Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy

Jørn Herrstedt, Wichit Apornwirat, Ahmed Shaharyar, Zeba Aziz, Fausto Roila, Simon Van Belle, Mark W Russo, Jeremey Levin, Salabha Ranganathan, Mary Guckert, Steven M Grunberg

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: 2009-Nov-10
OriginalsprogEngelsk
TidsskriftJournal of Clinical Oncology
Vol/bind27
Udgave nummer32
Sider (fra-til)5363-9
Antal sider6
ISSN0732-183X
DOI
StatusUdgivet - 10. nov. 2009

Fingeraftryk

Placebos
casopitant
Ondansetron
Controlled Clinical Trials
Safety

Citer dette

Herrstedt, Jørn ; Apornwirat, Wichit ; Shaharyar, Ahmed ; Aziz, Zeba ; Roila, Fausto ; Van Belle, Simon ; Russo, Mark W ; Levin, Jeremey ; Ranganathan, Salabha ; Guckert, Mary ; Grunberg, Steven M. / Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. I: Journal of Clinical Oncology. 2009 ; Bind 27, Nr. 32. s. 5363-9.
@article{5eda43900a5311dfaefb000ea68e967b,
title = "Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy",
abstract = "PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic chemotherapy (MEC). PATIENTS AND METHODS: Predominantly female patients (98{\%}) diagnosed with breast cancer (96{\%}) who were chemotherapy-na{\"i}ve and scheduled to receive an anthracycline and cyclophosphamide (AC) -based regimen were enrolled onto this multinational, randomized, double-blind, parallel-group, placebo-controlled clinical trial. All patients received dexamethasone 8 mg intravenously (IV) on day 1 and oral ondansetron 8 mg twice daily on days 1 to 3. Patients were randomly assigned to a control arm (placebo), a single oral dose casopitant arm (150 mg orally [PO] on day 1), a 3-day oral casopitant arm (150 mg PO on day 1 plus 50 mg PO on days 2 to 3), or a 3-day IV/oral casopitant arm (90 mg IV on day 1 plus 50 mg PO on days 2 to 3). The primary end point was the proportion of patients achieving complete response (no vomiting/retching or rescue medications) in the first 120 hours after the initiation of MEC. RESULTS: A significantly greater proportion of patients in the single-dose oral casopitant arm, 3-day oral casopitant arm, and 3-day IV/oral casopitant arm achieved complete response (73{\%}, 73{\%}, and 74{\%}, respectively) versus control (59{\%}; P < .0001). The study did not demonstrate a reduced proportion of patients with nausea or significant nausea in those receiving casopitant. Adverse events were balanced among study arms. CONCLUSION: All casopitant regimens studied were more effective than the control regimen. Casopitant was generally well tolerated.",
keywords = "Administration, Oral, Alopecia, Anthracyclines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Constipation, Cyclophosphamide, Dexamethasone, Double-Blind Method, Drug Therapy, Combination, Female, Headache, Humans, Injections, Intravenous, Kaplan-Meiers Estimate, Male, Middle Aged, Nausea, Neoplasms, Neutropenia, Ondansetron, Piperazines, Piperidines, Receptors, Neurokinin-1, Treatment Outcome, Vomiting",
author = "J{\o}rn Herrstedt and Wichit Apornwirat and Ahmed Shaharyar and Zeba Aziz and Fausto Roila and {Van Belle}, Simon and Russo, {Mark W} and Jeremey Levin and Salabha Ranganathan and Mary Guckert and Grunberg, {Steven M}",
year = "2009",
month = "11",
day = "10",
doi = "10.1200/JCO.2009.21.8511",
language = "English",
volume = "27",
pages = "5363--9",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "32",

}

Herrstedt, J, Apornwirat, W, Shaharyar, A, Aziz, Z, Roila, F, Van Belle, S, Russo, MW, Levin, J, Ranganathan, S, Guckert, M & Grunberg, SM 2009, 'Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy', Journal of Clinical Oncology, bind 27, nr. 32, s. 5363-9. https://doi.org/10.1200/JCO.2009.21.8511

Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. / Herrstedt, Jørn; Apornwirat, Wichit; Shaharyar, Ahmed; Aziz, Zeba; Roila, Fausto; Van Belle, Simon; Russo, Mark W; Levin, Jeremey; Ranganathan, Salabha; Guckert, Mary; Grunberg, Steven M.

I: Journal of Clinical Oncology, Bind 27, Nr. 32, 10.11.2009, s. 5363-9.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy

AU - Herrstedt, Jørn

AU - Apornwirat, Wichit

AU - Shaharyar, Ahmed

AU - Aziz, Zeba

AU - Roila, Fausto

AU - Van Belle, Simon

AU - Russo, Mark W

AU - Levin, Jeremey

AU - Ranganathan, Salabha

AU - Guckert, Mary

AU - Grunberg, Steven M

PY - 2009/11/10

Y1 - 2009/11/10

N2 - PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic chemotherapy (MEC). PATIENTS AND METHODS: Predominantly female patients (98%) diagnosed with breast cancer (96%) who were chemotherapy-naïve and scheduled to receive an anthracycline and cyclophosphamide (AC) -based regimen were enrolled onto this multinational, randomized, double-blind, parallel-group, placebo-controlled clinical trial. All patients received dexamethasone 8 mg intravenously (IV) on day 1 and oral ondansetron 8 mg twice daily on days 1 to 3. Patients were randomly assigned to a control arm (placebo), a single oral dose casopitant arm (150 mg orally [PO] on day 1), a 3-day oral casopitant arm (150 mg PO on day 1 plus 50 mg PO on days 2 to 3), or a 3-day IV/oral casopitant arm (90 mg IV on day 1 plus 50 mg PO on days 2 to 3). The primary end point was the proportion of patients achieving complete response (no vomiting/retching or rescue medications) in the first 120 hours after the initiation of MEC. RESULTS: A significantly greater proportion of patients in the single-dose oral casopitant arm, 3-day oral casopitant arm, and 3-day IV/oral casopitant arm achieved complete response (73%, 73%, and 74%, respectively) versus control (59%; P < .0001). The study did not demonstrate a reduced proportion of patients with nausea or significant nausea in those receiving casopitant. Adverse events were balanced among study arms. CONCLUSION: All casopitant regimens studied were more effective than the control regimen. Casopitant was generally well tolerated.

AB - PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic chemotherapy (MEC). PATIENTS AND METHODS: Predominantly female patients (98%) diagnosed with breast cancer (96%) who were chemotherapy-naïve and scheduled to receive an anthracycline and cyclophosphamide (AC) -based regimen were enrolled onto this multinational, randomized, double-blind, parallel-group, placebo-controlled clinical trial. All patients received dexamethasone 8 mg intravenously (IV) on day 1 and oral ondansetron 8 mg twice daily on days 1 to 3. Patients were randomly assigned to a control arm (placebo), a single oral dose casopitant arm (150 mg orally [PO] on day 1), a 3-day oral casopitant arm (150 mg PO on day 1 plus 50 mg PO on days 2 to 3), or a 3-day IV/oral casopitant arm (90 mg IV on day 1 plus 50 mg PO on days 2 to 3). The primary end point was the proportion of patients achieving complete response (no vomiting/retching or rescue medications) in the first 120 hours after the initiation of MEC. RESULTS: A significantly greater proportion of patients in the single-dose oral casopitant arm, 3-day oral casopitant arm, and 3-day IV/oral casopitant arm achieved complete response (73%, 73%, and 74%, respectively) versus control (59%; P < .0001). The study did not demonstrate a reduced proportion of patients with nausea or significant nausea in those receiving casopitant. Adverse events were balanced among study arms. CONCLUSION: All casopitant regimens studied were more effective than the control regimen. Casopitant was generally well tolerated.

KW - Administration, Oral

KW - Alopecia

KW - Anthracyclines

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Breast Neoplasms

KW - Constipation

KW - Cyclophosphamide

KW - Dexamethasone

KW - Double-Blind Method

KW - Drug Therapy, Combination

KW - Female

KW - Headache

KW - Humans

KW - Injections, Intravenous

KW - Kaplan-Meiers Estimate

KW - Male

KW - Middle Aged

KW - Nausea

KW - Neoplasms

KW - Neutropenia

KW - Ondansetron

KW - Piperazines

KW - Piperidines

KW - Receptors, Neurokinin-1

KW - Treatment Outcome

KW - Vomiting

U2 - 10.1200/JCO.2009.21.8511

DO - 10.1200/JCO.2009.21.8511

M3 - Journal article

VL - 27

SP - 5363

EP - 5369

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 32

ER -