Evidence map›Paper›PMID 33901921›Full record

Trial reportBreast (Edinburgh, Scotland)2021

A multi-centre study comparing granulocyte-colony stimulating factors to antibiotics for primary prophylaxis of docetaxel-cyclophosphamide induced febrile neutropenia.

Mark Clemons, Dean Fergusson, Anil A Joy, Kednapa Thavorn, Judith Meza-Junco, Julie Price Hiller, John Mackey, Terry Ng, Xiaofu Zhu, Mohammed F K Ibrahim and 11 more

Open access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast (Edinburgh, Scotland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Cost-effectiveness of granulocyte colony-stimulating factors (G-CSFs) for the prevention of febrile neutropenia (FN) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  5. Article
  6. Article
  7. Review
  8. 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

21 authors at 5 institutions in 1 country.

Mark ClemonsDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada. Electronic address: mclemons@toh.ca.
Dean FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
Anil A JoyDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
Kednapa ThavornClinical Epidemiology Program, Ottawa Hospital Research Institute and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
Judith Meza-JuncoDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
Julie Price HillerDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
John MackeyDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
Terry NgDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Xiaofu ZhuDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
Mohammed F K IbrahimDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Marta SienkiewiczCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Deanna SaundersCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Lisa VandermeerCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Gregory PondDepartment of Oncology, McMaster University, Hamilton, Canada.
Bassam BasulaimanDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Arif AwanDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Lacey PitreDepartment of Oncology, Northeast Cancer Centre, Sudbury, Canada.
Nancy A NixonDivision of Medical Oncology, Department of Oncology, University of Alberta, Tom Baker Cancer Centre, Calgary, Canada.
Brian HuttonClinical Epidemiology Program, Ottawa Hospital Research Institute and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
John F HiltonDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
REThinking Clinical Trials (REaCT) investigators
University of Ottawa · CAUniversity of Alberta · CAOttawa Hospital · CAMcMaster University · CANortheast Cancer Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrimary febrile neutropenia (FN) prophylaxis with ciprofloxacin or granulocyte-colony stimulating factors (G-CSF) is recommended with docetaxel-cyclophosphamide (TC) chemotherapy for early-stage breast cancer (EBC). A pragmatic randomised trial compared the superiority of G-CSF to ciprofloxacin and a cost-utility analysis were conducted.

methodsEBC patients receiving TC chemotherapy were randomised to ciprofloxacin or G-CSF. The primary outcome was a composite of FN and non-FN treatment-related hospitalisation. Secondary outcomes included; rates of FN, non-FN treatment-related hospitalisation, chemotherapy dose reductions/delays/discontinuations. Primary analysis was performed with the intention to treat population. Cost-utility analyses were conducted from the Canadian public payer perspective.

results458 eligible patients were randomised: 228 to ciprofloxacin and 230 to G-CSF. For the primary endpoint there was non-statistically significant difference (Risk difference = -6.7%, 95%CI = -13.5%-0.1%, p = 0.061) between ciprofloxacin patients (46,20.2%) and G-CSF (31,13.5%). Patients receiving ciprofloxacin were more likely to experience FN (36/228, 15.8% vs 13/230, 5.7%) than patients receiving G-CSF (p < 0.001). Non-FN treatment-related hospitalisation occurred in 40/228 (17.5%) of ciprofloxacin patients vs 28/230 (12.2%) of G-CSF patients (p = 0.12). There were no differences in other secondary outcomes. G-CSF was associated with an incremental cost-effectiveness ratio of C$1,760,796 per one quality-adjusted life year gained.

conclusionThe primary endpoint of superiority of G-CSF over ciprofloxacin was not demonstrated. While there were reduced FN rates with G-CSF, there were no differences in chemotherapy dose delays/reductions or discontinuations. With the commonly used willingness to pay value of C$50,000/QALY, G-CSF use was not cost-effective compared to ciprofloxacin and deserves scrutiny from the payer perspective.

Indexed as

Breast NeoplasmsFebrile NeutropeniaAnti-Bacterial AgentsAntineoplastic Combined Chemotherapy ProtocolsCanadaCyclophosphamideDocetaxelFemaleGranulocyte Colony-Stimulating FactorGranulocytesHumansAnti-Bacterial AgentsCyclophosphamideDocetaxelGranulocyte Colony-Stimulating FactorBreast cancerCiprofloxacinDocetaxel-cyclophosphamideFebrile neutropeniaG-CSF

Identifiers

PMID33901921
PMCPMC8095051
OpenAlexW3149636610

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.