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Randomized Controlled Trial
. 2024 Jun 5;150(6):290.
doi: 10.1007/s00432-024-05766-7.

Two doses of fosaprepitant included prophylactic treatment for the three-day cisplatin-based chemotherapy induced nausea and vomiting

Yanying Li #  1 , Yuming Wan #  2   3 , Xiaoyun Yang  4 , Ping Chen  5 , Yan Gui  6 , Lang He  7 , Yingwei Xie  8 , Jing Tian  9 , Ping Duan  10 , Guangguo Liu  11 , Yu Sun  12 , Jiang Zhu  13   14
Affiliations
Randomized Controlled Trial

Two doses of fosaprepitant included prophylactic treatment for the three-day cisplatin-based chemotherapy induced nausea and vomiting

Yanying Li et al. J Cancer Res Clin Oncol. .

Abstract

Purpose: Neurokinin 1 receptor antagonists included prophylactic treatment was recommended for patients who receive one-day cisplatin chemotherapy. It is unclear whether the prolonged administration of fosaprepitant is effective for three-day cisplatin-based chemotherapy induced nausea and vomiting (CINV). We aim to explore the prophylactic antiemetic efficacy and safety of two doses of fosaprepitant included regimen in the patients receiving multiple-day cisplatin chemotherapy.

Methods: This randomized, parallel-group, open-labelled study was conducted in nine hospitals between February 2021 and February 2023. Patients diagnosed as lung cancer and chemotherapy naive were screened. Eligible participants were scheduled to be treated with highly emetogenic chemotherapy regimen which including three days of cisplatin. Then they were randomly divided into the experimental group (two doses of fosaprepitant, Group 2DF) and the control group (one dose of fosaprepitant, Group C). The primary endpoints included the safety and the average none CINV days (NCDs). This study was registered on the website of chictr.org.cn, number ChiCTR2100042665.

Results: Overall, 204 participants were randomly assigned, and 198 patients were analyzed. No statistical difference in adverse events was found between the two groups. All treatment-related adverse effects for fosaprepitant observed were of grade 1-2. The average NCDs of Group 2DF was significantly more than Group C (18.21 ± 3.40 days vs 16.14 ± 5.20 days, P = 0.001). Furthermore, the better life function score was achieved in Group 2DF according to FLIE questionnaire.

Conclusion: The administration of two-dose fosaprepitant was safe and more effective than one dose in protecting patients from CINV induced by three-day cisplatin included chemotherapy.

Keywords: CINV; Fosaprepitant; Three-day cisplatin; Two doses.

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Conflict of interest statement

There is no conflict of interest.

Figures

Fig. 1
Fig. 1
Flow chart of the study
Fig. 2
Fig. 2
None CINV days (NCDs) in different phases
Fig. 3
Fig. 3
Score of FLIE in different phases
Fig. 4
Fig. 4
Time to appetite recovery
See this image and copyright information in PMC

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