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Multi‐Institutional Phase II Study of S‐1 Monotherapy in Advanced Gastric Cancer with Pharmacokinetic and Pharmacogenomic Evaluations

This study describes the first phase II study of S‐1, a novel oral fluoropyrimidine, in a non‐Japanese Asian population with advanced gastric cancer. S‐1 was administered twice daily for 28 days every 6 weeks. A pharmacokinetic study was performed on day 28 of cycles 1 and 3. Genomic DNA from periph...

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Published in:The oncologist (Dayton, Ohio) Ohio), 2007-05, Vol.12 (5), p.543-554
Main Authors: Jeung, Hei‐Cheul, Rha, Sun Young, Kim, Hoon Kyo, Lim, Ho Young, Kim, Samyong, Kim, Si Young, Gong, Soo Jeong, Park, Chan Hee, Ahn, Joong Bae, Noh, Sung Hoon, Chung, Hyun Cheol
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cited_by cdi_FETCH-LOGICAL-c4813-78ada5fae83037a6ab71f718b02daf31ed773504df83c1290f185240b115c57c3
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container_title The oncologist (Dayton, Ohio)
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creator Jeung, Hei‐Cheul
Rha, Sun Young
Kim, Hoon Kyo
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Ahn, Joong Bae
Noh, Sung Hoon
Chung, Hyun Cheol
description This study describes the first phase II study of S‐1, a novel oral fluoropyrimidine, in a non‐Japanese Asian population with advanced gastric cancer. S‐1 was administered twice daily for 28 days every 6 weeks. A pharmacokinetic study was performed on day 28 of cycles 1 and 3. Genomic DNA from peripheral mononuclear cells was analyzed using a cDNA microarray‐based comparative genomic hybridization (CGH) method. Thirty‐one patients were initially given a dose of 35 mg/m2 twice daily (bid) (group 1); then, the protocol was amended by increasing the dose to 40 mg/m2 bid for an additional 31 patients (group 2) because of good tolerability to S‐1. The overall response rate was 19.3% (95% confidence interval, 9.2%–29.5%). Over a median follow‐up duration of 265 days, the median time to progression and overall survival time were 126 and 264 days, respectively. The 1‐year survival rate was 34%. There was no grade 4 toxicity and the major adverse event was anemia. Pharmacokinetic parameters were similar to those of the previous Japanese reports. Microarray CGH identified 18 genes with copy number changes that were associated with hemoglobin reduction with S‐1 treatment. A logistic regression analysis, integrating one clinical parameter (initial hemoglobin level) combined with three genetic copy number variations (HIST1H2BL, C10orf127, and XPNPEP2), provided a predictive model for the development of severe hemoglobin reduction. In conclusion, this study showed the feasibility of using S‐1 at 35 mg/m2 bid in gastric cancer. We suggest that the pharmacogenomic markers identified in this study may be potential candidates for predicting anemia after S‐1 treatment. Disclosure of potential conflicts of interest is found at the end of this article.
doi_str_mv 10.1634/theoncologist.12-5-543
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Microarray CGH identified 18 genes with copy number changes that were associated with hemoglobin reduction with S‐1 treatment. A logistic regression analysis, integrating one clinical parameter (initial hemoglobin level) combined with three genetic copy number variations (HIST1H2BL, C10orf127, and XPNPEP2), provided a predictive model for the development of severe hemoglobin reduction. In conclusion, this study showed the feasibility of using S‐1 at 35 mg/m2 bid in gastric cancer. We suggest that the pharmacogenomic markers identified in this study may be potential candidates for predicting anemia after S‐1 treatment. 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Microarray CGH identified 18 genes with copy number changes that were associated with hemoglobin reduction with S‐1 treatment. A logistic regression analysis, integrating one clinical parameter (initial hemoglobin level) combined with three genetic copy number variations (HIST1H2BL, C10orf127, and XPNPEP2), provided a predictive model for the development of severe hemoglobin reduction. In conclusion, this study showed the feasibility of using S‐1 at 35 mg/m2 bid in gastric cancer. We suggest that the pharmacogenomic markers identified in this study may be potential candidates for predicting anemia after S‐1 treatment. 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Rha, Sun Young ; Kim, Hoon Kyo ; Lim, Ho Young ; Kim, Samyong ; Kim, Si Young ; Gong, Soo Jeong ; Park, Chan Hee ; Ahn, Joong Bae ; Noh, Sung Hoon ; Chung, Hyun Cheol</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4813-78ada5fae83037a6ab71f718b02daf31ed773504df83c1290f185240b115c57c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adenocarcinoma - drug therapy</topic><topic>Adenocarcinoma - genetics</topic><topic>Adult</topic><topic>Advanced gastric cancer</topic><topic>Aged</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>Antimetabolites, Antineoplastic - pharmacokinetics</topic><topic>Antimetabolites, Antineoplastic - therapeutic use</topic><topic>Area Under Curve</topic><topic>Asian Continental Ancestry Group - genetics</topic><topic>Body Surface Area</topic><topic>DNA, Neoplasm - analysis</topic><topic>DNA, Neoplasm - drug effects</topic><topic>DNA, Neoplasm - genetics</topic><topic>Drug Combinations</topic><topic>Drug Evaluation</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hemoglobins - drug effects</topic><topic>Hemoglobins - metabolism</topic><topic>Humans</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nucleic Acid Hybridization</topic><topic>Oligonucleotide Array Sequence Analysis</topic><topic>Oxonic Acid - adverse effects</topic><topic>Oxonic Acid - pharmacokinetics</topic><topic>Oxonic Acid - therapeutic use</topic><topic>Pharmacogenetics</topic><topic>Pharmacogenomics</topic><topic>Pharmacokinetics</topic><topic>Predictive marker</topic><topic>Predictive Value of Tests</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - genetics</topic><topic>Survival Analysis</topic><topic>S‐1</topic><topic>Tegafur - adverse effects</topic><topic>Tegafur - pharmacokinetics</topic><topic>Tegafur - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Jeung, Hei‐Cheul</creatorcontrib><creatorcontrib>Rha, Sun Young</creatorcontrib><creatorcontrib>Kim, Hoon Kyo</creatorcontrib><creatorcontrib>Lim, Ho Young</creatorcontrib><creatorcontrib>Kim, Samyong</creatorcontrib><creatorcontrib>Kim, Si Young</creatorcontrib><creatorcontrib>Gong, Soo Jeong</creatorcontrib><creatorcontrib>Park, Chan Hee</creatorcontrib><creatorcontrib>Ahn, Joong Bae</creatorcontrib><creatorcontrib>Noh, Sung Hoon</creatorcontrib><creatorcontrib>Chung, Hyun Cheol</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>The oncologist (Dayton, Ohio)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Jeung, Hei‐Cheul</au><au>Rha, Sun Young</au><au>Kim, Hoon Kyo</au><au>Lim, Ho Young</au><au>Kim, Samyong</au><au>Kim, Si Young</au><au>Gong, Soo Jeong</au><au>Park, Chan Hee</au><au>Ahn, Joong Bae</au><au>Noh, Sung Hoon</au><au>Chung, Hyun Cheol</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multi‐Institutional Phase II Study of S‐1 Monotherapy in Advanced Gastric Cancer with Pharmacokinetic and Pharmacogenomic Evaluations</atitle><jtitle>The oncologist (Dayton, Ohio)</jtitle><addtitle>Oncologist</addtitle><date>2007-05</date><risdate>2007</risdate><volume>12</volume><issue>5</issue><spage>543</spage><epage>554</epage><pages>543-554</pages><issn>1083-7159</issn><eissn>1549-490X</eissn><abstract>This study describes the first phase II study of S‐1, a novel oral fluoropyrimidine, in a non‐Japanese Asian population with advanced gastric cancer. 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Microarray CGH identified 18 genes with copy number changes that were associated with hemoglobin reduction with S‐1 treatment. A logistic regression analysis, integrating one clinical parameter (initial hemoglobin level) combined with three genetic copy number variations (HIST1H2BL, C10orf127, and XPNPEP2), provided a predictive model for the development of severe hemoglobin reduction. In conclusion, this study showed the feasibility of using S‐1 at 35 mg/m2 bid in gastric cancer. We suggest that the pharmacogenomic markers identified in this study may be potential candidates for predicting anemia after S‐1 treatment. Disclosure of potential conflicts of interest is found at the end of this article.</abstract><cop>Durham, NC, USA</cop><pub>AlphaMed Press</pub><pmid>17522242</pmid><doi>10.1634/theoncologist.12-5-543</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Adenocarcinoma - drug therapy
Adenocarcinoma - genetics
Adult
Advanced gastric cancer
Aged
Antimetabolites, Antineoplastic - adverse effects
Antimetabolites, Antineoplastic - pharmacokinetics
Antimetabolites, Antineoplastic - therapeutic use
Area Under Curve
Asian Continental Ancestry Group - genetics
Body Surface Area
DNA, Neoplasm - analysis
DNA, Neoplasm - drug effects
DNA, Neoplasm - genetics
Drug Combinations
Drug Evaluation
Feasibility Studies
Female
Follow-Up Studies
Hemoglobins - drug effects
Hemoglobins - metabolism
Humans
Logistic Models
Male
Middle Aged
Nucleic Acid Hybridization
Oligonucleotide Array Sequence Analysis
Oxonic Acid - adverse effects
Oxonic Acid - pharmacokinetics
Oxonic Acid - therapeutic use
Pharmacogenetics
Pharmacogenomics
Pharmacokinetics
Predictive marker
Predictive Value of Tests
Stomach Neoplasms - drug therapy
Stomach Neoplasms - genetics
Survival Analysis
S‐1
Tegafur - adverse effects
Tegafur - pharmacokinetics
Tegafur - therapeutic use
Treatment Outcome
title Multi‐Institutional Phase II Study of S‐1 Monotherapy in Advanced Gastric Cancer with Pharmacokinetic and Pharmacogenomic Evaluations
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