Abstract
Background
Guidelines recommend etoposide, methotrexate, actinomycin D (EMA)/cyclophosphamide, vincristine (CO) as first-line treatment for high-risk gestational trophoblastic neoplasia (GTN). However, the floxuridine, actinomycin D, etoposide and vincristine (FAEV) regimen is commonly used to treat these patients in China. We conducted a randomised controlled trial to compare the efficacies and toxicities of FAEV and EMA/CO.
Methods
Ninety-four patients with GTN were enrolled between May 2015 and April 2019 and randomly assigned to the FAEV or EMA/CO regimen. The rates of complete remission and relapse and the toxicities were compared in August 2021.
Results
Five patients were excluded from the analysis. There were 46 patients in the FAEV group and 43 patients in the EMA/CO group. The complete remission rates following primary treatment were 89.1% and 79.1% (P = 0.193), respectively. The relapse rates were 8.7% and 9.3% (P = 0.604). The apparent incidences of grade 4 myelosuppression were 60.9% and 32.6% (P = 0.008), respectively; however, they became both 32.6% (P = 0.996) after granulocyte colony-stimulating factor support. Other adverse reactions were similar in the two groups. No patient died of disease.
Conclusion
FAEV has comparable efficacy and toxicity to EMA/CO as the primary treatment for high-risk GTN, and may thus be another first-line choice of chemotherapy.
Clinical trial registration
chictr.org.cn: ChiCTR1800017423.
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Data availability
The data that support the findings of this study are available from the authors upon reasonable request and with permission of Peking Union Medical College Hospital.
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Acknowledgements
We thank Susan Furness, PhD, from Liwen Bianji (Edanz) (www.liwenbianji.cn/) for editing the English text of a draft of this manuscript.
Funding
This work was supported by grants from the National Natural Science Foundation of China (grant no. 81971475) and the National Key Technology R&D Program of China (grant no. 22019YFC1005204).
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MJ and SJ participated in data collection, data interpretation, statistical analyses and wrote the original draft. JZ, XW, FF, TR, JY and YX participated in the patient enrollment, investigation and data curation. JZ and YX conceived the study, and participated in its design, supervision, data interpretation, analysis and manuscript revision. All authors read and approved the final manuscript.
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This open-label randomised controlled trial (ChiCTR1800017423) was conducted at PUMCH. The study protocol was approved by the Ethics Committee of PUMCH (ZS-1601). The study was carried out in accordance with the guidelines for Good Clinical Practice and the Declaration of Helsinki. All patients provided signed informed consent.
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Ji, M., Jiang, S., Zhao, J. et al. Efficacies of FAEV and EMA/CO regimens as primary treatment for gestational trophoblastic neoplasia. Br J Cancer 127, 524–530 (2022). https://doi.org/10.1038/s41416-022-01809-3
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DOI: https://doi.org/10.1038/s41416-022-01809-3