ESMO 2021 | STAR: drug-free interval strategy for renal cell carcinoma

Janet E. Brown, BMedSci, MB BS, MSc, MD, FRCP, The University of Sheffield, Sheffield, UK, discusses results from the Phase II/III STAR trial which compared the use of a drug-free interval strategy (DFIS) to a conventional continuation strategy (CSS) in terms of non-inferiority for first-line tyrosine kinase inhibitor (TKI) treatment for advanced renal cell carcinoma (RCC). 920 patients received either sunitinib or pazopanib and underwent 4 cycles of standard treatment before being randomised 1:1 to either the DFIS arm (n=459) or CSS arm (n=461). Patients on the DFIS arm remained on a treatment break until disease progression. The co-primary endpoints of the study were overall survival (OS) and Quality Adjusted Life Years (QALYs). Analyses were carried out in the intention-to-treat (ITT) and per-protocol (PP) populations. The non-inferiority cut-off was met by the ITT population and just missed by the PP population. For quality of life, both populations met the non-inferiority cut-off. The DFIS arm was significantly cheaper than the CSS arm. The DFIS treatment regimen had fewer severe TKI-related adverse events. This interview took place at the European Society for Medical Oncology (ESMO) 2021 congress.