Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study
Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer. We r...
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| Veröffentlicht in: | Clinical therapeutics 2020-04, Vol.42 (4), p.712-719 |
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| creator | Kawazoe, Hitoshi Mori, Natsuki Ido, Shizuka Uozumi, Ryuji Tsuneoka, Kikue Takeuchi, Akane Matsuo, Mayumi Yamauchi, Misako Nakai, Masaki Sumikawa, Satomi Nakamura, Tomonori Yakushijin, Yoshihiro |
| description | Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.
We retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.
A total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11–1.40 [P |
| doi_str_mv | 10.1016/j.clinthera.2020.02.010 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2417030575</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0149291820301120</els_id><sourcerecordid>2417030575</sourcerecordid><originalsourceid>FETCH-LOGICAL-c399t-267fe014e1846b89ddbb743c9a8ec3dbe17c1773f62dcf36997cbcdc462b69c73</originalsourceid><addsrcrecordid>eNqFkFtrGzEQRkVpadykf6EV9Hm3uqylVd-MSdKAoaGXJG9CO5olMrbWkbSB_PsqOM1rYWBezjeXQ8hnzlrOuPq6bWEXYrnH5FrBBGuZaBlnb8iC99o0nHd3b8mC8c40wvD-hHzIecsYk2Yp3pMTKbhiRpkFGTfhYQ6eXkxpP-9cCVOk00gvcQ-huCFEpFcRErqMmd5gnOZMr12ItNZ1xTGWTG9DuadrFwHTN7qiP7GkKR8QSnhE-qvM_umMvBvdLuPHl35K_lyc_15_bzY_Lq_Wq00D0pjSCKVHrFcj7zs19Mb7YdCdBON6BOkH5Bq41nJUwsMolTEaBvDQKTEoA1qeki_HuYc0PcyYi91Oc4p1pRUd10yypV5WSh8pqHfmhKM9pLB36clyZp_92q199Wuf_VombPVbk59e5s_DHv1r7p_QCqyOANYvHwMmm6FKAvQhVSHWT-G_S_4CyhyRJQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2417030575</pqid></control><display><type>article</type><title>Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><source>ProQuest Central UK/Ireland</source><creator>Kawazoe, Hitoshi ; Mori, Natsuki ; Ido, Shizuka ; Uozumi, Ryuji ; Tsuneoka, Kikue ; Takeuchi, Akane ; Matsuo, Mayumi ; Yamauchi, Misako ; Nakai, Masaki ; Sumikawa, Satomi ; Nakamura, Tomonori ; Yakushijin, Yoshihiro</creator><creatorcontrib>Kawazoe, Hitoshi ; Mori, Natsuki ; Ido, Shizuka ; Uozumi, Ryuji ; Tsuneoka, Kikue ; Takeuchi, Akane ; Matsuo, Mayumi ; Yamauchi, Misako ; Nakai, Masaki ; Sumikawa, Satomi ; Nakamura, Tomonori ; Yakushijin, Yoshihiro</creatorcontrib><description>Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.
We retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.
A total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11–1.40 [P < 0.001]; and liquid formulation, adjusted OR = 12.43, 95% CI, 5.61–27.51 [P < 0.001]), whereas age, course number of gemcitabine, and use of the soft-back product of 5% glucose solution were significantly associated with a reduced risk for venous pain (age, adjusted OR = 0.75; 95% CI, 0.57–0.98 [P = 0.037]; course number, adjusted OR = 0.96; 95% CI, 0.92–0.99 [P = 0.023]; and soft back, adjusted OR = 0.39; 95% CI, 0.21–0.74 [P = 0.004]).
The use of the liquid formulation of gemcitabine was associated with a significant increase in the frequency of gemcitabine-induced venous pain despite dilution with 5% glucose solution compared to that with the lyophilized formulation. The lyophilized formulation of gemcitabine should hence be used in peripheral intravenous infusion for the treatment of patients with cancer.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2020.02.010</identifier><identifier>PMID: 32160969</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Age ; Aged ; Aged, 80 and over ; Analgesics ; Antimetabolites, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - adverse effects ; Antimetabolites, Antineoplastic - chemistry ; Body mass index ; Cancer ; Chemotherapy ; Comorbidity ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - chemistry ; Dilution ; Drug Compounding ; Electronic health records ; Electronic medical records ; Female ; Freeze Drying ; Gemcitabine ; Generic drugs ; Glucose ; Health services ; Hospitals ; Humans ; Infusions, Intravenous ; Intravenous administration ; Intravenous infusion ; liquid formulation ; Male ; Middle Aged ; Multivariate analysis ; Neoplasms - drug therapy ; Pain ; Pain - chemically induced ; Patient satisfaction ; Patients ; Pharmacists ; Regression analysis ; Retrospective Studies ; Risk analysis ; Risk Factors ; Risk management ; Risk reduction ; Terminology ; venous pain</subject><ispartof>Clinical therapeutics, 2020-04, Vol.42 (4), p.712-719</ispartof><rights>2020 Elsevier Inc.</rights><rights>Copyright © 2020 Elsevier Inc. All rights reserved.</rights><rights>2020. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-267fe014e1846b89ddbb743c9a8ec3dbe17c1773f62dcf36997cbcdc462b69c73</citedby><cites>FETCH-LOGICAL-c399t-267fe014e1846b89ddbb743c9a8ec3dbe17c1773f62dcf36997cbcdc462b69c73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2417030575?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32160969$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kawazoe, Hitoshi</creatorcontrib><creatorcontrib>Mori, Natsuki</creatorcontrib><creatorcontrib>Ido, Shizuka</creatorcontrib><creatorcontrib>Uozumi, Ryuji</creatorcontrib><creatorcontrib>Tsuneoka, Kikue</creatorcontrib><creatorcontrib>Takeuchi, Akane</creatorcontrib><creatorcontrib>Matsuo, Mayumi</creatorcontrib><creatorcontrib>Yamauchi, Misako</creatorcontrib><creatorcontrib>Nakai, Masaki</creatorcontrib><creatorcontrib>Sumikawa, Satomi</creatorcontrib><creatorcontrib>Nakamura, Tomonori</creatorcontrib><creatorcontrib>Yakushijin, Yoshihiro</creatorcontrib><title>Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.
We retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.
A total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11–1.40 [P < 0.001]; and liquid formulation, adjusted OR = 12.43, 95% CI, 5.61–27.51 [P < 0.001]), whereas age, course number of gemcitabine, and use of the soft-back product of 5% glucose solution were significantly associated with a reduced risk for venous pain (age, adjusted OR = 0.75; 95% CI, 0.57–0.98 [P = 0.037]; course number, adjusted OR = 0.96; 95% CI, 0.92–0.99 [P = 0.023]; and soft back, adjusted OR = 0.39; 95% CI, 0.21–0.74 [P = 0.004]).
The use of the liquid formulation of gemcitabine was associated with a significant increase in the frequency of gemcitabine-induced venous pain despite dilution with 5% glucose solution compared to that with the lyophilized formulation. The lyophilized formulation of gemcitabine should hence be used in peripheral intravenous infusion for the treatment of patients with cancer.</description><subject>Adult</subject><subject>Age</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analgesics</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>Antimetabolites, Antineoplastic - chemistry</subject><subject>Body mass index</subject><subject>Cancer</subject><subject>Chemotherapy</subject><subject>Comorbidity</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - chemistry</subject><subject>Dilution</subject><subject>Drug Compounding</subject><subject>Electronic health records</subject><subject>Electronic medical records</subject><subject>Female</subject><subject>Freeze Drying</subject><subject>Gemcitabine</subject><subject>Generic drugs</subject><subject>Glucose</subject><subject>Health services</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Intravenous administration</subject><subject>Intravenous infusion</subject><subject>liquid formulation</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate analysis</subject><subject>Neoplasms - drug therapy</subject><subject>Pain</subject><subject>Pain - chemically induced</subject><subject>Patient satisfaction</subject><subject>Patients</subject><subject>Pharmacists</subject><subject>Regression analysis</subject><subject>Retrospective Studies</subject><subject>Risk analysis</subject><subject>Risk Factors</subject><subject>Risk management</subject><subject>Risk reduction</subject><subject>Terminology</subject><subject>venous pain</subject><issn>0149-2918</issn><issn>1879-114X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkFtrGzEQRkVpadykf6EV9Hm3uqylVd-MSdKAoaGXJG9CO5olMrbWkbSB_PsqOM1rYWBezjeXQ8hnzlrOuPq6bWEXYrnH5FrBBGuZaBlnb8iC99o0nHd3b8mC8c40wvD-hHzIecsYk2Yp3pMTKbhiRpkFGTfhYQ6eXkxpP-9cCVOk00gvcQ-huCFEpFcRErqMmd5gnOZMr12ItNZ1xTGWTG9DuadrFwHTN7qiP7GkKR8QSnhE-qvM_umMvBvdLuPHl35K_lyc_15_bzY_Lq_Wq00D0pjSCKVHrFcj7zs19Mb7YdCdBON6BOkH5Bq41nJUwsMolTEaBvDQKTEoA1qeki_HuYc0PcyYi91Oc4p1pRUd10yypV5WSh8pqHfmhKM9pLB36clyZp_92q199Wuf_VombPVbk59e5s_DHv1r7p_QCqyOANYvHwMmm6FKAvQhVSHWT-G_S_4CyhyRJQ</recordid><startdate>202004</startdate><enddate>202004</enddate><creator>Kawazoe, Hitoshi</creator><creator>Mori, Natsuki</creator><creator>Ido, Shizuka</creator><creator>Uozumi, Ryuji</creator><creator>Tsuneoka, Kikue</creator><creator>Takeuchi, Akane</creator><creator>Matsuo, Mayumi</creator><creator>Yamauchi, Misako</creator><creator>Nakai, Masaki</creator><creator>Sumikawa, Satomi</creator><creator>Nakamura, Tomonori</creator><creator>Yakushijin, Yoshihiro</creator><general>Elsevier Inc</general><general>Elsevier Limited</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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope></search><sort><creationdate>202004</creationdate><title>Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study</title><author>Kawazoe, Hitoshi ; Mori, Natsuki ; Ido, Shizuka ; Uozumi, Ryuji ; Tsuneoka, Kikue ; Takeuchi, Akane ; Matsuo, Mayumi ; Yamauchi, Misako ; Nakai, Masaki ; Sumikawa, Satomi ; Nakamura, Tomonori ; Yakushijin, Yoshihiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-267fe014e1846b89ddbb743c9a8ec3dbe17c1773f62dcf36997cbcdc462b69c73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Age</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analgesics</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>Antimetabolites, Antineoplastic - chemistry</topic><topic>Body mass index</topic><topic>Cancer</topic><topic>Chemotherapy</topic><topic>Comorbidity</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - chemistry</topic><topic>Dilution</topic><topic>Drug Compounding</topic><topic>Electronic health records</topic><topic>Electronic medical records</topic><topic>Female</topic><topic>Freeze Drying</topic><topic>Gemcitabine</topic><topic>Generic drugs</topic><topic>Glucose</topic><topic>Health services</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Intravenous administration</topic><topic>Intravenous infusion</topic><topic>liquid formulation</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate analysis</topic><topic>Neoplasms - drug therapy</topic><topic>Pain</topic><topic>Pain - chemically induced</topic><topic>Patient satisfaction</topic><topic>Patients</topic><topic>Pharmacists</topic><topic>Regression analysis</topic><topic>Retrospective Studies</topic><topic>Risk analysis</topic><topic>Risk Factors</topic><topic>Risk management</topic><topic>Risk reduction</topic><topic>Terminology</topic><topic>venous pain</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kawazoe, Hitoshi</creatorcontrib><creatorcontrib>Mori, Natsuki</creatorcontrib><creatorcontrib>Ido, Shizuka</creatorcontrib><creatorcontrib>Uozumi, Ryuji</creatorcontrib><creatorcontrib>Tsuneoka, Kikue</creatorcontrib><creatorcontrib>Takeuchi, Akane</creatorcontrib><creatorcontrib>Matsuo, Mayumi</creatorcontrib><creatorcontrib>Yamauchi, Misako</creatorcontrib><creatorcontrib>Nakai, Masaki</creatorcontrib><creatorcontrib>Sumikawa, Satomi</creatorcontrib><creatorcontrib>Nakamura, Tomonori</creatorcontrib><creatorcontrib>Yakushijin, Yoshihiro</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 Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical 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>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</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>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</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><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kawazoe, Hitoshi</au><au>Mori, Natsuki</au><au>Ido, Shizuka</au><au>Uozumi, Ryuji</au><au>Tsuneoka, Kikue</au><au>Takeuchi, Akane</au><au>Matsuo, Mayumi</au><au>Yamauchi, Misako</au><au>Nakai, Masaki</au><au>Sumikawa, Satomi</au><au>Nakamura, Tomonori</au><au>Yakushijin, Yoshihiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2020-04</date><risdate>2020</risdate><volume>42</volume><issue>4</issue><spage>712</spage><epage>719</epage><pages>712-719</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Venous pain induced by peripheral intravenous infusion of gemcitabine has remained an unresolved issue in clinical practice. This study aimed to identify differences between gemcitabine formulations as well as risk factors associated with gemcitabine-induced venous pain in patients with cancer.
We retrospectively analyzed data from consecutive patients with cancer who had received chemotherapy including a lyophilized or liquid formulation of gemcitabine diluted with 5% glucose solution via a peripheral vein. The study was conducted at Ehime University Hospital using electronic medical records dated between January 2015 and July 2017. The primary end point was the prevalence of venous pain at the administration site during gemcitabine infusion, classified as injection site reaction of grade ≥2 according to the Common Terminology Criteria for Adverse Events, version 4.0. A multivariate logistic regression analysis with generalized estimating equations for longitudinal data was used to identify risk factors for venous pain during all courses of gemcitabine treatment.
A total of 1150 treatment courses in 141 Japanese patients were evaluated in this study. Venous pain occurred in 115 courses (10.0%) and in 49 patients (34.8%). The multivariate logistic regression analysis with generalized estimating equations revealed that a dose increase of gemcitabine and use of the liquid formulation of gemcitabine were significantly associated with an increased risk for venous pain (dose increase, adjusted odds ratio [OR] = 1.25; 95% CI, 1.11–1.40 [P < 0.001]; and liquid formulation, adjusted OR = 12.43, 95% CI, 5.61–27.51 [P < 0.001]), whereas age, course number of gemcitabine, and use of the soft-back product of 5% glucose solution were significantly associated with a reduced risk for venous pain (age, adjusted OR = 0.75; 95% CI, 0.57–0.98 [P = 0.037]; course number, adjusted OR = 0.96; 95% CI, 0.92–0.99 [P = 0.023]; and soft back, adjusted OR = 0.39; 95% CI, 0.21–0.74 [P = 0.004]).
The use of the liquid formulation of gemcitabine was associated with a significant increase in the frequency of gemcitabine-induced venous pain despite dilution with 5% glucose solution compared to that with the lyophilized formulation. The lyophilized formulation of gemcitabine should hence be used in peripheral intravenous infusion for the treatment of patients with cancer.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32160969</pmid><doi>10.1016/j.clinthera.2020.02.010</doi><tpages>8</tpages></addata></record> |
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| subjects | Adult Age Aged Aged, 80 and over Analgesics Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - chemistry Body mass index Cancer Chemotherapy Comorbidity Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - chemistry Dilution Drug Compounding Electronic health records Electronic medical records Female Freeze Drying Gemcitabine Generic drugs Glucose Health services Hospitals Humans Infusions, Intravenous Intravenous administration Intravenous infusion liquid formulation Male Middle Aged Multivariate analysis Neoplasms - drug therapy Pain Pain - chemically induced Patient satisfaction Patients Pharmacists Regression analysis Retrospective Studies Risk analysis Risk Factors Risk management Risk reduction Terminology venous pain |
| title | Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study |
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