Evidence map›Paper›PMID 34727875›Full record

Trial reportBMC cancer2021

Phase II trail of nab-paclitaxel in metastatic breast cancer patients with visceral metastases.

Yizhao Xie, Chengcheng Gong, Jian Zhang, Leiping Wang, Jun Cao, Zhonghua Tao, Ting Li, Yannan Zhao, Yi Li, Shihui Hu and 2 more

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

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02687490 (A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 34% 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.

NCT02687490 phase2completednot on this map

A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

TypeinterventionalSponsorFudan UniversityRan2017 to 2020Enrolled81ConditionsMetastatic Breast CancerArmsAbraxane
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
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

12 authors at 2 institutions in 1 country.

Yizhao Xie *Department of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Chengcheng Gong *Department of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Jian ZhangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Leiping WangDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Jun CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Zhonghua TaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Ting LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Yannan ZhaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Yi LiDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Shihui HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China.
Biyun Wang *Department of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China. wangbiyun0107@hotmail.com.
Xichun Hu *Department of Medical Oncology, Fudan University Shanghai Cancer Center, No.270, Dong'an Road, Xuhui District, Shanghai, 200032, China. huxichun2017@163.com.
Fudan University Shanghai Cancer Center · CNShanghai Medical College of Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVisceral metastases account for 48-67% of metastatic breast cancer (MBC) patients and presage a worse overall survival. Previous study suggested potential effect of nab-paclitaxel on patients with visceral metastases subgroups. This phase II trial was conducted to explore the efficacy and safety of nab-paclitaxel in such a high-risk group of patients.

methodsIn this prospective, single-center, open-label, phase II study, MBC patients with visceral metastases (N = 80) received nab-paclitaxel (Abraxane, 125 mg/m2, D1, D8, D15 every 28 days).

resultsThe median PFS was 5.1 months (95% CI: 4.2-6.0 months), with an ORR of 33.8% (95% CI 21.3-43.8%) and CBR of 66.2% (95% CI 56.3-75.0%). In univariate analysis, patients with premenopausal status had a trend of better treatment outcome. Multivariate analysis demonstrated non brain metastasis (adjusted HR 0.31, 95% CI 0.12-0.83, P = 0.019) and first line treatment (adjusted HR 0.37, 95% CI 0.17-0.81, P = 0.013) as independent predictors of longer PFS. The overall safety was acceptable with most common treatment-related, grade ≥ 3 toxicities of neutropenia (16.3%) and sensory neuropathy (3.7%).

conclusionsThis phase II trial documented satisfactory efficacy and safety of nab-paclitaxel in MBC patients with visceral metastases, providing evidence for relative clinical practice. Patients in first line therapy had better treatment outcome. For patients with premenopausal status or brain metastasis, further alternatives (for example, combined chemotherapy or targeting therapy) might be required. This study also demonstrated the efficacy and safety of 125 mg/m2 nab-paclitaxel among Asian patients.

trial registrationThis research is registered under clinicaltrials.gov (NCT02687490, February 22, 2016).

Indexed as

VisceraAdultAgedAged, 80 and overAlbumin-Bound PaclitaxelAlbuminsAnalysis of VarianceAntineoplastic Agents, PhytogenicBrain NeoplasmsBreast NeoplasmsChinaConfidence IntervalsFemaleHumansMiddle AgedNeutropenia130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelChemotherapyMetastatic breast CancerNab-paclitaxel

Identifiers

PMID34727875
PMCPMC8565069
OpenAlexW3210908728

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.