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Abstract
Objective This study explored the prophylactic effects of long-acting granulocyte colony-stimulating factor (G-CSF) for febrile neutropenia (FN) in newly diagnosed patients with epithelial ovarian cancer (EOC).
Methods Patients were randomised into a study group (long-acting G-CSF for all chemotherapy cycles) and a control group (short-acting G-CSF for first cycle and treatment per physician discretion for subsequent cycles) at a ratio of 1:2. The incidences of FN and myelosuppression and the number of clinical visits, medication doses, complete blood count (CBC) tests and adverse events were compared between the two groups. A regression model was used to determine the risk factors for FN.
Results From 30 November 2018 to 1 April 2019, 84 cases were included in the final analysis; there were 24 (28.6%) and 60 (71.4%) patients in the study and control groups, respectively, and 605 chemotherapy cycles. The study group or chemotherapy cycles utilising long-acting G-CSF had significantly fewer utilisations and doses of short-acting G-CSF; clinical visits; CBC tests; and incidences of FN and myelosuppression; and less G-CSF-associated pain. The utilisation of G-CSF was the only independent factor for FN in a binary regression model.
Conclusion Long-acting G-CSF could effectively reduce the incidences of FN and myelosuppression and had mild adverse effects in newly diagnosed patients with EOC receiving chemotherapy.
Trial registration number NCT03740464.
- Granulocyte colony-stimulating factor
- febrile neutropenia
- myelosuppression
- ovarian cancer
- adverse events
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Footnotes
Contributors SM conceived of the original idea for the study, interpreted results, carried out the statistical analysis, edited the paper and was overall guarantor. LL obtained ethical approval, contributed to the preparation of the dataset, interpreted results and contributed to drafts of the paper. MW, XT, SZ and JL contributed to the study design, interpretation of results and commented on drafts of the paper.
Funding This study was supported by the Chinese Academy of Medical Sciences Initiative for Innovative Medicine (CAMS-2017-I2M-1-002), and by the National Science-technology Support Plan Projects (2015BAI13B04).
Disclaimer The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests None declared.
Patient consent for publication Obtained.
Ethics approval The Institutional Review Board of Peking Union Medical College Hospital has approved this study (No. JS1723). The registration No. is NCT03740464 (clinicaltrials.gov). All patients provided consent before participation.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.