Evidence map›Paper›PMID 25376790›Full record

Trial reportBMC cancer2014

Multicenter phase II study of apatinib in non-triple-negative metastatic breast cancer.

Xichun Hu, Jun Cao, Wenwei Hu, Changping Wu, Yueyin Pan, Li Cai, Zhongsheng Tong, Shusen Wang, Jin Li, Zhonghua Wang and 3 more

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

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01653561 (A Multi-institutional, Open-label, Single Arm Study of Apatinib in Non-triple-negative Metastatic Breast Cancer), which is not on this map. Cited by 134 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 3 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT01653561 phase2completednot on this map

A Multi-institutional, Open-label, Single Arm Study of Apatinib in Non-triple-negative Metastatic Breast Cancer

TypeinterventionalSponsorFudan UniversityRan2011 to 2012Enrolled20ConditionsBreast NeoplasmsArmsApatinib
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 3 syntheses or guidelines pooled it, 234 citations in OpenAlex.

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74 more citing papers are in PubMed but not listed here.

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 at 9 institutions in 1 country.

Xichun HuDepartment of Medical Oncology, Fudan University Cancer Hospital, Shanghai Medical School, Shanghai, China. huxicun@gmail.com.
Jun Cao
Wenwei Hu
Changping Wu
Yueyin Pan
Li Cai
Zhongsheng Tong
Shusen Wang
Jin Li
Zhonghua Wang
Biyun Wang
Xiaoyu Chen
Hao Yu
Fudan University Shanghai Cancer Center · CNShanghai Medical College of Fudan University · CNAnhui Medical University · CNChildren's Hospital of Suzhou University · CNNanjing Medical University · CNSoochow University · CNSun Yat-sen University Cancer Center · CNThird Affiliated Hospital of Harbin Medical University · CNTianjin Medical University Cancer Institute and Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2). This study was conducted to assess the efficacy and safety of apatinib in patients with non-triple-negative metastatic breast cancer who had received prior chemotherapy for their metastatic disease.

methodsThis multicenter, open-label, single arm study enrolled patients with non-triple-negative breast cancer, pretreated with anthracycline, taxanes and capecitabine, and who failed in the metastatic setting at least 1 and at most 4 prior chemotherapy regimens and at least one endocrine drug for hormone receptor-positive patients as well as at least one anti-Her2 drug for Her2-positive patients. The primary end point of this study was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity. Apatinib was administered as 500 mg daily on days 1 through 28 of each 4-week cycle.

results38 patients were enrolled with a median age of 49 years (range, 35 to 62 years) and received apatinib for a median of 4 cycles (range from 0 to 10 cycles). 18 (47.4%) patients experienced dose reduction during treatment. The median relative dose intensity (relative to assigned dose for each cycle) was 82% (range, 45.0% to 100.0%). Median follow-up time was 10.1 months. Median PFS of all 38 patients was 4.0 months (95% confidence interval (CI), 2.8 m - 5.2 m). 36 patients were eligible for efficacy analysis. ORR was 16.7% (6/36). DCR was 66.7% (24/36). Median OS was 10.3 months (95% CI, 9.1 m - 11.6 m). The most common grade 3/4 treatment-related AEs were hypertension (20.5%), hand-foot syndrome (10.3%), and proteinuria (5.1%). Of three possibly drug-related SAEs recorded in the study, 2 (3.4%) deaths occurred within 28 days of last treatment and were both considered to be the result of disease progression. The other one was grade 2 diarrhea needing hospitalization.

conclusionsApatinib exhibited objective efficacy in heavily pretreated, metastatic non-triple-negative breast cancer with manageable toxicity, and it might be better to be tested in breast cancer with high angiogenesis dependency.

trial registrationClinicalTrials.gov: NCT01653561.

Indexed as

AdultAntineoplastic AgentsDisease-Free SurvivalFemaleHand-Foot SyndromeHumansHypertensionMiddle AgedProtein Kinase InhibitorsProteinuriaPyridinesRetreatmentSurvival RateTreatment OutcomeTriple Negative Breast NeoplasmsAntineoplastic AgentsapatinibProtein Kinase InhibitorsPyridines

Identifiers

PMID25376790
PMCPMC4237755
OpenAlexW1981186476

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.