Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial

被引：72

作者：

Makawita, Shalini ^{[1
]}

Abou-Alfa, Ghassan K. ^{[2
,3
]}

Roychowdhury, Sameek ^{[4
,5
]}

Sadeghi, Saeed ^{[6
]}

Borbath, Ivan ^{[7
,8
]}

Goyal, Lipika ^{[9
,10
]}

Cohn, Allen ^{[11
,12
]}

Lamarca, Angela ^{[13
]}

Oh, Do-Youn ^{[14
]}

Macarulla, Teresa ^{[15
]}

Shroff, Rachna T. ^{[16
]}

Howland, Michael ^{[17
]}

Li, Ai ^{[17
]}

Cho, Terry ^{[17
]}

Pande, Amit ^{[17
]}

Javle, Milind ^{[1
,18
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Div Canc Med, Houston, TX 77030 USA

[2] Mem Sloan Kettering Canc Ctr, Dept Med, New York, NY 10065 USA

[3] Weill Cornell Med Coll, Dept Med, New York, NY 10065 USA

[4] Ohio State Univ, Dept Internal Med, Div Med Oncol, James Canc Hosp, Columbus, OH 43210 USA

[5] Ohio State Univ, Ctr Comprehens Canc, Columbus, OH 43210 USA

[6] Univ Calif Los Angeles, Dept Med, Div Hematol Oncol, Los Angeles, CA 90404 USA

[7] Clin Univ St Luc, Dept Gastroenterol & Digest Oncol, Brussels, Belgium

[8] Catholic Univ Louvain, Brussels, Belgium

[9] Massachusetts Gen Hosp, Ctr Canc, Boston, MA 02114 USA

[10] Harvard Med Sch, Dept Med, Boston, MA 02115 USA

[11] Rocky Mt Canc Ctr, Denver, CO 80218 USA

[12] US Oncol Res, Denver, CO 80218 USA

[13] Univ Manchester, Div Canc Sci, Christie NHS Fdn Trust, Dept Med Oncol, Manchester, Lancs, England

[14] Seoul Natl Univ Hosp, Dept Internal Med, Seoul, South Korea

[15] Vall dHebron Univ Hosp, Vall dHebron Inst Oncol & IOB quiron, Barcelona, Spain

[16] Univ Arizona, Ctr Canc, Div Hematol Oncol, Tucson, AZ 85724 USA

[17] QED Therapeut, San Francisco, CA USA

[18] Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Houston, TX 77030 USA

来源：

FUTURE ONCOLOGY | 2020年 / 16卷 / 30期

关键词：

cholangiocarcinoma; fibroblast growth factor receptor inhibitor; infigratinib; targeted therapy; CANCER; INHIBITOR; BGJ398; TARGET;

D O I：

10.2217/fon-2020-0299

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Cholangiocarcinoma is an aggressive malignancy with poor overall survival. Approximately 15% of intrahepatic cholangiocarcinomas contain FGFR alterations. Infigratinib is an oral FGFR 1-3 kinase inhibitor. Favorable results from a Phase II trial of infigratinib in advanced/metastatic FGFR-altered cholangiocarcinomas has led to its further investigation in the front-line setting. In this article we describe the design, objectives and rationale for PROOF 301, a Phase III multicenter, open label, randomized trial of infigratinib in comparison to standard of care gemcitabine and cisplatin in advanced/metastatic cholangiocarcinoma with FGFR2 translocations. The results of this study have the potential to define a new role for a chemotherapy-free, targeted therapy option in the front-line setting for these patients.

引用

页码：2375 / 2384

页数：10

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