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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
Main Authors: 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
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cited_by cdi_FETCH-LOGICAL-c432t-fc342d9245894c89cd8f8913840d08fd8469d46ec6032803edb0107a542e0e673
cites cdi_FETCH-LOGICAL-c432t-fc342d9245894c89cd8f8913840d08fd8469d46ec6032803edb0107a542e0e673
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
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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 &amp; dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs &amp; 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 &amp; Public Health ; Middle Aged ; Neutropenia - chemically induced ; Oncology ; Organoplatinum Compounds - administration &amp; dosage ; Organoplatinum Compounds - adverse effects ; Original Article ; Pharmacology. 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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 &amp; dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs &amp; 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. 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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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ispartof Cancer chemotherapy and pharmacology, 2010-03, Vol.65 (4), p.641-647
issn 0344-5704
1432-0843
language eng
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source Springer Link
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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