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ESMO 2021: Temporary Treatment Cessation Versus Continuation in Advanced Kidney Cancer

By: Vanessa A. Carter, BS
Posted: Friday, September 24, 2021

Janet E. Brown, MD, of the University of Sheffield, Leeds, Great Britain, and colleagues conducted the phase II/III STAR study to determine how a drug-free interval strategy would compare with a conventional treatment continuation strategy in terms of overall survival and quality-adjusted life years (QALYs) of patients with renal cell carcinoma treated with standard first-line therapy (sunitinib or pazopanib). Presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract LBA28), their results showed that although differences between survival and quality of life were not significant, a drug-free interval strategy was acceptable and potentially cost-effective.

A total of 920 patients with advanced renal cell carcinoma were administered 24 weeks of sunitinib or pazopanib treatment. Patients undergoing the drug-free interval strategy (n = 459) took a break from treatment until disease progression, with additional breaks depending on patient/clinician choice and disease response. Patients undergoing the conventional treatment continuation strategy (n = 461) continued treatment until disease progression, intolerance, or death.

Just over half of patients in both the conventional treatment continuation (52.1%) and drug-free interval (54.0%) strategy groups continued the trial after week 24. The median break from treatment was 87 days. Hazard ratios among the intent-to-treat and per-protocol groups for overall survival were 0.97 and 0.94, respectively, suggesting a small but not statistically significant difference.

Conclusions on noninferiority were found to be consistent regarding QALYs, as the intent-to-treat population had a score of –0.05 and the per-protocol population had a score of 0.04. Most notably, the drug-free interval strategy appeared to be associated with a cost savings of almost £7,000 per participant over 2 years.

Disclosure: For full disclosures of the study authors, visit

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