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

共 50 条

[21] Updated results from a phase II study of infigratinib (BGJ398), a selective pan-FGFR kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions
Javle, M.
Kelley, R. K.
Roychowdhury, S.
Weiss, K. H.
Abou-Alfa, G. K.
Macarulla, T.
Sadeghi, S.
Waldschmidt, D.
Zhu, A. X.
Goyal, L.
Borad, M.
Yong, W. P.
Borbath, I.
El-Khoueiry, A.
Philip, P.
Moran, S.
Ye, Y.
Ising, M.
Lewis, N.
Bekaii-Saab, T.
ANNALS OF ONCOLOGY, 2018, 29 : 720 - 720
[22] Pemigatinib for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements
Walden, Daniel
Eslinger, Cody
Bekaii-Saab, Tanios
THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2022, 15
[23] Efficacy of derazantinib in intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions, mutations or amplifications
Borad, M.
Javle, M.
Shaib, W. L.
Mody, K.
Bergamo, F.
Harris, W. P.
Damjanov, N.
Macarulla, T.
Brandi, G.
Masi, G.
Busset, M. Droz Dit
Boncompagni, A.
Dimova-Dobreva, M.
Engelhardt, M.
Saulay, M.
Halfdanarson, T. R.
Knox, J.
Abou-Alfa, G. K.
Personeni, N.
Mazzaferro, V.
ANNALS OF ONCOLOGY, 2022, 33 (07) : S567 - S568
[24] Cholangiocarcinoma patients with FGFR2 fusions/ rearrangements but primary refractory to pemigatinib: the real challenge?
Rizzo, A.
Ricci, A. D.
Brandi, G.
ESMO OPEN, 2024, 9 (10)
[25] Fibroblast growth factor receptor 2 (FGFR2) fusions in Japanese patients with intrahepatic cholangiocarcinoma
Tsujie, Masanori
Iwai, Tomohisa
Kubo, Shoji
Ura, Takashi
Hatano, Etsuro
Sakai, Daisuke
Takeda, Yutaka
Kaibori, Masaki
Kobayashi, Tomoe
Katanuma, Akio
Katayose, Yu
Fukase, Koji
JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2021, 51 (06) : 911 - 917
[26] FGFR2 fusions assessed by NGS, FISH, and immunohistochemistry in intrahepatic cholangiocarcinoma
Cao, Zi
Yang, Yichen
Liu, Shasha
Sun, Lin
Liu, Yanxue
Luo, Ye
Wang, Jian
Sun, Yan
JOURNAL OF GASTROENTEROLOGY, 2025, 60 (02) : 235 - 246
[27] Pharmacokinetics of infigratinib and its active metabolites in Chinese patients with advanced gastric cancer harboring FGFR2 gene amplification
Yuan, Jiajia
Shen, Lin
Liu, Tian Shu
Xu, Huiting
Yang, Jianwei
Wei, Jia
Jiang, Haiping
Deng, Yanhong
Pan, Hongming
Wang, Yusheng
Zhang, Xiaotian
Peng, Zhi
Qi, Changsong
Zhang, Lingli
Hsu, Peiwen
Song, Lin
Mu, Lei
Sun, Qiao
Gong, Jifang
Lyu, Cheng
CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 17 (12):
[28] COST-EFFECTIVENESS OF PEMIGATINIB FOR PATIENTS WITH ADVANCED INTRAHEPATIC CHOLANGIOCARCINOMA AND FGFR2 FUSIONS/ REARRANGEMENTS: 2024 FIGHT-202 TRIAL FINAL RESULTS
Huang, W. M.
Wang, I. T.
Chen, H. L.
Chueh, C. H.
Chiang, N. J.
Tsai, Y. W.
VALUE IN HEALTH, 2024, 27 (12)
[29] Efficacy and safety of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with FGFR2 gene amplification
Yuan, J.
Shen, L.
Liu, T.
Xu, H.
Yang, J.
Wei, J.
Jiang, H.
Deng, Y.
Wang, Y.
Zhang, X.
Gong, J.
Lyu, C.
Li, Y.
Song, L.
ANNALS OF ONCOLOGY, 2023, 34 : S859 - S860
[30] Gene und Pathways: FGFR2‑Translokationen und FusionsanalytikGenes and pathways: FGFR2 translocations and gene fusion analysis
Olaf Neumann
Markus Ball
Ulrich Lehmann
Peter Schirmacher
Albrecht Stenzinger
Daniel Kazdal
Die Pathologie, 2022, 43 (5) : 384 - 386

← 1 2 3 4 5 →