Evidence map›Paper›PMID 30099602›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2019

Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC).

Mark Clemons, Sasha Mazzarello, John Hilton, Anil Joy, Julie Price-Hiller, Xiaofu Zhu, Shailendra Verma, Anne Kehoe, Mohammed Fk Ibrahim, Marta Sienkiewicz and 5 more

Registry-linked trialAbstract readComparative StudyPragmatic Clinical TrialRandomized 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02173262 (Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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.

NCT02173262 phase4completednot on this map

Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2014 to 2017Enrolled142ConditionsBreast CancerArmsG-CSF, Ciprofloxacin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. 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

15 authors at 3 institutions in 1 country.

Mark ClemonsDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada. mclemons@toh.ca.ORCID http://orcid.org/0000-0002-0738-2713
Sasha MazzarelloCancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
John HiltonDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.
Anil JoyDivision 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.
Xiaofu ZhuDivision of Medical Oncology, Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Canada.
Shailendra VermaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.
Anne KehoeDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.
Mohammed Fk IbrahimDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital Cancer Centre, The University of Ottawa, Ottawa, Canada.
Marta SienkiewiczCancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Carol StoberCancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Lisa VandermeerCancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Brian HuttonClinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Ranjeeta MallickClinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Dean FergussonClinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Canada.
Ottawa Hospital · CAUniversity of Ottawa · CAUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOptimal primary febrile neutropenia (FN) prophylaxis (i.e. ciprofloxacin or granulocyte-colony stimulating factors [G-CSF]) for patients receiving docetaxel-cyclophosphamide (TC) chemotherapy is unknown. We assessed the feasibility of using a novel pragmatic comparative effectiveness trial to compare these standard-of-care options.

methodsEarly-stage breast cancer patients receiving TC chemotherapy were randomised to either ciprofloxacin or G-CSF. Trial methodology consists of broad eligibility criteria, simply-defined endpoints, integrated consent model incorporating oral consent, and web-based randomisation in the clinic. Primary feasibility endpoints included patient and physician engagement (if > 50% of patients approached agree to participate and if > 50% of physicians approached patients for the study). Secondary clinical endpoints included the following: first occurrence rates of FN, treatment-related hospitalisation, or chemotherapy dose reduction/delay/discontinuation, as well as patient satisfaction with the oral consent process.

resultsOf 204 patients approached, 91.2% (186/204) agreed to randomisation. Sixteen of twenty (80%) participating medical oncologists randomised patients. Median patient age was 57.7 (range 31.8-84.1). The 186 patients received 557 cycles of chemotherapy. Overall incidences of first events by patient (n = 186) were as follows: FN (18/186, 21.43%), treatment-related hospitalisation (11/186, 13.10%), chemotherapy reduction (19/186, 22.62%), chemotherapy discontinuation (16/186, 19.05%), and chemotherapy delays (5/186, 5.95%). A total of 37.77% (69/186) of patients and 12.39% (69/557) of chemotherapy cycles had at least one of these first events. Patients were highly satisfied with the oral consent process.

conclusionThis study met its feasibility endpoints. This model offers a means of comparing standard-of-care treatments in a practical and cost-efficient manner.

trial registrationTrial registration: ClinicalTrials.gov : NCT02173262.

Indexed as

AdultAntibiotic ProphylaxisAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCiprofloxacinFeasibility StudiesFebrile NeutropeniaFemaleGranulocyte Colony-Stimulating FactorHumansMiddle AgedPrimary PreventionTreatment OutcomeCiprofloxacinGranulocyte Colony-Stimulating FactorBreast cancerCiprofloxacinFebrile neutropeniaFilgrastimIntegrated consent model

Identifiers

PMID30099602
OpenAlexW2887724188

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.