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Granisetron Vs Ondansetron for Prevention of Nausea and Vomiting

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Granisetron Vs Ondansetron for Prevention of Nausea and Vomiting Bone Marrow Transplantation (2004) 34, 963–968 & 2004 Nature Publishing Group All rights reserved 0268-3369/04 $30.00 www.nature.com/bmt Granisetron vs ondansetron for prevention of nausea and vomiting in hematopoietic stem cell transplant patients: results of a prospective, double-blind, randomized trial T Walsh1,4, AK Morris2, LM Holle3, N Callander1,4, P Bradshaw4, AW Valley5, G Clark6 and CO Freytes1,4 1South Texas Veterans Health Care System, Audie L Murphy Division, San Antonio, TX, USA; 2Duke University Medical Center, Durham, NC, USA; 3Syntaxx Communications Inc., Storrs, CT, USA; 4University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; 5Pharmacy Healthcare Solutions, San Antonio, TX, USA; and 6OSI Pharmaceuticals Inc., Boulder, CO, USA Summary: Nausea and vomiting (N/V) are well-recognized adverse The serotonin type-3 (5-HT3)antagonists represent a effects of chemotherapy. In the setting of hematopoietic significant advance in the prevention of acute nausea and stem cell transplantation (HSCT), where high doses of vomiting (N/V)from highly emetogenic chemotherapy. We chemotherapy are generally employed, these symptoms are sought to determine if any differences in efficacy or adverse almost universal and can have profound clinical and effects exist between two such agents, ondansetron and psychological implications for the patient. One significant granisetron, during conditioning therapy for hematopoietic advance in the prevention of chemotherapy-induced N/V stem cell transplantation (HSCT). Patients were rando- (CINV) has been the introduction of the serotonin type-3 mized to receive either ondansetron 0.15 mg/kg intrave- (5-HT3) receptor antagonists, which inhibit the binding of nously every 8 h or granisetron 10 lg/kg intravenously serotonin to vagal afferent fibers located in the gastro- daily. Additionally, all patients received scheduled dexa- intestinal tract and 5-HT3 receptors in the vomiting 1 methasone and lorazepam. Prophylaxis was continued until center. Currently, four 5-HT3 receptor antagonists are 24 h after completion of chemotherapy. Nausea and distress approved in the United States for the prevention of acute were measured subjectively with visual analog scales and N/V associated with cancer chemotherapy, including emetic episodes were quantified. Of the 110 randomized ondansetron (Zofrans, GlaxoSmithKline, Research patients, 96 were evaluable for efficacy and safety. No Triangle Park, NC, USA), granisetron (Kytrils, Roche significant differences in efficacy were observed between the Laboratories, Nutley, NJ, USA), dolasetron (Anzemets, ondansetron- and granisetron-treated patients, evaluated by Aventis Pharmaceuticals, Kansas City, MO, USA), and comparing the degree of nausea and distress, number of palonosetron (Aloxit, MGI Pharma Inc., Minneapolis, emetic episodes and overall control of emesis. The adverse MN, USA). Palonosetron is also indicated for the effects were also comparable and no patients were removed prevention of delayed N/V associated with moderately from study because of severe toxicities. This trial demon- emetogenic chemotherapy. Outside of the HSCT setting, strates that ondansetron and granisetron are equally numerous studies have concluded that these agents effective at preventing acute N/V associated with conditio- provide equivalent control of N/V induced by highly ning therapy frequently used for HSCT. The agent of choice emetogenic chemotherapy when administered at equipo- should be based on drug acquisition cost or preference. tent doses.2–8 Although three of these agents have been Bone Marrow Transplantation (2004) 34, 963–968. extensively studied in HSCT patients over the last doi:10.1038/sj.bmt.1704714 8 years,9–23 limited data directly comparing these agents 21–23 Published online 18 October 2004 is available. Ondansetron, the first 5-HT3 receptor Keywords: hematopoietic stem cell transplantation; nau- antagonist approved in the United States, has been the sea; vomiting; granisetron; ondansetron most widely studied and is most effectively used in combination with corticosteroids for prevention of CINV; granisetron’s effects are also enhanced with the use of corticosteroids. This study was designed to directly compare the efficacy and adverse effects of ondansetron and granisetron, in Correspondence: Dr T Walsh, South Texas Veterans Healthcare System, combination with other antiemetics, for the prevention of Audie L Murphy Division, 7400 Merton Minter Boulevard, Department 119, San Antonio, TX 78229, USA; E-mail: [email protected] acute CINV associated with common, nontotal body Received 29 April 2004; accepted 13 August 2004 irradiation (TBI)-containing conditioning regimens utilized Published online 18 October 2004 in HSCT. Prevention of nausea/vomiting in stem cell transplantation T Walsh et al 964 Patients and methods Granisetron 10 µg/kg intravenously daily Patient eligibility + 0.9% Normal saline intravenously twice All in-patients undergoing autologous or allogeneic HSCT daily (to maintain blind) for any malignancy who gave written informed consent + were eligible for enrollment in the study. Patients were Dexamethasone 10 mg intravenously excluded if they were scheduled to receive TBI as part of daily + their conditioning regimen or any radiation therapy within Lorazepam 1 mg intravenously every 24 h of study initiation or during the study period. Other 8 hours exclusion criteria included (1) nausea or vomiting within HSCT Patient 24 h prior to initiation of therapy, (2) receipt of any medication with antiemetic activity within 24 h of study RANDOMIZE Ondansetron 0.15 mg/kg intravenously initiation or during the study period such as metoclopra- every 8 hours mide or dronabinol, and (3) known hypersensitivity to any + Dexamethasone 10 mg intravenously 5-HT3 receptor antagonist or other study medication. Permitted medications included antihistamines as a pre- daily + medication for blood transfusions and triazolam or Lorazepam 1 mg intravenously every diphenhydramine for insomnia. Patients were required to 8 hours meet all institutional requirements for HSCT with respect Figure 1 Treatment schema. Patients randomized to ondansetron or to laboratory tests, physical examination, vital signs, and granisetron, administered in a double-blind fashion. performance status. Patients must have been X18 years of age, and a b-hCG test was performed to rule out pregnancy in female patients. episodes within a 24 h period or if the patient requested the medication. Patients were removed from the study if they Study design experienced a Southwestern Oncology Group (SWOG) grade 3 or 4 toxicity, other than myelotoxicity, unless it was This was a prospective, randomized, double-blind trial believed to be unrelated to the study medication.24 conducted at two hospitals, both affiliated with the University of Texas Health Science Center HSCT Program. Patients were evaluated and enrolled within 1 weekof study Statistical analyses initiation. It was assumed that the therapy would be 75–95% effective Patients were randomized according to a computer- in preventing N/V in this patient population. In order to generated scheme to either the granisetron group or detect a difference in response of 20% between the two ondansetron group in a 1:1 distribution. The randomiza- groups with a P-value of 0.05 and power of 80%, a total of tion tookinto account the conditioning regimen, prior 98 patients were required to complete the study (49 patients history of CINV, and previous alcohol or drug use, to per treatment arm). Nausea, distress, and overall control of assure that both arms were balanced regarding these emesis at each day were analyzed using Fisher’s exact test clinical parameters. due to small expected cell frequencies for certain categories of response. Nausea and distress were categorized into none Treatment plan to mild and moderate to severe and overall emetic control was grouped into complete to major response vs minor Following consent, eligible patients were randomized to response to failure. Differences in toxicity, measured as the receive either intravenous granisetron 10 mg/kg daily or number of adverse events per subject between the two ondansetron 0.15 mg/kg intravenously every 8 h. Addition- treatment groups over the entire study, were analyzed with ally, both treatment groups received intravenous dexa- Wilcoxon’s rank-sum test while incidence of specific events methasone 10 mg daily and lorazepam 1 mg intravenously was compared across the two groups using the w2 or every 8 h. To maintain the study blind, patients randomized Fisher’s exact test as appropriate. For the baseline to receive granisetron also received 50 ml of 0.9% normal demographics, Wilcoxon’s rank-sum tests were performed saline as a placebo twice daily (Figure 1). The first dose of for the continuous variables and Fisher’s exact test for the study drug was administered 30 min prior to the first categorical variables. The computer software used for the scheduled dose of chemotherapy and continued for 24 h statistical analyses was Stata v. 8 (College Station, TX, after the completion of chemotherapy. Patients who USA). received busulfan and cyclophosphamide as their condi- tioning regimen did not begin the study drug until the Efficacy measurements cyclophosphamide was administered, because busulfan alone has little emetogenic potential. The total number of The primary objectives of the study were to compare the days of study drug administration was dependent on the efficacy of granisetron and ondansetron
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