Optimal dose of sunitinib for long-term treatment in Japanese patients with renal cell carcinoma

Yamada, Yuto; Ohno, Yuta; Kato, Yu; Kobayashi, Ryo; Hayashi, Hideki; Miyahara, Shiho; Nakane, Keita; Mizutani, Kosuke; Yokoi, Shigeaki; Fujii, Hironori; Iihara, Hirotoshi; Ishihara, Takuma; Deguchi, Takashi; Sugiyama, Tadashi; Suzuki, Akio

doi:10.1007/s00280-019-03935-x

Cited by 3 publications

(2 citation statements)

References 20 publications

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“…No between‐study differences were observed in abnormal laboratory values. The safety and tolerability of cabozantinib in this study were consistent with previously reported cabozantinib data and comparable with other TKIs in Japanese populations 16,17 …”

Section: Discussionsupporting

confidence: 91%

“…The safety and tolerability of cabozantinib in this study were consistent with previously reported cabozantinib data and comparable with other TKIs in Japanese populations. 16,17 The median daily dose of cabozantinib in the present study (26 mg; median dose intensity 43%) was lower than that in METEOR (43 mg, relative dose intensity 71%), 12 potentially due to discrepancies in the PK profile of different patient groups; steady-state plasma exposures of cabozantinib in Japanese patients have been shown to be approximately 30% higher than those in their non-Japanese counterparts. 14 As the risk of AEs is dependent on cabozantinib exposure, 18 more patients in the present study required dose adjustments than in METEOR (91% vs 62%).…”

Section: Discussionmentioning

confidence: 49%

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Cabozantinib in advanced renal cell carcinoma: A phase II, open‐label, single‐arm study of Japanese patients

et al. 2020

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Objectives: To evaluate the efficacy and safety of cabozantinib, through a bridging study to METEOR, in Japanese patients with advanced renal cell carcinoma who had progressed after prior tyrosine kinase inhibitor therapy. Methods: This phase II, open-label, single-arm study (ClinicalTrials.gov registration number: NCT03339219) included adult Japanese patients with advanced renal cell carcinoma and measurable disease who had received one or more tyrosine kinase inhibitors. Patients received cabozantinib 60 mg orally once daily while there was clinical benefit, or until unacceptable toxicity or disease progression. The primary end-point was objective response rate per Response Evaluation Criteria in Solid Tumors Version 1.1. Secondary end-points included clinical benefit rate (complete or partial response, or ≥8week stable disease), progression-free survival, overall survival and safety. Results: Of the 35 patients enrolled, 68.6%, 22.9% and 8.6% had previously received one, two and three prior tyrosine kinase inhibitors, respectively. The median duration of cabozantinib exposure was 27.0 weeks (range 5.1-43.0 weeks). The objective response rate was 20.0% (90% confidence interval 9.8-34.3%), and the clinical benefit rate was 85.7% (95% confidence interval 69.7-95.2%). The 6-month estimated progression-free survival was 72.3% (95% confidence interval 53.3-84.6%); the median progression-free survival and overall survival were not reached. All patients reported adverse events, which were manageable by supportive treatment or dose modification; two patients (5.7%) discontinued therapy due to adverse events. Conclusions: The results showed that findings from METEOR can be extrapolated, and that cabozantinib 60 mg/day is a viable treatment option in Japanese patients with advanced renal cell carcinoma who had progressed after prior tyrosine kinase inhibitor therapy.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 49%

Cabozantinib in advanced renal cell carcinoma: A phase II, open‐label, single‐arm study of Japanese patients

et al. 2020

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PDZK1 confers sensitivity to sunitinib in clear cell renal cell carcinoma by suppressing the PDGFR-β pathway

Wang,

Zhang,

Liu

et al. 2024

Br J Cancer

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Sunitinib therapy for imatinib-resistant and/or intolerant gastrointestinal stromal tumors: comparison of safety and efficacy between standard and reduced dosage regimens

Sasaki

Kanda²,

Matsumoto

et al. 2023

Japanese Journal of Clinical Oncology

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Background Sunitinib therapy for patients with imatinib-resistant and/or intolerant gastrointestinal stromal tumors (GISTs) often causes severe adverse events (AEs) that lead to treatment discontinuation. Methods We retrospectively reviewed the clinical records of imatinib-resistant and/or intolerant GIST patients who underwent sunitinib therapy in our institutions between 2007 and 2020. Forty-one patients were enrolled and divided into two groups on the basis of the starting dosage: the standard dosage group (50 mg/day, 21 patients) and the reduced dosage group (37.5 mg/day, 20 patients). Tolerability, safety and clinical efficacy of the two groups were compared. Results Three patients (14%) in the standard dosage group and another three (15%) in the reduced dosage group (P = 1.000) discontinued sunitinib therapy because of AEs. The incidences of grade 3 or more severe treatment-related AEs were 90 and 75%, respectively (P = 0.238). Two possible treatment-related deaths were noted in the standard dosage group. Clinical efficacy was comparable between the two groups: median time to treatment failure and overall survival were 4.5 months [interquartile range (IQR), 3.6–9.0] and 13.7 months (IQR, 7.5–22.9) in the standard dosage group and 4.6 months (IQR, 2.7–17.0) and 13.4 months (IQR, 9.3–36.8) in the reduced dosage group, respectively. Conclusions The reduced dosage of 37.5 mg sunitinib tended to decrease toxicity and the incidences of severe AEs and treatment-related deaths. This reduced dosage regimen showed equivalent clinical efficacy including patient survival. The reduced dosage of 37.5 mg sunitinib can be adopted as an alternative therapy for patients with imatinib-resistant and/or intolerant GISTs.

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Optimal dose of sunitinib for long-term treatment in Japanese patients with renal cell carcinoma

Cited by 3 publications

References 20 publications

Cabozantinib in advanced renal cell carcinoma: A phase II, open‐label, single‐arm study of Japanese patients

Cabozantinib in advanced renal cell carcinoma: A phase II, open‐label, single‐arm study of Japanese patients

PDZK1 confers sensitivity to sunitinib in clear cell renal cell carcinoma by suppressing the PDGFR-β pathway

Sunitinib therapy for imatinib-resistant and/or intolerant gastrointestinal stromal tumors: comparison of safety and efficacy between standard and reduced dosage regimens

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