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Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial
Purpose Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (...
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Published in: | Cancer chemotherapy and pharmacology 2010-03, Vol.65 (4), p.641-647 |
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container_end_page | 647 |
container_issue | 4 |
container_start_page | 641 |
container_title | Cancer chemotherapy and pharmacology |
container_volume | 65 |
creator | Jang, Joung-Soon Lim, Ho Yeong Hwang, In Gyu Song, Hong Suk Yoo, NaeChoon Yoon, SoYoung Kim, Yeul Hong Park, Eunsik Byun, Jae Ho Lee, Myung Ah Oh, Suk Joong Lee, Kyung Hee Kim, Bong Seog Oh, Sang Cheul Kim, Sam Yong Lee, Sang Jae |
description | Purpose
Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.
Methods
We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m
2
(day 1 and 8) and oxaliplatin 100 mg/m
2
(day 1), every 3 weeks.
Results
Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1–6.5, 95% CI) and median overall survival was 8.3 months (5.8–10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).
Conclusions
The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs. |
doi_str_mv | 10.1007/s00280-009-1069-7 |
format | article |
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Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.
Methods
We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m
2
(day 1 and 8) and oxaliplatin 100 mg/m
2
(day 1), every 3 weeks.
Results
Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1–6.5, 95% CI) and median overall survival was 8.3 months (5.8–10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).
Conclusions
The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-009-1069-7</identifier><identifier>PMID: 19652971</identifier><identifier>CODEN: CCPHDZ</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biliary Tract Neoplasms - drug therapy ; Biliary Tract Neoplasms - pathology ; Biological and medical sciences ; Cancer Research ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Diarrhea - chemically induced ; Drug Administration Schedule ; Female ; Gallbladder Neoplasms - drug therapy ; Gallbladder Neoplasms - pathology ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Neutropenia - chemically induced ; Oncology ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Original Article ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Survival Analysis ; Thrombocytopenia - chemically induced ; Treatment Outcome ; Tumors</subject><ispartof>Cancer chemotherapy and pharmacology, 2010-03, Vol.65 (4), p.641-647</ispartof><rights>Springer-Verlag 2009</rights><rights>2015 INIST-CNRS</rights><rights>Springer-Verlag 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c432t-fc342d9245894c89cd8f8913840d08fd8469d46ec6032803edb0107a542e0e673</citedby><cites>FETCH-LOGICAL-c432t-fc342d9245894c89cd8f8913840d08fd8469d46ec6032803edb0107a542e0e673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22351164$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19652971$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Jang, Joung-Soon</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Hwang, In Gyu</creatorcontrib><creatorcontrib>Song, Hong Suk</creatorcontrib><creatorcontrib>Yoo, NaeChoon</creatorcontrib><creatorcontrib>Yoon, SoYoung</creatorcontrib><creatorcontrib>Kim, Yeul Hong</creatorcontrib><creatorcontrib>Park, Eunsik</creatorcontrib><creatorcontrib>Byun, Jae Ho</creatorcontrib><creatorcontrib>Lee, Myung Ah</creatorcontrib><creatorcontrib>Oh, Suk Joong</creatorcontrib><creatorcontrib>Lee, Kyung Hee</creatorcontrib><creatorcontrib>Kim, Bong Seog</creatorcontrib><creatorcontrib>Oh, Sang Cheul</creatorcontrib><creatorcontrib>Kim, Sam Yong</creatorcontrib><creatorcontrib>Lee, Sang Jae</creatorcontrib><title>Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose
Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.
Methods
We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m
2
(day 1 and 8) and oxaliplatin 100 mg/m
2
(day 1), every 3 weeks.
Results
Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1–6.5, 95% CI) and median overall survival was 8.3 months (5.8–10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).
Conclusions
The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biliary Tract Neoplasms - drug therapy</subject><subject>Biliary Tract Neoplasms - pathology</subject><subject>Biological and medical sciences</subject><subject>Cancer Research</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Diarrhea - chemically induced</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gallbladder Neoplasms - drug therapy</subject><subject>Gallbladder Neoplasms - pathology</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neutropenia - chemically induced</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Original Article</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Survival Analysis</subject><subject>Thrombocytopenia - chemically induced</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0344-5704</issn><issn>1432-0843</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><recordid>eNp1kduKFDEQhoMo7jj6AN5IEMSr1sqhD_FOBh0HF7xQr0M6qZ7Nkkm3STe6r-ETm6EHFwQhkFD11V-V-gl5zuANA2jfZgDeQQWgKgaNqtoHZMOk4BV0UjwkGxBSVnUL8oo8yfkWACQT4jG5YqqpuWrZhvze48n62fQ-IjXR0fGXCX4KZvaRljOVB8Y5059-vqFLTJjRFjwg7X3wJt1Ra6LFVGAbFufjkR5NCLQPxrkSXrPvqKGfx4Qm0t2Kf50Xd0f3aVwmOt2YjPRwoHPyJjwljwYTMj673Fvy_eOHb7tP1fWX_WH3_rqy5YtzNVghuVNc1p2StlPWdUOnmOgkOOgG18lGOdmgbUCULQl0PTBoTS05Ajat2JLXq-6Uxh8L5lmffLYYgok4Llm3siioppRuyct_yNtxSbEMpzkTdc2YOMuxFbJpzDnhoKfkT2VBmoE-26VXu3SxS5_t0ueaFxfhpT-hu6-4-FOAVxfAZGvCkMryfP7LcS5K80YWjq9cLql4xHQ_4f-7_wG_jqz-</recordid><startdate>20100301</startdate><enddate>20100301</enddate><creator>Jang, Joung-Soon</creator><creator>Lim, Ho Yeong</creator><creator>Hwang, In Gyu</creator><creator>Song, Hong Suk</creator><creator>Yoo, NaeChoon</creator><creator>Yoon, SoYoung</creator><creator>Kim, Yeul Hong</creator><creator>Park, Eunsik</creator><creator>Byun, Jae Ho</creator><creator>Lee, Myung Ah</creator><creator>Oh, Suk Joong</creator><creator>Lee, Kyung Hee</creator><creator>Kim, Bong Seog</creator><creator>Oh, Sang Cheul</creator><creator>Kim, Sam Yong</creator><creator>Lee, Sang Jae</creator><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</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>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20100301</creationdate><title>Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial</title><author>Jang, Joung-Soon ; Lim, Ho Yeong ; Hwang, In Gyu ; Song, Hong Suk ; Yoo, NaeChoon ; Yoon, SoYoung ; Kim, Yeul Hong ; Park, Eunsik ; Byun, Jae Ho ; Lee, Myung Ah ; Oh, Suk Joong ; Lee, Kyung Hee ; Kim, Bong Seog ; Oh, Sang Cheul ; Kim, Sam Yong ; Lee, Sang Jae</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c432t-fc342d9245894c89cd8f8913840d08fd8469d46ec6032803edb0107a542e0e673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biliary Tract Neoplasms - drug therapy</topic><topic>Biliary Tract Neoplasms - pathology</topic><topic>Biological and medical sciences</topic><topic>Cancer Research</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Diarrhea - chemically induced</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Gallbladder Neoplasms - drug therapy</topic><topic>Gallbladder Neoplasms - pathology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neutropenia - chemically induced</topic><topic>Oncology</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Original Article</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Survival Analysis</topic><topic>Thrombocytopenia - chemically induced</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jang, Joung-Soon</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Hwang, In Gyu</creatorcontrib><creatorcontrib>Song, Hong Suk</creatorcontrib><creatorcontrib>Yoo, NaeChoon</creatorcontrib><creatorcontrib>Yoon, SoYoung</creatorcontrib><creatorcontrib>Kim, Yeul Hong</creatorcontrib><creatorcontrib>Park, Eunsik</creatorcontrib><creatorcontrib>Byun, Jae Ho</creatorcontrib><creatorcontrib>Lee, Myung Ah</creatorcontrib><creatorcontrib>Oh, Suk Joong</creatorcontrib><creatorcontrib>Lee, Kyung Hee</creatorcontrib><creatorcontrib>Kim, Bong Seog</creatorcontrib><creatorcontrib>Oh, Sang Cheul</creatorcontrib><creatorcontrib>Kim, Sam Yong</creatorcontrib><creatorcontrib>Lee, Sang Jae</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>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>ProQuest - Health & Medical Complete保健、医学与药学数据库</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</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)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jang, Joung-Soon</au><au>Lim, Ho Yeong</au><au>Hwang, In Gyu</au><au>Song, Hong Suk</au><au>Yoo, NaeChoon</au><au>Yoon, SoYoung</au><au>Kim, Yeul Hong</au><au>Park, Eunsik</au><au>Byun, Jae Ho</au><au>Lee, Myung Ah</au><au>Oh, Suk Joong</au><au>Lee, Kyung Hee</au><au>Kim, Bong Seog</au><au>Oh, Sang Cheul</au><au>Kim, Sam Yong</au><au>Lee, Sang Jae</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2010-03-01</date><risdate>2010</risdate><volume>65</volume><issue>4</issue><spage>641</spage><epage>647</epage><pages>641-647</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><coden>CCPHDZ</coden><abstract>Purpose
Chemotherapy represents a palliative treatment, with poor response rates and a median survival of less than 6 months in patients with biliary tract cancers (BTCs). The aim of this study was to evaluate the efficacy and safety of the combination chemotherapy with gemcitabine and oxaliplatin (GEMOX) in patients with BTCs including gall bladder cancer.
Methods
We carried out a nationwide multicenter phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTCs received gemcitabine 1,000 mg/m
2
(day 1 and 8) and oxaliplatin 100 mg/m
2
(day 1), every 3 weeks.
Results
Fifty-three patients were evaluated, 60% had cholangiocarcinoma and the remaining 40% gall bladder cancer; the objective response rate was 18.9% (10/53 patients including 1 Complete response) [14.9%; 95% confidence interval (CI), 7.4–25.7%] in the treated population. Stable disease were observed in 27/53 (50.9%) patients, disease control rate was achieved in 69.8% of all patients. Median progression-free survival was 4.8 months (3.1–6.5, 95% CI) and median overall survival was 8.3 months (5.8–10.8, 95% CI). Grade 3/4 toxicities included neutropenia (33.9% of patients) and thrombocytopenia (7.6%).
Conclusions
The GEMOX regimen demonstrated a modest antitumor activity and is well tolerated in patients with advanced BTCs.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>19652971</pmid><doi>10.1007/s00280-009-1069-7</doi><tpages>7</tpages></addata></record> |
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subjects | Adult Aged Aged, 80 and over Antineoplastic agents Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biliary Tract Neoplasms - drug therapy Biliary Tract Neoplasms - pathology Biological and medical sciences Cancer Research Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Diarrhea - chemically induced Drug Administration Schedule Female Gallbladder Neoplasms - drug therapy Gallbladder Neoplasms - pathology Gastroenterology. Liver. Pancreas. Abdomen Humans Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Medicine Medicine & Public Health Middle Aged Neutropenia - chemically induced Oncology Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - adverse effects Original Article Pharmacology. Drug treatments Pharmacology/Toxicology Survival Analysis Thrombocytopenia - chemically induced Treatment Outcome Tumors |
title | Gemcitabine and oxaliplatin in patients with unresectable biliary cancer including gall bladder cancer: a Korean Cancer Study Group phase II trial |
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