Skip to main content
Top
Published in: BMC Cancer 1/2023

Open Access 01-12-2023 | Nausea | Research

Prolonged usage of fosaprepitant for prevention of delayed chemotherapy-induced nausea and vomiting(CINV) in patients receiving highly emetogenic chemotherapy

Authors: Ai Gao, Shasha Guan, Yinjuan Sun, Lingling Wang, Fanlu Meng, Xia Liu, Liyan Gu, Guo Li, Diansheng Zhong, Linlin Zhang

Published in: BMC Cancer | Issue 1/2023

Login to get access

Abstract

Background

Even though chemotherapy-induced nausea and vomiting (CINV) can be well controlled in the acute phase, the incidence of delayed CINV remains high. In this study, we intend to investigate whether prolonged use of NK-1 receptor antagonist (RA) in addition to 5-HT3 RA and dexamethasone (DEX) was more effective in preventing delayed CINV.

Methods

This randomised, open-label, controlled study was designed to compare the efficacy and safety of fosaprepitant 150 mg given on days 1,3 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC). All patients also treated with palonosetron on day 1 and DEX on days 1–3. The primary endpoint was the incidence of delayed nausea and vomiting. The second endpoint was AEs. All the above endpoints were defined according to CTCAE 5.0.

Results

Seventy-seven patients were randomly assigned to prolonged group and seventy-nine to regular group. Prolonged group demonstrated superiority in controlling delayed CINV to regular group, with statistically significant lower incidence of nausea (6.17% vs 12.66%, P = 0.0056), and slightly lower incidence of grade 1 vomiting (1.62% vs 3.80%, P = 0.0953) in the delayed phase. In addition, prolonged use of fosaprepitant was safe. No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in delayed phase.

Conclusions

Prolonged use of fosaprepitant can effectively and safely prevent delayed CINV in patients receiving HEC.
Appendix
Available only for authorised users
Literature
1.
go back to reference Griffin AM, et al. On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996;7(2):189–95.CrossRefPubMed Griffin AM, et al. On the receiving end. V: Patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996;7(2):189–95.CrossRefPubMed
2.
go back to reference Cohen L, et al. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007;15(5):497–503.CrossRefPubMed Cohen L, et al. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007;15(5):497–503.CrossRefPubMed
3.
4.
go back to reference Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016;374(14):1356–67.CrossRefPubMed Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016;374(14):1356–67.CrossRefPubMed
6.
go back to reference Aogi K, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26(1):1–17.CrossRefPubMed Aogi K, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26(1):1–17.CrossRefPubMed
7.
go back to reference Bloechl-Daum B, et al. Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472–8.CrossRefPubMed Bloechl-Daum B, et al. Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472–8.CrossRefPubMed
8.
go back to reference Kraut L, Fauser AA. Anti-emetics for cancer chemotherapy-induced emesis: Potential of alternative delivery systems. Drugs. 2001;61(11):1553–62.CrossRefPubMed Kraut L, Fauser AA. Anti-emetics for cancer chemotherapy-induced emesis: Potential of alternative delivery systems. Drugs. 2001;61(11):1553–62.CrossRefPubMed
9.
go back to reference Lasseter KC, et al. Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects. J Clin Pharmacol. 2007;47(7):834–40.CrossRefPubMed Lasseter KC, et al. Tolerability of fosaprepitant and bioequivalency to aprepitant in healthy subjects. J Clin Pharmacol. 2007;47(7):834–40.CrossRefPubMed
10.
go back to reference Grunberg S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol–EASE. J Clin Oncol. 2011;29(11):1495–501.CrossRefPubMed Grunberg S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol–EASE. J Clin Oncol. 2011;29(11):1495–501.CrossRefPubMed
11.
go back to reference Weinstein C, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016;27(1):172–8.CrossRefPubMed Weinstein C, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016;27(1):172–8.CrossRefPubMed
12.
go back to reference Radhakrishnan V, et al. Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial. Pediatr Blood Cancer. 2019;66(3):e27551.CrossRefPubMed Radhakrishnan V, et al. Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial. Pediatr Blood Cancer. 2019;66(3):e27551.CrossRefPubMed
13.
14.
go back to reference Albany C, et al. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012;30(32):3998–4003.CrossRefPubMed Albany C, et al. Randomized, double-blind, placebo-controlled, phase III cross-over study evaluating the oral neurokinin-1 antagonist aprepitant in combination with a 5HT3 receptor antagonist and dexamethasone in patients with germ cell tumors receiving 5-day cisplatin combination chemotherapy regimens: a hoosier oncology group study. J Clin Oncol. 2012;30(32):3998–4003.CrossRefPubMed
15.
go back to reference Aapro M. 5-HT(3)-receptor antagonists in the management of nausea and vomiting in cancer and cancer treatment. Oncology. 2005;69(2):97–109.CrossRefPubMed Aapro M. 5-HT(3)-receptor antagonists in the management of nausea and vomiting in cancer and cancer treatment. Oncology. 2005;69(2):97–109.CrossRefPubMed
17.
go back to reference Tamura K, et al. Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan. Int J Clin Oncol. 2015;20(5):855–65.CrossRefPubMed Tamura K, et al. Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan. Int J Clin Oncol. 2015;20(5):855–65.CrossRefPubMed
18.
go back to reference Saito H, et al. Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Ann Oncol. 2013;24(4):1067–73.CrossRefPubMed Saito H, et al. Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Ann Oncol. 2013;24(4):1067–73.CrossRefPubMed
19.
go back to reference Gralla RJ, et al. A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann Oncol. 2014;25(7):1333–9.CrossRefPubMedPubMedCentral Gralla RJ, et al. A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann Oncol. 2014;25(7):1333–9.CrossRefPubMedPubMedCentral
20.
go back to reference Hata A, et al. Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE. J Clin Oncol. 2022;40(2):180–8.CrossRefPubMed Hata A, et al. Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE. J Clin Oncol. 2022;40(2):180–8.CrossRefPubMed
21.
go back to reference Jordan K, et al. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197–202.CrossRefPubMed Jordan K, et al. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197–202.CrossRefPubMed
Metadata
Title
Prolonged usage of fosaprepitant for prevention of delayed chemotherapy-induced nausea and vomiting(CINV) in patients receiving highly emetogenic chemotherapy
Authors
Ai Gao
Shasha Guan
Yinjuan Sun
Lingling Wang
Fanlu Meng
Xia Liu
Liyan Gu
Guo Li
Diansheng Zhong
Linlin Zhang
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2023
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-023-11070-3

Other articles of this Issue 1/2023

BMC Cancer 1/2023 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine