A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting.

2.50
Hdl Handle:
http://hdl.handle.net/10541/86379
Title:
A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting.
Authors:
Fauser, A A; Pizzocaro, G; Schueller, J; Khayat, D; Wilkinson, Peter M
Abstract:
Fractionated cisplatin-containing regimens are routinely used for chemotherapy in certain types of cancer. Dolasetron has been shown to be effective in preventing acute emesis related to high-dose cisplatin chemotherapy over 24 h; its effectiveness has not been evaluated in fractionated cisplatin-containing chemotherapy. This trial was designed to assess the efficacy of dolasetron alone or dolasetron plus dexamethasone in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. The patients were 210 cancer in-patients, who were randomised to receive 100 mg dolasetron i.v. or 100 mg dolasetron i.v. plus 20 mg dexamethasone before chemotherapy primarily with cisplatin (15-50 mg/m2) infused over < or =4 h for at least 2 but not more than 5 consecutive days. Dolasetron was administered to all patients 30 min before cisplatin. Dexamethasone was administered in double-blind fashion 5 min before cisplatin. Efficacy was measured at hour 24 of each study day using complete response (no vomiting and no rescue medication) and maximum severity of nausea, self-assessed by patients using a 100mm visual analogue scale. Most (198) of the patients completed the study and were evaluable. Overall complete response rates were significantly higher in the dolasetron plus dexamethasone group than in the dolasetron only group (72.9% vs. 40.8%, respectively; P<0.0001). Complete response rates on each study day were also significantly higher with dolasetron plus dexamethasone than with dolasetron alone (P<0.029), with an attenuated efficacy in the delayed phase in both groups. Chi-square test and logistic regression applied to daily response rates indicated a significant influence of treatment (day 1: P = 0.0002, day 2: P<0.0001, day 3: P = 0.0007, day 4: P = 0.0007, day 5: P = 0.029). Treatment and duration of chemotherapy exerted the only statistically significant subgroup effects on complete response (P<0.0001). Both treatments were administered safely. As seen with other 5-HT3 receptor antagonist antiemetics, the addition of dexamethasone to dolasetron significantly increases effectiveness in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. Both dolasetron and dolasetron plus dexamethasone were well tolerated.
Affiliation:
Klinik für Knochenmarktransplantation und Hämatologie/Onkologie, Idar-Oberstein, Germany. office@bmt-center-io.com
Citation:
A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting. 2000, 8 (1):49-54 Support Care Cancer
Journal:
Supportive Care in Cancer
Issue Date:
Jan-2000
URI:
http://hdl.handle.net/10541/86379
DOI:
10.1007/s005209900090
PubMed ID:
10650898
Type:
Article
Language:
en
ISSN:
0941-4355
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorFauser, A Aen
dc.contributor.authorPizzocaro, Gen
dc.contributor.authorSchueller, Jen
dc.contributor.authorKhayat, Den
dc.contributor.authorWilkinson, Peter Men
dc.date.accessioned2009-11-18T11:10:21Z-
dc.date.available2009-11-18T11:10:21Z-
dc.date.issued2000-01-
dc.identifier.citationA double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting. 2000, 8 (1):49-54 Support Care Canceren
dc.identifier.issn0941-4355-
dc.identifier.pmid10650898-
dc.identifier.doi10.1007/s005209900090-
dc.identifier.urihttp://hdl.handle.net/10541/86379-
dc.description.abstractFractionated cisplatin-containing regimens are routinely used for chemotherapy in certain types of cancer. Dolasetron has been shown to be effective in preventing acute emesis related to high-dose cisplatin chemotherapy over 24 h; its effectiveness has not been evaluated in fractionated cisplatin-containing chemotherapy. This trial was designed to assess the efficacy of dolasetron alone or dolasetron plus dexamethasone in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. The patients were 210 cancer in-patients, who were randomised to receive 100 mg dolasetron i.v. or 100 mg dolasetron i.v. plus 20 mg dexamethasone before chemotherapy primarily with cisplatin (15-50 mg/m2) infused over < or =4 h for at least 2 but not more than 5 consecutive days. Dolasetron was administered to all patients 30 min before cisplatin. Dexamethasone was administered in double-blind fashion 5 min before cisplatin. Efficacy was measured at hour 24 of each study day using complete response (no vomiting and no rescue medication) and maximum severity of nausea, self-assessed by patients using a 100mm visual analogue scale. Most (198) of the patients completed the study and were evaluable. Overall complete response rates were significantly higher in the dolasetron plus dexamethasone group than in the dolasetron only group (72.9% vs. 40.8%, respectively; P<0.0001). Complete response rates on each study day were also significantly higher with dolasetron plus dexamethasone than with dolasetron alone (P<0.029), with an attenuated efficacy in the delayed phase in both groups. Chi-square test and logistic regression applied to daily response rates indicated a significant influence of treatment (day 1: P = 0.0002, day 2: P<0.0001, day 3: P = 0.0007, day 4: P = 0.0007, day 5: P = 0.029). Treatment and duration of chemotherapy exerted the only statistically significant subgroup effects on complete response (P<0.0001). Both treatments were administered safely. As seen with other 5-HT3 receptor antagonist antiemetics, the addition of dexamethasone to dolasetron significantly increases effectiveness in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. Both dolasetron and dolasetron plus dexamethasone were well tolerated.en
dc.language.isoenen
dc.subjectCanceren
dc.subject.meshAdult-
dc.subject.meshAnalysis of Variance-
dc.subject.meshAntiemetics-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshCisplatin-
dc.subject.meshDexamethasone-
dc.subject.meshDouble-Blind Method-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshIndoles-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshLogistic Models-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNausea-
dc.subject.meshNeoplasms-
dc.subject.meshPatient Satisfaction-
dc.subject.meshQuinolizines-
dc.subject.meshStatistics, Nonparametric-
dc.subject.meshTreatment Outcome-
dc.subject.meshVomiting-
dc.titleA double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management of fractionated cisplatin-related nausea and vomiting.en
dc.typeArticleen
dc.contributor.departmentKlinik für Knochenmarktransplantation und Hämatologie/Onkologie, Idar-Oberstein, Germany. office@bmt-center-io.comen
dc.identifier.journalSupportive Care in Canceren

Related articles on PubMed

All Items in Christie are protected by copyright, with all rights reserved, unless otherwise indicated.