Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence
Identifieur interne : 001504 ( Main/Exploration ); précédent : 001503; suivant : 001505Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence
Auteurs : Jacquie H. Chirgwin [Hongrie] ; Anita Giobbie-Hurder [Hongrie] ; Alan S. Coates [Hongrie] ; Karen N. Price [Hongrie] ; Bent Ejlertsen [Hongrie] ; Marc Debled [Hongrie] ; Richard D. Gelber [Hongrie] ; Aron Goldhirsch [Hongrie] ; Ian Smith [Hongrie] ; Manuela Rabaglio [Hongrie] ; John F. Forbes [Hongrie] ; Patrick Neven [Hongrie] ; István Láng [Hongrie] ; Marco Colleoni [Hongrie] ; Beat Thürlimann [Hongrie]Source :
- Journal of Clinical Oncology [ 0732-183X ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Femelle, Humains, Méthode en double aveugle, Nitriles (administration et posologie), Nitriles (usage thérapeutique), Observance du traitement médicamenteux, Sujet âgé, Survie sans rechute, Tamoxifène (administration et posologie), Tamoxifène (usage thérapeutique), Triazoles (administration et posologie), Triazoles (usage thérapeutique), Tumeurs du sein (mortalité), Tumeurs du sein (traitement médicamenteux).
- MESH :
- administration et posologie : Nitriles, Tamoxifène, Triazoles.
- mortalité : Tumeurs du sein.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Nitriles, Tamoxifène, Triazoles.
- Adulte d'âge moyen, Femelle, Humains, Méthode en double aveugle, Observance du traitement médicamenteux, Sujet âgé, Survie sans rechute.
English descriptors
- KwdEn :
- Aged, Breast Neoplasms (drug therapy), Breast Neoplasms (mortality), Disease-Free Survival, Double-Blind Method, Female, Humans, Medication Adherence, Middle Aged, Nitriles (administration & dosage), Nitriles (therapeutic use), Tamoxifen (administration & dosage), Tamoxifen (therapeutic use), Triazoles (administration & dosage), Triazoles (therapeutic use).
- MESH :
- chemical , administration & dosage : Nitriles, Tamoxifen, Triazoles.
- drug therapy : Breast Neoplasms.
- mortality : Breast Neoplasms.
- chemical , therapeutic use : Nitriles, Tamoxifen, Triazoles.
- Aged, Disease-Free Survival, Double-Blind Method, Female, Humans, Medication Adherence, Middle Aged.
Abstract
To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial.
The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor–positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards models were used to evaluate the relationship between DFS and treatment adherence (persistence [duration] and compliance with dosage). Competing risks regression was used to assess demographic, disease, and treatment characteristics of the women who stopped treatment early because of adverse events.
Both aspects of low adherence (early cessation of letrozole and a compliance score of < 90%) were associated with reduced DFS (multivariable model hazard ratio, 1.45; 95% CI, 1.09 to 1.93;
Both persistence and compliance are associated with DFS. Toxicity management and, for sequential treatments, patient and physician awareness, may improve adherence.
Url:
DOI: 10.1200/JCO.2015.63.8619
PubMed: 27217455
PubMed Central: 4962733
Affiliations:
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Le document en format XML
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<author><name sortKey="Ejlertsen, Bent" sort="Ejlertsen, Bent" uniqKey="Ejlertsen B" first="Bent" last="Ejlertsen">Bent Ejlertsen</name>
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<author><name sortKey="Debled, Marc" sort="Debled, Marc" uniqKey="Debled M" first="Marc" last="Debled">Marc Debled</name>
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<author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name>
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<author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name>
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<author><name sortKey="Smith, Ian" sort="Smith, Ian" uniqKey="Smith I" first="Ian" last="Smith">Ian Smith</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Treatment Adherence and Its Impact on Disease-Free Survival in the Breast International Group 1-98 Trial of Tamoxifen and Letrozole, Alone and in Sequence</title>
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</author>
<author><name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="István" last="Láng">István Láng</name>
<affiliation wicri:level="3"><nlm:aff id="aff1">Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest, Hungary.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Hongrie</country>
<wicri:regionArea>Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest</wicri:regionArea>
<placeName><settlement type="city">Budapest</settlement>
<region nuts="2">Hongrie centrale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name>
<affiliation wicri:level="3"><nlm:aff id="aff1">Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest, Hungary.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Hongrie</country>
<wicri:regionArea>Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest</wicri:regionArea>
<placeName><settlement type="city">Budapest</settlement>
<region nuts="2">Hongrie centrale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Thurlimann, Beat" sort="Thurlimann, Beat" uniqKey="Thurlimann B" first="Beat" last="Thürlimann">Beat Thürlimann</name>
<affiliation wicri:level="3"><nlm:aff id="aff1">Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest, Hungary.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Hongrie</country>
<wicri:regionArea>Jacquie H. Chirgwin and John F. Forbes, University of Newcastle; John F. Forbes, Calvary Mater Newcastle, Newcastle; Alan S. Coates, University of Sydney School of Public Health, Sydney, New South Wales; Jacquie H. Chirgwin, Box Hill Hospital; Jacquie H. Chirgwin, Maroondah Hospital; Jacquie H. Chirgwin, Monash University, Melbourne, Victoria, Australia; Anita Giobbie-Hurder, Karen N. Price, and Richard D. Gelber, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard Medical School, Boston, MA; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergonié, Bordeaux, France; Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy; Ian Smith, The Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom; Manuela Rabaglio, Inselspital, Bern; Beat Thürlimann, Kantonsspital, St. Gallen, Switzerland; Patrick Neven, University of Leuven; Patrick Neven, University Hospitals Leuven, Leuven, Belgium; István Láng, National Institute of Oncology, Budapest</wicri:regionArea>
<placeName><settlement type="city">Budapest</settlement>
<region nuts="2">Hongrie centrale</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of Clinical Oncology</title>
<idno type="ISSN">0732-183X</idno>
<idno type="eISSN">1527-7755</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term>
<term>Breast Neoplasms (drug therapy)</term>
<term>Breast Neoplasms (mortality)</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Medication Adherence</term>
<term>Middle Aged</term>
<term>Nitriles (administration & dosage)</term>
<term>Nitriles (therapeutic use)</term>
<term>Tamoxifen (administration & dosage)</term>
<term>Tamoxifen (therapeutic use)</term>
<term>Triazoles (administration & dosage)</term>
<term>Triazoles (therapeutic use)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Méthode en double aveugle</term>
<term>Nitriles (administration et posologie)</term>
<term>Nitriles (usage thérapeutique)</term>
<term>Observance du traitement médicamenteux</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
<term>Tamoxifène (administration et posologie)</term>
<term>Tamoxifène (usage thérapeutique)</term>
<term>Triazoles (administration et posologie)</term>
<term>Triazoles (usage thérapeutique)</term>
<term>Tumeurs du sein (mortalité)</term>
<term>Tumeurs du sein (traitement médicamenteux)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Nitriles</term>
<term>Tamoxifen</term>
<term>Triazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Nitriles</term>
<term>Tamoxifène</term>
<term>Triazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Breast Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs du sein</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Nitriles</term>
<term>Tamoxifen</term>
<term>Triazoles</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs du sein</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Nitriles</term>
<term>Tamoxifène</term>
<term>Triazoles</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Medication Adherence</term>
<term>Middle Aged</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Femelle</term>
<term>Humains</term>
<term>Méthode en double aveugle</term>
<term>Observance du traitement médicamenteux</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Purpose</title>
<p>To investigate adherence to endocrine treatment and its relationship with disease-free survival (DFS) in the Breast International Group (BIG) 1-98 clinical trial.</p>
</sec>
<sec><title>Methods</title>
<p>The BIG 1-98 trial is a double-blind trial that randomly assigned 6,193 postmenopausal women with hormone receptor–positive early breast cancer in the four-arm option to 5 years of tamoxifen (Tam), letrozole (Let), or the agents in sequence (Let-Tam, Tam-Let). This analysis included 6,144 women who received at least one dose of study treatment. Conditional landmark analyses and marginal structural Cox proportional hazards models were used to evaluate the relationship between DFS and treatment adherence (persistence [duration] and compliance with dosage). Competing risks regression was used to assess demographic, disease, and treatment characteristics of the women who stopped treatment early because of adverse events.</p>
</sec>
<sec><title>Results</title>
<p>Both aspects of low adherence (early cessation of letrozole and a compliance score of < 90%) were associated with reduced DFS (multivariable model hazard ratio, 1.45; 95% CI, 1.09 to 1.93; <italic>P</italic>
= .01; and multivariable model hazard ratio, 1.61; 95% CI, 1.08 to 2.38; <italic>P</italic>
= .02, respectively). Sequential treatments were associated with higher rates of nonpersistence (Tam-Let, 20.8%; Let-Tam, 20.3%; Tam 16.9%; Let 17.6%). Adverse events were the reason for most trial treatment early discontinuations (82.7%). Apart from sequential treatment assignment, reduced adherence was associated with older age, smoking, node negativity, or prior thromboembolic event.</p>
</sec>
<sec><title>Conclusion</title>
<p>Both persistence and compliance are associated with DFS. Toxicity management and, for sequential treatments, patient and physician awareness, may improve adherence.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>Hongrie</li>
</country>
<region><li>Hongrie centrale</li>
</region>
<settlement><li>Budapest</li>
</settlement>
</list>
<tree><country name="Hongrie"><region name="Hongrie centrale"><name sortKey="Chirgwin, Jacquie H" sort="Chirgwin, Jacquie H" uniqKey="Chirgwin J" first="Jacquie H." last="Chirgwin">Jacquie H. Chirgwin</name>
</region>
<name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name>
<name sortKey="Colleoni, Marco" sort="Colleoni, Marco" uniqKey="Colleoni M" first="Marco" last="Colleoni">Marco Colleoni</name>
<name sortKey="Debled, Marc" sort="Debled, Marc" uniqKey="Debled M" first="Marc" last="Debled">Marc Debled</name>
<name sortKey="Ejlertsen, Bent" sort="Ejlertsen, Bent" uniqKey="Ejlertsen B" first="Bent" last="Ejlertsen">Bent Ejlertsen</name>
<name sortKey="Forbes, John F" sort="Forbes, John F" uniqKey="Forbes J" first="John F." last="Forbes">John F. Forbes</name>
<name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name>
<name sortKey="Giobbie Hurder, Anita" sort="Giobbie Hurder, Anita" uniqKey="Giobbie Hurder A" first="Anita" last="Giobbie-Hurder">Anita Giobbie-Hurder</name>
<name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name>
<name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="István" last="Láng">István Láng</name>
<name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name>
<name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name>
<name sortKey="Rabaglio, Manuela" sort="Rabaglio, Manuela" uniqKey="Rabaglio M" first="Manuela" last="Rabaglio">Manuela Rabaglio</name>
<name sortKey="Smith, Ian" sort="Smith, Ian" uniqKey="Smith I" first="Ian" last="Smith">Ian Smith</name>
<name sortKey="Thurlimann, Beat" sort="Thurlimann, Beat" uniqKey="Thurlimann B" first="Beat" last="Thürlimann">Beat Thürlimann</name>
</country>
</tree>
</affiliations>
</record>
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