Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations.
Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations.
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DOI：
10.1158/2159-8290.cd-18-0229
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发表时间：
2018-07
期刊：
影响因子：
28.2
通讯作者：
Bajorin DF
中科院分区：
文献类型：
--
作者：
Pal SK;Rosenberg JE;Hoffman-Censits JH;Berger R;Quinn DI;Galsky MD;Wolf J;Dittrich C;Keam B;Delord JP;Schellens JHM;Gravis G;Medioni J;Maroto P;Sriuranpong V;Charoentum C;Burris HA;Grünwald V;Petrylak D;Vaishampayan U;Gez E;De Giorgi U;Lee JL;Voortman J;Gupta S;Sharma S;Mortazavi A;Vaughn DJ;Isaacs R;Parker K;Chen X;Yu K;Porter D;Graus Porta D;Bajorin DF
BGJ 398是一种有效的选择性泛成纤维细胞生长因子受体（FGFR）拮抗剂，在携带多种FGFR 3改变的转移性尿路上皮癌患者中进行了前瞻性评价。入组了无法接受铂类化疗的患者（N = 67）。大多数患者（70.1%）既往接受过两种或两种以上的化疗。BGJ 398以125 mg/天口服给药，给药3周，停药1周，直至出现不可接受的毒性或进展。主要终点是应答率。在接受治疗的67例患者中，观察到25.4%的总体缓解率，另外38.8%的患者病情稳定，转化为64.2%的疾病控制率。最常见的治疗后出现的毒性为高磷血症、肌酐升高、疲乏、便秘和食欲下降。在这种疾病背景下进一步检查BGJ 398是必要的。
BGJ398, a potent and selective pan-fibroblast growth factor receptor (FGFR) antagonist, was prospectively evaluated in patients with metastatic urothelial carcinoma bearing a diverse array of FGFR3 alterations. Patients (N = 67) who were unable to receive platinum chemotherapy were enrolled. The majority (70.1%) had received two or more prior antineoplastic therapies. BGJ398 was administered orally at 125 mg/day on a 3 weeks on, 1 week off schedule until unacceptable toxicity or progression. The primary endpoint was the response rate. Among 67 patients treated, an overall response rate of 25.4% was observed and an additional 38.8% of patients had disease stabilization, translating to a disease control rate of 64.2%. The most common treatment-emergent toxicities were hyperphosphatemia, elevated creatinine, fatigue, constipation and decreased appetite. Further examination of BGJ398 in this disease setting is warranted.