Evidence map›Paper›PMID 34491513›Full record

Trial reportBreast cancer (Tokyo, Japan)2022

Quality of life in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel in patients with metastatic breast cancer.

Naruto Taira, Kosuke Kashiwabara, Junji Tsurutani, Masahiro Kitada, Masato Takahashi, Hiroaki Kato, Yuichiro Kikawa, Eiko Sakata, Yoichi Naito, Yoshie Hasegawa and 6 more

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer (Tokyo, Japan), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 50% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 1 country.

Naruto TairaDepartment of Breast and Endocrine Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. ntaira@md.okayama-u.ac.jp.ORCID http://orcid.org/0000-0003-4266-1117
Kosuke KashiwabaraClinical Research Promotion Center, University of Tokyo Hospital, Tokyo, Japan.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
Masahiro KitadaBreast Disease Center, Asahikawa Medical University Hospital, Hokkaido, Japan.
Masato TakahashiDepartment of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Hokkaido, Japan.
Hiroaki KatoDepartment of Breast Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.
Yuichiro KikawaDepartment of Breast Surgery, Kansai Medical University Hospital, Osaka, Japan.
Eiko SakataDepartment of Breast Surgery, Niigata City General Hospital, Niigata, Japan.
Yoichi NaitoDepartment of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.
Yoshie HasegawaDepartment of Breast Surgery, Hirosaki Municipal Hospital, Aomori, Japan.
Tsuyoshi SaitoDepartment of Breast Surgery, Japanese Red Cross Saitama Hospital, Saitama, Japan.
Tsutomu IwasaDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
Tsutomu TakashimaDepartment of Breast and Endocrine Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan.
Tomohiko AiharaBreast Center, Aihara Hospital, Osaka, Japan.
Hirofumi MukaiDepartment of Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.
Fumikata HaraBreast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
National Cancer Center Hospital East · JPAsahikawa Medical University · JPJapanese Foundation For Cancer Research · JPKansai Medical University · JPKindai University · JPNational Hospital Organization Hokkaido Medical Center · JPNiigata City General Hospital · JPOgaki Municipal Hospital · JPOkayama University Hospital · JPOsaka City University · JPSaitama Red Cross Hospital · JPShowa University · JPTeine Keijinkai Hospital · JPUniversity of Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC).

methodsPatients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD 260 mg/m

resultsA total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD P < 0.001, LD vs. SD P < 0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (P = 0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD P = 0.011, LD vs. SD P < 0.001).

conclusionQoL of patients treated with 220 or 180 mg/m

trial registrationThe protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN000015516), on 01/11/2014. Details are available at the following address: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916.

Indexed as

Quality of LifeAlbuminsAntineoplastic Agents, PhytogenicBreast NeoplasmsDose-Response Relationship, DrugFemaleHumansJapanMiddle AgedPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelChemotherapyCIPNFatigueMetastatic breast cancerNab-paclitaxelQoL

Identifiers

PMID34491513
PMCPMC8421464
OpenAlexW4225906899

What OpenQuestion holds

Textmetadata
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.