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01-04-2019 | Original Article

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)

Authors: Mark Clemons, Sasha Mazzarello, John Hilton, Anil Joy, Julie Price-Hiller, Xiaofu Zhu, Shailendra Verma, Anne Kehoe, Mohammed FK Ibrahim, Marta Sienkiewicz, Carol Stober, Lisa Vandermeer, Brian Hutton, Ranjeeta Mallick, Dean Fergusson

Published in: Supportive Care in Cancer | Issue 4/2019

Abstract

Purpose

Optimal 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.

Methods

Early-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.

Results

Of 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.

Conclusion

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

Trial registration

Trial registration: ClinicalTrials.gov: NCT02173262

Available only for authorised users

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Title: 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)
Authors: Mark Clemons
Sasha Mazzarello
John Hilton
Anil Joy
Julie Price-Hiller
Xiaofu Zhu
Shailendra Verma
Anne Kehoe
Mohammed FK Ibrahim
Marta Sienkiewicz
Carol Stober
Lisa Vandermeer
Brian Hutton
Ranjeeta Mallick
Dean Fergusson
Publication date: 01-04-2019
Publisher: Springer Berlin Heidelberg
Published in: Supportive Care in Cancer / Issue 4/2019
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-018-4408-6

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Purpose

Methods

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