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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Urology 1/2015

Feasibly of axitinib as first-line therapy for advanced or metastatic renal cell carcinoma: a single-institution experience in Japan

Zeitschrift:
BMC Urology > Ausgabe 1/2015
Autoren:
Takuya Koie, Chikara Ohyama, Takahiro Yoneyama, Hayato Yamamoto, Atsushi Imai, Shingo Hatakeyama, Yasuhiro Hashimoto, Tohru Yoneyama, Yuki Tobisawa, Kazuyuki Mori
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

TK was involved in the drafting of the manuscript. TK, HY, AI, SH, TY and YH performed the clinical follow-up and contributed to the manuscript. TY, YT, and KM collected data and performed statistical analysis. YH reviewed the pathological specimen. CO and TK performed the operation. CO was responsible for the conception and design of this study, interpretation of the data, and critical revision of the manuscript. All authors read and approved the final manuscript.

Authors’ information

TK: Associate professor. CO: Professor and Chairman. TY: Lecturer. HY: Assistant professor. AI: Assistant professor. SH: Lecturer. YH: Associate professor. TY: Assistant professor. YT: Assistant professor. KM: Assistant professor. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.

Abstract

Background

Clinical benefit of axitinib as a first line agent to treat patients with metastatic renal cell carcinoma (mRCC), or locally advanced renal cell carcinoma (RCC) have not been clearly demonstrated. The aim of this study was to evaluate the efficacy and safety of axitinib as first-line therapy in Japanese patients with locally advanced RCC or mRCC.

Methods

In this retrospective study, we focused on eighteen patients who underwent first-line therapy with axitinib between May 2012 and May 2014 at Hirosaki University. Axitinib was orally administered at a dose of 10 mg daily. Progression-free survival (PFS) was the primary endpoint, while secondary endpoints included overall response rate (ORR) and adverse events (AEs).

Results

All patients had histologically proven clear cell RCC. The median duration of the administration of axitinib was 10.8 months. According to the response evaluation criteria for solid tumors, five patients (27.8%) achieved a partial response and nine (50%) had stable disease. The 1-year PFS rate was 84.4%, and the median PFS was 20.4 months (95% confidence interval, 17.5 – 21.7). No serious AEs were reported during the study, and there were no toxicity-related deaths.

Conclusions

In the current study, axitinib showed acceptable oncological outcomes and favorable safety profile as first-line therapy for locally advanced RCC or mRCC in treatment-naïve Japanese patients. Thus, first-line therapy with axitinib may provide a feasible option for treatment of advanced RCC or mRCC patients.
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