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소아청소년의 항암화학요법에 의한 오심, 구토 예방에 사용되는 Palonosetron과 Ondansetron의 효과 비교

Palonosetron versus Ondansetron for the Prevention of Chemotherapy induced Nausea and Vomiting in Children and Adolescents

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Background : In 2015, 0.02 mg/kg (max. 1.5 mg) dose of palonosetron was approved for the prevention of chemotherapy-induced nausea and vomiting in children. In Severance hospital, clinicians used a lower dose of palonosetron than approved for most pediatric patients, because of the safety concerns. Herein, we compared the efficacy and safety of palonosetron with ondansetron for the prevention of chemotherapy-induced nausea and vomiting in children. Methods : From January 1st 2015 to December 31th 2015, we retrospectively reviewed the electronic medical records of pediatric patients whose chemotherapy were moderately or highly emetogenic and no longer than 4 days. We compared the complete response (CR) rate, no vomiting rate, and no rescue medication rate of the palonosetron and ondansetron groups; and between the 0.02 mg/kg palonosetron and ondansetron groups. Results : Total cycle number of the palonosetron group was 147, and of the ondansetron group, 190. CR rate of the palonosetron group (42%) was significantly lower than that of the ondansetron group(57%) (p 0.05); whereas, the 0.02 mg/kg palonosetron group showed 46 cycles and no significant difference in the CR rate (46%) (p=0171) compared with the ondansetron group. The palonosetron group and 0.02 mg/kg palonosetron group had a higher proportion of highly emetogenic chemotherapy, and longer regimen days, as compared to the ondansetron group, with significance (p 0.05). Conclusion : In this study, the CR rate of the palonosetron group was lower than that of the ondansetron group. Treatment with 0.02 mg/kg palonosetron resulted in a high antiemetic effect without complication. This study has limitations, which include its retrospective design and differences in patients’baseline characteristics. Further study is needed to address these issues.

Abstract

Background : In 2015, 0.02 mg/kg (max. 1.5 mg) dose of palonosetron was approved for the prevention of chemotherapy-induced nausea and vomiting in children. In Severance hospital, clinicians used a lower dose of palonosetron than approved for most pediatric patients, because of the safety concerns. Herein, we compared the efficacy and safety of palonosetron with ondansetron for the prevention of chemotherapy-induced nausea and vomiting in children. Methods : From January 1st 2015 to December 31th 2015, we retrospectively reviewed the electronic medical records of pediatric patients whose chemotherapy were moderately or highly emetogenic and no longer than 4 days. We compared the complete response (CR) rate, no vomiting rate, and no rescue medication rate of the palonosetron and ondansetron groups; and between the 0.02 mg/kg palonosetron and ondansetron groups. Results : Total cycle number of the palonosetron group was 147, and of the ondansetron group, 190. CR rate of the palonosetron group (42%) was significantly lower than that of the ondansetron group(57%) (p 0.05); whereas, the 0.02 mg/kg palonosetron group showed 46 cycles and no significant difference in the CR rate (46%) (p=0171) compared with the ondansetron group. The palonosetron group and 0.02 mg/kg palonosetron group had a higher proportion of highly emetogenic chemotherapy, and longer regimen days, as compared to the ondansetron group, with significance (p 0.05). Conclusion : In this study, the CR rate of the palonosetron group was lower than that of the ondansetron group. Treatment with 0.02 mg/kg palonosetron resulted in a high antiemetic effect without complication. This study has limitations, which include its retrospective design and differences in patients’baseline characteristics. Further study is needed to address these issues.

참고문헌 (13)

  1. Kovacs G, "Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy : a randomised, phase 3, double-blind, double-dummy, non-inferiority study", Lancet Oncol, 17(3), pp.332~344 (2016)
  2. Patil V, "Comparison of antiemetic efficacy and safety of palonosetron vs ondansetron in the prevention of chemotherapy-induced nausea and vomiting in children", J Community Support Oncol, 13(6), pp.209~213 (2015)
  3. Rapoport B, "Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy", Eur J Cancer, 57, pp.23~30 (2016)
  4. Hasler S.B, "Safety of ondansetron loading doses in children with cancer", Support Care Cancer, 16(5), pp.469~475 (2008)
  5. Sepulveda-Vildosola A.C, "Palonosetron hydrochloride is an effective and safe option to prevent chemotherapy-induced nausea and vomiting in children", Arch Med Res, 39(6), pp.601~606 (2008)
  6. 홍창의, "소아과학", pp.119~ (2012), (주)미래엔
  7. Herrstedt J, "2016Updated MASCC", ESMO Consensus Recommendations : Prevention of Nausea and Vomiting Following High Emetic Risk Chemotherapy, 2017, pp.25(1), 277~288
  8. Ripaldi M, "Palonosetron to prevent nausea and vomiting in children undergoing BMT : efficacy and safety", Bone Marrow Transplant, 45(11), pp.1663~1664 (2010)
  9. "암환자에게 처방, 투여하는약제에 대한 요양급여의 적용기준 및 방법에 관한세부사항: 항구토제" (2015)[URL]
  10. "ALOXI (palonosetron HCl) insert paper" (2014)[URL]
  11. Flank J, "Guideline for the Treatment of Breakthrough and the Prevention of Refractory Chemotherapy-Induced Nausea and Vomiting in Children With Cancer", Pediatr Blood Cancer, 63(7), pp.1144~1151 (2016)
  12. Affronti M.L, "Palonosetron in the management of chemotherapy-induced nausea and vomiting in patients receiving multiple-day chemotherapy", Cancer Manag Res, 6, pp.329~337 (2014)
  13. Wang J, "Exposure-Response of Palonosetron for Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients", J Pediatr Gastroenterol Nutr, 63(4), pp.412~416 (2016)

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