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
Hauptverfasser: NIO, Yoshinori, KOIKE, Makoto, OMORI, Hiroshi, HASHIMOTO, Koji, ITAKURA, Masayuki, YANO, Seiji, HIGAMI, Tetsuya, MARUYAMA, Riruke
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container_end_page 1887
container_issue 3B
container_start_page 1879
container_title Anticancer research
container_volume 24
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.
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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><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 &amp; 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. 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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 &amp; 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 &amp; dosage</subject><subject>Tumors</subject><subject>Uracil - administration &amp; 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 &amp; 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 &amp; dosage</topic><topic>Tumors</topic><topic>Uracil - administration &amp; 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. 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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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