Abstract
Objective: This study aim to assess the efficacy and safety of sunitinib in Japanese patients with metastatic renal cell carcinoma (mRCC) in general clinical practice. Patients and Methods: Non-selected fifty eight Japanese patients with mRCC were treated with sunitinib. Overall survival (OS) and time to treatment failure (TTF) were estimated. Response rate and safety profiles were also assessed. Results: Partial response, stable disease, and progressive disease were observed in 13 (22.4%), 26 (44.8%), and 19 (32.8%) patients, respectively. The median TTF was 5.4 months, and the median OS was 11.2 months. In the prior nephrectomy group, the median TTF was 9.0 months, and the median OS was 16.4 months. In the non-nephrectomy group, the median TTF was 1.1 months, and the median OS was 2.8 months. The most frequently occurring Grade 3/4 adverse events (AEs) were anorexia (17.2%), fatigue (12.1%), thrombocytopenia (13.8%), and anemia (12.1%). Conclusions: Sunitinib has a favorable risk/benefit profile in Japanese mRCC patients with a history of nephrectomy.
Highlights
Renal cell carcinoma (RCC) is the most common cancer of the kidney [1]
The median treatment failure (TTF) was 5.4 (95% confidence interval [CI]: 2.83, 10.2) months (Figure 1(a)), progression-free survival (PFS) was 5.8 months (Figure 1(b)), and the median Overall survival (OS) was 11.2 months (Figure 1(c))
In the prior nephrectomy group, the median TTF was 9.0 months (Figure 2(a)), and the median OS was 16.4 months (Figure 2(b))
Summary
Renal cell carcinoma (RCC) is the most common cancer of the kidney [1]. RCC presents with metastatic disease in up to 30% of patients, and recurrence develops in ~40% of patients treated for a localized tumor [2]. RCC currently constitutes
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