| 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)
|
|---|---|
| Published in |
Supportive Care in Cancer, August 2018
|
| DOI | 10.1007/s00520-018-4408-6 |
| Pubmed ID | |
| 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 |
| Abstract |
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. 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. 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. 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: ClinicalTrials.gov : NCT02173262. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 65 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 65 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Bachelor | 7 | 11% |
| Student > Master | 6 | 9% |
| Other | 5 | 8% |
| Researcher | 4 | 6% |
| Student > Ph. D. Student | 4 | 6% |
| Other | 10 | 15% |
| Unknown | 29 | 45% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 20% |
| Nursing and Health Professions | 8 | 12% |
| Biochemistry, Genetics and Molecular Biology | 3 | 5% |
| Sports and Recreations | 3 | 5% |
| Agricultural and Biological Sciences | 2 | 3% |
| Other | 5 | 8% |
| Unknown | 31 | 48% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 15 August 2018.
All research outputs
#18,646,262
of 23,099,576 outputs
Outputs from Supportive Care in Cancer
#3,654
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Outputs of similar age
#255,014
of 331,523 outputs
Outputs of similar age from Supportive Care in Cancer
#92
of 104 outputs
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