AustralieFrV1, PascalFrancis, Curation, bibRecord, 002A61

Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Identifieur interne : 002A61 ( PascalFrancis/Curation ); précédent : 002A60; suivant : 002A62

Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Auteurs : Daniel G. Holler [États-Unis, Royaume-Uni, Australie, Belgique, Allemagne, France, Suède, Espagne, Suisse] ; Jim Cassidy ; Stephen J. Clarke ; David Cunningham ; Eric Van Cutsem ; Paulo M. Hoff ; Mace L. Rothenberg ; Leonard B. Saltz ; Hans-Joachim Schmoll ; Carmen Allegra ; Joseph R. Bertino ; Jean-Yves Douillard ; Bengt G. Gustavsson ; Gerard Milano ; Michael O'Connell ; Youcef Rustum ; Josep Tabernero ; Frank Gilberg ; Florin Sirzen ; Chris Twelves

Source :

Journal of clinical oncology [ 0732-183X ] ; 2008.

RBID : Pascal:08-0248546

Descripteurs français

Pascal (Inist)
- Variation géographique, Cancérologie.

English descriptors

KwdEn :
- Cancerology, Geographical variation.

Abstract

Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.

A01	`01`	`1`		`@0 0732-183X`
A03		`1`		`@0 J. clin. oncol.`
A05				`@2 26`
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A08	`01`	`1`	`ENG`	`@1 Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines`
A11	`01`	`1`		`@1 HOLLER (Daniel G.)`
A11	`02`	`1`		`@1 CASSIDY (Jim)`
A11	`03`	`1`		`@1 CLARKE (Stephen J.)`
A11	`04`	`1`		`@1 CUNNINGHAM (David)`
A11	`05`	`1`		`@1 VAN CUTSEM (Eric)`
A11	`06`	`1`		`@1 HOFF (Paulo M.)`
A11	`07`	`1`		`@1 ROTHENBERG (Mace L.)`
A11	`08`	`1`		`@1 SALTZ (Leonard B.)`
A11	`09`	`1`		`@1 SCHMOLL (Hans-Joachim)`
A11	`10`	`1`		`@1 ALLEGRA (Carmen)`
A11	`11`	`1`		`@1 BERTINO (Joseph R.)`
A11	`12`	`1`		`@1 DOUILLARD (Jean-Yves)`
A11	`13`	`1`		`@1 GUSTAVSSON (Bengt G.)`
A11	`14`	`1`		`@1 MILANO (Gerard)`
A11	`15`	`1`		`@1 O'CONNELL (Michael)`
A11	`16`	`1`		`@1 RUSTUM (Youcef)`
A11	`17`	`1`		`@1 TABERNERO (Josep)`
A11	`18`	`1`		`@1 GILBERG (Frank)`
A11	`19`	`1`		`@1 SIRZEN (Florin)`
A11	`20`	`1`		`@1 TWELVES (Chris)`
A14	`01`			`@1 Abramson Cancer Center at the University of Pennsylvania @2 Philadelphia @3 USA`
A14	`02`			`@1 NSABP Foundation @2 Pittsburgh, PA @3 USA`
A14	`03`			`@1 University of Texas, M.D. Anderson Cancer Center @2 Houston, TX @3 USA`
A14	`04`			`@1 Vanderbilt-lngram Cancer Center @2 Nashville, TN @3 USA`
A14	`05`			`@1 Memorial Sloan-Kettering Cancer Center @2 New York @3 USA`
A14	`06`			`@1 Roswell Park Cancer Institute @2 Buffalo, NY @3 USA`
A14	`07`			`@1 NCI-Navy Medical Oncology Branch, National Cancer Institute @2 Bethesda, MD @3 USA`
A14	`08`			`@1 Cancer Institute of New Jersey @2 New Brunswick, NJ @3 USA`
A14	`09`			`@1 Glasgow University @2 Glasgow @3 GBR`
A14	`10`			`@1 Royal Marsden Hospital @2 London @3 GBR`
A14	`11`			`@1 University of Leeds and Bradford NHS Trust @2 Bradford @3 GBR`
A14	`12`			`@1 University of Sydney and Sydney Cancer Centre @2 Sydney @3 AUS`
A14	`13`			`@1 University Hospital Gasthuisberg @2 Leuven @3 BEL`
A14	`14`			`@1 Martin Luther University @2 Halle @3 DEU`
A14	`15`			`@1 Centre René Gauducheau @2 St Herblain @3 FRA`
A14	`16`			`@1 Centre Antoine-Lacassagne @2 Nice @3 FRA`
A14	`17`			`@1 Gothenburg University @2 Gothenburg @3 SWE`
A14	`18`			`@1 Vail d'Hebron University Hospital @2 Barcelona @3 ESP`
A14	`19`			`@1 F. Hoffmann-La Roche @2 Basel @3 CHE`
A20				`@1 2118-2123`
A21				`@1 2008`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 20094 @5 354000195882440130`
A44				`@0 0000 @1 © 2008 INIST-CNRS. All rights reserved.`
A45				`@0 27 ref.`
A47	`01`	`1`		`@0 08-0248546`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Journal of clinical oncology`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.
C02	`01`	`X`		`@0 002B04`
C03	`01`	`X`	`FRE`	`@0 Variation géographique @5 02`
C03	`01`	`X`	`ENG`	`@0 Geographical variation @5 02`
C03	`01`	`X`	`SPA`	`@0 Variación geográfica @5 02`
C03	`02`	`X`	`FRE`	`@0 Cancérologie @5 03`
C03	`02`	`X`	`ENG`	`@0 Cancerology @5 03`
C03	`02`	`X`	`SPA`	`@0 Cancerología @5 03`
N21				`@1 162`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines</title>
<author><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name>
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<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University of Texas, M.D. Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Vanderbilt-lngram Cancer Center</s1>
<s2>Nashville, TN</s2>
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</inist:fA14>
<country>États-Unis</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Memorial Sloan-Kettering Cancer Center</s1>
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</inist:fA14>
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</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Roswell Park Cancer Institute</s1>
<s2>Buffalo, NY</s2>
<s3>USA</s3>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>NCI-Navy Medical Oncology Branch, National Cancer Institute</s1>
<s2>Bethesda, MD</s2>
<s3>USA</s3>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Cancer Institute of New Jersey</s1>
<s2>New Brunswick, NJ</s2>
<s3>USA</s3>
</inist:fA14>
<country>États-Unis</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Glasgow University</s1>
<s2>Glasgow</s2>
<s3>GBR</s3>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Royal Marsden Hospital</s1>
<s2>London</s2>
<s3>GBR</s3>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of Leeds and Bradford NHS Trust</s1>
<s2>Bradford</s2>
<s3>GBR</s3>
</inist:fA14>
<country>Royaume-Uni</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>University of Sydney and Sydney Cancer Centre</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
</inist:fA14>
<country>Australie</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>University Hospital Gasthuisberg</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
</inist:fA14>
<country>Belgique</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Martin Luther University</s1>
<s2>Halle</s2>
<s3>DEU</s3>
</inist:fA14>
<country>Allemagne</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Centre René Gauducheau</s1>
<s2>St Herblain</s2>
<s3>FRA</s3>
</inist:fA14>
<country>France</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Centre Antoine-Lacassagne</s1>
<s2>Nice</s2>
<s3>FRA</s3>
</inist:fA14>
<country>France</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Gothenburg University</s1>
<s2>Gothenburg</s2>
<s3>SWE</s3>
</inist:fA14>
<country>Suède</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Vail d'Hebron University Hospital</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
</inist:fA14>
<country>Espagne</country>
</affiliation>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>F. Hoffmann-La Roche</s1>
<s2>Basel</s2>
<s3>CHE</s3>
</inist:fA14>
<country>Suisse</country>
</affiliation>
</author>
<author><name sortKey="Cassidy, Jim" sort="Cassidy, Jim" uniqKey="Cassidy J" first="Jim" last="Cassidy">Jim Cassidy</name>
</author>
<author><name sortKey="Clarke, Stephen J" sort="Clarke, Stephen J" uniqKey="Clarke S" first="Stephen J." last="Clarke">Stephen J. Clarke</name>
</author>
<author><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name>
</author>
<author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name>
</author>
<author><name sortKey="Hoff, Paulo M" sort="Hoff, Paulo M" uniqKey="Hoff P" first="Paulo M." last="Hoff">Paulo M. Hoff</name>
</author>
<author><name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name>
</author>
<author><name sortKey="Saltz, Leonard B" sort="Saltz, Leonard B" uniqKey="Saltz L" first="Leonard B." last="Saltz">Leonard B. Saltz</name>
</author>
<author><name sortKey="Schmoll, Hans Joachim" sort="Schmoll, Hans Joachim" uniqKey="Schmoll H" first="Hans-Joachim" last="Schmoll">Hans-Joachim Schmoll</name>
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<author><name sortKey="Allegra, Carmen" sort="Allegra, Carmen" uniqKey="Allegra C" first="Carmen" last="Allegra">Carmen Allegra</name>
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<author><name sortKey="Bertino, Joseph R" sort="Bertino, Joseph R" uniqKey="Bertino J" first="Joseph R." last="Bertino">Joseph R. Bertino</name>
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<author><name sortKey="Douillard, Jean Yves" sort="Douillard, Jean Yves" uniqKey="Douillard J" first="Jean-Yves" last="Douillard">Jean-Yves Douillard</name>
</author>
<author><name sortKey="Gustavsson, Bengt G" sort="Gustavsson, Bengt G" uniqKey="Gustavsson B" first="Bengt G." last="Gustavsson">Bengt G. Gustavsson</name>
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<author><name sortKey="Milano, Gerard" sort="Milano, Gerard" uniqKey="Milano G" first="Gerard" last="Milano">Gerard Milano</name>
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<author><name sortKey="O Connell, Michael" sort="O Connell, Michael" uniqKey="O Connell M" first="Michael" last="O'Connell">Michael O'Connell</name>
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<author><name sortKey="Rustum, Youcef" sort="Rustum, Youcef" uniqKey="Rustum Y" first="Youcef" last="Rustum">Youcef Rustum</name>
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<author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name>
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<author><name sortKey="Sirzen, Florin" sort="Sirzen, Florin" uniqKey="Sirzen F" first="Florin" last="Sirzen">Florin Sirzen</name>
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<author><name sortKey="Twelves, Chris" sort="Twelves, Chris" uniqKey="Twelves C" first="Chris" last="Twelves">Chris Twelves</name>
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</analytic>
<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2008">2008</date>
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<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cancerology</term>
<term>Geographical variation</term>
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<front><div type="abstract" xml:lang="en">Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.</div>
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<fA11 i1="01" i2="1"><s1>HOLLER (Daniel G.)</s1>
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<fA11 i1="07" i2="1"><s1>ROTHENBERG (Mace L.)</s1>
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<fA11 i1="08" i2="1"><s1>SALTZ (Leonard B.)</s1>
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<fA11 i1="09" i2="1"><s1>SCHMOLL (Hans-Joachim)</s1>
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<fA14 i1="01"><s1>Abramson Cancer Center at the University of Pennsylvania</s1>
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<fA14 i1="14"><s1>Martin Luther University</s1>
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<fC01 i1="01" l="ENG"><s0>Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.</s0>
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Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

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