Palonosetron is a Better Choice Compared With Ondansetron for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in a Resource-limited Pediatric Oncology Center: Results From a Randomized Control Trial

Abstract

Palonosetron (PG) is a newer, safe, and effective long-acting 5-HT3 antagonist commonly used in adults, but data in children are limited. A randomized controlled trial was carried out among children with cancer during their first cycle of moderate or highly emetogenic chemotherapy to receive either PG or ondansetron (OG) with the aim of comparing their efficacy, safety, and cost-effectiveness. In total, 200 children (mean age, 8 y, male:female=1.8:1) were recruited, 100 in each arm. Complete response, defined as no vomiting, in acute (<24 h), delayed (24 to 120 h), and overall phases (0 to 120 h) was observed in 88%, 88%, and 81% of cases, respectively, for PG versus 84%, 79%, and 72%, respectively, for OG (P=0.42, 0.09 and 0.21, respectively). Complete protection rates, defined as no nausea and vomiting in children above 6 years of age, in acute, delayed, and overall phases were 84%, 81%, and 73%, respectively, for PG versus 79%, 67%, and 60%, respectively, for OG (P=0.44, 0.06 and 0.10, respectively). Overall, the efficacy and safety of PG in the prevention of chemotherapy-induced nausea and vomiting was comparable with OG, but PG was a more cost-effective and suitable choice for busy centers in resource-limited countries.

Chemotherapy-Induced Nausea and Vomiting in Gastrointestinal Cancer Patients: Do We Need to Revisit Guidelines?

“…The doses of the antiemetic used in the study were as per the standard recommendations and available studies published from India. 4 5 6 7 …”

“…The doses of the antiemetic used in the study were as per the standard recommendations and available studies published from India. [4][5][6][7] All participants receiving HEC regimen received a 5HT3 (5-hydroxytryptamine) receptor antagonist (0.25-mg palonosetron intravenously or 1-mg granisetron intravenously, with the specific agent chosen by the primary clinician) on day 1 of chemotherapy, dexamethasone (8-12 mg intravenously on day 1 and 8-mg orally on days 2, 3, and 4), an NK1 (neurokinnin 1) receptor antagonist (125-mg aprepitant orally on day 1 and 80 mg on days 2 and 3, or 150mg fosaprepitant intravenously on day 1), and olanzapine (10 mg per day orally from day 1-4) in the selected cohort.…”

Palonosetron for Patients Undergoing High or Moderate Emetogenic Chemotherapy

“…The detailed characteristics of the included SR 21 (Table 2), primary clinical studies (RCTs) [22][23][24][25][26][27][28][29][30][31][32][33][34][35] (Table 3), economic studies [36][37][38][39][40] (Table 4), and guidelines [41][42][43][44][45][46][47] (Table 5) are provided in Appendix 2.…”

The prevention and treatment of chemotherapy-induced nausea and vomiting in children and adolescents receiving cancer treatment: the current status and possibilities for improvement

“…В мире зарегистрировано для клинического применения 5 препаратов из этой группы -ондансетрон, трописетрон, гранисетрон, доласетрон и палоносетрон, однако, как показали индивидуальные клинические исследования (некоторые частично или полностью состоящие из пациентов детского возраста) и их систематический анализ, в рекомендованных дозах все эти препараты имеют сопоставимые эффективность и безопасность [18]. Возможно, наиболее длительно действующий представитель классапалоносетрон имеет определенные преимущества при проведении многодневной химиотерапии или невозможности использовать кортикостероиды и/или NK-1-антагонисты [19][20][21], однако в большинстве случаев они не являются решающими при выборе 5-НТ3-антагониста в педиатрической практике. Современные педиатрические рекомендации перечисляют этот препарат наравне с другими 5-НТ3-антагонистами, не отдавая предпочтения, за исключением ситуаций, когда для профилактики ТИР, обусловленной высоко-или среднеэметогенной терапией, не могут быть использованы ни кортикостероиды, ни NK-1-антагонисты.…”