Abstract 2276
Background
Patients with biliary tract carcinomas (BTC) have a dismal prognosis. The FGFR2-fusion gene has been recently implicated in 14-17% of intrahepatic cholangiocarcinomas (ICC) and is expected to be a promising novel druggable target. However, the exact frequency in patients of advanced BTC (including cancers other than ICC) and detailed clinicopathological background of the FGFR2-fusion have not been sufficiently elucidated.
Methods
Histologically confirmed advanced or recurrent BTC patients who planned to or received systemic chemotherapy were eligible. Because FGFR2-fusion gene was identified in only ICC and perihilar cholangiocarcinoma (PCC) among first 209 patients (March 2014 to February 2016), we limited the subjects to those with ICC/PCC and continued enrollments until November 2018. To determine FGFR2-fusion status, break-apart fluorescent in situ hybridization and target RNA sequencing were performed on formalin fixed, paraffin-embedded tumor samples obtained by resection or core biopsy.
Results
During the entire study period, 445 patients were registered and 423patients (272 ICC, 83 PCC, 20 distal cholangiocarcinoma, 43 carcinoma of gallbladder, and 5 ampullary carcinoma) were successfully tested for FGFR2-fusion status. Among those, 21 ICC and 4 PCC patients were identified as harboring the FGFR2-fusion. Characteristics of FGFR2-fusion positive patients were as follows: male/female = 19/6; median age (range) = 60 (41-76); stage (metastatic/locally advanced/recurrent) = 15/2/8. Macroscopic type was mass forming type in all 21 ICC patients. Age of < 65 (0.032), consumption of > 60g of ethanol/day (p = 0.023), and HCV Ab and/or HBs Ag positive (p = 0.012) were significantly related with FGFR2-fusion positive status (logistic regression).
Conclusions
In this study, frequency of FGFR2-fusion was 7.7% in advanced ICC patients, which was lesser than the previous reports. We found that 4.8% of the PCC patients also harbored the FGFR2-fusion. Younger age, alcohol abuse, and hepatitis B or C positive status were related to FGFR2-fusion positive status. The survival data of FGFR2-fusion positive patients will be presented at the meeting.
Clinical trial identification
UMIN000014767.
Editorial acknowledgement
Legal entity responsible for the study
National Cancer Center.
Funding
National Cancer Center Research and Development Fund.
Disclosure
M. Ikeda: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bayer Yakuhin; Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eisai; Honoraria (self): Taiho Pharmaceutical; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly Japan; Research grant / Funding (institution): Yakult; Advisory / Consultancy: Otsuka Pharmaceutical; Advisory / Consultancy: Daiichi-Sankyo; Honoraria (self): Sumitomo Dainippon Pharma; Honoraria (self), Advisory / Consultancy: Teijin Pharma; Honoraria (self): EA Pharma; Honoraria (self): Kaken Pharmaceutical; Advisory / Consultancy: Shire; Honoraria (self): MSD; Advisory / Consultancy, Research grant / Funding (institution): ASLAN Pharmaceuticals; Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharmaceutical; Research grant / Funding (institution): Ono Pharmaceutical; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Nano Carrier; Honoraria (institution): Gilead; Advisory / Consultancy: Astellas Pharma; Research grant / Funding (institution): Takeda Pharmaceutical; Research grant / Funding (institution): J-Pharma; Advisory / Consultancy: Micron. M. Ueno: Honoraria (self), Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Yakult Honsha; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): Teijin Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Shire; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): MSD; Research grant / Funding (institution): NanoCarrier; Research grant / Funding (institution): Dainippon Sumitomo Pharma; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Aslan Pharmaceuticals. T. Ioka: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho; Honoraria (self): Yakult Honsha; Honoraria (self): Chugai; Honoraria (self), Advisory / Consultancy: Daiichi-Sankyo; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Shire Japan; Honoraria (self), Advisory / Consultancy: Otsuka; Research grant / Funding (institution): Dainippon Sumitomo; Research grant / Funding (institution): Takara-bio; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Nihon Zouki. A. Naganuma: Speaker Bureau / Expert testimony: AbbVie; Speaker Bureau / Expert testimony: Eisai; Speaker Bureau / Expert testimony: Gilead; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Chugai; Speaker Bureau / Expert testimony: Taiho; Speaker Bureau / Expert testimony: Novartis. Y. Nakai: Honoraria (self), Research grant / Funding (self): Taiho Pharmaceutical; Honoraria (self): Daiichi Sankyo; Honoraria (self): AstraZeneca; Research grant / Funding (self): Eisai; Research grant / Funding (self): Yakult Honsha; Research grant / Funding (self): J-Pharma. M. Kanai: Licensing / Royalties: Therabiopharma Ltd; Licensing / Royalties: JMS Co., Ltd. S. Shimizu: Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Baxalta Japan; Research grant / Funding (institution): Taiho pharmaceutical; Research grant / Funding (institution): Sumitomo Dainippon Pharma; Research grant / Funding (institution): Yakult; Research grant / Funding (institution): IQVIA Survices Japan. T. Yamanaka: Honoraria (self): Pfizer. T. Shibata: Advisory / Consultancy: MSD. C. Morizane: Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self): Lilly; Honoraria (self), Research grant / Funding (institution): Nobelpharma; Honoraria (self): Fujifilm; Honoraria (self): Teijin Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Eisai; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Yakult Honsha; Honoraria (self): AbbVie; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Ono Pharmaceutical; Research grant / Funding (institution): J-Pharma. T. Okusaka: Honoraria (self), Research grant / Funding (institution): Novartis Pharma KK; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho; Honoraria (self), Research grant / Funding (institution): Eli Lilly; Honoraria (self), Research grant / Funding (institution): Bayer Yakuhin; Honoraria (self): Nobel Pharma; Honoraria (self), Research grant / Funding (institution): Yakult; Honoraria (self): FUJIFILM; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Ono; Honoraria (self): EA pharma; Honoraria (self), Research grant / Funding (institution): Eisai; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self): Teijin; Honoraria (self), Advisory / Consultancy: Daiichi Sankyo; Honoraria (self): Shire; Honoraria (self): Takara Bio; Honoraria (self): AbbVie; Honoraria (self): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Dainippon Sumitomo; Advisory / Consultancy: Zeria; Advisory / Consultancy, Research grant / Funding (institution): Bristol Myers; Research grant / Funding (institution): Kowa; Research grant / Funding (institution): Kyowa Hakko Kirin; Research grant / Funding (institution): Chugai. All other authors have declared no conflicts of interest.
Resources from the same session
3911 - Defining a SUV decrease cut-off in PET/CT response monitoring after one cycle of preoperative breast cancer chemotherapy
Presenter: Marcin Kubeczko
Session: Poster Display session 2
Resources:
Abstract
1849 - Effect of thioredoxin 1 quantity detection to complement the mammography in breast cancer diagnosis
Presenter: Younju Lee
Session: Poster Display session 2
Resources:
Abstract
2221 - Identification of ultralow risk breast cancer patients (probable overdiagnosis)
Presenter: Salvador Gamez Casado
Session: Poster Display session 2
Resources:
Abstract
5291 - Prevalence of Vitamin D3 deficiency among women with early breast cancer receiving chemotherapy in an oncology dayward.
Presenter: Warner Finstad
Session: Poster Display session 2
Resources:
Abstract
4247 - Changes in ER pathway activity score during neoadjuvant letrozole to assess therapy response and predict disease free survival (DFS) in ER positive breast cancer patients
Presenter: Arran Turnbull
Session: Poster Display session 2
Resources:
Abstract
568 - Second primary malignancies in patients with breast cancer.
Presenter: Carlos Erasun Lecuona
Session: Poster Display session 2
Resources:
Abstract
1428 - Phase II randomized trial of neoadjuvant trastuzumab and pertuzumab (TP) with either palbociclib + letrozole (Pal+L) or paclitaxel (Pac) for elderly patients with estrogen receptor & HER2 positive (ER+/HER2+) Breast Cancer (BC) (International Breast Cancer Study Group IBCSG 55-17, TOUCH)
Presenter: Laura Biganzoli
Session: Poster Display session 2
Resources:
Abstract
1479 - Neoadjuvant HER2-targeted therapy with or without immunotherapy with pembrolizumab (neoHIP): an open label randomized phase 2 trial
Presenter: Heather McArthur
Session: Poster Display session 2
Resources:
Abstract
1481 - A randomized phase 2 study of peri-operative ipilimumab, nivolumab and cryoablation versus standard care in women with residual, early stage/resectable, triple negative breast cancer after standard-of-care neoadjuvant chemotherapy
Presenter: Heather McArthur
Session: Poster Display session 2
Resources:
Abstract
4334 - ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer.
Presenter: Michail Ignatiadis
Session: Poster Display session 2
Resources:
Abstract