Evidence map›Paper›PMID 28103904›Full record

Trial reportJournal of hematology & oncology2017

Safety and efficacy of fruquintinib in patients with previously treated metastatic colorectal cancer: a phase Ib study and a randomized double-blind phase II study.

Rui-Hua Xu, Jin Li, Yuxian Bai, Jianming Xu, Tianshu Liu, Lin Shen, Liwei Wang, Hongming Pan, Junning Cao, Dongsheng Zhang and 3 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 48 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT01975077 phase1 / phase2completednot on this map

A Randomized, Open-label Phase Ib Trial of Fruquintinib "4mg Once Daily Continuous"Versus "5mg Once Daily 3wks on/1wk Off" in Patients With Metastatic Colorectal Carcinoma as 3rd Therapy

TypeinterventionalSponsorHutchison Medipharma LimitedRan2012 to 2014Enrolled62ConditionsColorectal CancerArmsfruquintinib
NCT02196688 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Colorectal Cancer as 3rd or Above Therapy

TypeinterventionalSponsorHutchison Medipharma LimitedRan2014 to 2015Enrolled71ConditionsColorectal CancerArmsfruquintinib, placebo
NCT05168527 phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer

TypeinterventionalSponsorFudan UniversityRan2021 to 2024Enrolled30ConditionsPancreatic CancerArmsFruquintinib,Albumin Paclitaxel,Gemcitabine
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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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

13 authors.

Rui-Hua XuDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.
Jin LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai Medical College, Shanghai, 200032, China. tianyoulijin@163.com.
Yuxian BaiDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, 150081, China.
Jianming XuDepartment of Medical Oncology, 307th Hospital of PLA, Academy of Military Medical Sciences, Beijing, 100071, China.
Tianshu LiuDepartment of Medical Oncology, Fudan University Zhongshan Hospital, Shanghai Medical College, Shanghai, 200032, China.
Lin ShenDepartment of Medical Oncology, Beijing Cancer Hospital, Beijing, 100142, China.
Liwei WangDepartment of Medical Oncology, Shanghai First People's Hospital, Shanghai, 200090, China.
Hongming PanDepartment of Medical Oncology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, China.
Junning CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai Medical College, Shanghai, 200032, China.
Dongsheng ZhangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.
Songhua FanHutchison MediPharma Ltd, Shanghai, 201203, China.
Ye HuaHutchison MediPharma Ltd, Shanghai, 201203, China.
Weiguo SuHutchison MediPharma Ltd, Shanghai, 201203, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo assess the efficacy and safety of fruquintinib, a vascular endothelial growth factor receptor (VEGFR) inhibitor, in metastatic colorectal cancer (mCRC) patients.

methodsA phase Ib open-label study and phase II randomized, placebo-controlled trial compared the efficacy of fruquintinib plus best supportive care (BSC) with placebo plus BSC in mCRC patients with ≥2 lines of prior therapies. The primary endpoint was progression-free survival (PFS).

resultsIn the phase Ib study, 42 patients took fruquintinib 5 mg for 3 weeks on/1 week off. The median PFS was 5.80 months, and the median overall survival (OS) was 8.88 months. In the phase II study, 71 patients were randomized (47 to fruquintinib, 24 to placebo). PFS was significantly improved with fruquintinib plus BSC (4.73 months; 95% confidence interval [CI] 2.86-5.59) versus placebo plus BSC (0.99 months; 95% CI 0.95-1.58); (hazard ratio [HR] 0.30; 95% CI 0.15-0.59; P < 0.001). The median OS was 7.72 versus 5.52 months (HR 0.71; 95% CI 0.38-1.34). The most common grade 3-4 adverse events were hypertension and hand-foot skin reaction.

conclusionsFruquintinib showed a significant PFS benefit of 3.7 months in patients with treatment-refractory mCRC. The safety profile was consistent with that of VEGFR tyrosine kinase inhibitors. A randomized phase III confirmatory study in mCRC is underway.

trial registrationNCT01975077 and NCT02196688.

Indexed as

AdenocarcinomaAgedAngiogenesis InhibitorsAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBenzofuransColorectal NeoplasmsDisease-Free SurvivalDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMolecular Targeted TherapyNeoplasm ProteinsAngiogenesis InhibitorsAntineoplastic Agents, ImmunologicalBenzofuransHMPL-013Neoplasm ProteinsProtein Kinase InhibitorsQuinazolinesReceptors, Vascular Endothelial Growth FactorFruquintinibMetastatic colorectal cancerProgression-free survivalVEGFR

Identifiers

PMID28103904
PMCPMC5244709

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.