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

doi: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

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

54 Citations (Scopus)

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-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.

Original language	English
Journal	Journal of Clinical Oncology
Volume	27
Issue number	32
Pages (from-to)	5363-9
Number of pages	7
ISSN	0732-183X
DOIs	https://doi.org/10.1200/JCO.2009.21.8511
Publication status	Published - 2009

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10.1200/JCO.2009.21.8511

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Herrstedt, J., Apornwirat, W., Shaharyar, A., Aziz, Z., Roila, F., Van Belle, S., Russo, M. W., Levin, J., Ranganathan, S., Guckert, M., & Grunberg, S. M. (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, 27(32), 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 et al.
In: Journal of Clinical Oncology, Vol. 27, No. 32, 2009, p. 5363-9.

Research output: Contribution to journal › Journal article › Research › peer-review

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, vol. 27, no. 32, pp. 5363-9. https://doi.org/10.1200/JCO.2009.21.8511

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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.",

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}",

note = "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",

year = "2009",

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",

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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

N1 - 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

PY - 2009

Y1 - 2009

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.

U2 - 10.1200/JCO.2009.21.8511

DO - 10.1200/JCO.2009.21.8511

M3 - Journal article

C2 - 19805683

SN - 0732-183X

VL - 27

SP - 5363

EP - 5369

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 32

ER -

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

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