Efficacy and tolerability of a low-dose, 2-week administration of sunitinib followed by a week rest (2/1 schedule) for metastatic renal cell carcinoma: a single center experience of six cases

BACKGROUND: Sunitinib, an oral multitarget tyrosine kinase inhibitor and standard first-line treatment for metastatic renal cell carcinoma (mRCC), is generally administered on a 6-week schedule (4 weeks on/2 weeks off). However, drug toxicity often leads to temporary treatment interruption, resulting in reduced treatment efficacy. In this report, we investigated whether sunitinib administration of at a dose of 25 mg/day in a 2-weeks-on/1-week-off cycle would reduce the incidence of drug-related side effects while maintaining drug efficacy. FINDINGS: A total of six patients with mRCC were orally administered sunitinib at a dose of 25 mg/day in a 2-weeks-on/1-week-off regimen until intolerable toxicities occurred. All enrolled patients were assessed for toxicity and response. The median treatment period was 24 months (range, 9–40 months). Objective responses were as follows: disease stabilization of >6 months was achieved in all patients. The most important toxicities were neutropenia, fatigue, and proteinuria, but all were controlled. CONCLUSIONS: Oral sunitinib at 25 mg/day in a 2-weeks-on/1-week-off regimen to Japanese patients can avoid drug-related toxicities while achieving the same dose intensity as a 6-week schedule. Because these data were derived from a small number of patients, future prospective studies of modified sunitinib administration schedules are warranted.