Evidence map›Paper›PMID 27709313›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2017

A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer.

K H Park, S Lee, J H Park, S Y Kang, H Y Kim, I H Park, Y H Park, Y H Im, H J Lee, S Park and 4 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 26% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
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

14 authors at 11 institutions in 1 country.

K H ParkDivision of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, 73 Inchonro, Sungbuk-Gu, Seoul, 02481, South Korea.
S LeeDivision of Oncology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
J H ParkDivision of Oncology/Hematology, Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan, South Korea.
S Y KangDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
H Y KimDivision of Oncology/Hematology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Pyeongchon, Anyang-si, Gyeonggi-do, South Korea.
I H ParkCenter for Breast Cancer and Center for Clinical Trials, National Cancer Center, Goyang-si, South Korea.
Y H ParkDivision of Hematology/Oncology, Department of Internal Medicine, Samsung Medical Center, Seoul, South Korea.
Y H ImDivision of Hematology/Oncology, Department of Internal Medicine, Samsung Medical Center, Seoul, South Korea.
H J LeeProduct Development HQ, Dong-A ST, Seoul, South Korea.
S ParkDivision of Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine, Seoul, South Korea.
S I LeeDivision of Oncology/Hematology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
K H JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Y S KimDivision of Oncology/Hematology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, South Korea.
Jae Hong SeoDivision of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, 73 Inchonro, Sungbuk-Gu, Seoul, 02481, South Korea. cancer@korea.ac.kr.
Korea University · KRSamsung Medical Center · KRUlsan College · KRAjou University · KRDong-A ST (South Korea) · KRHallym University Sacred Heart Hospital · KRKosin University Gospel Hospital · KRNational Cancer Center · KRSeverance Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN).

methodsSeventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m

resultsThe mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm

conclusionsDA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy-Induced Febrile NeutropeniaCyclophosphamideDocetaxelDoxorubicinDrug Administration ScheduleFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansInjections, SubcutaneousMiddle AgedPolyethylene GlycolsCyclophosphamideDocetaxelDoxorubicinFilgrastimGranulocyte Colony-Stimulating Factorpegylated granulocyte colony-stimulating factor, humanPolyethylene GlycolsTaxoidsBreast cancerNeutropeniaPegylated G-CSFTAC chemotherapy

Identifiers

PMID27709313
OpenAlexW2528477403

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.