Evidence map›Paper›PMID 19014494›Full record

Trial reportBMC cancer2008

XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy.

A del Giglio, A Eniu, D Ganea-Motan, E Topuzov, H Lubenau

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 7 pooled it
2.4field-weighted citation impact, top 11% 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

45 citing papers in PubMed, 7 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
  2. Meta-analysis and indirect treatment comparison of lipegfilgrastim with pegfilgrastim and filgrastim for the reduction of chemotherapy-induced neutropenia-related events.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2018
    Pooled it
  3. A systematic literature review of the efficacy, effectiveness, and safety of filgrastim.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Pooled it
  4. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
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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

5 authors at 3 institutions in 2 countries.

A del GiglioFaculdade de Medicina do ABC, Sao Paulo, Brazil. sandrabr@netpoint.com.br
A Eniu
D Ganea-Motan
E Topuzov
H Lubenau
Faculdade de Medicina do ABC · BRInstitute of Oncology Prof. Dr. Ion Chiricuta · ROSpitalul Clinic Judetean de Urgenta Sibiu · RO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen after myelotoxic chemotherapy in breast cancer (BC) patients.

methodsA total of 348 patients with BC receiving docetaxel/doxorubicin chemotherapy were randomised to treatment with daily injections (subcutaneous 5 microg/kg/day) for at least 5 days and a maximum of 14 days in each cycle of XM02 (n = 140), Neupogen (n = 136) or placebo (n = 72). The primary endpoint was the duration of severe neutropenia (DSN) in cycle 1.

resultsThe mean DSN in cycle 1 was 1.1, 1.1, and 3.9 days in the XM02, Neupogen, and placebo group, respectively. Superiority of XM02 over placebo and equivalence of XM02 with Neupogen could be demonstrated. Toxicities were similar between XM02 and Neupogen.

conclusionXM02 was superior to placebo and equivalent to Neupogen in reducing DSN after myelotoxic chemotherapy.

Indexed as

AdultAgedAnalysis of VarianceAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBreast Neoplasms, MaleDocetaxelDouble-Blind MethodDoxorubicinFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMaleMiddle AgedNeoplasm StagingDocetaxelDoxorubicinFilgrastimGranulocyte Colony-Stimulating FactorRecombinant ProteinsTaxoids

Identifiers

PMID19014494
PMCPMC2628928
OpenAlexW1969787209

What OpenQuestion holds

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LicenceCC BY
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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.