Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type
Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantl...
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| Vydáno v: | BMC cancer Ročník 20; číslo 1; s. 918 - 10 |
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| Jazyk: | angličtina |
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BioMed Central
25.09.2020
BioMed Central Ltd Springer Nature B.V BMC |
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| ISSN: | 1471-2407, 1471-2407 |
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| Abstract | Background
Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen (
ClinicalTrials.gov
, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers).
Methods
Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed.
Results
CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups.
Conclusions
This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.
Trial registration
ClinicalTrials.gov
NCT01594749
, registered May 9, 2012. |
|---|---|
| AbstractList | Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25-120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers).BACKGROUNDResults from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25-120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers).Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed.METHODSSubjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed.CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups.RESULTSCR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups.This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.CONCLUSIONSThis post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.ClinicalTrials.gov NCT01594749 , registered May 9, 2012.TRIAL REGISTRATIONClinicalTrials.gov NCT01594749 , registered May 9, 2012. Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25-120 h after chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Methods Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. Results CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups ([greater than or equai to]87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. Conclusions This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Trial registration ClinicalTrials.govNCT01594749, registered May 9, 2012. Keywords: Chemotherapy-induced nausea and vomiting (CINV), Fosaprepitant, Gastrointestinal cancer, Lung cancer, Breast cancer, Gynecologic cancer Abstract Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Methods Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. Results CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. Conclusions This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Trial registration ClinicalTrials.gov NCT01594749 , registered May 9, 2012. Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25-120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. ClinicalTrials.gov NCT01594749 , registered May 9, 2012. Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen ( ClinicalTrials.gov , NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Methods Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. Results CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. Conclusions This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Trial registration ClinicalTrials.gov NCT01594749 , registered May 9, 2012. Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)-based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0-120 h and 0-24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2-22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups ([greater than or equai to]87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers). Methods Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed. Results CR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups. Conclusions This post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type. Trial registration ClinicalTrials.govNCT01594749, registered May 9, 2012. |
| ArticleNumber | 918 |
| Audience | Academic |
| Author | Jordan, Karin Weinstein, Cindy Green, Stuart Beckford-Brathwaite, Elizabeth Pong, Annpey Rapoport, Bernardo L. Vallejos, Waldimir Khanani, Saleem Noga, Stephen J. |
| Author_xml | – sequence: 1 givenname: Cindy surname: Weinstein fullname: Weinstein, Cindy email: cindy.l.weinstein@merck.com organization: Merck & Co., Inc – sequence: 2 givenname: Karin surname: Jordan fullname: Jordan, Karin organization: University of Heidelberg – sequence: 3 givenname: Stuart surname: Green fullname: Green, Stuart organization: Merck & Co., Inc – sequence: 4 givenname: Saleem surname: Khanani fullname: Khanani, Saleem organization: Heywood Hospital – sequence: 5 givenname: Elizabeth surname: Beckford-Brathwaite fullname: Beckford-Brathwaite, Elizabeth organization: Merck & Co., Inc – sequence: 6 givenname: Waldimir surname: Vallejos fullname: Vallejos, Waldimir organization: Merck & Co., Inc – sequence: 7 givenname: Annpey surname: Pong fullname: Pong, Annpey organization: Merck & Co., Inc – sequence: 8 givenname: Stephen J. surname: Noga fullname: Noga, Stephen J. organization: Weinberg Cancer Institute – sequence: 9 givenname: Bernardo L. surname: Rapoport fullname: Rapoport, Bernardo L. organization: Department of Immunology, Faculty of Health Sciences, University of Pretoria, The Medical Oncology Centre of Rosebank |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32988373$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1089_neu_2022_0510 crossref_primary_10_1186_s12885_025_13469_6 crossref_primary_10_12688_f1000research_147910_1 |
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| Keywords | Chemotherapy-induced nausea and vomiting (CINV) Breast cancer Fosaprepitant Gastrointestinal cancer Lung cancer Gynecologic cancer |
| Language | English |
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| References_xml | – volume: 35 start-page: 3240 year: 2017 ident: 7259_CR9 publication-title: J Clin Oncol doi: 10.1200/JCO.2017.74.4789 – volume: 22 start-page: 719 year: 1959 ident: 7259_CR15 publication-title: J Natl Cancer Inst – volume: 1 start-page: 65 year: 2013 ident: 7259_CR3 publication-title: Mol Clin Oncol doi: 10.3892/mco.2012.33 – volume: 29 start-page: 4189 year: 2011 ident: 7259_CR13 publication-title: J Clin Oncol doi: 10.1200/JCO.2010.34.4614 – volume: 28 start-page: 1260 year: 2017 ident: 7259_CR18 publication-title: Ann Oncol doi: 10.1093/annonc/mdx100 – volume: 11 start-page: 2621 year: 2017 ident: 7259_CR21 publication-title: Drug Des Devel Ther doi: 10.2147/DDDT.S133943 – volume: 27 start-page: 172 year: 2016 ident: 7259_CR11 publication-title: Ann Oncol doi: 10.1093/annonc/mdv482 – ident: 7259_CR8 – ident: 7259_CR6 – volume: 4 start-page: 213 year: 1985 ident: 7259_CR16 publication-title: Stat Med doi: 10.1002/sim.4780040211 – volume: 20 start-page: 576 year: 2015 ident: 7259_CR14 publication-title: Oncologist doi: 10.1634/theoncologist.2014-0438 – volume: 26 start-page: 3773 year: 2018 ident: 7259_CR19 publication-title: Support Care Cancer doi: 10.1007/s00520-018-4242-x – volume: 26 start-page: 1081 year: 2015 ident: 7259_CR5 publication-title: Ann Oncol doi: 10.1093/annonc/mdv138 – ident: 7259_CR10 – volume: 3 start-page: 151 year: 2011 ident: 7259_CR1 publication-title: Breast Cancer (Auckl) – volume: 16 start-page: 1079 year: 2015 ident: 7259_CR20 publication-title: Lancet Oncol doi: 10.1016/S1470-2045(15)00035-2 – volume: 53 start-page: 457 year: 1958 ident: 7259_CR17 publication-title: J Am Stat Assoc doi: 10.1080/01621459.1958.10501452 – volume: 7 start-page: 84533 year: 2016 ident: 7259_CR23 publication-title: Oncotarget doi: 10.18632/oncotarget.13023 – volume: 39 start-page: 113 year: 2013 ident: 7259_CR22 publication-title: Cancer Treat Rev doi: 10.1016/j.ctrv.2012.09.002 – volume: 12 start-page: 883 year: 2018 ident: 7259_CR24 publication-title: Ecancermedicalscience doi: 10.3332/ecancer.2018.883 – volume: 140 start-page: 559 year: 2016 ident: 7259_CR2 publication-title: Gynecol Oncol doi: 10.1016/j.ygyno.2015.12.029 – volume: 4 start-page: 191 year: 1999 ident: 7259_CR7 publication-title: Oncologist doi: 10.1634/theoncologist.4-3-191 – volume: 24 start-page: 2932 year: 2006 ident: 7259_CR12 publication-title: J Clin Oncol doi: 10.1200/JCO.2006.06.9591 – volume: 27 start-page: v119 year: 2016 ident: 7259_CR4 publication-title: Ann Oncol doi: 10.1093/annonc/mdw270 |
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Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention... Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of... Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention... Subjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV)... Abstract Background Results from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the... |
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| Title | Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type |
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