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Article: Comparative efficacy of three 5-HT3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: A randomized crossover study

TitleComparative efficacy of three 5-HT3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: A randomized crossover study
Authors
KeywordsAcute emesis
Cisplatin
Dexamethasone
Granisetron
Ondansetron
Tropisetron
Issue Date2000
PublisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.amjclinicaloncology.com
Citation
American Journal Of Clinical Oncology: Cancer Clinical Trials, 2000, v. 23 n. 2, p. 185-191 How to Cite?
AbstractThe purpose of this study was to compare the antiemetic efficacy of three 5-HT3 antagonists (granisetron, ondansetron, tropisetron) plus dexamethasone for the prevention of acute ernesis induced by high-dose cisplatin chemotherapy. This was a randomized, open label, crossover study. Recruited into the study were 94 chemotherapy-naive patients of whom five were excluded because chemotherapy was not given, noncisplatin regimen was used instead, or presence of anticipatory vomiting. The remaining 89 evaluable patients were mostly (86.5%) male, and were all treated for head and neck cancers. The antiemetic regimens consisted of 1) granisetron 3 mg i.v. and dexamethasone 20 mg i.v. on day 1 (GRADEX); 2) tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. on day 1 (TRODEX); and 3) ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. to be followed by ondansetron 8 mg p.o. X 2 on day 1 (ONDEX). Patients were randomized to receive one of the three regimens in the first cycle, and treatment was crossed over to the other two regimens in subsequent cycles. Antiemetic efficacy was assessed using self-report diaries recording the number of vomiting episodes as well as duration and severity of nausea within the first 24 hours. Complete response was defined as no vomiting with or without mild nausea, and major response was defined as one vomiting episode and/or moderate to severe nausea. Major efficacy refers to either complete or major response. A total of 219 cycles was given to 89 patients: 16 received one cycle only, 16 received two cycles, and 57 received three cycles. No carryover effects were observed between cycles. Using pooled data from all cycles, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 68%, and 71%, respectively (p = 0.11); the corresponding major efficacy rates were 91%, 93%, and 86%, respectively (p = 0.36). When only the first cycle was considered, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 75%, and 74%, respectively (p = 0.58); the corresponding major efficacy rates were 92%, 94%, and 84%, respectively (p = 0.38). Analysis of the crossover data showed that the majority of patients achieved complete response or major efficacy with the different pairs of regimens, and there were no significant differences between different regimens in terms of complete response or major efficacy. The only exception was GRADEX versus TRODEX, in which 15.5% of patient achieved complete response with GRADEX as compared with 1.7% with TRODEX (p = 0.025). The majority of patients (53%) did not report any preference, whereas 14% preferred GRADEX, 15% preferred TRODEX, and 18% preferred ONDEX. The three 5-HT3 antagonists, when used in combination with steroids, had similar major efficacy for prophylaxis against cisplatin-induced acute emesis. Although GRADEX was superior to TRODEX in terms of complete response, this may not be of clinical significance. The choice of antiemetic regimens should therefore depend on patient preference and drug cost.
Persistent Identifierhttp://hdl.handle.net/10722/150753
ISSN
2015 Impact Factor: 2.977
2015 SCImago Journal Rankings: 0.846
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorChua, DTTen_HK
dc.contributor.authorSham, JSTen_HK
dc.contributor.authorKwong, DLWen_HK
dc.contributor.authorKwok, CCHen_HK
dc.contributor.authorYue, Aen_HK
dc.contributor.authorFoo, YCen_HK
dc.contributor.authorChan, Ren_HK
dc.date.accessioned2012-06-26T06:09:54Z-
dc.date.available2012-06-26T06:09:54Z-
dc.date.issued2000en_HK
dc.identifier.citationAmerican Journal Of Clinical Oncology: Cancer Clinical Trials, 2000, v. 23 n. 2, p. 185-191en_HK
dc.identifier.issn0277-3732en_HK
dc.identifier.urihttp://hdl.handle.net/10722/150753-
dc.description.abstractThe purpose of this study was to compare the antiemetic efficacy of three 5-HT3 antagonists (granisetron, ondansetron, tropisetron) plus dexamethasone for the prevention of acute ernesis induced by high-dose cisplatin chemotherapy. This was a randomized, open label, crossover study. Recruited into the study were 94 chemotherapy-naive patients of whom five were excluded because chemotherapy was not given, noncisplatin regimen was used instead, or presence of anticipatory vomiting. The remaining 89 evaluable patients were mostly (86.5%) male, and were all treated for head and neck cancers. The antiemetic regimens consisted of 1) granisetron 3 mg i.v. and dexamethasone 20 mg i.v. on day 1 (GRADEX); 2) tropisetron 5 mg i.v. and dexamethasone 20 mg i.v. on day 1 (TRODEX); and 3) ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. to be followed by ondansetron 8 mg p.o. X 2 on day 1 (ONDEX). Patients were randomized to receive one of the three regimens in the first cycle, and treatment was crossed over to the other two regimens in subsequent cycles. Antiemetic efficacy was assessed using self-report diaries recording the number of vomiting episodes as well as duration and severity of nausea within the first 24 hours. Complete response was defined as no vomiting with or without mild nausea, and major response was defined as one vomiting episode and/or moderate to severe nausea. Major efficacy refers to either complete or major response. A total of 219 cycles was given to 89 patients: 16 received one cycle only, 16 received two cycles, and 57 received three cycles. No carryover effects were observed between cycles. Using pooled data from all cycles, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 68%, and 71%, respectively (p = 0.11); the corresponding major efficacy rates were 91%, 93%, and 86%, respectively (p = 0.36). When only the first cycle was considered, the complete response rates to GRADEX, TRODEX, and ONDEX were 81%, 75%, and 74%, respectively (p = 0.58); the corresponding major efficacy rates were 92%, 94%, and 84%, respectively (p = 0.38). Analysis of the crossover data showed that the majority of patients achieved complete response or major efficacy with the different pairs of regimens, and there were no significant differences between different regimens in terms of complete response or major efficacy. The only exception was GRADEX versus TRODEX, in which 15.5% of patient achieved complete response with GRADEX as compared with 1.7% with TRODEX (p = 0.025). The majority of patients (53%) did not report any preference, whereas 14% preferred GRADEX, 15% preferred TRODEX, and 18% preferred ONDEX. The three 5-HT3 antagonists, when used in combination with steroids, had similar major efficacy for prophylaxis against cisplatin-induced acute emesis. Although GRADEX was superior to TRODEX in terms of complete response, this may not be of clinical significance. The choice of antiemetic regimens should therefore depend on patient preference and drug cost.en_HK
dc.languageengen_US
dc.publisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.amjclinicaloncology.comen_HK
dc.relation.ispartofAmerican Journal of Clinical Oncology: Cancer Clinical Trialsen_HK
dc.subjectAcute emesisen_HK
dc.subjectCisplatinen_HK
dc.subjectDexamethasoneen_HK
dc.subjectGranisetronen_HK
dc.subjectOndansetronen_HK
dc.subjectTropisetronen_HK
dc.subject.meshAdulten_US
dc.subject.meshAgeden_US
dc.subject.meshAntiemetics - Pharmacology - Therapeutic Useen_US
dc.subject.meshAntineoplastic Agents - Adverse Effectsen_US
dc.subject.meshCisplatin - Adverse Effectsen_US
dc.subject.meshCross-Over Studiesen_US
dc.subject.meshDexamethasone - Pharmacology - Therapeutic Useen_US
dc.subject.meshFemaleen_US
dc.subject.meshGranisetron - Pharmacology - Therapeutic Useen_US
dc.subject.meshHead And Neck Neoplasms - Drug Therapyen_US
dc.subject.meshHumansen_US
dc.subject.meshIndoles - Pharmacology - Therapeutic Useen_US
dc.subject.meshInjections, Intravenousen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshOndansetron - Pharmacology - Therapeutic Useen_US
dc.subject.meshPatient Satisfactionen_US
dc.subject.meshTreatment Outcomeen_US
dc.subject.meshVomiting - Chemically Induced - Prevention & Controlen_US
dc.titleComparative efficacy of three 5-HT3 antagonists (granisetron, ondansetron, and tropisetron) plus dexamethasone for the prevention of cisplatin-induced acute emesis: A randomized crossover studyen_HK
dc.typeArticleen_HK
dc.identifier.emailChua, DTT: dttchua@hkucc.hku.hken_HK
dc.identifier.emailKwong, DLW: dlwkwong@hku.hken_HK
dc.identifier.authorityChua, DTT=rp00415en_HK
dc.identifier.authorityKwong, DLW=rp00414en_HK
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1097/00000421-200004000-00016en_HK
dc.identifier.pmid10776982-
dc.identifier.scopuseid_2-s2.0-0033637675en_HK
dc.identifier.hkuros52953-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0033637675&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume23en_HK
dc.identifier.issue2en_HK
dc.identifier.spage185en_HK
dc.identifier.epage191en_HK
dc.identifier.isiWOS:000086471200016-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridChua, DTT=7006773480en_HK
dc.identifier.scopusauthoridSham, JST=7101655565en_HK
dc.identifier.scopusauthoridKwong, DLW=15744231600en_HK
dc.identifier.scopusauthoridKwok, CCH=7102029180en_HK
dc.identifier.scopusauthoridYue, A=18041361700en_HK
dc.identifier.scopusauthoridFoo, YC=7005251223en_HK
dc.identifier.scopusauthoridChan, R=8663654400en_HK

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