Sains Malaysiana 50(6)(2021): 1707-1714
http://doi.org/10.17576/jsm-2021-5006-17
Efficacy
of Granisetron in the Prevention of Nausea and Vomiting among Paediatric
Oncology Patients Receiving Moderate to Highly Emetogenic Chemotherapy: A
Single-Blinded, Non-Inferiority Trial
(Keberkesanan
Granisetron dalam Mencegah Loya dan Muntah di Kalangan Pesakit Pediatrik
Onkologi yang Menerima Kemoterapi Emetogenik Sederhana hingga Tinggi: Suatu
Kajian Kesamarataan, Rabun Satu Pihak)
SIE CHONG DORIS
LAU, CHENG KHAI SOH, C-KHAI LOH, SYED ZULKIFLI SYED ZAKARIA & HAMIDAH ALIAS*
Department of Paediatrics, Faculty of
Medicine, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, 56000
Kuala Lumpur, Federal Territory, Malaysia
Diserahkan: 18 Mac 2020/Diterima: 15 Oktober
2020
ABSTRACT
This single-blinded, non-inferiority trial was
conducted over an 8-month period to examine the efficacy of intravenous
granisetron at two differing doses in preventing acute and delayed
chemotherapy-induced nausea and vomiting (CINV) among paediatric patients
receiving moderate to highly emetogenic chemotherapy. Seventeen patients (9
males and 8 females) were recruited and randomly assigned to receive
alternating granisetron dosages of 0.01 mg/kg and 0.04 mg/kg during each
chemotherapy cycle. The severity of CINV during and three days post-completion
of chemotherapy, as well as common side effects of granisetron were recorded. A
total of 78 cycles of chemotherapy (38 cycles of 0.01 mg/kg and 40 cycles of
0.04 mg/kg) were evaluated. The median age of the study population was 5.2
years (interquartile range 25th, 3.8; 75th, 8.7). Patients’ diagnoses comprised
of haematological malignancy, bone tumour and cerebral neoplasm. From this
study, we demonstrated that intravenous (IV) granisetron 0.01 mg/kg was
non-inferior to 0.04 mg/kg in terms of achieving a complete response for acute
CINV. However, a similar observation was not seen in the post-treatment period
analysis (delayed CINV). In conclusion, IV granisetron at 0.04 mg/kg/dose
provides effective protection and prophylaxis of both acute and delayed CINV.
Further study with a larger sample size may be required before a definite
conclusion can be made with regards to efficacy of 0.01 mg/kg dose.
Keywords: Chemotherapy; granisetron; nausea and
vomiting; non-inferiority; paediatric
ABSTRAK
Kajian kesamarataan, rabun satu pihak ini dijalankan
selama tempoh 8 bulan untuk melihat keberkesanan ubat granisetron intravena
pada 2 dos yang berbeza dalam mencegah loya dan muntah di kalangan pesakit
pediatrik yang menerima kemoterapi tahap emetogenik sederhana hingga tinggi.
Tujuh belas pesakit (9 lelaki dan 8 perempuan) telah direkrut dan dibahagikan
secara rawak untuk menerima dos granisetron 0.01 mg/kg dan 0.04 mg/kg secara
berselang setiap kitaran kemoterapi. Tahap keterukan loya dan muntah semasa
(akut) dan 3 hari selepas (tertangguh) kemoterapi, serta kesan sampingan
granisetron dicatatkan. Sebanyak 78 kitaran kemoterapi (38 kitaran dengan dos
0.01 mg/kg dan 40 kitaran dengan dos 0.04 mg/kg) telah dikaji. Umur median
pesakit kajian adalah 5.2 tahun (kuartil ke-25, 3.8; ke-75, 8.7). Diagnosis
pesakit merangkumi kanser darah, tulang dan otak. Daripada kajian ini, kami
menunjukkan bahawa granisetron intravena dos 0.01 mg/kg tidak kurang
keberkesanannya apabila dibandingkan dengan dos 0.04 mg/kg untuk mencapai
respons sepenuhnya bagi mencegah loya dan muntah akut. Namun, pemerhatian yang
sama tidak dilihat untuk loya dan muntah tertangguh selepas kemoterapi.
Kesimpulannya, dos granisetron intravena 0.04 mg/kg memberikan perlindungan dan
pencegahan yang berkesan untuk loya dan muntah akut serta tertangguh. Kajian
lanjut dengan saiz sampel yang lebih besar diperlukan sebelum kesimpulan yang
pasti boleh dibuat mengenai keberkesanan dos 0.01 mg/kg.
Kata kunci: Kemoterapi; granisetron; kesamarataan; loya
dan muntah; pediatrik
RUJUKAN
Aksoylar, S., Akman,
S.A., Özgenç, F. & Kansoy, S. 2001. Comparison of tropisetron and
granisetron in the control of nausea and vomiting in children receiving
combined cancer chemotherapy. Pediatric
Hematology and Oncology 18(6): 397-406.
Baxter, A.L., Watcha,
M.F., Baxter, W.V., Leong, T. & Wyatt, M.M. 2011. Development and validation
of a pictorial nausea rating scale for children. Pediatrics 127(6): e1542-e1549.
Bender, C.M.,
McDaniel, R.W., Murphy-Ende, K., Pickett, M., Rittenberg, C.N., Rogers, M.P.,
Schneider, S.M. & Schwartz, R.N. 2002. Chemotherapy-induced nausea and vomiting. Clinical Journal of Oncology Nursing 6(2): 94-102.
Berrak, S.G.,
Ozdemir, N., Bakirci, N., Turkkan, E., Canpolat, C., Beker, B. & Yoruk, A.
2007. A double-blind, crossover, randomized dose-comparison trial of
granisetron for the prevention of acute and delayed nausea and emesis in
children receiving moderately emetogenic carboplatin-based chemotherapy. Supportive Care in Cancer 15(10):
1163-1168.
Dupuis, L.L. &
Nathan, P.C. 2010. Optimizing emetic control in children receiving
antineoplastic therapy beyond the guidelines. Pediatric Drugs 12(1): 51-61.
Dupuis, L.L., Sung,
L., Molassiotis, A., Orsey, A.D., Tissing, W. & van de Wetering, M. 2017.
2016 updated MASCC/ESMO consensus recommendations: Prevention of acute
chemotherapy-induced nausea and vomiting in children. Supportive Care in Cancer 25(1): 323-331.
Dupuis, L.L.,
Boodhan, S., Holdsworth, M., Robinson, P.D., Hain, R., Portwine, C.,
O’Shaughnessy, E. & Sung, L. 2013. Guideline for the prevention of acute
nausea and vomiting due to antineoplastic medication in pediatric cancer
patients. Pediatric Blood & Cancer 60(7): 1073-1082.
Dupuis, L.L.,
Boodhan, S., Sung, L., Portwine, C., Hain, R., McCarthy, P. & Holdsworth,
M. 2011. Guideline for classification of the acute emetogenic potential of
antineoplastic medication in pediatric cancer patients. Pediatric Blood & Cancer 57(2):
191-198.
Emir, S.,
Erturgut, P. & Vidinlisan, S. 2013. Comparison of granisetron plus
dexamethasone versus an antiemetic cocktail containing midazolam and
diphenhydramine for chemotherapy induced nausea and vomiting in children. Indian Journal of Medical and Paediatric
Oncology 34(4): 270-273.
Flank, J., Robinson,
P.D., Holdsworth, M., Phillips, R., Portwine, C., Gibson, P., Maan, C., Stefin,
N., Sung, L. & Dupuis, L.L. 2016. Guideline for the treatment of
breakthrough and the prevention of refractory chemotherapy-induced nausea and
vomiting in children with cancer. Pediatric
Blood & Cancer 63(7): 1144-1151.
Hählen, K., Quintana,
E., Pinkerton, C.R. & Cedar, E. 1995. A randomized comparison of
intravenously administered granisetron versus chlorpromazine plus dexamethasone
in the prevention of ifosfamide-induced emesis in children. The Journal of Pediatrics 126(2): 309-313.
Hesketh, P.J. 2008.
Chemotherapy-induced nausea and vomiting. New
England Journal of Medicine 358(23): 2482-2494.
Jaing,
T.H., Tsay, P.K., Hung, I.J., Yang, C.P. & Hu, W.Y. 2004. Single-dose oral granisetron
versus multidose intravenous
ondansetron for moderately emetogenic cyclophosphamide-based chemotherapy in pediatric
outpatients with acute lymphoblastic leukemia. Pediatric Hematology and Oncology 21(3): 227-235.
Komada, Y.,
Matsuyama, T., Takao, A., Hongo, T., Nishimura, Y., Horibe, K. & Sakurai,
M. 1991. A randomised dose-comparison trial of granisetron in preventing emesis
in children with leukaemia receiving emetogenic chemotherapy. European Journal of Cancer 35(7):
1095-1101.
Lemerle, J., Amaral,
D., Southall, D.P., Upward, J. & Murdoch, R.D. 1991. Efficacy and safety of
granisetron in the prevention of chemotherapy-induced emesis in paediatric
patients. European Journal of Cancer and
Clinical Oncology 27(9): 1081-1083.
Mabro, M., Cohn, R., Zanesco, L., Madon, E., Hählen, K., Margueritte, G.,
Breatnach, F., Gentet, J.C. & Plouvier, É. 2000. Granisétron en solution
buvable dans la prevention des vomissements chimio-induits de l’enfant: Comparison en double aveugle de deux posologies. Bulletin du Cancer 87(3): 259-264.
Morrow, G.R., Roscoe,
J.A., Kirshner, J.J., Hynes, H.E. & Rosenbluth, R.J. 1998. Anticipatory
nausea and vomiting in the era of 5-HT 3 antiemetics. Supportive Care in Cancer 6(3): 244-247.
Roscoe, J.A., Morrow,
G.R., Aapro, M.S., Molassiotis, A. & Olver, I. 2011. Anticipatory nausea
and vomiting. Supportive Care in Cancer 19(10): 1533-1538.
Tsuchida, Y.,
Hayashi, Y., Asami, K., Yamamoto, K., Yokoyama, J., Mugishima, H., Honna, T.,
Mimaya, J., Hara, F., Sawada, T., Matsumura, T., Suita, S., Sugimoto, T. &
Kaneko, M. 1999. Effects of granisetron in children undergoing high-dose
chemotherapy: A multi-institutional, cross-over study. International Journal of Oncology 14(4): 673-679.
*Pengarang untuk
surat-menyurat; email: midalias@ppukm.ukm.edu.my
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