A multi-centre study comparing granulocyte-colony stimulating factors to antibiotics for primary prophylaxis of docetaxel-cyclophosphamide induced febrile neutropenia
| Autor: | Julie A. Price Hiller, Nancy A. Nixon, Anil A. Joy, Bassam Basulaiman, John Hilton, Terry L. Ng, Mohammed F.K. Ibrahim, Dean Fergusson, Marta Sienkiewicz, Arif Awan, Brian Hutton, Mark Clemons, Lisa Vandermeer, John R. Mackey, Deanna Saunders, Xiaofu Zhu, Gregory R. Pond, Judith Meza-Junco, Lacey D. Pitre, Kednapa Thavorn |
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| Rok vydání: | 2021 |
| Předmět: |
Canada
medicine.medical_specialty medicine.drug_class medicine.medical_treatment Febrile neutropenia Population Antibiotics Breast Neoplasms Docetaxel G-CSF 03 medical and health sciences Breast cancer 0302 clinical medicine Ciprofloxacin Internal medicine Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Clinical endpoint Humans 030212 general & internal medicine education Cyclophosphamide RC254-282 Chemotherapy education.field_of_study Intention-to-treat analysis Docetaxel-cyclophosphamide business.industry Neoplasms. Tumors. Oncology. Including cancer and carcinogens General Medicine medicine.disease Anti-Bacterial Agents 3. Good health 030220 oncology & carcinogenesis Female Original Article Surgery business Granulocytes medicine.drug |
| Zdroj: | The Breast : Official Journal of the European Society of Mastology Breast, Vol 58, Iss, Pp 42-49 (2021) |
| ISSN: | 0960-9776 |
| Popis: | Background Primary 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. Methods EBC 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. Results 458 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 Highlights • Primary febrile neutropenia (FN) prophylaxis is indicated for docetaxel-cyclophosphamide (TC) chemotherapy. • In this multicentre trial 458 breast cancer patients receiving TC chemotherapy were randomised to ciprofloxacin or to G-CSF. • For the primary endpoint of FN and non-FN treatment-related hospitalizations, G-CSF was not superior over ciprofloxacin. • While there were reduced FN rates with G-CSF, the incremental cost-effectiveness ratio was C$1,760,796 per one QALYWALY gained. |
| Databáze: | OpenAIRE |
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