Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study
Abstract Background/purpose Complications from biliary drainage in biliary tract cancer (BTC) may influence the relative dose intensity of chemotherapy or increase adverse events during chemotherapy. BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III...
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| Veröffentlicht in: | HPB (Oxford, England) England), 2012-04, Vol.14 (4), p.221-227 |
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| creator | Fukutomi, Akira Furuse, Junji Okusaka, Takuji Miyazaki, Masaru Taketsuna, Masanori Koshiji, Minori Nimura, Yuji |
| description | Abstract Background/purpose Complications from biliary drainage in biliary tract cancer (BTC) may influence the relative dose intensity of chemotherapy or increase adverse events during chemotherapy. BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III trial in non-Japanese that demonstrated the effectiveness of gemcitabine plus cisplatin combination therapy (GC) in BTC. The purpose of this exploratory analysis of the BT22 study was to identify the possible effects of biliary drainage on the efficacy and safety of GC or gemcitabine monotherapy (G). Patients and Methods The 83 BTC patients who received GC or G in BT22 were retrospectively analysed in two subgroups dependent upon whether biliary drainage was performed before study entry. Efficacy and safety of treatment (GC vs. G) were compared in these two groups. Results The GC arm had a higher 1-year survival rate and longer median survival time (MST) than the G arm independent of prior biliary drainage. Patients in the drainage subgroup developed cholangitis more frequently, however, the frequency of grade 3/4 adverse events did not differ between the treatment regimens with/without drainage. Conclusions Biliary drainage before chemotherapy did not affect the therapeutic efficacy or tolerability of chemotherapy using G or GC. |
| doi_str_mv | 10.1111/j.1477-2574.2011.00431.x |
| format | Article |
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BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III trial in non-Japanese that demonstrated the effectiveness of gemcitabine plus cisplatin combination therapy (GC) in BTC. The purpose of this exploratory analysis of the BT22 study was to identify the possible effects of biliary drainage on the efficacy and safety of GC or gemcitabine monotherapy (G). Patients and Methods The 83 BTC patients who received GC or G in BT22 were retrospectively analysed in two subgroups dependent upon whether biliary drainage was performed before study entry. Efficacy and safety of treatment (GC vs. G) were compared in these two groups. Results The GC arm had a higher 1-year survival rate and longer median survival time (MST) than the G arm independent of prior biliary drainage. Patients in the drainage subgroup developed cholangitis more frequently, however, the frequency of grade 3/4 adverse events did not differ between the treatment regimens with/without drainage. Conclusions Biliary drainage before chemotherapy did not affect the therapeutic efficacy or tolerability of chemotherapy using G or GC.</description><identifier>ISSN: 1365-182X</identifier><identifier>EISSN: 1477-2574</identifier><identifier>DOI: 10.1111/j.1477-2574.2011.00431.x</identifier><identifier>PMID: 22404259</identifier><language>eng</language><publisher>Oxford, UK: Elsevier Ltd</publisher><subject>Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; biliary drainage ; biliary tract cancer ; Biliary Tract Neoplasms - drug therapy ; Biliary Tract Neoplasms - mortality ; Biliary Tract Neoplasms - therapy ; chemotherapy ; cholangitis ; Cholangitis - etiology ; cisplatin ; Cisplatin - administration & dosage ; Clinical Trials, Phase II as Topic ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; Drainage - adverse effects ; Drainage - methods ; Drainage - mortality ; Female ; Gastroenterology and Hepatology ; gemcitabine ; Humans ; Japan ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multicenter Studies as Topic ; Multivariate Analysis ; Neoadjuvant Therapy ; Original ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome</subject><ispartof>HPB (Oxford, England), 2012-04, Vol.14 (4), p.221-227</ispartof><rights>International Hepato-Pancreato-Biliary Association</rights><rights>2012 International Hepato-Pancreato-Biliary Association</rights><rights>2012 International Hepato‐Pancreato‐Biliary Association</rights><rights>2012 International Hepato-Pancreato-Biliary Association.</rights><rights>2012 International Hepato-Pancreato-Biliary Association 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6241-9a38160ea215a8c1f2d746e9c0458c5afe7b670fef1c5290ba928803a74c7d993</citedby><cites>FETCH-LOGICAL-c6241-9a38160ea215a8c1f2d746e9c0458c5afe7b670fef1c5290ba928803a74c7d993</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3371207/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3371207/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,315,728,781,785,886,1418,27929,27930,45579,45580,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22404259$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fukutomi, Akira</creatorcontrib><creatorcontrib>Furuse, Junji</creatorcontrib><creatorcontrib>Okusaka, Takuji</creatorcontrib><creatorcontrib>Miyazaki, Masaru</creatorcontrib><creatorcontrib>Taketsuna, Masanori</creatorcontrib><creatorcontrib>Koshiji, Minori</creatorcontrib><creatorcontrib>Nimura, Yuji</creatorcontrib><title>Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study</title><title>HPB (Oxford, England)</title><addtitle>HPB (Oxford)</addtitle><description>Abstract Background/purpose Complications from biliary drainage in biliary tract cancer (BTC) may influence the relative dose intensity of chemotherapy or increase adverse events during chemotherapy. BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III trial in non-Japanese that demonstrated the effectiveness of gemcitabine plus cisplatin combination therapy (GC) in BTC. The purpose of this exploratory analysis of the BT22 study was to identify the possible effects of biliary drainage on the efficacy and safety of GC or gemcitabine monotherapy (G). Patients and Methods The 83 BTC patients who received GC or G in BT22 were retrospectively analysed in two subgroups dependent upon whether biliary drainage was performed before study entry. Efficacy and safety of treatment (GC vs. G) were compared in these two groups. Results The GC arm had a higher 1-year survival rate and longer median survival time (MST) than the G arm independent of prior biliary drainage. Patients in the drainage subgroup developed cholangitis more frequently, however, the frequency of grade 3/4 adverse events did not differ between the treatment regimens with/without drainage. Conclusions Biliary drainage before chemotherapy did not affect the therapeutic efficacy or tolerability of chemotherapy using G or GC.</description><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>biliary drainage</subject><subject>biliary tract cancer</subject><subject>Biliary Tract Neoplasms - drug therapy</subject><subject>Biliary Tract Neoplasms - mortality</subject><subject>Biliary Tract Neoplasms - therapy</subject><subject>chemotherapy</subject><subject>cholangitis</subject><subject>Cholangitis - etiology</subject><subject>cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Clinical Trials, Phase II as Topic</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease-Free Survival</subject><subject>Drainage - adverse effects</subject><subject>Drainage - methods</subject><subject>Drainage - mortality</subject><subject>Female</subject><subject>Gastroenterology and Hepatology</subject><subject>gemcitabine</subject><subject>Humans</subject><subject>Japan</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Multivariate Analysis</subject><subject>Neoadjuvant Therapy</subject><subject>Original</subject><subject>Proportional Hazards Models</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1365-182X</issn><issn>1477-2574</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUttu1DAQjRCIlsIvIP9Agi9JnCBUia3aXVDFRS2Xt9GsM-l6m01WdrbdiJ_HYSECnuoXW5pzznjOmShigicinFfrRKRaxzLTaSK5EAnnqRLJ_lF0PBUeh7fKs1gU8vtR9Mz7NedScFE-jY6kTHkqs_I4-nFe12R61tVsaRuLbmCVQ9viDbGuZWZFm65fkcPtwGzLtthbanvP7m2_mhi9wyBhsDXkXjNsGe23Teew70IRW2wGb_3YIiix2bWUzPe7angePamx8fTi930Sfbk4vz5bxJcf5-_O3l7GJpepiEtUhcg5oRQZFkbUstJpTqXhaVaYDGvSy1zzmmphMlnyJZayKLhCnRpdlaU6iU4PutvdckOVCQM4bGDr7Cb8Hjq08G-ltSu46e5AKS0k10GgOAgY13nvqJ64gsMYCKxh9B1G32EMBH4FAvtAffl374n4J4EAeHMA3NuGhgcLw-LTLDwCPT7Qre9pP9HR3UKulc7g24c5XL3_fPFVqjksAn52wFMw_M6SA29CooYq68IeQNXZhwx1-p-IaWxrDTa3NJBfdzsXQvcgwEvgcDXu4biGIlM8C5aqnxwL1Ws</recordid><startdate>201204</startdate><enddate>201204</enddate><creator>Fukutomi, Akira</creator><creator>Furuse, Junji</creator><creator>Okusaka, Takuji</creator><creator>Miyazaki, Masaru</creator><creator>Taketsuna, Masanori</creator><creator>Koshiji, Minori</creator><creator>Nimura, Yuji</creator><general>Elsevier Ltd</general><general>Blackwell Publishing Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>BSCLL</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>5PM</scope></search><sort><creationdate>201204</creationdate><title>Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study</title><author>Fukutomi, Akira ; Furuse, Junji ; Okusaka, Takuji ; Miyazaki, Masaru ; Taketsuna, Masanori ; Koshiji, Minori ; Nimura, Yuji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6241-9a38160ea215a8c1f2d746e9c0458c5afe7b670fef1c5290ba928803a74c7d993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>biliary drainage</topic><topic>biliary tract cancer</topic><topic>Biliary Tract Neoplasms - drug therapy</topic><topic>Biliary Tract Neoplasms - mortality</topic><topic>Biliary Tract Neoplasms - therapy</topic><topic>chemotherapy</topic><topic>cholangitis</topic><topic>Cholangitis - etiology</topic><topic>cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Clinical Trials, Phase II as Topic</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease-Free Survival</topic><topic>Drainage - adverse effects</topic><topic>Drainage - methods</topic><topic>Drainage - mortality</topic><topic>Female</topic><topic>Gastroenterology and Hepatology</topic><topic>gemcitabine</topic><topic>Humans</topic><topic>Japan</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multicenter Studies as Topic</topic><topic>Multivariate Analysis</topic><topic>Neoadjuvant Therapy</topic><topic>Original</topic><topic>Proportional Hazards Models</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fukutomi, Akira</creatorcontrib><creatorcontrib>Furuse, Junji</creatorcontrib><creatorcontrib>Okusaka, Takuji</creatorcontrib><creatorcontrib>Miyazaki, Masaru</creatorcontrib><creatorcontrib>Taketsuna, Masanori</creatorcontrib><creatorcontrib>Koshiji, Minori</creatorcontrib><creatorcontrib>Nimura, Yuji</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>HPB (Oxford, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fukutomi, Akira</au><au>Furuse, Junji</au><au>Okusaka, Takuji</au><au>Miyazaki, Masaru</au><au>Taketsuna, Masanori</au><au>Koshiji, Minori</au><au>Nimura, Yuji</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study</atitle><jtitle>HPB (Oxford, England)</jtitle><addtitle>HPB (Oxford)</addtitle><date>2012-04</date><risdate>2012</risdate><volume>14</volume><issue>4</issue><spage>221</spage><epage>227</epage><pages>221-227</pages><issn>1365-182X</issn><eissn>1477-2574</eissn><abstract>Abstract Background/purpose Complications from biliary drainage in biliary tract cancer (BTC) may influence the relative dose intensity of chemotherapy or increase adverse events during chemotherapy. BT22 was a randomized phase II trial, the results of which were consistent with those of a phase III trial in non-Japanese that demonstrated the effectiveness of gemcitabine plus cisplatin combination therapy (GC) in BTC. The purpose of this exploratory analysis of the BT22 study was to identify the possible effects of biliary drainage on the efficacy and safety of GC or gemcitabine monotherapy (G). Patients and Methods The 83 BTC patients who received GC or G in BT22 were retrospectively analysed in two subgroups dependent upon whether biliary drainage was performed before study entry. Efficacy and safety of treatment (GC vs. G) were compared in these two groups. Results The GC arm had a higher 1-year survival rate and longer median survival time (MST) than the G arm independent of prior biliary drainage. Patients in the drainage subgroup developed cholangitis more frequently, however, the frequency of grade 3/4 adverse events did not differ between the treatment regimens with/without drainage. Conclusions Biliary drainage before chemotherapy did not affect the therapeutic efficacy or tolerability of chemotherapy using G or GC.</abstract><cop>Oxford, UK</cop><pub>Elsevier Ltd</pub><pmid>22404259</pmid><doi>10.1111/j.1477-2574.2011.00431.x</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use biliary drainage biliary tract cancer Biliary Tract Neoplasms - drug therapy Biliary Tract Neoplasms - mortality Biliary Tract Neoplasms - therapy chemotherapy cholangitis Cholangitis - etiology cisplatin Cisplatin - administration & dosage Clinical Trials, Phase II as Topic Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease-Free Survival Drainage - adverse effects Drainage - methods Drainage - mortality Female Gastroenterology and Hepatology gemcitabine Humans Japan Kaplan-Meier Estimate Male Middle Aged Multicenter Studies as Topic Multivariate Analysis Neoadjuvant Therapy Original Proportional Hazards Models Randomized Controlled Trials as Topic Retrospective Studies Risk Assessment Risk Factors Time Factors Treatment Outcome |
| title | Effect of biliary drainage on chemotherapy in patients with biliary tract cancer: an exploratory analysis of the BT22 study |
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