A Randomized Consent Design Trial of Neoadjuvant Chemotherapy with Tegafur Plus Uracil (UFT) for Gastric Cancer - A Single Institute Study
Objective: Various forms of neoadjuvant chemotherapy (NAC) have been applied in the treatment of gastric cancer. The present study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized consent trial as described by Zelen. Patients and...
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Veröffentlicht in: | Anticancer research 2004-05, Vol.24 (3B), p.1879-1887 |
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creator | NIO, Yoshinori KOIKE, Makoto OMORI, Hiroshi HASHIMOTO, Koji ITAKURA, Masayuki YANO, Seiji HIGAMI, Tetsuya MARUYAMA, Riruke |
description | Objective: Various forms of neoadjuvant chemotherapy (NAC) have been applied in the treatment of gastric cancer. The present
study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized
consent trial as described by Zelen. Patients and Methods: The present study included 295 patients with resectable gastric
cancer between 1991 and 1999. After the patients had been pre-randomized into two groups, a control (no-NAC) group (n=120)
and a treatment group (n=175), the treatment group patients were then further stratified into two groups, namely those who
wished to join the control group and those who wished to receive NAC with UFT (NAC-UFT group). Patient outcome was surveyed
in January 2003. Results: Randomization did not necessarily result in an appropriate registration of the patients, and ultimately
193 patients were included in the control group and 102 patients received NAC-UFT. The NAC-UFT was well tolerated by the patients
and side-effects were not severe. However, the NAC-UFT group included the patients with significantly higher stages of cancers
than the control group. The survival benefit of NAC-UFT was seen in stage 2 or 3 patients, and multivariate analysis also
revealed that NAC-UFT was a significant prognostic variable, as were pT, pN, M and the level of nodal dissection, but patient
age, gender and histological grade were not significant variables. Conclusion: NAC-UFT may be beneficial in the improvement
of survival rate after gastric cancer surgery and this treatment modality is worthy of further study with a larger patient
sample size. |
format | Article |
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study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized
consent trial as described by Zelen. Patients and Methods: The present study included 295 patients with resectable gastric
cancer between 1991 and 1999. After the patients had been pre-randomized into two groups, a control (no-NAC) group (n=120)
and a treatment group (n=175), the treatment group patients were then further stratified into two groups, namely those who
wished to join the control group and those who wished to receive NAC with UFT (NAC-UFT group). Patient outcome was surveyed
in January 2003. Results: Randomization did not necessarily result in an appropriate registration of the patients, and ultimately
193 patients were included in the control group and 102 patients received NAC-UFT. The NAC-UFT was well tolerated by the patients
and side-effects were not severe. However, the NAC-UFT group included the patients with significantly higher stages of cancers
than the control group. The survival benefit of NAC-UFT was seen in stage 2 or 3 patients, and multivariate analysis also
revealed that NAC-UFT was a significant prognostic variable, as were pT, pN, M and the level of nodal dissection, but patient
age, gender and histological grade were not significant variables. Conclusion: NAC-UFT may be beneficial in the improvement
of survival rate after gastric cancer surgery and this treatment modality is worthy of further study with a larger patient
sample size.</description><identifier>ISSN: 0250-7005</identifier><identifier>EISSN: 1791-7530</identifier><identifier>PMID: 15274369</identifier><language>eng</language><publisher>Attiki: International Institute of Anticancer Research</publisher><subject>Aged ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Informed Consent ; Male ; Medical sciences ; Middle Aged ; Multivariate Analysis ; Neoadjuvant Therapy ; Prospective Studies ; Randomized Controlled Trials as Topic - ethics ; Randomized Controlled Trials as Topic - methods ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - surgery ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Survival Rate ; Tegafur - administration & dosage ; Tumors ; Uracil - administration & dosage</subject><ispartof>Anticancer research, 2004-05, Vol.24 (3B), p.1879-1887</ispartof><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15963854$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15274369$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>NIO, Yoshinori</creatorcontrib><creatorcontrib>KOIKE, Makoto</creatorcontrib><creatorcontrib>OMORI, Hiroshi</creatorcontrib><creatorcontrib>HASHIMOTO, Koji</creatorcontrib><creatorcontrib>ITAKURA, Masayuki</creatorcontrib><creatorcontrib>YANO, Seiji</creatorcontrib><creatorcontrib>HIGAMI, Tetsuya</creatorcontrib><creatorcontrib>MARUYAMA, Riruke</creatorcontrib><title>A Randomized Consent Design Trial of Neoadjuvant Chemotherapy with Tegafur Plus Uracil (UFT) for Gastric Cancer - A Single Institute Study</title><title>Anticancer research</title><addtitle>Anticancer Res</addtitle><description>Objective: Various forms of neoadjuvant chemotherapy (NAC) have been applied in the treatment of gastric cancer. The present
study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized
consent trial as described by Zelen. Patients and Methods: The present study included 295 patients with resectable gastric
cancer between 1991 and 1999. After the patients had been pre-randomized into two groups, a control (no-NAC) group (n=120)
and a treatment group (n=175), the treatment group patients were then further stratified into two groups, namely those who
wished to join the control group and those who wished to receive NAC with UFT (NAC-UFT group). Patient outcome was surveyed
in January 2003. Results: Randomization did not necessarily result in an appropriate registration of the patients, and ultimately
193 patients were included in the control group and 102 patients received NAC-UFT. The NAC-UFT was well tolerated by the patients
and side-effects were not severe. However, the NAC-UFT group included the patients with significantly higher stages of cancers
than the control group. The survival benefit of NAC-UFT was seen in stage 2 or 3 patients, and multivariate analysis also
revealed that NAC-UFT was a significant prognostic variable, as were pT, pN, M and the level of nodal dissection, but patient
age, gender and histological grade were not significant variables. Conclusion: NAC-UFT may be beneficial in the improvement
of survival rate after gastric cancer surgery and this treatment modality is worthy of further study with a larger patient
sample size.</description><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Informed Consent</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Neoadjuvant Therapy</subject><subject>Prospective Studies</subject><subject>Randomized Controlled Trials as Topic - ethics</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - surgery</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>Survival Rate</subject><subject>Tegafur - administration & dosage</subject><subject>Tumors</subject><subject>Uracil - administration & dosage</subject><issn>0250-7005</issn><issn>1791-7530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpNkM1u1EAQhC0EIkvgFVBfQHCwNOP5sX1cHBIiRYDI7tlqe3rWE43tZWZMtDwCT40lFsGl69CfqlT1JNvwsuZ5qQR7mm1YoVheMqYushcxPjCmdV2J59kFV0Upha432a8tfMPJzKP7SQaaeYo0Jbii6A4T7IJDD7OFzzSjeVh-4PprBhrnNFDA4wkeXRpgRwe0S4CvfomwD9g7D-_217v3YOcANxhTcD00OPUUIIct3Lvp4Alup5hcWhLBfVrM6WX2zKKP9Oqsl9n--uOu-ZTffbm5bbZ3-VDoKuWG1YYXjDpUSiitq15KW3HLZMUVWSqY6qzhxNZbd0p0va2M7HvJjUZRMnGZvf3jewzz94ViakcXe_IeJ5qX2Gq9biOFWsHXZ3DpRjLtMbgRw6n9u94KvDkDGHv0NqwVXfyPq7WolPyXOLjD8OgCtXFE71db0WIoZCs-tLwqa_EbG5eG6g</recordid><startdate>20040501</startdate><enddate>20040501</enddate><creator>NIO, Yoshinori</creator><creator>KOIKE, Makoto</creator><creator>OMORI, Hiroshi</creator><creator>HASHIMOTO, Koji</creator><creator>ITAKURA, Masayuki</creator><creator>YANO, Seiji</creator><creator>HIGAMI, Tetsuya</creator><creator>MARUYAMA, Riruke</creator><general>International Institute of Anticancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20040501</creationdate><title>A Randomized Consent Design Trial of Neoadjuvant Chemotherapy with Tegafur Plus Uracil (UFT) for Gastric Cancer - A Single Institute Study</title><author>NIO, Yoshinori ; KOIKE, Makoto ; OMORI, Hiroshi ; HASHIMOTO, Koji ; ITAKURA, Masayuki ; YANO, Seiji ; HIGAMI, Tetsuya ; MARUYAMA, Riruke</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-h268t-d09d120eba5535668c44f81f04815efe205bfd1e0bfd9b53bcf8d4cc41d6a3703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Informed Consent</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Neoadjuvant Therapy</topic><topic>Prospective Studies</topic><topic>Randomized Controlled Trials as Topic - ethics</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - surgery</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>Survival Rate</topic><topic>Tegafur - administration & dosage</topic><topic>Tumors</topic><topic>Uracil - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>NIO, Yoshinori</creatorcontrib><creatorcontrib>KOIKE, Makoto</creatorcontrib><creatorcontrib>OMORI, Hiroshi</creatorcontrib><creatorcontrib>HASHIMOTO, Koji</creatorcontrib><creatorcontrib>ITAKURA, Masayuki</creatorcontrib><creatorcontrib>YANO, Seiji</creatorcontrib><creatorcontrib>HIGAMI, Tetsuya</creatorcontrib><creatorcontrib>MARUYAMA, Riruke</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>MEDLINE - Academic</collection><jtitle>Anticancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>NIO, Yoshinori</au><au>KOIKE, Makoto</au><au>OMORI, Hiroshi</au><au>HASHIMOTO, Koji</au><au>ITAKURA, Masayuki</au><au>YANO, Seiji</au><au>HIGAMI, Tetsuya</au><au>MARUYAMA, Riruke</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Consent Design Trial of Neoadjuvant Chemotherapy with Tegafur Plus Uracil (UFT) for Gastric Cancer - A Single Institute Study</atitle><jtitle>Anticancer research</jtitle><addtitle>Anticancer Res</addtitle><date>2004-05-01</date><risdate>2004</risdate><volume>24</volume><issue>3B</issue><spage>1879</spage><epage>1887</epage><pages>1879-1887</pages><issn>0250-7005</issn><eissn>1791-7530</eissn><abstract>Objective: Various forms of neoadjuvant chemotherapy (NAC) have been applied in the treatment of gastric cancer. The present
study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized
consent trial as described by Zelen. Patients and Methods: The present study included 295 patients with resectable gastric
cancer between 1991 and 1999. After the patients had been pre-randomized into two groups, a control (no-NAC) group (n=120)
and a treatment group (n=175), the treatment group patients were then further stratified into two groups, namely those who
wished to join the control group and those who wished to receive NAC with UFT (NAC-UFT group). Patient outcome was surveyed
in January 2003. Results: Randomization did not necessarily result in an appropriate registration of the patients, and ultimately
193 patients were included in the control group and 102 patients received NAC-UFT. The NAC-UFT was well tolerated by the patients
and side-effects were not severe. However, the NAC-UFT group included the patients with significantly higher stages of cancers
than the control group. The survival benefit of NAC-UFT was seen in stage 2 or 3 patients, and multivariate analysis also
revealed that NAC-UFT was a significant prognostic variable, as were pT, pN, M and the level of nodal dissection, but patient
age, gender and histological grade were not significant variables. Conclusion: NAC-UFT may be beneficial in the improvement
of survival rate after gastric cancer surgery and this treatment modality is worthy of further study with a larger patient
sample size.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>15274369</pmid><tpages>9</tpages></addata></record> |
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source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
subjects | Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Female Gastroenterology. Liver. Pancreas. Abdomen Humans Informed Consent Male Medical sciences Middle Aged Multivariate Analysis Neoadjuvant Therapy Prospective Studies Randomized Controlled Trials as Topic - ethics Randomized Controlled Trials as Topic - methods Stomach Neoplasms - drug therapy Stomach Neoplasms - surgery Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Survival Rate Tegafur - administration & dosage Tumors Uracil - administration & dosage |
title | A Randomized Consent Design Trial of Neoadjuvant Chemotherapy with Tegafur Plus Uracil (UFT) for Gastric Cancer - A Single Institute Study |
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