並列タイトル等イマチニブ耐性または不耐の消化管間質腫瘍に対するスニチニブ治療における標準投与法と減量投与法の安全性と有効性の比較
一般注記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.
Japanese Journal of Clinical Oncology. 2023, 53(4), 297-303.
新大院博(医)第1114号
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