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

[1] Infigratinib versus gemcitabine plus cisplatin as first-line therapy in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: phase 3 PROOF trial
Abou-Alfa, G.
Borbath, I.
Cohn, A.
Goyal, L.
Lamarca, A.
Macarulla, T.
Oh, D.
Roychowdhury, S.
Sadeghi, S.
Shroff, R.
Howland, M.
Li, A.
Cho, T.
Pande, A.
Javle, M.
ANNALS OF ONCOLOGY, 2020, 31 : S136 - S137
[2] Infigratinib versus gemcitabine plus cisplatin multicenter, open-label, randomized, phase III study in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF trial
Abou-Alfa, G. K.
Borbath, I.
Clarke, S. J.
Hitre, E.
Louvet, C.
Macarulla, T.
Oh, D-Y.
Spratlin, J. L.
Valle, J. W.
Weiss, K. H.
Berman, C.
Howland, M.
Ye, Y.
Cho, T.
Moran, S.
Javle, M. M.
ANNALS OF ONCOLOGY, 2019, 30
[3] Infigratinib for the Treatment of Metastatic or Locally Advanced Cholangiocarcinoma With Known FGFR2 Gene Fusions or Rearrangements
White, Kathryn
Anwar, Ahmed I.
Jin, Kevin
Bollich, Victoria
Kelkar, Rucha A.
Talbot, Norris C.
Klapper, Rachel J.
Ahmadzadeh, Shahab
Viswanath, Omar
Varrassi, Giustino
Shekoohi, Sahar
Kaye, Alan D.
CUREUS JOURNAL OF MEDICAL SCIENCE, 2023, 15 (10)
[4] Infigratinib in pretreated cholangiocarcinoma with FGFR2 fusions or rearrangements
Neuzillet, Cindy
LANCET GASTROENTEROLOGY & HEPATOLOGY, 2021, 6 (10): : 773 - 775
[5] Infigratinib versus gemcitabine plus cisplatin multicenter, open-label, randomized, phase 3 study in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: The PROOF trial.
Javle, Milind M.
Borbath, Ivan
Clarke, Stephen John
Hitre, Erika
Louvet, Christophe
Mercade, Teresa Macarulla
Oh, Do-Youn
Spratlin, Jennifer L.
Valle, Juan W.
Weiss, Karl Heinz
Berman, Craig
Howland, Michael
Ye, Yining
Cho, Terry
Moran, Susan
Abou-Alfa, Ghassan K.
JOURNAL OF CLINICAL ONCOLOGY, 2019, 37 (15)
[6] Phase 3 multicenter, open-label, randomized study of infigratinib versus gemcitabine plus cisplatin in the first-line treatment of patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF trial
Javle, M.
Borbath, I.
Clarke, S.
Hitre, E.
Louver, C.
Macarulla, T.
Oh, D.
Spratlin, J.
Valee, J.
Weiss, K.
Berman, C.
Howland, M.
Ye, Y.
Cho, T.
Moran, S.
Abou-Alfa, C.
ANNALS OF ONCOLOGY, 2019, 30 : 62 - 62
[7] PROOF 301: A multicenter, open-label, randomized, phase 3 trial of infigratinib versus gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma with an FGFR2 gene fusion/rearrangement
Abou-Alfa, Ghassan K.
Borbath, Ivan
Goyal, Lipika
Lamarca, Angela
Macarulla, Teresa
Oh, Do-Youn
Roychowdhury, Sameek
Sadeghi, Saeed
Shroff, Rachna T.
Li, Ai
Soto, Jose
Avogadri, Francesca
Dambkowski, Carl L.
Javle, Milind M.
JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (16)
[8] PROOF 301: A multicenter, open-label, randomized, phase 3 trial of infigratinib vs gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma with an FGFR2 gene fusion/rearrangement
Abou-Alfa, G.
Borbath, I.
Goyal, L.
Lamarca, A.
Macarulla, T.
Oh, D.
Roychowdhury, S.
Sadeghi, S.
Shroff, R.
Soto, J.
Pedrioli, G.
Fumagalli, L.
Dambkowski, C.
Javle, M.
ANNALS OF ONCOLOGY, 2022, 33 : S251 - S252
[9] Natural history of patients with advanced cholangiocarcinoma and FGFR2 gene fusions/rearrangements.
Shroff, Rachna T.
Avogadri, Francesca
Weng, Richard
Li, Ai
Dambkowski, Carl L.
Lamarca, Angela
JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (04)
[10] PROOF 301: Results of an early discontinued randomized phase 3 trial of the oral FGFR inhibitor infigratinib vs. gemcitabine plus cisplatin in patients with advanced cholangiocarcinoma (CCA) with an FGFR2 gene fusion/rearrangement.
Abou-Alfa, Ghassan K.
Borbath, Ivan
Roychowdhury, Sameek
Goyal, Lipika
Lamarca, Angela
Macarulla, Teresa
Shroff, Rachna T.
Oh, Do-Youn
Javle, Milind M.
Tamas, Catalin
Savastano, David M.
Van Veenhuyzen, David Friedrich
Xu, Cindy
Solanas, Jacki
Freas, Elizabeth
JOURNAL OF CLINICAL ONCOLOGY, 2024, 42 (3_SUPPL) : 516 - 516

← 1 2 3 4 5 →