PMID- 25887125 OWN - NLM STAT- MEDLINE DCOM- 20160210 LR - 20181202 IS - 1471-2490 (Electronic) IS - 1471-2490 (Linking) VI - 15 DP - 2015 Apr 16 TI - Feasibly of axitinib as first-line therapy for advanced or metastatic renal cell carcinoma: a single-institution experience in Japan. PG - 32 LID - 10.1186/s12894-015-0027-4 [doi] LID - 32 AB - 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-naive Japanese patients. Thus, first-line therapy with axitinib may provide a feasible option for treatment of advanced RCC or mRCC patients. FAU - Koie, Takuya AU - Koie T AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. goodwin@cc.hirosaki-u.ac.jp. FAU - Ohyama, Chikara AU - Ohyama C AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. coyama@cc.hirosaki-u.ac.jp. FAU - Yoneyama, Takahiro AU - Yoneyama T AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. uroyone@cc.hirosaki-u.ac.jp. FAU - Yamamoto, Hayato AU - Yamamoto H AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. ha-yama@cc.hirosaki-u.ac.jp. FAU - Imai, Atsushi AU - Imai A AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tsushi.imai@gmail.com. FAU - Hatakeyama, Shingo AU - Hatakeyama S AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. shingorilla2@gmail.com. FAU - Hashimoto, Yasuhiro AU - Hashimoto Y AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. y-hashi@cc.hirosaki-u.ac.jp. FAU - Yoneyama, Tohru AU - Yoneyama T AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tohruyon@cc.hirosaki-u.ac.jp. FAU - Tobisawa, Yuki AU - Tobisawa Y AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tobisawa@cc.hirosaki-u.ac.jp. FAU - Mori, Kazuyuki AU - Mori K AD - Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. moribio@cc.hirosaki-u.ac.jp. LA - eng PT - Journal Article DEP - 20150416 PL - England TA - BMC Urol JT - BMC urology JID - 100968571 RN - 0 (Imidazoles) RN - 0 (Indazoles) RN - 0 (Protein Kinase Inhibitors) RN - C9LVQ0YUXG (Axitinib) SB - IM MH - Aged MH - Axitinib MH - Carcinoma, Renal Cell/*drug therapy/secondary/surgery MH - Female MH - Humans MH - Imidazoles/*therapeutic use MH - Indazoles/*therapeutic use MH - Kidney Neoplasms/*drug therapy/secondary/surgery MH - Male MH - Middle Aged MH - Nephrectomy MH - Protein Kinase Inhibitors/*therapeutic use MH - Retrospective Studies MH - Treatment Outcome PMC - PMC4417199 EDAT- 2015/04/19 06:00 MHDA- 2016/02/11 06:00 PMCR- 2015/04/16 CRDT- 2015/04/19 06:00 PHST- 2014/09/29 00:00 [received] PHST- 2015/04/07 00:00 [accepted] PHST- 2015/04/19 06:00 [entrez] PHST- 2015/04/19 06:00 [pubmed] PHST- 2016/02/11 06:00 [medline] PHST- 2015/04/16 00:00 [pmc-release] AID - 10.1186/s12894-015-0027-4 [pii] AID - 27 [pii] AID - 10.1186/s12894-015-0027-4 [doi] PST - epublish SO - BMC Urol. 2015 Apr 16;15:32. doi: 10.1186/s12894-015-0027-4.