Multicenter phase 2-3 trial of temporary treatment cessation versus continuation of first-line TKI for advanced clear cell renal cell carcinoma

Temporary drug treatment cessation might alleviate toxicity without substantially compromising efficacy in patients with cancer. The non-inferiority phase 2-3 STAR trial, at 60 centers in the UK, evaluated temporary treatment cessation versus continuation of first-line TKI for advanced clear cell renal cell carcinoma. Patients in the temporary treatment cessation group were treated for 24 weeks followed by a treatment break until disease progression, when treatment was reinstated. There was no clinically meaningful difference in life expectancy between the group with temporary treatment cessation and the group with continuation of treatment. There was also no significant difference in QALYs between the groups.