Evaluation of Risk Factors Predicting Chemotherapy-Related Nausea and Vomiting: Results From a European Prospective Observational Study

Abstract Context Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross...

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Veröffentlicht in:Journal of pain and symptom management 2014-05, Vol.47 (5), p.839-848.e4
Hauptverfasser: Molassiotis, Alexander, RN, PhD, Aapro, Matti, MD, Dicato, Mario, MD, FRCP, Gascon, Pere, MD, PhD, Novoa, Sylvia A., MD, Isambert, Nicolas, MD, Burke, Thomas A., PhD, Gu, Anna, MD, PhD, Roila, Fausto, MD
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container_end_page 848.e4
container_issue 5
container_start_page 839
container_title Journal of pain and symptom management
container_volume 47
creator Molassiotis, Alexander, RN, PhD
Aapro, Matti, MD
Dicato, Mario, MD, FRCP
Gascon, Pere, MD, PhD
Novoa, Sylvia A., MD
Isambert, Nicolas, MD
Burke, Thomas A., PhD
Gu, Anna, MD, PhD
Roila, Fausto, MD
description Abstract Context Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses. Objectives To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy. Methods This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0–100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0–100 mm VAS), and prechemotherapy nausea (0–100 mm VAS) measured during the 24-hour period before chemotherapy initiation. Results There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P  
doi_str_mv 10.1016/j.jpainsymman.2013.06.012
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Objectives To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy. Methods This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0–100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0–100 mm VAS), and prechemotherapy nausea (0–100 mm VAS) measured during the 24-hour period before chemotherapy initiation. Results There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P  &lt; 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway. Conclusion The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.</description><identifier>ISSN: 0885-3924</identifier><identifier>EISSN: 1873-6513</identifier><identifier>DOI: 10.1016/j.jpainsymman.2013.06.012</identifier><identifier>PMID: 24075401</identifier><identifier>CODEN: JSPME2</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Age Factors ; Aged ; Anesthesia &amp; Perioperative Care ; Anticipation, Psychological ; Antiemetics - therapeutic use ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Anxiety ; Biological and medical sciences ; Chemotherapy ; emesis ; Europe - epidemiology ; Female ; Humans ; Inconsistency ; Male ; Medical sciences ; Middle Aged ; Nausea ; Nausea - chemically induced ; Nausea - drug therapy ; Nausea - epidemiology ; Nausea - psychology ; Neoplasms - drug therapy ; Neoplasms - epidemiology ; Pain Medicine ; Pharmacology. Drug treatments ; Practice Guidelines as Topic ; prediction ; Prospective Studies ; risk factor ; Risk Factors ; Vomiting ; Vomiting - chemically induced ; Vomiting - drug therapy ; Vomiting - epidemiology ; Vomiting - psychology</subject><ispartof>Journal of pain and symptom management, 2014-05, Vol.47 (5), p.839-848.e4</ispartof><rights>U.S. Cancer Pain Relief Committee</rights><rights>2014 U.S. Cancer Pain Relief Committee</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c645t-4393cdab9009a72d63438518793c2d87641d14b1280b961d9e4aafa1928010d13</citedby><cites>FETCH-LOGICAL-c645t-4393cdab9009a72d63438518793c2d87641d14b1280b961d9e4aafa1928010d13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0885392413003977$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,30977,65534</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=28535651$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24075401$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Molassiotis, Alexander, RN, PhD</creatorcontrib><creatorcontrib>Aapro, Matti, MD</creatorcontrib><creatorcontrib>Dicato, Mario, MD, FRCP</creatorcontrib><creatorcontrib>Gascon, Pere, MD, PhD</creatorcontrib><creatorcontrib>Novoa, Sylvia A., MD</creatorcontrib><creatorcontrib>Isambert, Nicolas, MD</creatorcontrib><creatorcontrib>Burke, Thomas A., PhD</creatorcontrib><creatorcontrib>Gu, Anna, MD, PhD</creatorcontrib><creatorcontrib>Roila, Fausto, MD</creatorcontrib><title>Evaluation of Risk Factors Predicting Chemotherapy-Related Nausea and Vomiting: Results From a European Prospective Observational Study</title><title>Journal of pain and symptom management</title><addtitle>J Pain Symptom Manage</addtitle><description>Abstract Context Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses. Objectives To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy. Methods This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0–100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0–100 mm VAS), and prechemotherapy nausea (0–100 mm VAS) measured during the 24-hour period before chemotherapy initiation. Results There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P  &lt; 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway. Conclusion The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Anesthesia &amp; Perioperative Care</subject><subject>Anticipation, Psychological</subject><subject>Antiemetics - therapeutic use</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Anxiety</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>emesis</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>Humans</subject><subject>Inconsistency</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Nausea - chemically induced</subject><subject>Nausea - drug therapy</subject><subject>Nausea - epidemiology</subject><subject>Nausea - psychology</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - epidemiology</subject><subject>Pain Medicine</subject><subject>Pharmacology. Drug treatments</subject><subject>Practice Guidelines as Topic</subject><subject>prediction</subject><subject>Prospective Studies</subject><subject>risk factor</subject><subject>Risk Factors</subject><subject>Vomiting</subject><subject>Vomiting - chemically induced</subject><subject>Vomiting - drug therapy</subject><subject>Vomiting - epidemiology</subject><subject>Vomiting - psychology</subject><issn>0885-3924</issn><issn>1873-6513</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNqNks2O0zAQgCMEYpfCKyBzQOKSYseOE3NAQlULSCsWdYGrNbWnrLtJnLWTSn0CXhuHlh9x6snS6JsZz3yTZS8YnTPK5OvdfNeD6-KhbaGbF5TxOZVzyooH2SWrK57LkvGH2SWt6zLnqhAX2ZMYd5TSkkv-OLsoBK1KQdll9mO5h2aEwfmO-C1Zu3hHVmAGHyL5HNA6M7juO1ncYuuHWwzQH_I1NjCgJZ9gjAgEOku--dZN4Buyxjg2QySr4FsCZDkG3yN0qZiPPaZqeyTXm4hh_6spNORmGO3hafZoC03EZ6d3ln1dLb8sPuRX1-8_Lt5d5UaKcsgFV9xY2ChKFVSFlVzwukwzp3Bh60oKZpnYsKKmGyWZVSgAtsBUCjBqGZ9lr451--DvR4yDbl002DTQoR-jZqVgqiqZPAflopCKyfIMtGCKcVrJhKojatJCYsCt7oNrIRw0o3qyq3f6H7t6squp1Mluyn1-ajNuWrR_Mn_rTMDLEwDRQLMN0BkX_3J1ycvpNmbZ4shhWvXeYdDROOxM8h2SI229O-s7b_-rYhrXudT4Dg8Yd34MyW-aXsdCU30zneN0jWkRlKuq4j8BBCDd7w</recordid><startdate>20140501</startdate><enddate>20140501</enddate><creator>Molassiotis, Alexander, RN, PhD</creator><creator>Aapro, Matti, MD</creator><creator>Dicato, Mario, MD, FRCP</creator><creator>Gascon, Pere, MD, PhD</creator><creator>Novoa, Sylvia A., MD</creator><creator>Isambert, Nicolas, MD</creator><creator>Burke, Thomas A., PhD</creator><creator>Gu, Anna, MD, PhD</creator><creator>Roila, Fausto, MD</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</scope><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>7X8</scope><scope>ASE</scope><scope>FPQ</scope><scope>K6X</scope><scope>7QJ</scope></search><sort><creationdate>20140501</creationdate><title>Evaluation of Risk Factors Predicting Chemotherapy-Related Nausea and Vomiting: Results From a European Prospective Observational Study</title><author>Molassiotis, Alexander, RN, PhD ; Aapro, Matti, MD ; Dicato, Mario, MD, FRCP ; Gascon, Pere, MD, PhD ; Novoa, Sylvia A., MD ; Isambert, Nicolas, MD ; Burke, Thomas A., PhD ; Gu, Anna, MD, PhD ; Roila, Fausto, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c645t-4393cdab9009a72d63438518793c2d87641d14b1280b961d9e4aafa1928010d13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Anesthesia &amp; Perioperative Care</topic><topic>Anticipation, Psychological</topic><topic>Antiemetics - therapeutic use</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Anxiety</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy</topic><topic>emesis</topic><topic>Europe - epidemiology</topic><topic>Female</topic><topic>Humans</topic><topic>Inconsistency</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nausea</topic><topic>Nausea - chemically induced</topic><topic>Nausea - drug therapy</topic><topic>Nausea - epidemiology</topic><topic>Nausea - psychology</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - epidemiology</topic><topic>Pain Medicine</topic><topic>Pharmacology. Drug treatments</topic><topic>Practice Guidelines as Topic</topic><topic>prediction</topic><topic>Prospective Studies</topic><topic>risk factor</topic><topic>Risk Factors</topic><topic>Vomiting</topic><topic>Vomiting - chemically induced</topic><topic>Vomiting - drug therapy</topic><topic>Vomiting - epidemiology</topic><topic>Vomiting - psychology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Molassiotis, Alexander, RN, PhD</creatorcontrib><creatorcontrib>Aapro, Matti, MD</creatorcontrib><creatorcontrib>Dicato, Mario, MD, FRCP</creatorcontrib><creatorcontrib>Gascon, Pere, MD, PhD</creatorcontrib><creatorcontrib>Novoa, Sylvia A., MD</creatorcontrib><creatorcontrib>Isambert, Nicolas, MD</creatorcontrib><creatorcontrib>Burke, Thomas A., PhD</creatorcontrib><creatorcontrib>Gu, Anna, MD, PhD</creatorcontrib><creatorcontrib>Roila, Fausto, MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>British Nursing Index</collection><collection>British Nursing Index (BNI) (1985 to Present)</collection><collection>British Nursing Index</collection><collection>Applied Social Sciences Index &amp; Abstracts (ASSIA)</collection><jtitle>Journal of pain and symptom management</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Molassiotis, Alexander, RN, PhD</au><au>Aapro, Matti, MD</au><au>Dicato, Mario, MD, FRCP</au><au>Gascon, Pere, MD, PhD</au><au>Novoa, Sylvia A., MD</au><au>Isambert, Nicolas, MD</au><au>Burke, Thomas A., PhD</au><au>Gu, Anna, MD, PhD</au><au>Roila, Fausto, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of Risk Factors Predicting Chemotherapy-Related Nausea and Vomiting: Results From a European Prospective Observational Study</atitle><jtitle>Journal of pain and symptom management</jtitle><addtitle>J Pain Symptom Manage</addtitle><date>2014-05-01</date><risdate>2014</risdate><volume>47</volume><issue>5</issue><spage>839</spage><epage>848.e4</epage><pages>839-848.e4</pages><issn>0885-3924</issn><eissn>1873-6513</eissn><coden>JSPME2</coden><abstract>Abstract Context Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses. Objectives To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy. Methods This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0–100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0–100 mm VAS), and prechemotherapy nausea (0–100 mm VAS) measured during the 24-hour period before chemotherapy initiation. Results There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P  &lt; 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway. Conclusion The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>24075401</pmid><doi>10.1016/j.jpainsymman.2013.06.012</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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subjects Age Factors
Aged
Anesthesia & Perioperative Care
Anticipation, Psychological
Antiemetics - therapeutic use
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Anxiety
Biological and medical sciences
Chemotherapy
emesis
Europe - epidemiology
Female
Humans
Inconsistency
Male
Medical sciences
Middle Aged
Nausea
Nausea - chemically induced
Nausea - drug therapy
Nausea - epidemiology
Nausea - psychology
Neoplasms - drug therapy
Neoplasms - epidemiology
Pain Medicine
Pharmacology. Drug treatments
Practice Guidelines as Topic
prediction
Prospective Studies
risk factor
Risk Factors
Vomiting
Vomiting - chemically induced
Vomiting - drug therapy
Vomiting - epidemiology
Vomiting - psychology
title Evaluation of Risk Factors Predicting Chemotherapy-Related Nausea and Vomiting: Results From a European Prospective Observational Study
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