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Symptoms of endocrine treatment and outcome in the BIG 1–98 study

Identifieur interne : 004465 ( Main/Exploration ); précédent : 004464; suivant : 004466

Symptoms of endocrine treatment and outcome in the BIG 1–98 study

Auteurs : J. Huober [Suisse] ; B. F. Cole [États-Unis] ; M. Rabaglio [Suisse] ; A. Giobbie-Hurder [États-Unis] ; J. Wu [États-Unis] ; B. Ejlertsen [Danemark] ; H. Bonnefoi [France] ; J. F. Forbes [Australie] ; P. Neven [Belgique] ; I. Láng [Hongrie] ; I. Smith [Royaume-Uni] ; A. Wardley [Royaume-Uni] ; K. N. Price [États-Unis] ; A. Goldhirsch [Italie] ; A. S. Coates [Suisse, Australie] ; M. Colleoni [Italie] ; R. D. Gelber [États-Unis] ; B. Thürlimann [Suisse]

Source :

RBID : PMC:3913479

Abstract

Background

There may be a relationship between the incidence of vasomotor and arthralgia/myalgia symptoms and treatment outcomes for postmenopausal breast cancer patients with endocrine-responsive disease who received adjuvant letrozole or tamoxifen.

Patients and methods

Data on patients randomized into the monotherapy arms of the BIG 1–98 clinical trial who did not have either vasomotor or arthralgia/myalgia/carpal tunnel (AMC) symptoms reported at baseline, started protocol treatment and were alive and disease-free at the 3-month landmark (n=4798) and at the 12-month landmark (n=4682) were used for this report. Cohorts of patients with vasomotor symptoms, AMC symptoms, neither, or both were defined at both 3 and 12 months from randomization. Landmark analyses were performed using Kaplan-Meier method for disease-free survival (DFS) and competing risk methodology for breast cancer free interval (BCFI). Median follow-up was 7.0 years.

Results

Reporting of AMC symptoms was associated with better outcome for both the 3- and 12-month landmark analyses (e.g. 12-month landmark, HR (95% CI) for DFS=0.65 (0.49–0.87), and for BCFI=0.70 (0.49–0.99)). By contrast, reporting of vasomotor symptoms was less clearly associated with DFS (12-month DFS HR (95% CI)=0.82 (0.70–0.96)) and BCFI (12-month DFS HR (95% CI)=0.97 (0.80–1.18). Interaction tests indicated no effect of treatment group on associations between symptoms and outcomes.

Conclusions

While reporting of AMC symptoms was clearly associated with better DFS and BCFI, the association between vasomotor symptoms and outcome was less clear, especially with respect to breast cancer-related events.


Url:
DOI: 10.1007/s10549-013-2792-7
PubMed: 24305979
PubMed Central: 3913479


Affiliations:


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<nlm:aff id="A9">Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Belgium</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven</wicri:regionArea>
<wicri:noRegion>Catholic University of Leuven</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Lang, I" sort="Lang, I" uniqKey="Lang I" first="I." last="Láng">I. Láng</name>
<affiliation wicri:level="3">
<nlm:aff id="A10">National Institute of Oncology, Budapest, Hungary</nlm:aff>
<country xml:lang="fr">Hongrie</country>
<wicri:regionArea>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="Smith, I" sort="Smith, I" uniqKey="Smith I" first="I." last="Smith">I. Smith</name>
<affiliation wicri:level="3">
<nlm:aff id="A11">The Royal Marsden Hospital, London, United Kingdom</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>The Royal Marsden Hospital, London</wicri:regionArea>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Wardley, A" sort="Wardley, A" uniqKey="Wardley A" first="A." last="Wardley">A. Wardley</name>
<affiliation wicri:level="1">
<nlm:aff id="A12">Christie Hospital NHS Trust, South Manchester University Hospital Trust, Manchester, England, United Kingdom</nlm:aff>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Christie Hospital NHS Trust, South Manchester University Hospital Trust, Manchester, England</wicri:regionArea>
<wicri:noRegion>England</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Price, K N" sort="Price, K N" uniqKey="Price K" first="K. N." last="Price">K. N. Price</name>
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<nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<nlm:aff id="A13">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Frontier Science and Technology Research Foundation, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Goldhirsch, A" sort="Goldhirsch, A" uniqKey="Goldhirsch A" first="A." last="Goldhirsch">A. Goldhirsch</name>
<affiliation wicri:level="3">
<nlm:aff id="A14">Department of Medicine. European Institute of Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Medicine. European Institute of Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Coates, A S" sort="Coates, A S" uniqKey="Coates A" first="A. S." last="Coates">A. S. Coates</name>
<affiliation wicri:level="3">
<nlm:aff id="A4">International Breast Cancer Study Group, Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>International Breast Cancer Study Group, Bern</wicri:regionArea>
<placeName>
<settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
</placeName>
</affiliation>
<affiliation wicri:level="4">
<nlm:aff id="A15">University of Sydney, Sydney, New South Wales, Australia</nlm:aff>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>University of Sydney, Sydney, New South Wales</wicri:regionArea>
<orgName type="university">Université de Sydney</orgName>
<placeName>
<settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Colleoni, M" sort="Colleoni, M" uniqKey="Colleoni M" first="M." last="Colleoni">M. Colleoni</name>
<affiliation wicri:level="3">
<nlm:aff id="A16">Research Unit in Medical Senology, Department of Medicine. European Institute of Oncology, Milan, Italy</nlm:aff>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Research Unit in Medical Senology, Department of Medicine. European Institute of Oncology, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name>
<affiliation wicri:level="2">
<nlm:aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<nlm:aff id="A13">Frontier Science and Technology Research Foundation, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Frontier Science and Technology Research Foundation, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
<affiliation wicri:level="2">
<nlm:aff id="A17">Harvard School of Public Health and Harvard Medical School, Boston, MA, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Harvard School of Public Health and Harvard Medical School, Boston, MA</wicri:regionArea>
<placeName>
<region type="state">Massachusetts</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Thurlimann, B" sort="Thurlimann, B" uniqKey="Thurlimann B" first="B." last="Thürlimann">B. Thürlimann</name>
<affiliation wicri:level="3">
<nlm:aff id="A18">Breast Center, Kantonsspital, St. Gallen, Switzerland, and Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Breast Center, Kantonsspital, St. Gallen, Switzerland, and Swiss Group for Clinical Cancer Research (SAKK), Bern</wicri:regionArea>
<placeName>
<settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Breast cancer research and treatment</title>
<idno type="ISSN">0167-6806</idno>
<idno type="eISSN">1573-7217</idno>
<imprint>
<date when="2013">2013</date>
</imprint>
</series>
</biblStruct>
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</fileDesc>
<profileDesc>
<textClass></textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec id="S1">
<title>Background</title>
<p id="P1">There may be a relationship between the incidence of vasomotor and arthralgia/myalgia symptoms and treatment outcomes for postmenopausal breast cancer patients with endocrine-responsive disease who received adjuvant letrozole or tamoxifen.</p>
</sec>
<sec id="S2">
<title>Patients and methods</title>
<p id="P2">Data on patients randomized into the monotherapy arms of the BIG 1–98 clinical trial who did not have either vasomotor or arthralgia/myalgia/carpal tunnel (AMC) symptoms reported at baseline, started protocol treatment and were alive and disease-free at the 3-month landmark (n=4798) and at the 12-month landmark (n=4682) were used for this report. Cohorts of patients with vasomotor symptoms, AMC symptoms, neither, or both were defined at both 3 and 12 months from randomization. Landmark analyses were performed using Kaplan-Meier method for disease-free survival (DFS) and competing risk methodology for breast cancer free interval (BCFI). Median follow-up was 7.0 years.</p>
</sec>
<sec id="S3">
<title>Results</title>
<p id="P3">Reporting of AMC symptoms was associated with better outcome for both the 3- and 12-month landmark analyses (e.g. 12-month landmark, HR (95% CI) for DFS=0.65 (0.49–0.87), and for BCFI=0.70 (0.49–0.99)). By contrast, reporting of vasomotor symptoms was less clearly associated with DFS (12-month DFS HR (95% CI)=0.82 (0.70–0.96)) and BCFI (12-month DFS HR (95% CI)=0.97 (0.80–1.18). Interaction tests indicated no effect of treatment group on associations between symptoms and outcomes.</p>
</sec>
<sec id="S4">
<title>Conclusions</title>
<p id="P4">While reporting of AMC symptoms was clearly associated with better DFS and BCFI, the association between vasomotor symptoms and outcome was less clear, especially with respect to breast cancer-related events.</p>
</sec>
</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Belgique</li>
<li>Danemark</li>
<li>France</li>
<li>Hongrie</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Aquitaine</li>
<li>Canton de Berne</li>
<li>Grand Londres</li>
<li>Hongrie centrale</li>
<li>Hovedstaden</li>
<li>Lombardie</li>
<li>Massachusetts</li>
<li>Nouvelle-Aquitaine</li>
<li>Nouvelle-Galles du Sud</li>
<li>Vermont</li>
</region>
<settlement>
<li>Berne</li>
<li>Bordeaux</li>
<li>Budapest</li>
<li>Copenhague</li>
<li>Londres</li>
<li>Milan</li>
<li>Sydney</li>
</settlement>
<orgName>
<li>Université de Bordeaux</li>
<li>Université de Sydney</li>
</orgName>
</list>
<tree>
<country name="Suisse">
<region name="Canton de Berne">
<name sortKey="Huober, J" sort="Huober, J" uniqKey="Huober J" first="J." last="Huober">J. Huober</name>
</region>
<name sortKey="Coates, A S" sort="Coates, A S" uniqKey="Coates A" first="A. S." last="Coates">A. S. Coates</name>
<name sortKey="Rabaglio, M" sort="Rabaglio, M" uniqKey="Rabaglio M" first="M." last="Rabaglio">M. Rabaglio</name>
<name sortKey="Rabaglio, M" sort="Rabaglio, M" uniqKey="Rabaglio M" first="M." last="Rabaglio">M. Rabaglio</name>
<name sortKey="Thurlimann, B" sort="Thurlimann, B" uniqKey="Thurlimann B" first="B." last="Thürlimann">B. Thürlimann</name>
</country>
<country name="États-Unis">
<region name="Vermont">
<name sortKey="Cole, B F" sort="Cole, B F" uniqKey="Cole B" first="B. F." last="Cole">B. F. Cole</name>
</region>
<name sortKey="Cole, B F" sort="Cole, B F" uniqKey="Cole B" first="B. F." last="Cole">B. F. Cole</name>
<name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name>
<name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name>
<name sortKey="Gelber, R D" sort="Gelber, R D" uniqKey="Gelber R" first="R. D." last="Gelber">R. D. Gelber</name>
<name sortKey="Giobbie Hurder, A" sort="Giobbie Hurder, A" uniqKey="Giobbie Hurder A" first="A." last="Giobbie-Hurder">A. Giobbie-Hurder</name>
<name sortKey="Price, K N" sort="Price, K N" uniqKey="Price K" first="K. N." last="Price">K. N. Price</name>
<name sortKey="Price, K N" sort="Price, K N" uniqKey="Price K" first="K. N." last="Price">K. N. Price</name>
<name sortKey="Wu, J" sort="Wu, J" uniqKey="Wu J" first="J." last="Wu">J. Wu</name>
</country>
<country name="Danemark">
<region name="Hovedstaden">
<name sortKey="Ejlertsen, B" sort="Ejlertsen, B" uniqKey="Ejlertsen B" first="B." last="Ejlertsen">B. Ejlertsen</name>
</region>
</country>
<country name="France">
<region name="Nouvelle-Aquitaine">
<name sortKey="Bonnefoi, H" sort="Bonnefoi, H" uniqKey="Bonnefoi H" first="H." last="Bonnefoi">H. Bonnefoi</name>
</region>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Forbes, J F" sort="Forbes, J F" uniqKey="Forbes J" first="J. F." last="Forbes">J. F. Forbes</name>
</noRegion>
<name sortKey="Coates, A S" sort="Coates, A S" uniqKey="Coates A" first="A. S." last="Coates">A. S. Coates</name>
</country>
<country name="Belgique">
<noRegion>
<name sortKey="Neven, P" sort="Neven, P" uniqKey="Neven P" first="P." last="Neven">P. Neven</name>
</noRegion>
</country>
<country name="Hongrie">
<region name="Hongrie centrale">
<name sortKey="Lang, I" sort="Lang, I" uniqKey="Lang I" first="I." last="Láng">I. Láng</name>
</region>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Smith, I" sort="Smith, I" uniqKey="Smith I" first="I." last="Smith">I. Smith</name>
</region>
<name sortKey="Wardley, A" sort="Wardley, A" uniqKey="Wardley A" first="A." last="Wardley">A. Wardley</name>
</country>
<country name="Italie">
<region name="Lombardie">
<name sortKey="Goldhirsch, A" sort="Goldhirsch, A" uniqKey="Goldhirsch A" first="A." last="Goldhirsch">A. Goldhirsch</name>
</region>
<name sortKey="Colleoni, M" sort="Colleoni, M" uniqKey="Colleoni M" first="M." last="Colleoni">M. Colleoni</name>
</country>
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</affiliations>
</record>

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