Evidence map›Paper›PMID 33892670›Full record

Trial reportBMC cancer2021

Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial.

Safa Najafi, Maryam Ansari, Vahid Kaveh, Shahpar Haghighat

Abstract readEquivalence TrialRandomized Controlled Trial
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. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Primary Prophylaxis LapelgaCurrent oncology (Toronto, Ont.) · 2023
    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

4 authors.

Safa NajafiBreast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran.
Maryam AnsariBreast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran.
Vahid KavehDepartment of Hematology and Medical Oncology, Firoozgar Hospital, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Shahpar HaghighatBreast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. sha_haghighat@yahoo.com.ORCID http://orcid.org/0000-0001-6938-467X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial.

methodsIn this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy.

resultsHematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.

conclusionIt seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia.

trial registrationIRCT20190504043465N1 , May 2019.

Indexed as

AdultAntineoplastic AgentsBlood Cell CountBreast NeoplasmsChemotherapy-Induced Febrile NeutropeniaFemaleFilgrastimHematologic AgentsHumansInjections, SubcutaneousMiddle AgedPolyethylene GlycolsAntineoplastic AgentsFilgrastimHematologic AgentspegfilgrastimPolyethylene GlycolsBreast cancerChemotherapyFilgrastimIranPegfilgrastim

Identifiers

PMID33892670
PMCPMC8066442

What OpenQuestion holds

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Registered trials

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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.