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The efficacy and safety of sunitinib given on an individualised schedule as first-line therapy for metastatic renal cell carcinoma: A phase 2 clinical trial

European Journal of Cancer Feb 10, 2019

Bjarnason GA, et al. - Since sunitinib is administered on a rigid schedule that may not be optimal for all patients, researchers investigated whether toxicity-driven dose and schedule changes could optimize drug exposure and outcome for each patient. This was tested among 117 patients with metastatic clear cell renal cell cancer who were started on sunitinib 50 mg/day with the aim to treat for 28 days in this phase 2 trial. Based on toxicity, they individualised sunitinib dose and the number of days on therapy. They aimed for ≤ grade II toxicity with dose escalation in patients with minimal toxicity. The median progression-free survival (PFS) was 12.5 months and median overall survival was 38.5 months. Clinical benefit was seen in 84.6% of patients and quality of life did not decline during therapy. Dose reduction or discontinuation due to toxicity was required in fewer patients compared to standard sunitinib dosing. Overall, the findings revealed the feasibility, safety as well as the efficacy of individualised sunitinib therapy for managing toxicity with one of the best efficacy seen for oral vascular endothelial growth factor inhibitors in metastatic renal cell carcinoma.
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