Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial
CONTEXT Among patients with locally advanced metastatic pancreatic adenocarcinoma, gemcitabine has been shown to improve outcomes compared with fluorouracil. OBJECTIVE To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2008-03, Vol.299 (9), p.1019-1026 |
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| creator | Regine, William F Winter, Kathryn A Abrams, Ross A Safran, Howard Hoffman, John P Konski, Andre Benson, Al B Macdonald, John S Kudrimoti, Mahesh R Fromm, Mitchel L Haddock, Michael G Schaefer, Paul Willett, Christopher G Rich, Tyvin A |
| description | CONTEXT Among patients with locally advanced metastatic pancreatic adenocarcinoma,
gemcitabine has been shown to improve outcomes compared with fluorouracil. OBJECTIVE To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival for patients with resected pancreatic adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma and no prior radiation or chemotherapy enrolled between July 1998 and July 2002 with follow-up through August 18, 2006, at 164 US and Canadian institutions. INTERVENTION Chemotherapy with either fluorouracil (continuous infusion of 250 mg/m2 per day; n = 230) or gemcitabine (30-minute infusion of 1000 mg/m2 once per week; n = 221)
for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy. Chemoradiation with a continuous infusion of fluorouracil (250 mg/m2 per day) was the same for all patients (50.4 Gy). MAIN OUTCOME MEASURES Survival for all patients and survival for patients with pancreatic head tumors were the primary end points. Secondary end points included toxicity. RESULTS A total of 451 patients were randomized, eligible, and analyzable.
Patients with pancreatic head tumors (n = 388) had a median survival of 20.5 months and a 3-year survival of 31% in the gemcitabine group vs a median survival of 16.9 months and a 3-year survival of 22% in the fluorouracil group (hazard ratio, 0.82 [95% confidence interval, 0.65-1.03]; P = .09).
The treatment effect was strengthened on multivariate analysis (hazard ratio, 0.80 [95% confidence interval, 0.63-1.00]; P = .05). Grade 4 hematologic toxicity was 1% in the fluorouracil group and 14% in the gemcitabine group (P 85%). CONCLUSIONS The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00003216 |
| doi_str_mv | 10.1001/jama.299.9.1019 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_journals_211413168</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>181567</ama_id><sourcerecordid>1454439231</sourcerecordid><originalsourceid>FETCH-LOGICAL-a284t-abfbe31e9c28078ae681f6d7a001791df3537992dd6e3ced98f412f6537dd3a63</originalsourceid><addsrcrecordid>eNpNkcFOGzEQhi1UVELoGfWCLCSOG3bWm127txA1tBISCME5mtjj4mjXDvaGir5SX7KmSSvm4vHom3_0zzB2CuUEyhIu19jjpFJqovIf1AEbwVTIQkyV_MBGZalk0dayPmLHKa3LHCDaj-wIpABVQzVivxfdNsSwjahdx18Sv6ZeuwFXzhOfP1EfhieKuHnlV2RDJI7e8JkdKPL3ncUVJjK7hojG4eCC54vQdeGn8z_4PSXSf2vB8jv0OlJGNJ8Z8kFj1M6HHr_wGb_PA0Lvfr2pBT_ELJHTh-iwO2GHFrtEn_bvmD0uvj7MvxU3t9ff57ObAitZDwWu7IoEkNKVLFuJ1EiwjWkxu28VGCumolWqMqYhockoafMqbJOrxghsxJid73Q3MTxvKQ3Ldbbp88hlBVCDgEZm6GwPbVc9meUmuh7j6_LfajNwsQcwaexszK5d-s9V-RTqTWzMPu-4fMp3KjBtWvEHH8qT_A</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>211413168</pqid></control><display><type>article</type><title>Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Regine, William F ; Winter, Kathryn A ; Abrams, Ross A ; Safran, Howard ; Hoffman, John P ; Konski, Andre ; Benson, Al B ; Macdonald, John S ; Kudrimoti, Mahesh R ; Fromm, Mitchel L ; Haddock, Michael G ; Schaefer, Paul ; Willett, Christopher G ; Rich, Tyvin A</creator><creatorcontrib>Regine, William F ; Winter, Kathryn A ; Abrams, Ross A ; Safran, Howard ; Hoffman, John P ; Konski, Andre ; Benson, Al B ; Macdonald, John S ; Kudrimoti, Mahesh R ; Fromm, Mitchel L ; Haddock, Michael G ; Schaefer, Paul ; Willett, Christopher G ; Rich, Tyvin A</creatorcontrib><description>CONTEXT Among patients with locally advanced metastatic pancreatic adenocarcinoma,
gemcitabine has been shown to improve outcomes compared with fluorouracil. OBJECTIVE To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival for patients with resected pancreatic adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma and no prior radiation or chemotherapy enrolled between July 1998 and July 2002 with follow-up through August 18, 2006, at 164 US and Canadian institutions. INTERVENTION Chemotherapy with either fluorouracil (continuous infusion of 250 mg/m2 per day; n = 230) or gemcitabine (30-minute infusion of 1000 mg/m2 once per week; n = 221)
for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy. Chemoradiation with a continuous infusion of fluorouracil (250 mg/m2 per day) was the same for all patients (50.4 Gy). MAIN OUTCOME MEASURES Survival for all patients and survival for patients with pancreatic head tumors were the primary end points. Secondary end points included toxicity. RESULTS A total of 451 patients were randomized, eligible, and analyzable.
Patients with pancreatic head tumors (n = 388) had a median survival of 20.5 months and a 3-year survival of 31% in the gemcitabine group vs a median survival of 16.9 months and a 3-year survival of 22% in the fluorouracil group (hazard ratio, 0.82 [95% confidence interval, 0.65-1.03]; P = .09).
The treatment effect was strengthened on multivariate analysis (hazard ratio, 0.80 [95% confidence interval, 0.63-1.00]; P = .05). Grade 4 hematologic toxicity was 1% in the fluorouracil group and 14% in the gemcitabine group (P < .001) without a difference in febrile neutropenia or infection. There were no differences in the ability to complete chemotherapy or radiation therapy (>85%). CONCLUSIONS The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00003216</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.299.9.1019</identifier><identifier>PMID: 18319412</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Adenocarcinoma - drug therapy ; Adenocarcinoma - radiotherapy ; Adenocarcinoma - surgery ; Adult ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic - therapeutic use ; Biological and medical sciences ; Chemotherapy ; Combined Modality Therapy ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Female ; Fluorouracil - therapeutic use ; Gastroenterology. Liver. Pancreas. Abdomen ; General aspects ; Humans ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Middle Aged ; Pancreatic cancer ; Pancreatic Neoplasms - drug therapy ; Pancreatic Neoplasms - radiotherapy ; Pancreatic Neoplasms - surgery ; Patients ; Radiation therapy ; Survival Analysis ; Tumors</subject><ispartof>JAMA : the journal of the American Medical Association, 2008-03, Vol.299 (9), p.1019-1026</ispartof><rights>2008 INIST-CNRS</rights><rights>Copyright American Medical Association Mar 5, 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.299.9.1019$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.299.9.1019$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20139141$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18319412$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Regine, William F</creatorcontrib><creatorcontrib>Winter, Kathryn A</creatorcontrib><creatorcontrib>Abrams, Ross A</creatorcontrib><creatorcontrib>Safran, Howard</creatorcontrib><creatorcontrib>Hoffman, John P</creatorcontrib><creatorcontrib>Konski, Andre</creatorcontrib><creatorcontrib>Benson, Al B</creatorcontrib><creatorcontrib>Macdonald, John S</creatorcontrib><creatorcontrib>Kudrimoti, Mahesh R</creatorcontrib><creatorcontrib>Fromm, Mitchel L</creatorcontrib><creatorcontrib>Haddock, Michael G</creatorcontrib><creatorcontrib>Schaefer, Paul</creatorcontrib><creatorcontrib>Willett, Christopher G</creatorcontrib><creatorcontrib>Rich, Tyvin A</creatorcontrib><title>Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT Among patients with locally advanced metastatic pancreatic adenocarcinoma,
gemcitabine has been shown to improve outcomes compared with fluorouracil. OBJECTIVE To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival for patients with resected pancreatic adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma and no prior radiation or chemotherapy enrolled between July 1998 and July 2002 with follow-up through August 18, 2006, at 164 US and Canadian institutions. INTERVENTION Chemotherapy with either fluorouracil (continuous infusion of 250 mg/m2 per day; n = 230) or gemcitabine (30-minute infusion of 1000 mg/m2 once per week; n = 221)
for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy. Chemoradiation with a continuous infusion of fluorouracil (250 mg/m2 per day) was the same for all patients (50.4 Gy). MAIN OUTCOME MEASURES Survival for all patients and survival for patients with pancreatic head tumors were the primary end points. Secondary end points included toxicity. RESULTS A total of 451 patients were randomized, eligible, and analyzable.
Patients with pancreatic head tumors (n = 388) had a median survival of 20.5 months and a 3-year survival of 31% in the gemcitabine group vs a median survival of 16.9 months and a 3-year survival of 22% in the fluorouracil group (hazard ratio, 0.82 [95% confidence interval, 0.65-1.03]; P = .09).
The treatment effect was strengthened on multivariate analysis (hazard ratio, 0.80 [95% confidence interval, 0.63-1.00]; P = .05). Grade 4 hematologic toxicity was 1% in the fluorouracil group and 14% in the gemcitabine group (P < .001) without a difference in febrile neutropenia or infection. There were no differences in the ability to complete chemotherapy or radiation therapy (>85%). CONCLUSIONS The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00003216</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - radiotherapy</subject><subject>Adenocarcinoma - surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antimetabolites, Antineoplastic - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>Combined Modality Therapy</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Female</subject><subject>Fluorouracil - therapeutic use</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>General aspects</subject><subject>Humans</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pancreatic cancer</subject><subject>Pancreatic Neoplasms - drug therapy</subject><subject>Pancreatic Neoplasms - radiotherapy</subject><subject>Pancreatic Neoplasms - surgery</subject><subject>Patients</subject><subject>Radiation therapy</subject><subject>Survival Analysis</subject><subject>Tumors</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNkcFOGzEQhi1UVELoGfWCLCSOG3bWm127txA1tBISCME5mtjj4mjXDvaGir5SX7KmSSvm4vHom3_0zzB2CuUEyhIu19jjpFJqovIf1AEbwVTIQkyV_MBGZalk0dayPmLHKa3LHCDaj-wIpABVQzVivxfdNsSwjahdx18Sv6ZeuwFXzhOfP1EfhieKuHnlV2RDJI7e8JkdKPL3ncUVJjK7hojG4eCC54vQdeGn8z_4PSXSf2vB8jv0OlJGNJ8Z8kFj1M6HHr_wGb_PA0Lvfr2pBT_ELJHTh-iwO2GHFrtEn_bvmD0uvj7MvxU3t9ff57ObAitZDwWu7IoEkNKVLFuJ1EiwjWkxu28VGCumolWqMqYhockoafMqbJOrxghsxJid73Q3MTxvKQ3Ldbbp88hlBVCDgEZm6GwPbVc9meUmuh7j6_LfajNwsQcwaexszK5d-s9V-RTqTWzMPu-4fMp3KjBtWvEHH8qT_A</recordid><startdate>20080305</startdate><enddate>20080305</enddate><creator>Regine, William F</creator><creator>Winter, Kathryn A</creator><creator>Abrams, Ross A</creator><creator>Safran, Howard</creator><creator>Hoffman, John P</creator><creator>Konski, Andre</creator><creator>Benson, Al B</creator><creator>Macdonald, John S</creator><creator>Kudrimoti, Mahesh R</creator><creator>Fromm, Mitchel L</creator><creator>Haddock, Michael G</creator><creator>Schaefer, Paul</creator><creator>Willett, Christopher G</creator><creator>Rich, Tyvin A</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>20080305</creationdate><title>Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial</title><author>Regine, William F ; Winter, Kathryn A ; Abrams, Ross A ; Safran, Howard ; Hoffman, John P ; Konski, Andre ; Benson, Al B ; Macdonald, John S ; Kudrimoti, Mahesh R ; Fromm, Mitchel L ; Haddock, Michael G ; Schaefer, Paul ; Willett, Christopher G ; Rich, Tyvin A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a284t-abfbe31e9c28078ae681f6d7a001791df3537992dd6e3ced98f412f6537dd3a63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - radiotherapy</topic><topic>Adenocarcinoma - surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antimetabolites, Antineoplastic - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy</topic><topic>Combined Modality Therapy</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Female</topic><topic>Fluorouracil - therapeutic use</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>General aspects</topic><topic>Humans</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pancreatic cancer</topic><topic>Pancreatic Neoplasms - drug therapy</topic><topic>Pancreatic Neoplasms - radiotherapy</topic><topic>Pancreatic Neoplasms - surgery</topic><topic>Patients</topic><topic>Radiation therapy</topic><topic>Survival Analysis</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Regine, William F</creatorcontrib><creatorcontrib>Winter, Kathryn A</creatorcontrib><creatorcontrib>Abrams, Ross A</creatorcontrib><creatorcontrib>Safran, Howard</creatorcontrib><creatorcontrib>Hoffman, John P</creatorcontrib><creatorcontrib>Konski, Andre</creatorcontrib><creatorcontrib>Benson, Al B</creatorcontrib><creatorcontrib>Macdonald, John S</creatorcontrib><creatorcontrib>Kudrimoti, Mahesh R</creatorcontrib><creatorcontrib>Fromm, Mitchel L</creatorcontrib><creatorcontrib>Haddock, Michael G</creatorcontrib><creatorcontrib>Schaefer, Paul</creatorcontrib><creatorcontrib>Willett, Christopher G</creatorcontrib><creatorcontrib>Rich, Tyvin A</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>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Regine, William F</au><au>Winter, Kathryn A</au><au>Abrams, Ross A</au><au>Safran, Howard</au><au>Hoffman, John P</au><au>Konski, Andre</au><au>Benson, Al B</au><au>Macdonald, John S</au><au>Kudrimoti, Mahesh R</au><au>Fromm, Mitchel L</au><au>Haddock, Michael G</au><au>Schaefer, Paul</au><au>Willett, Christopher G</au><au>Rich, Tyvin A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2008-03-05</date><risdate>2008</risdate><volume>299</volume><issue>9</issue><spage>1019</spage><epage>1026</epage><pages>1019-1026</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Among patients with locally advanced metastatic pancreatic adenocarcinoma,
gemcitabine has been shown to improve outcomes compared with fluorouracil. OBJECTIVE To determine if the addition of gemcitabine to adjuvant fluorouracil chemoradiation (chemotherapy plus radiation) improves survival for patients with resected pancreatic adenocarcinoma. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma and no prior radiation or chemotherapy enrolled between July 1998 and July 2002 with follow-up through August 18, 2006, at 164 US and Canadian institutions. INTERVENTION Chemotherapy with either fluorouracil (continuous infusion of 250 mg/m2 per day; n = 230) or gemcitabine (30-minute infusion of 1000 mg/m2 once per week; n = 221)
for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy. Chemoradiation with a continuous infusion of fluorouracil (250 mg/m2 per day) was the same for all patients (50.4 Gy). MAIN OUTCOME MEASURES Survival for all patients and survival for patients with pancreatic head tumors were the primary end points. Secondary end points included toxicity. RESULTS A total of 451 patients were randomized, eligible, and analyzable.
Patients with pancreatic head tumors (n = 388) had a median survival of 20.5 months and a 3-year survival of 31% in the gemcitabine group vs a median survival of 16.9 months and a 3-year survival of 22% in the fluorouracil group (hazard ratio, 0.82 [95% confidence interval, 0.65-1.03]; P = .09).
The treatment effect was strengthened on multivariate analysis (hazard ratio, 0.80 [95% confidence interval, 0.63-1.00]; P = .05). Grade 4 hematologic toxicity was 1% in the fluorouracil group and 14% in the gemcitabine group (P < .001) without a difference in febrile neutropenia or infection. There were no differences in the ability to complete chemotherapy or radiation therapy (>85%). CONCLUSIONS The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00003216</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>18319412</pmid><doi>10.1001/jama.299.9.1019</doi><tpages>8</tpages></addata></record> |
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| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2008-03, Vol.299 (9), p.1019-1026 |
| issn | 0098-7484 1538-3598 |
| language | eng |
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| source | MEDLINE; American Medical Association Journals |
| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - radiotherapy Adenocarcinoma - surgery Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic - therapeutic use Biological and medical sciences Chemotherapy Combined Modality Therapy Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Female Fluorouracil - therapeutic use Gastroenterology. Liver. Pancreas. Abdomen General aspects Humans Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged Pancreatic cancer Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - radiotherapy Pancreatic Neoplasms - surgery Patients Radiation therapy Survival Analysis Tumors |
| title | Fluorouracil vs Gemcitabine Chemotherapy Before and After Fluorouracil-Based Chemoradiation Following Resection of Pancreatic Adenocarcinoma: A Randomized Controlled Trial |
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