RCT | Temporary cessation vs. continuation of first-line tyrosine kinase inhibitor in advanced clear cell renal cell carcinoma

Summary: The STAR trial investigated whether a tyrosine kinase inhibitor drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. All patients received standard dosing schedules of oral sunitinib (50 mg per day) or oral pazopanib (800 mg per day) for 24 weeks before moving into their randomly allocated group. Although non-inferiority could not be concluded for the primary endpoint of overall survival, temporary treatment cessation was found to preserve quality of life and was cost-effective. Therefore, planned breaks in tyrosine kinase inhibitor treatment represent a reasonable option for selected patients with renal cell carcinoma, providing potential lifestyle and health economic benefits. The study provides a rationale for further exploration of treatment breaks in patients with other cancers.

Article: Temporary treatment cessation versus continuation of first-line tyrosine kinase inhibitor in patients with advanced clear cell renal cell carcinoma (STAR): an open-label, non-inferiority, randomised, controlled, phase 2/3 trial – The Lancet Oncology

Commentary on Twitter

NOW OF: The STAR open-label ph 2/3 RCT could not conclude that a TKI drug-free interval strategy was non-inferior to a conventional continuation strategy for first-line treatment of advanced clear cell renal cell carcinoma. #rccsmhttps://t.co/xzCU1jdLE7 pic.twitter.com/Ks1Eh0vMId

— The Lancet Oncology (@TheLancetOncol) February 14, 2023