improvement in OS or DFS

Question 5

What is the opinion of KCRNC regarding use of adjuvant TKI therapy for RCC?

Answer 5

TKI adjuvant therapy should not be recommended for routine use after nephrectomy for nmRCC. However, it can be considered an option for highly motivated patient.