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

Received: 18 March 2020/Accepted: 15 October 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

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*Corresponding author; email: midalias@ppukm.ukm.edu.my