Evidence map›Paper›PMID 29273089›Full record

Trial reportChinese journal of cancer2017

Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial.

Rui-Hua Xu, Lin Shen, Ke-Ming Wang, Gang Wu, Chun-Mei Shi, Ke-Feng Ding, Li-Zhu Lin, Jin-Wan Wang, Jian-Ping Xiong, Chang-Ping Wu and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Chinese journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01762293 (A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
1.1field-weighted citation impact, top 20% 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.

NCT01762293 phase2completednot on this map

A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2012 to 2014Enrolled154ConditionsColorectal Cancer, Colorectal Cancer Metastatic, Colorectal Cancer RecurrentArmsFamitinib, placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.

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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

21 authors at 19 institutions in 2 countries.

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, Guangdong, P. R. China.
Lin ShenKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, No 52, Fucheng Road, Haidian District, Beijing, 100142, P. R. China. lin100@medmail.com.cn.ORCID 0000-0002-1205-049X
Ke-Ming WangDepartment of Medical Oncology, Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu, P. R. China.
Gang WuCancer Center of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China.
Chun-Mei ShiDepartment of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou, 350001, Fujian, P. R. China.
Ke-Feng DingDepartment of Surgical Oncology, Second Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, 310009, Zhejiang, P. R. China.
Li-Zhu LinDepartment of Oncology, First Affiliated Hospital of Guangzhou Medical University of Chinese Medicine, Guangzhou, 510405, Guangdong, P. R. China.
Jin-Wan WangDepartment of Medical Oncology, Chinese Academy of Medical Sciences Cancer Hospital, Beijing, 100021, P. R. China.
Jian-Ping XiongDepartment of Medical Oncology, First Affiliated Hospital of Nanchang University, Nanchang, 330006, Jiangxi, P. R. China.
Chang-Ping WuDepartment of Medical Oncology, First People's Hospital of Changzhou, Changzhou, 213003, Jiangsu, P. R. China.
Jin LiDepartment of Medical Oncology, Fudan University Cancer Hospital, Shanghai, 200032, P. R. China.
Yun-Peng LiuDepartment of Medical Oncology, First Hospital of China Medical University, Shenyang, 110001, Liaoning, P. R. China.
Dong WangCancer Center, Daping Hospital and Institute of Surgery Research, Third Military Medical University, Chongqing, 400042, P. R. China.
Yi BaDepartment of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, 300060, P. R. China.
Jue-Ping FengDepartment of Oncology, PuAi Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430032, Hubei, P. R. China.
Yu-Xian BaiDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, 150081, Heilongjiang, P. R. China.
Jing-Wang BiDepartment of Oncology, Jinan Military General Hospital, Jinan, 250000, Shandong, P. R. China.
Li-Wen MaDepartment of Tumor Chemotherapy and Radiology, Peking University Third Hospital, Beijing, 100191, P. R. China.
Jian LeiDepartment of Gastrointestinal Surgery, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510120, Guangdong, P. R. China.
Qing YangDepartment of Clinical Medicine, Jiangsu Hengrui Medicine Co., Ltd, Lianyungang, 222047, Jiangsu, P. R. China.
Hao YuDepartment of Epidemic and Health Statistics, Nanjing Medical University, Nanjing, 211166, Jiangsu, P. R. China.
First Affiliated Hospital of Guangzhou Medical University · CNPeking University · CNArmy Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Hospital of China Medical University · CNFudan University Shanghai Cancer Center · CNFujian Medical University · CNHarbin Medical University · CNHuazhong University of Science and Technology · CNJiangsu Hengrui Medicine (China) · CNJinan Military General Hospital · CNNanchang University · CNNanjing Medical University · CNSecond Affiliated Hospital of Nanjing Medical University · CNSecond Affiliated Hospital of Zhejiang University · CNSun Yat-sen University · CNThe First People's Hospital of Changzhou · CNTianjin Medical University Cancer Institute and Hospital · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastatic colorectal cancer (mCRC) patients with progressive disease after all available standard therapies need new medication for further treatment. Famitinib is a small-molecule multikinase inhibitor, with promising anticancer activities. This multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial was designed to evaluate the safety and efficacy of famitinib in mCRC.

methodsFamitinib or placebo was administered orally once daily. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), quality-of-life (QoL), and safety.

resultsBetween July 18, 2012 and Jan 22, 2014, a total of 167 patients were screened, and 154 patients were randomized in a 2:1 ratio to receive either famitinib (n = 99) or placebo (n = 55). The median PFS was 2.8 and 1.5 months in the famitinib and placebo groups (hazard ratio = 0.60, 95% confidence interval = 0.41-0.86, P = 0.004). The DCR was 59.8% and 31.4% (P = 0.002) and the ORR was 2.2% and 0.0% (P = 0.540) in the famitinib and placebo groups, respectively. The most frequent grade 3-4 adverse events were hypertension (11.1%), hand-foot syndrome (10.1%), thrombocytopenia (10.1%), and neutropenia (9.1%). Serious adverse events occurred in 11 (11.1%) patients in the famitinib group and 5 (9.1%) in the placebo group (P = 0.788). The median OS of the famitinib and placebo groups was 7.4 and 7.2 months (P = 0.657).

conclusionFamitinib prolonged PFS in refractory mCRC patients with acceptable tolerability. Trial registration This study was registered on ClinicalTrials.gov (NCT01762293) and was orally presented in the 2015 ASCO-Gastrointestinal Symposium.

Indexed as

Administration, OralAdultAgedColorectal NeoplasmsDouble-Blind MethodDrug Administration ScheduleFemaleHumansIndolesMaleNeoplasm MetastasisProtein Kinase InhibitorsPyrrolesSurvival AnalysisTreatment OutcomefamitinibIndolesProtein Kinase InhibitorsPyrrolesColorectal cancerEfficacyFamitinibSafety

Identifiers

PMID29273089
PMCPMC5741870
OpenAlexW2778489590

What OpenQuestion holds

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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.