Japanese Journal of Clinical Oncology Advance Access published online on November 7, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp146
© The Author (2009). Published by Oxford University Press. All rights reserved
A Phase II Study of Sunitinib in Japanese Patients with Metastatic Renal Cell Carcinoma: Insights into the Treatment, Efficacy and Safety
1 Department of Urology, Kinki University School of Medicine, Osaka
2 Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo
3 Department of Urology, Akita University School of Medicine, Akita
4 Department of Urology, Yamagata University School of Medicine, Yamagata
5 Department of Urology, National Cancer Center Hospital, Tokyo
6 Division of Urology, Shizuoka Cancer Center Hospital, Shizuoka
7 Department of Urology, Hamamatsu University School of Medicine, Hamamatsu
8 Department of Urology, Kyoto Prefectural University of Medicine, Kyoto
9 Department of Urology, Osaka University Graduate School of Medicine, Osaka
10 Department of Urology, University of Tokushima Graduate School, Tokushima
11 Department of Urology, National Kyushu Cancer Center Hospital, Fukuoka
12 Pfizer Japan Inc, Tokyo, Japan
13 Pfizer Global Research and Development, La Jolla, USA
14 Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka
15 Department of Urology, University of Tsukuba, Graduate School of Comprehensive Human Sciences, Tsukuba, Japan
For reprints and all correspondence: Hideyuki Akaza, Department of Urology, University of Tsukuba, Graduate School of Comprehensive Human Sciences, Tsukuba 305-8576, Japan. E-mail: akazah{at}md.tsukuba.ac.jp
Received June 23, 2009; accepted October 1, 2009
Objective: This study aims to assess the efficacy and safety of sunitinib in Japanese patients with metastatic renal cell carcinoma (RCC).
Methods: Fifty-one Japanese patients with prior nephrectomy, 25 treatment-naive patients (first-line group) and 26 cytokine-refractory patients (pretreated group) were enrolled in this phase II trial. Patients received sunitinib 50 mg orally, once daily, in repeated 6-week cycles (4 weeks on treatment, 2 weeks off). The primary endpoint was RECIST-defined objective response rate (ORR) with tumour assessments every 6 weeks via computed tomography or magnetic resonance imaging. Toxicity was assessed regularly. In the primary efficacy analysis of the intent-to-treat (ITT) population, ORR and 95% confidence interval were calculated based on independent review. Secondary time-to-event endpoints, such as progression-free survival (PFS), were estimated using the Kaplan–Meier method.
Results: In the ITT population, ORR was 48.0% in the first-line group (after a median 4 cycles), 46.2% in the pretreated group (5 cycles) and 47.1% overall, with median times to tumour response of 7.1, 10.7 and 10.0 weeks, respectively. Median PFS was 46.0, 33.6 and 46.0 weeks, respectively. The most common treatment-related grade 3/4 adverse events and laboratory abnormalities were fatigue (20%), hand-foot syndrome (14%) and hypertension (12%), decreased platelet count (55%), decreased neutrophil count (51%), increased lipase (39%) and decreased lymphocyte count (33%).
Conclusions: In Japanese patients with RCC, sunitinib is consistently effective and tolerable with similar risk/benefit as that in Western patients, though there was a trend toward greater antitumour efficacy and higher incidence of haematological adverse events in Japanese patients.
Key Words: Japanese • phase II • renal cell carcinoma • sunitinib