Effective control over CMF-related emesis with high-dose dexamethasone

Results of a double-blind crossover trial with metoclopramide and placebo

C. F. Pollera, M. Nardi, P. Marolla, P. Pinnaro, E. Terzoli, D. Giannarelli

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

To establish the antiemetic activity of both dexamethasone (DXM) and metoclopramide (MCP) in patients receiving i.v. cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), 25 women with stage II breast cancer were entered into this study. A randomized, double-blind, crossover design was employed to evaluate DXM (24 mg in 5 doses) versus MCP (1 mg/kg as a single dose) versus a combination of both drugs (as above) or placebo (PLC). The patients were requested to complete a questionnaire evaluating the antiemetic effect. All but one patient completed the planned antiemetic program during the first four CMF courses. As compared to PLC, both the DXM-MCP combination and DXM alone provided a higher complete antiemetic protection rate (p = 0.01 and p = 0.006, respectively). The DXM regimens were more effective than both PLC (p = 0.004 and p = 0.01) and MCP (p = 0.002 and p = 0.006) in reducing the prevalence of severe vomiting. A compared to MCP, the DXM regimens provided a better control of the nausea (p <0.04 and p <0.01) and reduced both the episodes and the duration of vomiting p <0.02 and p <0.05). The DXM regimens were also associated with a better patient opinion than the PLC (p <0.002 and p <0.0002). No significant differences were found betwen MCP and PLC, nbor between the DXM regimens. Except for two dystonic reactions, MCP-related toxicity was mild, whereas that induced by DXM was negligible in patients with no contraindications to corticosteroids. As employed in this study, DXM provided safe and effective antiemetic protection for patients receiving adjuvant i.v. CMF. Data available do not support the use of a short-course MCP, either alone or in combination with DXM. The search for better antiemetic treatments is mandatory, especially for patients receiving adjuvant chemotherapy. To date, we recommend the use of DXM as a standard regimen and as a control for further studies.

Original languageEnglish
Pages (from-to)524-529
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume12
Issue number6
Publication statusPublished - 1989

Fingerprint

Metoclopramide
Methotrexate
Fluorouracil
Cyclophosphamide
Cross-Over Studies
Dexamethasone
Vomiting
Placebos
Antiemetics
Drug Combinations
Adjuvant Chemotherapy
Nausea
Adrenal Cortex Hormones

ASJC Scopus subject areas

  • Cancer Research

Cite this

@article{529b3df82010410fab8a971796ea09a0,
title = "Effective control over CMF-related emesis with high-dose dexamethasone: Results of a double-blind crossover trial with metoclopramide and placebo",
abstract = "To establish the antiemetic activity of both dexamethasone (DXM) and metoclopramide (MCP) in patients receiving i.v. cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), 25 women with stage II breast cancer were entered into this study. A randomized, double-blind, crossover design was employed to evaluate DXM (24 mg in 5 doses) versus MCP (1 mg/kg as a single dose) versus a combination of both drugs (as above) or placebo (PLC). The patients were requested to complete a questionnaire evaluating the antiemetic effect. All but one patient completed the planned antiemetic program during the first four CMF courses. As compared to PLC, both the DXM-MCP combination and DXM alone provided a higher complete antiemetic protection rate (p = 0.01 and p = 0.006, respectively). The DXM regimens were more effective than both PLC (p = 0.004 and p = 0.01) and MCP (p = 0.002 and p = 0.006) in reducing the prevalence of severe vomiting. A compared to MCP, the DXM regimens provided a better control of the nausea (p <0.04 and p <0.01) and reduced both the episodes and the duration of vomiting p <0.02 and p <0.05). The DXM regimens were also associated with a better patient opinion than the PLC (p <0.002 and p <0.0002). No significant differences were found betwen MCP and PLC, nbor between the DXM regimens. Except for two dystonic reactions, MCP-related toxicity was mild, whereas that induced by DXM was negligible in patients with no contraindications to corticosteroids. As employed in this study, DXM provided safe and effective antiemetic protection for patients receiving adjuvant i.v. CMF. Data available do not support the use of a short-course MCP, either alone or in combination with DXM. The search for better antiemetic treatments is mandatory, especially for patients receiving adjuvant chemotherapy. To date, we recommend the use of DXM as a standard regimen and as a control for further studies.",
author = "Pollera, {C. F.} and M. Nardi and P. Marolla and P. Pinnaro and E. Terzoli and D. Giannarelli",
year = "1989",
language = "English",
volume = "12",
pages = "524--529",
journal = "American Journal of Clinical Oncology",
issn = "0277-3732",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Effective control over CMF-related emesis with high-dose dexamethasone

T2 - Results of a double-blind crossover trial with metoclopramide and placebo

AU - Pollera, C. F.

AU - Nardi, M.

AU - Marolla, P.

AU - Pinnaro, P.

AU - Terzoli, E.

AU - Giannarelli, D.

PY - 1989

Y1 - 1989

N2 - To establish the antiemetic activity of both dexamethasone (DXM) and metoclopramide (MCP) in patients receiving i.v. cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), 25 women with stage II breast cancer were entered into this study. A randomized, double-blind, crossover design was employed to evaluate DXM (24 mg in 5 doses) versus MCP (1 mg/kg as a single dose) versus a combination of both drugs (as above) or placebo (PLC). The patients were requested to complete a questionnaire evaluating the antiemetic effect. All but one patient completed the planned antiemetic program during the first four CMF courses. As compared to PLC, both the DXM-MCP combination and DXM alone provided a higher complete antiemetic protection rate (p = 0.01 and p = 0.006, respectively). The DXM regimens were more effective than both PLC (p = 0.004 and p = 0.01) and MCP (p = 0.002 and p = 0.006) in reducing the prevalence of severe vomiting. A compared to MCP, the DXM regimens provided a better control of the nausea (p <0.04 and p <0.01) and reduced both the episodes and the duration of vomiting p <0.02 and p <0.05). The DXM regimens were also associated with a better patient opinion than the PLC (p <0.002 and p <0.0002). No significant differences were found betwen MCP and PLC, nbor between the DXM regimens. Except for two dystonic reactions, MCP-related toxicity was mild, whereas that induced by DXM was negligible in patients with no contraindications to corticosteroids. As employed in this study, DXM provided safe and effective antiemetic protection for patients receiving adjuvant i.v. CMF. Data available do not support the use of a short-course MCP, either alone or in combination with DXM. The search for better antiemetic treatments is mandatory, especially for patients receiving adjuvant chemotherapy. To date, we recommend the use of DXM as a standard regimen and as a control for further studies.

AB - To establish the antiemetic activity of both dexamethasone (DXM) and metoclopramide (MCP) in patients receiving i.v. cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), 25 women with stage II breast cancer were entered into this study. A randomized, double-blind, crossover design was employed to evaluate DXM (24 mg in 5 doses) versus MCP (1 mg/kg as a single dose) versus a combination of both drugs (as above) or placebo (PLC). The patients were requested to complete a questionnaire evaluating the antiemetic effect. All but one patient completed the planned antiemetic program during the first four CMF courses. As compared to PLC, both the DXM-MCP combination and DXM alone provided a higher complete antiemetic protection rate (p = 0.01 and p = 0.006, respectively). The DXM regimens were more effective than both PLC (p = 0.004 and p = 0.01) and MCP (p = 0.002 and p = 0.006) in reducing the prevalence of severe vomiting. A compared to MCP, the DXM regimens provided a better control of the nausea (p <0.04 and p <0.01) and reduced both the episodes and the duration of vomiting p <0.02 and p <0.05). The DXM regimens were also associated with a better patient opinion than the PLC (p <0.002 and p <0.0002). No significant differences were found betwen MCP and PLC, nbor between the DXM regimens. Except for two dystonic reactions, MCP-related toxicity was mild, whereas that induced by DXM was negligible in patients with no contraindications to corticosteroids. As employed in this study, DXM provided safe and effective antiemetic protection for patients receiving adjuvant i.v. CMF. Data available do not support the use of a short-course MCP, either alone or in combination with DXM. The search for better antiemetic treatments is mandatory, especially for patients receiving adjuvant chemotherapy. To date, we recommend the use of DXM as a standard regimen and as a control for further studies.

UR - http://www.scopus.com/inward/record.url?scp=0024785796&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0024785796&partnerID=8YFLogxK

M3 - Article

VL - 12

SP - 524

EP - 529

JO - American Journal of Clinical Oncology

JF - American Journal of Clinical Oncology

SN - 0277-3732

IS - 6

ER -