5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: A URCC CCOP randomised controlled trial

Jane T. Hickok, Joseph A. Roscoe, Gary R. Morrow, Christopher W. Bole, Hongwei Zhao, Karen L. Hoelzer, Shaker R. Dakhil, Timothy Moore, Tom R. Fitch

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Background: Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50% of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin. Methods: 691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat. Findings: 519 (77%) of the 671 evaluable patients had delayed nausea, with a mean severity of 3·33 (95% CI 3·22-3·44). 161 (71%) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3·37 [3·16-3·58]), as did 179 (79%) of 226 patients assigned 5-HT-receptor antagonists (3·29 [3·09-3·48]) and 179 (82%) of 219 patients assigned prochlorperazine as needed (3·33 [3·15-3·50]); groups did not differ in mean severity (p=0·853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0·05, t test) and those allocated prochlorperazine as needed (p=0·009, t test). Interpretation: Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.

Original languageEnglish (US)
Pages (from-to)765-772
Number of pages8
JournalLancet Oncology
Volume6
Issue number10
DOIs
StatePublished - Oct 2005

Fingerprint

Prochlorperazine
Serotonin Antagonists
Serotonin Receptors
Doxorubicin
Nausea
Randomized Controlled Trials
Vomiting
Drug Therapy
Dexamethasone
Analysis of Variance
Quality of Life

ASJC Scopus subject areas

  • Oncology

Cite this

5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin : A URCC CCOP randomised controlled trial. / Hickok, Jane T.; Roscoe, Joseph A.; Morrow, Gary R.; Bole, Christopher W.; Zhao, Hongwei; Hoelzer, Karen L.; Dakhil, Shaker R.; Moore, Timothy; Fitch, Tom R.

In: Lancet Oncology, Vol. 6, No. 10, 10.2005, p. 765-772.

Research output: Contribution to journalArticle

Hickok, Jane T. ; Roscoe, Joseph A. ; Morrow, Gary R. ; Bole, Christopher W. ; Zhao, Hongwei ; Hoelzer, Karen L. ; Dakhil, Shaker R. ; Moore, Timothy ; Fitch, Tom R. / 5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin : A URCC CCOP randomised controlled trial. In: Lancet Oncology. 2005 ; Vol. 6, No. 10. pp. 765-772.
@article{8853d725875f405d89482b16b0eae847,
title = "5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: A URCC CCOP randomised controlled trial",
abstract = "Background: Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50{\%} of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin. Methods: 691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat. Findings: 519 (77{\%}) of the 671 evaluable patients had delayed nausea, with a mean severity of 3·33 (95{\%} CI 3·22-3·44). 161 (71{\%}) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3·37 [3·16-3·58]), as did 179 (79{\%}) of 226 patients assigned 5-HT-receptor antagonists (3·29 [3·09-3·48]) and 179 (82{\%}) of 219 patients assigned prochlorperazine as needed (3·33 [3·15-3·50]); groups did not differ in mean severity (p=0·853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0·05, t test) and those allocated prochlorperazine as needed (p=0·009, t test). Interpretation: Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.",
author = "Hickok, {Jane T.} and Roscoe, {Joseph A.} and Morrow, {Gary R.} and Bole, {Christopher W.} and Hongwei Zhao and Hoelzer, {Karen L.} and Dakhil, {Shaker R.} and Timothy Moore and Fitch, {Tom R.}",
year = "2005",
month = "10",
doi = "10.1016/S1470-2045(05)70325-9",
language = "English (US)",
volume = "6",
pages = "765--772",
journal = "The Lancet Oncology",
issn = "1470-2045",
publisher = "Lancet Publishing Group",
number = "10",

}

TY - JOUR

T1 - 5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin

T2 - A URCC CCOP randomised controlled trial

AU - Hickok, Jane T.

AU - Roscoe, Joseph A.

AU - Morrow, Gary R.

AU - Bole, Christopher W.

AU - Zhao, Hongwei

AU - Hoelzer, Karen L.

AU - Dakhil, Shaker R.

AU - Moore, Timothy

AU - Fitch, Tom R.

PY - 2005/10

Y1 - 2005/10

N2 - Background: Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50% of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin. Methods: 691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat. Findings: 519 (77%) of the 671 evaluable patients had delayed nausea, with a mean severity of 3·33 (95% CI 3·22-3·44). 161 (71%) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3·37 [3·16-3·58]), as did 179 (79%) of 226 patients assigned 5-HT-receptor antagonists (3·29 [3·09-3·48]) and 179 (82%) of 219 patients assigned prochlorperazine as needed (3·33 [3·15-3·50]); groups did not differ in mean severity (p=0·853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0·05, t test) and those allocated prochlorperazine as needed (p=0·009, t test). Interpretation: Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.

AB - Background: Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50% of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin. Methods: 691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat. Findings: 519 (77%) of the 671 evaluable patients had delayed nausea, with a mean severity of 3·33 (95% CI 3·22-3·44). 161 (71%) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3·37 [3·16-3·58]), as did 179 (79%) of 226 patients assigned 5-HT-receptor antagonists (3·29 [3·09-3·48]) and 179 (82%) of 219 patients assigned prochlorperazine as needed (3·33 [3·15-3·50]); groups did not differ in mean severity (p=0·853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0·05, t test) and those allocated prochlorperazine as needed (p=0·009, t test). Interpretation: Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.

UR - http://www.scopus.com/inward/record.url?scp=26444458865&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=26444458865&partnerID=8YFLogxK

U2 - 10.1016/S1470-2045(05)70325-9

DO - 10.1016/S1470-2045(05)70325-9

M3 - Article

C2 - 16198982

AN - SCOPUS:26444458865

VL - 6

SP - 765

EP - 772

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 10

ER -