A Phase II Study of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma: Insights into the Treatment, Efficacy and Safety

摘要: Objective: This study aims to assess the efficacy and safety of sunitinib in Japanese patients with metastatic renal cell carcinoma (RCC). Methods: Fifty-one prior nephrectomy, 25 treatment-naive (first-line group) 26 cytokine-refractory (pretreated were enrolled this phase II trial. Patients received 50 mg orally, once daily, repeated 6-week cycles (4 weeks on treatment, 2 off). The primary endpoint was RECIST-defined objective response rate (ORR) tumour assessments every 6 via computed tomography or magnetic resonance imaging. Toxicity assessed regularly. In analysis intent-to-treat (ITT) population, ORR 95% confidence interval calculated based independent review. Secondary time-to-event endpoints, such as progression-free survival (PFS), estimated using Kaplan-Meier method. Results: ITT 48.0% first-line group (after a median 4 cycles), 46.2% pretreated (5 cycles) 47.1% overall, times 7.1, 10.7 10.0 weeks, respectively. Median PFS 46.0, 33.6 46.0 most common treatment-related grade 3/4 adverse events laboratory abnormalities fatigue (20%), hand-foot syndrome (14%) hypertension (12%), decreased platelet count (55%), neutrophil (51 %), increased lipase (39%) lymphocyte (33%). Conclusions: RCC, is consistently effective tolerable similar risk/benefit that Western patients, though there trend toward greater antitumour higher incidence haematological patients.