Contribution to the treatment of nausea and emesis induced by chemotherapy in children and adolescents with osteosarcoma
Keywords:
Vomiting, Nausea, Child, Adolescent, Drug therapyAbstract
CONTEXT AND OBJECTIVE: Chemotherapy-in- duced emesis is a limiting factor in treating chil- dren with malignancies. Intensive chemotherapy regimens along with emetogenic drug administra- tion have increased the frequency and severity of emesis and nausea. Our study was designed to consider the importance of this problem and the need for improvement in emesis treatment for patients receiving chemotherapy. Our objective was to compare the efficacy and safety of the antiemetic drug granisetron and a regimen of metoclopramide plus dimenhydrinate. DESIGN AND SETTING: Open, prospective and randomized study at Instituto de Oncologia Pediátrica, Department of Pediatrics, Universi- dade Federal de São Paulo. METHODS: From February to August 1994, 26 patients (mean age: 14 years) with osteo- sarcoma received 80 chemotherapy cycles of iphosphamide (2,500 mg/m2) plus epirubicin (75 mg/m2) or carboplatin (600 mg/m2), or epirubicin (75 mg/m2) plus carboplatin (600 mg/m2). Eighty chemotherapy treatments were analyzed regarding nausea and vomiting control. Patients were randomized to receive either a single dose of granisetron (50 µg/kg) or metoclopramide (2 mg/kg) plus dimenhydrinate (5 mg/kg infused over eight hours). Emesis and nausea were monitored for 24 hours by means of the modified Morrow Assessment of Nausea and Emesis. Statistical analysis utilized the chi- squared, Student t and Mann-Whitney tests, plus data exploration techniques. RESULTS: 62.5% of the patients undergoing che- motherapy responded completely to granisetron, whereas 10% responded to metoclopramide plus dimenhydrinate (p < 0.0001). No severe adverse reactions were found in either of the treatments given. CONCLUSION: In children and adolescents with osteosarcoma, granisetron was safe and more efficient than metoclopramide plus dimenhydri- nate for controlling chemotherapy-induced emesis and nausea.
Downloads
References
Penta JS, Poster DS, Bruno S, Macdonald JS. Clinical trials with antiemetic agents in cancer patients receiving chemotherapy. J Clin Pharmacol. 1981;21(8-9 Suppl):11S-22S.
Miller M, Kearney N. Chemotherapy-related nausea and vomit- ing – past reflections, present practice and future management. Eur J Cancer Care (Engl). 2004;13(1):71-81.
Gralla RJ, Itri LM, Pisko SE, et al. Antiemetic efficacy of high-dose metoclopramide: randomized trials with placebo and prochlorperazine in patients with chemotherapy-induced nausea and vomiting. N Eng J Med. 1981;305(16):905-9.
Kris MG, Gralla RJ, Tyson LB, et al. Improved control of cisplatin-induced emesis with high-dose metoclopramide and with combinations of metoclopramide, dexamethasone, and diphenhydramine. Results of consecutive trials in 255 patients. Cancer. 1985;55(3):527-34.
Terrin BN, McWilliams NB, Maurer HM. Side effects of meto- clopramide as an antiemetic in childhood cancer chemotherapy. J Pediatr. 1984;104(1):138-40.
Allen JC, Gralla R, Reilly L, Kellick M, Young C. Metoclo- pramide: dose-related toxicity and preliminary antiemetic studies in children receiving cancer chemotherapy. J Clin Oncol. 1985;3(8):1136-41.
Walton SM. Advances in use of the 5-HT3 receptor antagonists. Expert Opin Pharmacother. 2000;1(2):207-23.
Miyajima Y, Numata S, Katayama I, Horibe K. Prevention of chemo- therapy-induced emesis with granisetron in children with malignant diseases. Am J Pediatr Hematol Oncol. 1994;16(3):236-41.
Morrow GR, Hickok JT, Rosenthal SN. Progress in reducing nausea and emesis. Comparisons of ondansetron (Zofran), granisetron (Kytril), and tropisetron (Navoban). Cancer. 1995;76(3):343-57.
Carmichael J, Keizer HJ, Cupissol D, Milliez J, Scheidel P, Schindler AE. Use of granisetron in patients refractory to previous treatment with antiemetics. Anticancer Drugs. 1998;9(5):381-5.
Tan M. Granisetron: new insights into its use for the treatment of chemotherapy-induced nausea and vomiting. Expert Opin Pharmacother. 2003;4(9):1563-71.
Morrow GR. Methodology in behavioral and psychosocial cancer research. The assessment of nausea and vomiting. Past problems, current issues and suggestions for future research. Cancer. 1984;53(10 Suppl):2267-80.
Tsuchida Y, Hayashi Y, Asami K, et al. Effects of granisetron in children undergoing high-dose chemotherapy: a multi-institu- tional, cross-over study. Int J Oncol. 1999;14(4):673-9.
Lemerle J, Amaral D, Southall DP, Upward J, Murdoch RD. Efficacy and safety of granisetron in the prevention of chemo- therapy-induced emesis in paediatric patients. Eur J Cancer. 1991;27(9):1081-3.
Zucker JM, Quintana E, Hahlen K, Pinkerton CR, Baton F, Cedar E. IV granisetron in children: a randomized comparative study. Proceedings of the 29th Annual Meeting american Society of Clinical; 1993 May 16-18, Orlando, FL. (abstract AI619).
Hirota T, Shimizu H, Fujimoto T, et al. Comparative trial of granisetron versus granisetron plus methylprednisolone for the prevention of nausea and vomiting induced by cancer chemo- therapy]. Gan To Kagaku Ryoho. 1994;21(1):91-6.
Jacobson SJ, Shore RW, Greenberg M, Spielberg SP. The efficacy and safety of granisetron in pediatric cancer patients who had failed standard antiemetic therapy during anticancer chemo- therapy. Am J Pediatr Hematol Oncol. 1994;16(3):231-5.
Morrow GR. Methodology in behavioral and psychosocial cancer research. The assessment of nausea and vomiting. Past problems, current issues and suggestions for future research. Cancer. 1984;53(10 Suppl):2267-80.