Evidence map›Paper›PMID 36605440›Full record

ArticleFrontiers in oncology2022

A multicenter randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Caelyx

Yinjuan Li, Lu Qi, Yu Wang, Yan Li, Chunpu Lei, Yingjuan Zhang, Xiaoqiang Cheng, Ju Liu, HaiHong Bai, Xia Zhao and 12 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. 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

22 authors at 3 institutions in 1 country.

Yinjuan LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Lu QiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yu WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yan LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunpu LeiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yingjuan ZhangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xiaoqiang ChengDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Ju LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
HaiHong BaiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xia ZhaoDepartment of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Shuzhen LvDepartment of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Bingjun XiongDepartment of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Juan LiuDepartment of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yehui ShiDepartment of Phase I Clinical Trial, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Huan ZhouNational Institute of Drug Clinical Trial, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Hongtao LiOncology Department, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Lihong LiuPharmacy Department, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Hongchuan JiangDepartment of Breast Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Weiwei OuyangOncology Department, The Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.
Xiaowen LiClinical Medical Center General Manager Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., Shanghai, China.
Yanping LiDepartment of Breast Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xinghe WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Capital Medical University · CNGuiyang Medical University · CNTianjin Medical University Cancer Institute and Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To compare the pharmacokinetic (PK) bioequivalence (BE) and safety of a generic pegylated liposomal doxorubicin (PLD) formulation with the reference product Caelyx Methods: A multicenter, single-dose, open-label, randomized, two-way crossover study was conducted in patients with breast cancer. For each period, the patients were administered with the test or the reference PLD intravenously at a dose of 50 mg/m Results: 48 patients were enrolled and randomised, of which 44 were included and analysed in bioequivalence set (BES). The 90% confidence intervals (CIs) of the geometric mean ratio (GMR) of C Conclusions: Bioequivalence between the test and the reference products was established for free and encapsulated doxorubicin. Clinical trial registration: http://www.chinadrugtrials.org.cn, identifier [CTR20210375].

Indexed as

bioequivalencebreast cancerencapsulated doxorubicinfree doxorubicinpegylated liposomal doxorubicin (PLD)pharmacokinetics

Identifiers

PMID36605440
PMCPMC9810385
OpenAlexW4312037842

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.