Relationships between sunitinib plasma concentration and clinical outcomes in Japanese patients with metastatic renal cell carcinoma

Shinya Takasaki, Yoshihide Kawasaki, Masafumi Kikuchi, Masaki Tanaka, Masato Suzuka, Aoi Noda, Yuji Sato, Shinichi Yamashita, Koji Mitsuzuka, Hideo Saito, Akihiro Ito, Hiroaki Yamaguchi, Yoichi Arai, Nariyasu Mano

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

Background: The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with metastatic renal cell carcinoma (mRCC). Methods: Twenty patients with mRCC were enrolled following treatment with sunitinib. To assess safety, the total sunitinib concentration range up to discontinuation of treatment and dosage reduction associated with adverse events within 6 weeks from initiating administration were analyzed. The longest administered sunitinib dosage was defined as the maintenance dose, and the relationship between total sunitinib concentration at the maintenance dosage and sunitinib efficacy was investigated. Results: Total sunitinib concentration was significantly higher in patients who discontinued treatment or had dosage reduction due to adverse events within 6 weeks after initiation of sunitinib than in patients who continued treatment with the initial dosage. The time to treatment failure, progression-free survival, and overall survival were better in patients with total sunitinib concentrations < 50 ng/mL than in those with concentrations ≥ 50 ng/mL. Conclusions: The present study demonstrated that the effective range of total sunitinib concentration in Japanese patients with mRCC was lower than 50–100 ng/mL which was previously reported. These results indicate that therapeutic drug monitoring could maintain the therapeutic effect of sunitinib while minimizing adverse events by personalizing sunitinib dosages for Japanese patients with mRCC.

Original languageEnglish
Pages (from-to)936-943
Number of pages8
JournalInternational Journal of Clinical Oncology
Volume23
Issue number5
DOIs
Publication statusPublished - 2018 Oct 1

Keywords

  • Pharmacokinetics
  • Renal cell carcinoma
  • Sunitinib
  • Therapeutic drug monitoring
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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