Evidence map›Paper›PMID 36127767›Full record

Trial reportCancer medicine2023

Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study.

Guo-Ming Shi, Xiao-Yong Huang, Tian-Fu Wen, Tian-Qiang Song, Ming Kuang, Hai-Bo Mou, Le-Qun Bao, Hai-Tao Zhao, Hong Zhao, Xie-Lin Feng and 20 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  9. Targeting FGFR for cancer therapy.Journal of hematology & oncology · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 17 institutions in 1 country.

Guo-Ming ShiLiver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiao-Yong HuangLiver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Tian-Fu WenHepatobiliary Surgery, West China Hospital, Sichuan University, Chengdu, China.
Tian-Qiang SongHepatobiliary Surgery, Tianjin Cancer Hospital, Tian Jin, China.ORCID 0000-0002-6510-0489
Ming KuangDepartment of Oncology, Hepatobiliary and Pancreatic Surgery Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.ORCID 0000-0003-0131-4848
Hai-Bo MouMedical Oncology, Shulan (Hangzhou) Hospital, Hangzhou, China.
Le-Qun BaoHepatobiliary Surgery, Hubei Cancer Hospital, Wuhan, China.
Hai-Tao ZhaoLiver Surgery, Peking Union Medical College Hospital, Beijing, China.
Hong ZhaoHematological Surgery Department, Cancer Hospital of Chinese Academy of Medical Science, Beijing, China.ORCID 0000-0002-3444-8044
Xie-Lin FengHepatobiliary and Pancreatic Surgery, Sichuan Cancer Hospital, Chengdu, China.
Bi-Xiang ZhangHepatobiliary Surgery, Tongji Hospital, Tongji Medical College of HUST, Wuhan, China.
Tao PengHepatological Surgery Department, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Yu-Bao ZhangHepatobiliary and Pancreatic Surgery, Cancer Hospital Affiliated to Harbin Medical University, Harbin, China.
Xiang-Cheng LiLiver Surgery, Jiangsu Province Hospital, Nanjing, China.
Hong-Sheng YuOncology Department, Affiliated Hospital of Qingdao University, Qingdao, China.
Yu CaoPhase 1 Clinical Research Center, Affiliated Hospital of Qingdao University, Qingdao, China.
Lian-Xin LiuHepatobiliary Surgery Department, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China.ORCID 0000-0002-3535-6467
Ti ZhangHepatobiliary Surgery Department, Tianjin Cancer Hospital, Tianjin, China.
Wei-Lin WangHepatopancreatobiliary Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0001-9432-2649
Jiang-Hua RanHepatopancreatobiliary Surgery, The First Hospital of Kunming, Kunming, China.
Ying-Bin LiuGeneral Surgery, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Wei GongGeneral Surgery, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ming-Xia ChenDepartment of Medical Science and Oncological Strategy, Innovent Biologics Inc., Suzhou, China.
Lian CaoDepartment of Medical Science and Oncological Strategy, Innovent Biologics Inc., Suzhou, China.
Yang LuoDepartment of Medical Science and Oncological Strategy, Innovent Biologics Inc., Suzhou, China.
Yan WangDepartment of Medical Science and Oncological Strategy, Innovent Biologics Inc., Suzhou, China.
Hui ZhouDepartment of Medical Science and Oncological Strategy, Innovent Biologics Inc., Suzhou, China.
Guo-Huan YangLiver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.
Jia FanLiver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0001-5158-629X
Jian ZhouLiver Surgery and Transplantation, Zhongshan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-2118-1117
Fudan University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNQingdao University · CNShanghai Jiao Tong University · CNTianjin Medical University Cancer Institute and Hospital · CNGuangxi Medical University · CNHangzhou Medical College · CNHarbin Medical University · CNHubei Cancer Hospital · CNJiangsu Province Hospital · CNSecond Affiliated Hospital of Zhejiang University · CNSichuan Cancer Hospital · CNSichuan University · CNSun Yat-sen University · CNThe First Hospital of Kunming · CNTongji Hospital · CNUniversity of Science and Technology of China · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study evaluated the antitumor activity and safety of pemigatinib in previously treated Chinese patients with advanced cholangiocarcinoma and fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements.

backgroundPemigatinib provided clinical benefits for previously treated patients with cholangiocarcinoma carrying FGFR2 fusions or rearrangements and was approved for this indication in multiple countries.

methodsIn this ongoing, multicenter, single-arm, phase II study, adult patients with locally advanced or metastatic cholangiocarcinoma carrying centrally confirmed FGFR2 fusions or rearrangements who had progressed on ≥1 systemic therapy received 13.5 mg oral pemigatinib once daily (3-week cycle; 2 weeks on, 1 week off) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was objective response rate (ORR) assessed by an independent radiology review committee.

resultsAs of January 29, 2021, 31 patients were enrolled. The median follow-up was 5.1 months (range, 1.5-9.3). Among 30 patients with FGFR2 fusions or rearrangements evaluated for efficacy, 15 patients achieved partial response (ORR, 50.0%; 95% confidence interval [CI], 31.3-68.7); 15 achieved stable disease, contributing to a disease control rate of 100% (95% CI, 88.4-100). The median time to response was 1.4 months (95% CI, 1.3-1.4), the median duration of response was not reached, and the median progression-free survival was 6.3 months (95% CI, 4.9-not estimable [NE]). Eight (25.8%) of 31 patients had ≥grade 3 treatment-emergent adverse events. Hyperphosphatemia, hypophosphatasemia, nail toxicities, and ocular disorders were mostly <grade 3, except for 2 events ≥grade 3.

conclusionsThe encouraging antitumor activity and favorable safety profile support the use of pemigatinib as a treatment in previously treated Chinese patients with cholangiocarcinoma and FGFR2 rearrangements.

Indexed as

Antineoplastic AgentsBile Duct NeoplasmsCholangiocarcinomaAdultBile Ducts, IntrahepaticEast Asian PeopleHumansMorpholinesPyrimidinesPyrrolesReceptor, Fibroblast Growth Factor, Type 2Antineoplastic AgentsFGFR2 protein, humanMorpholinespemigatinibPyrimidinesPyrrolesReceptor, Fibroblast Growth Factor, Type 2antitumor activitycholangiocarcinomaFGFR2 fusions or rearrangementspemigatinibphase II

Identifiers

PMID36127767
PMCPMC9972033
OpenAlexW4296959138

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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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.