Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG
Background: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil + adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm. Patients and methods: This report is a prospect...
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| Veröffentlicht in: | Annals of oncology 2006-02, Vol.17 (2), p.262-269 |
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| creator | Nitti, D. Wils, J. Dos Santos, J. Guimaraes Fountzilas, G. Conte, P.F. Sava, C. Tres, A. Coombes, R.C. Crivellari, D. Marchet, A. Sanchez, E. Bliss, J.M. Homewood, J. Couvreur, M.L. Hall, E. Baron, B. Woods, E. Emson, M. Van Cutsem, E. Lise, M. |
| description | Background: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil + adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm.
Patients and methods: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan–Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.
Results: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P = 0.87) or OS (hazards ratio: 0.98, P = 0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.
Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer. |
| doi_str_mv | 10.1093/annonc/mdj077 |
| format | Article |
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Patients and methods: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan–Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.
Results: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P = 0.87) or OS (hazards ratio: 0.98, P = 0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.
Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdj077</identifier><identifier>PMID: 16293676</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject><![CDATA[Adenocarcinoma - drug therapy ; Adenocarcinoma - surgery ; adjuvant chemotherapy ; Adult ; Aged ; Antineoplastic agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Biological and medical sciences ; Chemotherapy, Adjuvant ; Clinical Trials, Phase III as Topic ; Combined Modality Therapy ; Disease-Free Survival ; Doxorubicin - administration & dosage ; Epirubicin - administration & dosage ; FAMTX ; Female ; FEMTX ; Fluorouracil - administration & dosage ; gastric cancer ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Male ; Medical sciences ; Methotrexate - administration & dosage ; Middle Aged ; Pharmacology. Drug treatments ; Randomized Controlled Trials as Topic ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - surgery ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Analysis ; Tumors]]></subject><ispartof>Annals of oncology, 2006-02, Vol.17 (2), p.262-269</ispartof><rights>2005 European Society for Medical Oncology</rights><rights>2006 INIST-CNRS</rights><rights>Copyright Oxford University Press(England) Feb 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c473t-a7e7bbd706667312ff2057858f43746544ae1accb95611d4e732d4f0746d4b983</citedby><cites>FETCH-LOGICAL-c473t-a7e7bbd706667312ff2057858f43746544ae1accb95611d4e732d4f0746d4b983</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17508961$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16293676$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nitti, D.</creatorcontrib><creatorcontrib>Wils, J.</creatorcontrib><creatorcontrib>Dos Santos, J. Guimaraes</creatorcontrib><creatorcontrib>Fountzilas, G.</creatorcontrib><creatorcontrib>Conte, P.F.</creatorcontrib><creatorcontrib>Sava, C.</creatorcontrib><creatorcontrib>Tres, A.</creatorcontrib><creatorcontrib>Coombes, R.C.</creatorcontrib><creatorcontrib>Crivellari, D.</creatorcontrib><creatorcontrib>Marchet, A.</creatorcontrib><creatorcontrib>Sanchez, E.</creatorcontrib><creatorcontrib>Bliss, J.M.</creatorcontrib><creatorcontrib>Homewood, J.</creatorcontrib><creatorcontrib>Couvreur, M.L.</creatorcontrib><creatorcontrib>Hall, E.</creatorcontrib><creatorcontrib>Baron, B.</creatorcontrib><creatorcontrib>Woods, E.</creatorcontrib><creatorcontrib>Emson, M.</creatorcontrib><creatorcontrib>Van Cutsem, E.</creatorcontrib><creatorcontrib>Lise, M.</creatorcontrib><creatorcontrib>EORTC GI Group</creatorcontrib><creatorcontrib>ICCG</creatorcontrib><title>Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Background: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil + adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm.
Patients and methods: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan–Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.
Results: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P = 0.87) or OS (hazards ratio: 0.98, P = 0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.
Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.</description><subject>Adenocarcinoma - drug therapy</subject><subject>Adenocarcinoma - surgery</subject><subject>adjuvant chemotherapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy, Adjuvant</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Combined Modality Therapy</subject><subject>Disease-Free Survival</subject><subject>Doxorubicin - administration & dosage</subject><subject>Epirubicin - administration & dosage</subject><subject>FAMTX</subject><subject>Female</subject><subject>FEMTX</subject><subject>Fluorouracil - administration & dosage</subject><subject>gastric cancer</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Methotrexate - administration & dosage</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - surgery</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Survival Analysis</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kVFr2zAUhc3YWNNuj3sdYrC-uZUsW7IfQ0hSQ0ahZKXkRciS3CizJU-yu2X_Z_9zShwWGOxJQue7517dE0UfELxBsMC33BhrxG0rd5DSV9EEZaSIc5ii19EEFgmOaYbTi-jS-x2EkBRJ8Ta6QCQpMKFkEv1-4EbaVv9SEnRb7hUoyxL0TvPGA1sDLnfDCzc9WEy_rJ-AdWAxP1yEbTvuQtEP3W-BH9yzcnvAG2sU0AY45ZXog_zMfTATQHAjlLsB00NlpU2QuOHN3utjm36rwPz-YT0DyxIsnR26IMvjczmbLd9Fb-owkHp_Oq-ir4v5enYXr-6X5Wy6ikVKcR9zqmhVSQoJIRSjpK4TmNE8y-sU05RkacoV4kJURUYQkqmiOJFpDYMm06rI8VV0Pfp2zn4flO9Zq71QTcONsoNnwTnPCYYB_PQPuLODCx_yDBWE4BwdoXiEhLPeO1WzzumWuz1DkB3CY2N4bAwv8B9PpkPVKnmmT2kF4PMJ4F7wpnZhqdqfOZrBvCDo3Fj7Xv38q3P3jYW90IzdPW3Y42aVLB83iOHA05FXYbcvWjnmhVYhMKldiJFJq_8z8h-aX8Wn</recordid><startdate>20060201</startdate><enddate>20060201</enddate><creator>Nitti, D.</creator><creator>Wils, J.</creator><creator>Dos Santos, J. Guimaraes</creator><creator>Fountzilas, G.</creator><creator>Conte, P.F.</creator><creator>Sava, C.</creator><creator>Tres, A.</creator><creator>Coombes, R.C.</creator><creator>Crivellari, D.</creator><creator>Marchet, A.</creator><creator>Sanchez, E.</creator><creator>Bliss, J.M.</creator><creator>Homewood, J.</creator><creator>Couvreur, M.L.</creator><creator>Hall, E.</creator><creator>Baron, B.</creator><creator>Woods, E.</creator><creator>Emson, M.</creator><creator>Van Cutsem, E.</creator><creator>Lise, M.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>6I.</scope><scope>AAFTH</scope><scope>BSCLL</scope><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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>20060201</creationdate><title>Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG</title><author>Nitti, D. ; Wils, J. ; Dos Santos, J. Guimaraes ; Fountzilas, G. ; Conte, P.F. ; Sava, C. ; Tres, A. ; Coombes, R.C. ; Crivellari, D. ; Marchet, A. ; Sanchez, E. ; Bliss, J.M. ; Homewood, J. ; Couvreur, M.L. ; Hall, E. ; Baron, B. ; Woods, E. ; Emson, M. ; Van Cutsem, E. ; Lise, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-a7e7bbd706667312ff2057858f43746544ae1accb95611d4e732d4f0746d4b983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - surgery</topic><topic>adjuvant chemotherapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Biological and medical sciences</topic><topic>Chemotherapy, Adjuvant</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Combined Modality Therapy</topic><topic>Disease-Free Survival</topic><topic>Doxorubicin - administration & dosage</topic><topic>Epirubicin - administration & dosage</topic><topic>FAMTX</topic><topic>Female</topic><topic>FEMTX</topic><topic>Fluorouracil - administration & dosage</topic><topic>gastric cancer</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Methotrexate - administration & dosage</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - surgery</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Survival Analysis</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nitti, D.</creatorcontrib><creatorcontrib>Wils, J.</creatorcontrib><creatorcontrib>Dos Santos, J. 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Guimaraes</au><au>Fountzilas, G.</au><au>Conte, P.F.</au><au>Sava, C.</au><au>Tres, A.</au><au>Coombes, R.C.</au><au>Crivellari, D.</au><au>Marchet, A.</au><au>Sanchez, E.</au><au>Bliss, J.M.</au><au>Homewood, J.</au><au>Couvreur, M.L.</au><au>Hall, E.</au><au>Baron, B.</au><au>Woods, E.</au><au>Emson, M.</au><au>Van Cutsem, E.</au><au>Lise, M.</au><aucorp>EORTC GI Group</aucorp><aucorp>ICCG</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2006-02-01</date><risdate>2006</risdate><volume>17</volume><issue>2</issue><spage>262</spage><epage>269</epage><pages>262-269</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Background: In patients who underwent radical resection for gastric cancer, we investigate the relative efficacy of combined 5-fluorouracil + adriamycin or epirubicin and methotrexate with leucovorin rescue (FAMTX or FEMTX) compared with a control arm.
Patients and methods: This report is a prospective combined analysis of two randomized clinical trials conducted on patients who underwent radical resection for histologically proven adenocarcinoma of the stomach or esophago-gastric junction. Three hundred and ninety-seven untreated patients, 206 from 23 European Organization for Research and Treatment of Cancer (EORTC) institutions and 191 from 16 International Collaborative Cancer Group (ICCG) institutions, were randomized. Overall survival (OS) and disease-free survival (DFS) were estimated using the Kaplan–Meier method and the treatments were compared for these end-points by means of the log-rank test, retrospectively stratified by trial.
Results: In a planned combined analysis of the two trials, no significant differences were found between the treatment and control arms for either DFS (hazards ratio: 0.98, P = 0.87) or OS (hazards ratio: 0.98, P = 0.86). The 5-year OS was 43% in the treatment arm and 44% in the control arm and the 5-year DFS was 41% and 42%, respectively.
Conclusion: Neither FAMTX nor FEMTX can be advocated as adjuvant treatment in patients who undergo resection for gastric cancer.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>16293676</pmid><doi>10.1093/annonc/mdj077</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Annals of oncology, 2006-02, Vol.17 (2), p.262-269 |
| issn | 0923-7534 1569-8041 |
| language | eng |
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| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adenocarcinoma - drug therapy Adenocarcinoma - surgery adjuvant chemotherapy Adult Aged Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Combined Chemotherapy Protocols - administration & dosage Biological and medical sciences Chemotherapy, Adjuvant Clinical Trials, Phase III as Topic Combined Modality Therapy Disease-Free Survival Doxorubicin - administration & dosage Epirubicin - administration & dosage FAMTX Female FEMTX Fluorouracil - administration & dosage gastric cancer Gastroenterology. Liver. Pancreas. Abdomen Humans Male Medical sciences Methotrexate - administration & dosage Middle Aged Pharmacology. Drug treatments Randomized Controlled Trials as Topic Stomach Neoplasms - drug therapy Stomach Neoplasms - surgery Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Analysis Tumors |
| title | Randomized phase III trials of adjuvant FAMTX or FEMTX compared with surgery alone in resected gastric cancer. A combined analysis of the EORTC GI Group and the ICCG |
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