Evidence map›Paper›PMID 41110012›Full record

ArticleInternational journal of clinical oncology2025

Efficacy and safety of FOLFOX for Japanese patients with advanced biliary tract cancer as second-line or later chemotherapy (JON2107-B study).

Takeshi Terashima, Chigusa Morizane, Akihiko Chida, Akiko Todaka, Kumiko Umemoto, Yujiro Kawakami, Tatsuya Yamashita, Makoto Ueno, Junji Furuse, Hiroaki Nagano

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Article in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Takeshi TerashimaDepartment of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.
Chigusa MorizaneDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Chuo-Ku, Tokyo, 104-0045, Japan. cmorizan@ncc.go.jp.ORCID http://orcid.org/0000-0002-6560-7503
Akihiko ChidaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Akiko TodakaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto, Japan.
Kumiko UmemotoDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Yujiro KawakamiDepartment of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Tatsuya YamashitaDepartment of Gastroenterology, Kanazawa University Hospital, Kanazawa, Japan.
Makoto UenoDepartment of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Junji FuruseDepartment of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Ube, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral gemcitabine-based regimens are effective as first-line treatments for advanced biliary tract carcinoma (BTC), while fluorouracil, folinic acid, and oxaliplatin (FOLFOX) is commonly used as second-line therapy in Western countries. This study aimed to investigate the efficacy and safety of FOLFOX in Japanese patients.

methodsWe retrospectively reviewed cases of BTC patients who were refractory to or intolerant of at least one gemcitabine-based regimen and subsequently received FOLFOX. Data on clinical characteristics, adverse events, treatment responses, and patient outcomes were collected. Because the FOLFOX regimen have not been approved in Japan, we have followed the appropriate procedures for the off-label use of FOLFOX in accordance with each institution's regulations and relevant laws and regulations.

resultsA total of 50 patients were included. Grade 3 or higher adverse events occurred in 30 patients (60%), 21 patients (42%) requiring dose reduction, and 24 patients (48%) requiring treatment delays. No treatment-related deaths occurred. The objective response rate (ORR) was 6%, with a disease control rate of 56%. The median progression-free survival (PFS) and overall survival (OS) were 3.4 months and 6.8 months, respectively. Among 14 patients who received FOLFOX as second-line treatment after gemcitabine and cisplatin, the ORR, median PFS, and median OS were 14%, 4.6 months, and 7.5 months, respectively.

conclusionThis study suggested the efficacy and safety of FOLFOX as a second-line or later treatment option also for Japanese patients with advanced BTC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsAdultAgedAged, 80 and overEast Asian PeopleFemaleFluorouracilHumansJapanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsProgression-Free SurvivalRetrospective StudiesFluorouracilLeucovorinOrganoplatinum CompoundsBiliary tract cancerFOLFOXSecond-line chemotherapy

Identifiers

PMID41110012

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.