Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

Eghbali, Aziz; Kohpar, Fatemeh Khazaei; Ghaffari, Kazem; Afzal, Roghayeh Rahimi; Eghbali, Aygin; Ghasemi, Ali

doi:10.1016/j.htct.2022.02.004

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Original article • Hematol., Transfus. Cell Ther. 45 (3) • Jul-Sep 2023 • https://doi.org/10.1016/j.htct.2022.02.004 copy

Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Introduction:

This study was performed to evaluate the degree of 3-day chemotherapy-induced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX).

Methods:

This clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m² on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group.

Results:

There were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5% vs. 98.3%, respectively; p = 0.848).

Conclusion:

According to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and can be beneficial.

Keywords:
Aprepitant; Dexamethasone; Granisetron; Nausea; Vomiting

Characteristics	Group A (n = 56)	Group B (n = 57)	p-value
Gender, (%)			0.644^a a Pearsonʼs χ2 test was used.
Female	25 (44.6)	23 (40.3)
Male	31 (55.4)	34 (59.7)
Age, years ± SD;	10.21 ± 2.81	9.10 ± 3.13	0.689^b b Student t-test was used.
Min-Max	7 - 18	5 - 16
Type of cancer; (%)			0.891^a a Pearsonʼs χ2 test was used.
Acute lymphoblastic leukemia	12 (21.5)	14 (24.6)
Rhabdomyosarcoma	6 (10.8)	7 (12.3)
Wilms tumor	11 (19.6)	13 (22.8)
Acute myeloid leukemia	4 (7)	3 (5.3)
Osteosarcoma	17 (30.3)	12 (21)
Hepatocellular carcinoma	6 (10.8)	8 (14)
History of alcohol consumption, Yes (%)	2 (3.5)	3 (5.2)	0.662^a a Pearsonʼs χ2 test was used.
Chemotherapy regimen, (%)			0.974^a a Pearsonʼs χ2 test was used.
Dox + CP + Vincristine	18 (32.1)	20 (35.1)
Dox + Cisplatin	16 (28.6)	15 (26.3)
Dox + Dacarbazine + Vinblastine + Bleomycin	13 (23.2)	12 (21.1)
Actinomycin D + Vincristine + CP	9 (16.1)	10 (17.5)
Prior chemotherapy (non-naïve, %)	2 (3.5)	3 (5.2)	0.622^a a Pearsonʼs χ2 test was used.
History of motion sickness, Yes (%)	4 (7.1)	6 (10.5)	0.527^a a Pearsonʼs χ2 test was used.

Characteristics	Group A (n = 56)	Group B (n = 57)	p-value
Nausea^a a Severity of nausea using VAS. (mean ± SD);
Day 1	13.6 ± 31.4	9.8 ± 18.3	0.638^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Day 2	16.7 ± 22.4	12.2 ± 15.8	0.531^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Day 3	11.3 ± 26.9	17.7 ± 21.1	0.652^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Overall phase	13.4 ± 19.6	14.3 ± 17.5	0.937^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Vomiting^b b Number patients with emesis (%). (n, %);
Day 1	2 (3.5)	1 (1.7)	0.848^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Day 2	4 (7.1)	3 (5.2)	0.779^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Day 3	5 (8.9)	3 (5.2)	0.448^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Overall phase	5 (8.9)	3 (5.2)	0.448^e e Determined by using the Pearsonʼs χ2 test (3-day vs. 1-day).
Rescue therapy^c c Number of patients with breakthrough medication administered. (n, %);
Day 1	7 (12.5)	5 (8.8)	0.368^f f Determined by using the Fisher Exact test.
Day 2	23 (41.1)	16 (28.1)	0.105^f f Determined by using the Fisher Exact test.
Day 3	26 (46.4)	19 (33.3)	0.109^f f Determined by using the Fisher Exact test.
Overall phase	27 (48.2)	21 (36.8)	0.151^f f Determined by using the Fisher Exact test.
Complete response^d d Absence of vomiting and nausea. (n, %);
Day 1	39 (69.6)	42 (73.7)	0.680^f f Determined by using the Fisher Exact test.
Day 2	35 (62.5)	37 (64.9)	0.846^f f Determined by using the Fisher Exact test.
Day 3	33 (58.9)	34 (59.6)	1.000^f f Determined by using the Fisher Exact test.
Overall phase	29 (51.8)	30 (52.6)	1.000^f f Determined by using the Fisher Exact test.

Characteristics	Group A (n = 56)	Group B (n = 57)	p-value
Most common nonserious clinical adverse events, (%)			0.824^a a Pearsonʼs χ2 test was used.
Anemia	13 (23.2)	10 (17.5)
Headache	4 (7.1)	6 (10.5)
Constipation	9 (16)	11 (19.3)
Diarrhea	11 (19.6)	8 (14)
Fatigue	8 (14.3)	9 (15.8)

Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular (ABHH) R. Dr. Diogo de Faria, 775 cj 133, 04037-002, São Paulo / SP - Brasil - São Paulo - SP - Brazil
E-mail: htct@abhh.org.br

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[1] *Corresponding author at: Department of Biochemistry and Hematology, Faculty of Medicine Semnan University of Medical Sciences, Semnan, Iran. E-mail address: a.qasemi2012@yahoo.com (A. Ghasemi).