• Je něco špatně v tomto záznamu ?

Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial

SY. Rha, Y. Zhang, A. Elme, R. Pazo Cid, A. Alacacioglu, DC. Ziogas, K. Shitara, A. Ranceva, R. Nemecek, A. Santoro, CA. Calderon, K. Korphaisarn, T. Davis, A. Zahlten-Kuemeli, C. Conn, M. Tan, H. Honeycutt, ZA. Wainberg

. 2025 ; 9 (-) : e2400710. [pub] 20250124

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, klinické zkoušky, fáze III

Perzistentní odkaz   https://www.medvik.cz/link/bmc25010380

PURPOSE: Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression is an emerging biomarker in gastric cancer and gastroesophageal junction cancer (GC). We assessed FGFR2b protein overexpression prevalence in nearly 3,800 tumor samples as part of the prescreening process for a global phase III study in patients with newly diagnosed advanced or metastatic GC. METHODS: As of June 28, 2024, 3,782 tumor samples from prescreened patients from 37 countries for the phase III FORTITUDE-101 trial (ClinicalTrials.gov identifier: NCT05052801) were centrally tested for FGFR2b protein overexpression by immunohistochemistry (IHC) and had evaluable results. FGFR2b positivity was defined as both any % tumor cells (TC) and ≥10% TC exhibiting moderate-to-strong (2+/3+) membranous FGFR2b staining. Prevalence was analyzed across patient and sample characteristics. RESULTS: FGFR2b protein overexpression at any % and ≥10%, 2+/3+ TC positivity was 37.8% (1,428/3,782 [95% CI, 36.2 to 39.3]) and 16.2% (612/3,782 [95% CI, 15 to 17.4]), respectively. Of any %, 2+/3+ TC-positive tumors, 42.9% (612/1,428 [95% CI, 40.3 to 45.4]) were FGFR2b ≥10%, 2+/3+ TC positive. FGFR2b prevalence was not notably different within multiple patient and sample characteristics examined (age, sex, collection method [biopsy v resection], collection site, location of primary tumor, and geographic region). CONCLUSION: As of the data cutoff date, we report the largest prevalence assessment of FGFR2b protein overexpression in GC with more than one third (37.8%) of patients with GC exhibiting FGFR2b protein overexpression (any % TC, 2+/3+) by a validated IHC assay. Approximately 16% of patients had FGFR2b protein overexpression in ≥10% of TC. FGFR2b prevalence was similar across geographic regions and within defined patient and sample variables regardless of the level of expression.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25010380
003      
CZ-PrNML
005      
20250429135505.0
007      
ta
008      
250415e20250124xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/PO-24-00710 $2 doi
035    __
$a (PubMed)39854659
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Rha, Sun Young $u Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea $1 https://orcid.org/0000000225124531
245    10
$a Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial / $c SY. Rha, Y. Zhang, A. Elme, R. Pazo Cid, A. Alacacioglu, DC. Ziogas, K. Shitara, A. Ranceva, R. Nemecek, A. Santoro, CA. Calderon, K. Korphaisarn, T. Davis, A. Zahlten-Kuemeli, C. Conn, M. Tan, H. Honeycutt, ZA. Wainberg
520    9_
$a PURPOSE: Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression is an emerging biomarker in gastric cancer and gastroesophageal junction cancer (GC). We assessed FGFR2b protein overexpression prevalence in nearly 3,800 tumor samples as part of the prescreening process for a global phase III study in patients with newly diagnosed advanced or metastatic GC. METHODS: As of June 28, 2024, 3,782 tumor samples from prescreened patients from 37 countries for the phase III FORTITUDE-101 trial (ClinicalTrials.gov identifier: NCT05052801) were centrally tested for FGFR2b protein overexpression by immunohistochemistry (IHC) and had evaluable results. FGFR2b positivity was defined as both any % tumor cells (TC) and ≥10% TC exhibiting moderate-to-strong (2+/3+) membranous FGFR2b staining. Prevalence was analyzed across patient and sample characteristics. RESULTS: FGFR2b protein overexpression at any % and ≥10%, 2+/3+ TC positivity was 37.8% (1,428/3,782 [95% CI, 36.2 to 39.3]) and 16.2% (612/3,782 [95% CI, 15 to 17.4]), respectively. Of any %, 2+/3+ TC-positive tumors, 42.9% (612/1,428 [95% CI, 40.3 to 45.4]) were FGFR2b ≥10%, 2+/3+ TC positive. FGFR2b prevalence was not notably different within multiple patient and sample characteristics examined (age, sex, collection method [biopsy v resection], collection site, location of primary tumor, and geographic region). CONCLUSION: As of the data cutoff date, we report the largest prevalence assessment of FGFR2b protein overexpression in GC with more than one third (37.8%) of patients with GC exhibiting FGFR2b protein overexpression (any % TC, 2+/3+) by a validated IHC assay. Approximately 16% of patients had FGFR2b protein overexpression in ≥10% of TC. FGFR2b prevalence was similar across geographic regions and within defined patient and sample variables regardless of the level of expression.
650    _2
$a lidé $7 D006801
650    12
$a receptor fibroblastových růstových faktorů, typ 2 $x metabolismus $7 D051497
650    12
$a nádory žaludku $x patologie $x metabolismus $7 D013274
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a senioři $7 D000368
650    _2
$a dospělí $7 D000328
650    _2
$a prevalence $7 D015995
650    _2
$a nádorové biomarkery $7 D014408
655    _2
$a časopisecké články $7 D016428
655    _2
$a klinické zkoušky, fáze III $7 D017428
700    1_
$a Zhang, Yanqiao $u Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China $1 https://orcid.org/0000000262068364
700    1_
$a Elme, Anneli $u North Estonia Medical Centre Foundation, Tallinn, Estonia $1 https://orcid.org/0000000304322261
700    1_
$a Pazo Cid, Roberto $u Hospital Universitario Miguel Servet, Zaragoza, Spain
700    1_
$a Alacacioglu, Ahmet $u Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi, Menemen, Turkey
700    1_
$a Ziogas, Dimitrios C $u First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece $1 https://orcid.org/0000000326204004
700    1_
$a Shitara, Kohei $u Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa City, Japan $1 https://orcid.org/0000000151963630
700    1_
$a Ranceva, Anastasija $u Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Clinics, Vilnius, Lithuania
700    1_
$a Nemecek, Radim $u Department of Comprehensive Cancer Care, Masaryk Memorial Cancer Institute and Masaryk University, Faculty of Medicine, Brno, Czech Republic
700    1_
$a Santoro, Armando $u Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy $u Medical Oncology and Haematology Unit, IRCCS Humanitas Research Hospital, Humanitas Cancer Center, Rozzano, Milan, Italy $1 https://orcid.org/0000000317099492
700    1_
$a Calderon, Carlos Alberto $u Fundacion Cardiovascular de Colombia, Bucaramanga, Colombia
700    1_
$a Korphaisarn, Krittiya $u Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand $1 https://orcid.org/0000000157390175
700    1_
$a Davis, Tracy $u Roche Diagnostics Solutions, Tucson, AZ $1 https://orcid.org/0009000813864306
700    1_
$a Zahlten-Kuemeli, Anita $u Amgen, Inc, Thousand Oaks, CA
700    1_
$a Conn, Christopher $u Amgen, Inc, Thousand Oaks, CA
700    1_
$a Tan, Mengyao $u Amgen, Inc, Thousand Oaks, CA
700    1_
$a Honeycutt, Hayden $u Amgen, Inc, Thousand Oaks, CA
700    1_
$a Wainberg, Zev A $u Division of Hematology-Oncology, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA $1 https://orcid.org/0000000271421246
773    0_
$w MED00204957 $t JCO precision oncology $x 2473-4284 $g Roč. 9 (20250124), s. e2400710
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39854659 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250415 $b ABA008
991    __
$a 20250429135501 $b ABA008
999    __
$a ok $b bmc $g 2311625 $s 1247461
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 9 $c - $d e2400710 $e 20250124 $i 2473-4284 $m JCO precision oncology $n JCO Precis Oncol $x MED00204957
LZP    __
$a Pubmed-20250415
Zpět

Najít záznam

Citační ukazatele

Možnosti archivace