Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study
Purpose Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), asse...
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Veröffentlicht in: | Supportive care in cancer 2018-12, Vol.26 (12), p.4021-4029 |
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creator | De Laurentiis, Michelino Bonfadini, Chiara Lorusso, Vito Cilenti, Giuseppina Di Rella, Francesca Altavilla, Giuseppe Otero, Manuela Ardizzoia, Antonio Marchetti, Paolo Peverelli, Giorgia Amoroso, Domenico Vecchio, Stefania Fiorio, Elena Orecchia, Simona |
description | Purpose
Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.
Methods
Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.
Results
The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).
Conclusions
CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice. |
doi_str_mv | 10.1007/s00520-018-4259-1 |
format | Article |
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Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.
Methods
Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.
Results
The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).
Conclusions
CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.</description><identifier>ISSN: 0941-4355</identifier><identifier>EISSN: 1433-7339</identifier><identifier>DOI: 10.1007/s00520-018-4259-1</identifier><identifier>PMID: 29943152</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Aged ; Anthracyclines ; Anthracyclines - adverse effects ; Antiemetics - therapeutic use ; Breast cancer ; Breast Neoplasms - complications ; Breast Neoplasms - drug therapy ; Cancer patients ; Cancer research ; Care and treatment ; Chemotherapy ; Cyclophosphamide ; Cyclophosphamide - adverse effects ; Female ; Gastrointestinal agents ; Glucocorticoids ; Humans ; Incidence ; Italy ; Medicine ; Medicine & Public Health ; Middle Aged ; Nausea ; Nausea - chemically induced ; Nursing ; Nursing Research ; Observational studies ; Oncology ; Original Article ; Pain Medicine ; Prospective Studies ; Rehabilitation Medicine ; Side effects ; Vomiting ; Vomiting - chemically induced</subject><ispartof>Supportive care in cancer, 2018-12, Vol.26 (12), p.4021-4029</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2018</rights><rights>COPYRIGHT 2018 Springer</rights><rights>Supportive Care in Cancer is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-d5538405f83f80353ef256199e955e999da8131c95f5128d6fd958ab3ce7a7953</citedby><cites>FETCH-LOGICAL-c439t-d5538405f83f80353ef256199e955e999da8131c95f5128d6fd958ab3ce7a7953</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00520-018-4259-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00520-018-4259-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29943152$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De Laurentiis, Michelino</creatorcontrib><creatorcontrib>Bonfadini, Chiara</creatorcontrib><creatorcontrib>Lorusso, Vito</creatorcontrib><creatorcontrib>Cilenti, Giuseppina</creatorcontrib><creatorcontrib>Di Rella, Francesca</creatorcontrib><creatorcontrib>Altavilla, Giuseppe</creatorcontrib><creatorcontrib>Otero, Manuela</creatorcontrib><creatorcontrib>Ardizzoia, Antonio</creatorcontrib><creatorcontrib>Marchetti, Paolo</creatorcontrib><creatorcontrib>Peverelli, Giorgia</creatorcontrib><creatorcontrib>Amoroso, Domenico</creatorcontrib><creatorcontrib>Vecchio, Stefania</creatorcontrib><creatorcontrib>Fiorio, Elena</creatorcontrib><creatorcontrib>Orecchia, Simona</creatorcontrib><title>Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study</title><title>Supportive care in cancer</title><addtitle>Support Care Cancer</addtitle><addtitle>Support Care Cancer</addtitle><description>Purpose
Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.
Methods
Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.
Results
The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).
Conclusions
CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.</description><subject>Adult</subject><subject>Aged</subject><subject>Anthracyclines</subject><subject>Anthracyclines - adverse effects</subject><subject>Antiemetics - therapeutic use</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - complications</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Cancer patients</subject><subject>Cancer research</subject><subject>Care and treatment</subject><subject>Chemotherapy</subject><subject>Cyclophosphamide</subject><subject>Cyclophosphamide - adverse effects</subject><subject>Female</subject><subject>Gastrointestinal agents</subject><subject>Glucocorticoids</subject><subject>Humans</subject><subject>Incidence</subject><subject>Italy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Nausea - chemically induced</subject><subject>Nursing</subject><subject>Nursing Research</subject><subject>Observational studies</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Pain Medicine</subject><subject>Prospective Studies</subject><subject>Rehabilitation Medicine</subject><subject>Side effects</subject><subject>Vomiting</subject><subject>Vomiting - chemically induced</subject><issn>0941-4355</issn><issn>1433-7339</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1ks2OFCEUhStG47SjD-DGkLhxUyMU0FW460z86WSiGzVxRWi4dDGpghKoMfVKPqWUPf5Gw4Jw-c65F3Kq6jHBFwTj9nnCmDe4xqSrWcNFTe5UG8IorVtKxd1qgwUjNaOcn1UPUrrGmLQtb-5XZ40QjBLebKqve6-dAa8BBYu8mhMopLxBN2F02fkjch4dIqiUkVYFi2hS2YHPCeVSzmDQF5f7osl9VHrRg_OApmFOaD2EqQ9p6tVYmtQHlQquexhD7iGqaUERjm4En9Y2-6yG5QV6u_v4CYVDgnhTOgWvBpTybJaH1T2rhgSPbvfz6sOrl-8v39RX717vL3dXtWZU5NpwTjuGue2o7TDlFGzDt0QIEJyDEMKojlCiBbecNJ3ZWiN4pw5UQ6tawel59ezkO8XweYaU5eiShmFQHsKcZIN5cSr_TQr69C_0OsyxTPyd6jrGWvYbdVQDSOdtyOWnVlO541uMGacMF-riH1RZBkangwfrSv0PATkJdAwpRbByim5UcZEEyzUf8pQPWfIh13zIdZQntwPPhxHMT8WPQBSgOQGpXPkjxF8v-r_rN7XPxoE</recordid><startdate>20181201</startdate><enddate>20181201</enddate><creator>De Laurentiis, Michelino</creator><creator>Bonfadini, Chiara</creator><creator>Lorusso, Vito</creator><creator>Cilenti, Giuseppina</creator><creator>Di Rella, Francesca</creator><creator>Altavilla, Giuseppe</creator><creator>Otero, Manuela</creator><creator>Ardizzoia, Antonio</creator><creator>Marchetti, Paolo</creator><creator>Peverelli, Giorgia</creator><creator>Amoroso, Domenico</creator><creator>Vecchio, Stefania</creator><creator>Fiorio, Elena</creator><creator>Orecchia, Simona</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0-V</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88J</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ALSLI</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HEHIP</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2R</scope><scope>M2S</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20181201</creationdate><title>Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study</title><author>De Laurentiis, Michelino ; Bonfadini, Chiara ; Lorusso, Vito ; Cilenti, Giuseppina ; Di Rella, Francesca ; Altavilla, Giuseppe ; Otero, Manuela ; Ardizzoia, Antonio ; Marchetti, Paolo ; Peverelli, Giorgia ; Amoroso, Domenico ; Vecchio, Stefania ; Fiorio, Elena ; Orecchia, Simona</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-d5538405f83f80353ef256199e955e999da8131c95f5128d6fd958ab3ce7a7953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Anthracyclines</topic><topic>Anthracyclines - adverse effects</topic><topic>Antiemetics - therapeutic use</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - complications</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Cancer patients</topic><topic>Cancer research</topic><topic>Care and treatment</topic><topic>Chemotherapy</topic><topic>Cyclophosphamide</topic><topic>Cyclophosphamide - adverse effects</topic><topic>Female</topic><topic>Gastrointestinal agents</topic><topic>Glucocorticoids</topic><topic>Humans</topic><topic>Incidence</topic><topic>Italy</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nausea</topic><topic>Nausea - chemically induced</topic><topic>Nursing</topic><topic>Nursing Research</topic><topic>Observational studies</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Pain Medicine</topic><topic>Prospective Studies</topic><topic>Rehabilitation Medicine</topic><topic>Side effects</topic><topic>Vomiting</topic><topic>Vomiting - chemically induced</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>De Laurentiis, Michelino</creatorcontrib><creatorcontrib>Bonfadini, Chiara</creatorcontrib><creatorcontrib>Lorusso, Vito</creatorcontrib><creatorcontrib>Cilenti, Giuseppina</creatorcontrib><creatorcontrib>Di Rella, Francesca</creatorcontrib><creatorcontrib>Altavilla, Giuseppe</creatorcontrib><creatorcontrib>Otero, Manuela</creatorcontrib><creatorcontrib>Ardizzoia, Antonio</creatorcontrib><creatorcontrib>Marchetti, Paolo</creatorcontrib><creatorcontrib>Peverelli, Giorgia</creatorcontrib><creatorcontrib>Amoroso, Domenico</creatorcontrib><creatorcontrib>Vecchio, Stefania</creatorcontrib><creatorcontrib>Fiorio, Elena</creatorcontrib><creatorcontrib>Orecchia, Simona</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Social Sciences Premium Collection</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Social Science Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Social Science Premium Collection</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Sociology Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Social Science Database</collection><collection>Sociology Database (ProQuest)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Supportive care in cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>De Laurentiis, Michelino</au><au>Bonfadini, Chiara</au><au>Lorusso, Vito</au><au>Cilenti, Giuseppina</au><au>Di Rella, Francesca</au><au>Altavilla, Giuseppe</au><au>Otero, Manuela</au><au>Ardizzoia, Antonio</au><au>Marchetti, Paolo</au><au>Peverelli, Giorgia</au><au>Amoroso, Domenico</au><au>Vecchio, Stefania</au><au>Fiorio, Elena</au><au>Orecchia, Simona</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study</atitle><jtitle>Supportive care in cancer</jtitle><stitle>Support Care Cancer</stitle><addtitle>Support Care Cancer</addtitle><date>2018-12-01</date><risdate>2018</risdate><volume>26</volume><issue>12</issue><spage>4021</spage><epage>4029</epage><pages>4021-4029</pages><issn>0941-4355</issn><eissn>1433-7339</eissn><abstract>Purpose
Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event with cancer chemotherapy, despite the availability of effective antiemetic agents. This is a prospective observational study of Italian breast cancer patients treated with anthracycline plus cyclophosphamide (AC), assessed CINV incidence, adherence to national antiemetic guidelines (AIOM 2012), and the relationship with CINV outcomes.
Methods
Patients with breast cancer scheduled to receive their first cycle of an AC-based regimen were enrolled at 12 Italian centers and their clinical data prospectively recorded. CINV incidence was assessed from patient diaries after the first chemotherapy cycle. The relationship between guideline adherence and CINV outcomes was examined using multiple logistic regression.
Results
The overall incidence rates of nausea and vomiting among 246 evaluable patients were 63.0 and 25.4%, respectively. Most patients received a 5-HT3-RA agent and dexamethasone for acute phase CINV prophylaxis, whereas a triple combination including aprepitant (NK1-RA), consistent with national guidelines, was used in only 45.5% of cases. In the delayed phase, the guideline adherence was 48.8%, while the overall adherence was 43.5%. After adjusting for confounding factors, adherence to antiemetic prophylaxis guidelines was associated with a significant reduction in the odds of three endpoints, namely any nausea, “significant nausea,” and vomiting (OR = 0.49, OR = 0.54, and OR = 0.48, respectively), and a 90% increase in the odds of overall complete protection (OR = 1.90).
Conclusions
CINV is still a critical issue in AC-treated patients, despite antiemetic treatment. Non-adherence to antiemetic guidelines may lead to poorer outcomes and indicates the need for strategies to enhance the use of guidelines in clinical practice.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>29943152</pmid><doi>10.1007/s00520-018-4259-1</doi><tpages>9</tpages></addata></record> |
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subjects | Adult Aged Anthracyclines Anthracyclines - adverse effects Antiemetics - therapeutic use Breast cancer Breast Neoplasms - complications Breast Neoplasms - drug therapy Cancer patients Cancer research Care and treatment Chemotherapy Cyclophosphamide Cyclophosphamide - adverse effects Female Gastrointestinal agents Glucocorticoids Humans Incidence Italy Medicine Medicine & Public Health Middle Aged Nausea Nausea - chemically induced Nursing Nursing Research Observational studies Oncology Original Article Pain Medicine Prospective Studies Rehabilitation Medicine Side effects Vomiting Vomiting - chemically induced |
title | Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study |
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