Assessment of endpoints for clinical trials for localized prostate cancer
Identifieur interne : 000872 ( France/Analysis ); précédent : 000871; suivant : 000873Assessment of endpoints for clinical trials for localized prostate cancer
Auteurs : Paul Schellhammer [États-Unis] ; Abraham Cockett [États-Unis] ; Laurent Boccon-Gibod [France] ; Mary Gospodarowicz [Canada] ; Arnon Krongrad [États-Unis] ; Ian Murchie Thompson [États-Unis] ; Peter Scardino [États-Unis] ; Mark Soloway [États-Unis] ; Jan Adolfsson [Suède]Source :
- Urology [ 0090-4295 ] ; 1997.
Abstract
Abstract: ObjectivesThe AUA Practice Guidelines Panel convened to address the issue of appropriate endpoints for assessment of treatment modalities for localized carcinoma of the prostate.MethodsA review of the literature and the design of existing clinical trials produced a consensus, which was presented to and critiqued by the members of the general conference.ResultsThe pitfalls associated with identification of local failure endpoints were discussed, and the more accurate endpoints of freedom from metastatic progression and overall survival were recognized. The strict definition that must be fulfilled for intermediate endpoints to become surrogates for metastasis free and/or survival endpoints was stressed. For more efficient and rapid conduct of future clinical trials, the urgent need to validate such surrogate endpoints by evaluation in randomized control trials is obvious. PSA, while an indicator of disease activity and a critical marker for estimating disease progression or regression in response to therapy, is not a surrogate for metastasis free or overall survival.ConclusionUntil surrogate endpoints are validated, the committee has evaluated the endpoints in current use, reviewed their limitations, and stressed the importance of quality-of-life assessment together with the traditional endpoint assessment.
Url:
DOI: 10.1016/S0090-4295(99)80321-5
Affiliations:
- Canada, France, Suède, États-Unis
- Floride, Svealand, Texas, Virginie, État de New York, Île-de-France
- Paris, Stockholm
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Schellhammer, M.D., 600 Gresham Drive, Suite 203, River Pavilion, Norfolk</wicri:cityArea></affiliation></author><author><name sortKey="Cockett, Abraham" sort="Cockett, Abraham" uniqKey="Cockett A" first="Abraham" last="Cockett">Abraham Cockett</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Urology, University of Rochester School of Medicine, Rochester, New York</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Boccon Gibod, Laurent" sort="Boccon Gibod, Laurent" uniqKey="Boccon Gibod L" first="Laurent" last="Boccon-Gibod">Laurent Boccon-Gibod</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Urology, Hopital Birchat, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Gospodarowicz, Mary" sort="Gospodarowicz, Mary" uniqKey="Gospodarowicz M" first="Mary" last="Gospodarowicz">Mary Gospodarowicz</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Ontario Cancer Institute, Princes Margaret Hospital, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Krongrad, Arnon" sort="Krongrad, Arnon" uniqKey="Krongrad A" first="Arnon" last="Krongrad">Arnon Krongrad</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Miami School of Medicine, Miami, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Section of Urology, Veterans' Affairs Medical Center, Miami, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Thompson, Ian Murchie" sort="Thompson, Ian Murchie" uniqKey="Thompson I" first="Ian Murchie" last="Thompson">Ian Murchie Thompson</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Urology Service, Brooke Army Medical Center, Fort Sam Houston, Texas</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Scardino, Peter" sort="Scardino, Peter" uniqKey="Scardino P" first="Peter" last="Scardino">Peter Scardino</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Scott Department of Urology, Baylor College of Medicine, Houston, Texas</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Soloway, Mark" sort="Soloway, Mark" uniqKey="Soloway M" first="Mark" last="Soloway">Mark Soloway</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Miami School of Medicine, Miami, Florida</wicri:regionArea><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Adolfsson, Jan" sort="Adolfsson, Jan" uniqKey="Adolfsson J" first="Jan" last="Adolfsson">Jan Adolfsson</name><affiliation wicri:level="3"><country xml:lang="fr">Suède</country><wicri:regionArea>Department of Urology, Karolinska Hospital, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Urology</title><title level="j" type="abbrev">URL</title><idno type="ISSN">0090-4295</idno><imprint><publisher>ELSEVIER</publisher><date type="published" when="1997">1997</date><biblScope unit="volume">49</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="supplement">S1</biblScope><biblScope unit="page" from="27">27</biblScope><biblScope unit="page" to="38">38</biblScope></imprint><idno type="ISSN">0090-4295</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0090-4295</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Abstract: ObjectivesThe AUA Practice Guidelines Panel convened to address the issue of appropriate endpoints for assessment of treatment modalities for localized carcinoma of the prostate.MethodsA review of the literature and the design of existing clinical trials produced a consensus, which was presented to and critiqued by the members of the general conference.ResultsThe pitfalls associated with identification of local failure endpoints were discussed, and the more accurate endpoints of freedom from metastatic progression and overall survival were recognized. The strict definition that must be fulfilled for intermediate endpoints to become surrogates for metastasis free and/or survival endpoints was stressed. For more efficient and rapid conduct of future clinical trials, the urgent need to validate such surrogate endpoints by evaluation in randomized control trials is obvious. PSA, while an indicator of disease activity and a critical marker for estimating disease progression or regression in response to therapy, is not a surrogate for metastasis free or overall survival.ConclusionUntil surrogate endpoints are validated, the committee has evaluated the endpoints in current use, reviewed their limitations, and stressed the importance of quality-of-life assessment together with the traditional endpoint assessment.</div></front></TEI><affiliations><list><country><li>Canada</li><li>France</li><li>Suède</li><li>États-Unis</li></country><region><li>Floride</li><li>Svealand</li><li>Texas</li><li>Virginie</li><li>État de New York</li><li>Île-de-France</li></region><settlement><li>Paris</li><li>Stockholm</li></settlement></list><tree><country name="États-Unis"><region name="Virginie"><name sortKey="Schellhammer, Paul" sort="Schellhammer, Paul" uniqKey="Schellhammer P" first="Paul" last="Schellhammer">Paul Schellhammer</name></region><name sortKey="Cockett, Abraham" sort="Cockett, Abraham" uniqKey="Cockett A" first="Abraham" last="Cockett">Abraham Cockett</name><name sortKey="Krongrad, Arnon" sort="Krongrad, Arnon" uniqKey="Krongrad A" first="Arnon" last="Krongrad">Arnon Krongrad</name><name sortKey="Krongrad, Arnon" sort="Krongrad, Arnon" uniqKey="Krongrad A" first="Arnon" last="Krongrad">Arnon Krongrad</name><name sortKey="Scardino, Peter" sort="Scardino, Peter" uniqKey="Scardino P" first="Peter" last="Scardino">Peter Scardino</name><name sortKey="Schellhammer, Paul" sort="Schellhammer, Paul" uniqKey="Schellhammer P" first="Paul" last="Schellhammer">Paul Schellhammer</name><name sortKey="Soloway, Mark" sort="Soloway, Mark" uniqKey="Soloway M" first="Mark" last="Soloway">Mark Soloway</name><name sortKey="Thompson, Ian Murchie" sort="Thompson, Ian Murchie" uniqKey="Thompson I" first="Ian Murchie" last="Thompson">Ian Murchie Thompson</name></country><country name="France"><region name="Île-de-France"><name sortKey="Boccon Gibod, Laurent" sort="Boccon Gibod, Laurent" uniqKey="Boccon Gibod L" first="Laurent" last="Boccon-Gibod">Laurent Boccon-Gibod</name></region></country><country name="Canada"><noRegion><name sortKey="Gospodarowicz, Mary" sort="Gospodarowicz, Mary" uniqKey="Gospodarowicz M" first="Mary" last="Gospodarowicz">Mary Gospodarowicz</name></noRegion></country><country name="Suède"><region name="Svealand"><name sortKey="Adolfsson, Jan" sort="Adolfsson, Jan" uniqKey="Adolfsson J" first="Jan" last="Adolfsson">Jan Adolfsson</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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