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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Evaluating Letrozole and Tamoxifen Alone and in Sequence for Postmenopausal Women with Steroid Hormone Receptor-Positive Breast Cancer: the BIG 1-98 Randomized Clinical Trial at 8.1 years Median Follow-Up</title><author><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name></author><author><name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name></author><author><name sortKey="Giobbie Hurder, Anita" sort="Giobbie Hurder, Anita" uniqKey="Giobbie Hurder A" first="Anita" last="Giobbie-Hurder">Anita Giobbie-Hurder</name></author><author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name></author><author><name sortKey="Ejlertsen, Bent" sort="Ejlertsen, Bent" uniqKey="Ejlertsen B" first="Bent" last="Ejlertsen">Bent Ejlertsen</name></author><author><name sortKey="Mauriac, Louis" sort="Mauriac, Louis" uniqKey="Mauriac L" first="Louis" last="Mauriac">Louis Mauriac</name></author><author><name sortKey="Forbes, John F" sort="Forbes, John F" uniqKey="Forbes J" first="John F." last="Forbes">John F. Forbes</name></author><author><name sortKey="Smith, Ian" sort="Smith, Ian" uniqKey="Smith I" first="Ian" last="Smith">Ian Smith</name></author><author><name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="István" last="Láng">István Láng</name></author><author><name sortKey="Wardley, Andrew" sort="Wardley, Andrew" uniqKey="Wardley A" first="Andrew" last="Wardley">Andrew Wardley</name></author><author><name sortKey="Rabaglio, Manuela" sort="Rabaglio, Manuela" uniqKey="Rabaglio M" first="Manuela" last="Rabaglio">Manuela Rabaglio</name></author><author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name></author><author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name></author><author><name sortKey="Thurlimann, Beat" sort="Thurlimann, Beat" uniqKey="Thurlimann B" first="Beat" last="Thürlimann">Beat Thürlimann</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">22018631</idno><idno type="pmc">3235950</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3235950</idno><idno type="RBID">PMC:3235950</idno><idno type="doi">10.1016/S1470-2045(11)70270-4</idno><date when="2011">2011</date><idno type="wicri:Area/Pmc/Corpus">001536</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001536</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Evaluating Letrozole and Tamoxifen Alone and in Sequence for Postmenopausal Women with Steroid Hormone Receptor-Positive Breast Cancer: the BIG 1-98 Randomized Clinical Trial at 8.1 years Median Follow-Up</title><author><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name></author><author><name sortKey="Neven, Patrick" sort="Neven, Patrick" uniqKey="Neven P" first="Patrick" last="Neven">Patrick Neven</name></author><author><name sortKey="Giobbie Hurder, Anita" sort="Giobbie Hurder, Anita" uniqKey="Giobbie Hurder A" first="Anita" last="Giobbie-Hurder">Anita Giobbie-Hurder</name></author><author><name sortKey="Goldhirsch, Aron" sort="Goldhirsch, Aron" uniqKey="Goldhirsch A" first="Aron" last="Goldhirsch">Aron Goldhirsch</name></author><author><name sortKey="Ejlertsen, Bent" sort="Ejlertsen, Bent" uniqKey="Ejlertsen B" first="Bent" last="Ejlertsen">Bent Ejlertsen</name></author><author><name sortKey="Mauriac, Louis" sort="Mauriac, Louis" uniqKey="Mauriac L" first="Louis" last="Mauriac">Louis Mauriac</name></author><author><name sortKey="Forbes, John F" sort="Forbes, John F" uniqKey="Forbes J" first="John F." last="Forbes">John F. Forbes</name></author><author><name sortKey="Smith, Ian" sort="Smith, Ian" uniqKey="Smith I" first="Ian" last="Smith">Ian Smith</name></author><author><name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="István" last="Láng">István Láng</name></author><author><name sortKey="Wardley, Andrew" sort="Wardley, Andrew" uniqKey="Wardley A" first="Andrew" last="Wardley">Andrew Wardley</name></author><author><name sortKey="Rabaglio, Manuela" sort="Rabaglio, Manuela" uniqKey="Rabaglio M" first="Manuela" last="Rabaglio">Manuela Rabaglio</name></author><author><name sortKey="Price, Karen N" sort="Price, Karen N" uniqKey="Price K" first="Karen N." last="Price">Karen N. Price</name></author><author><name sortKey="Gelber, Richard D" sort="Gelber, Richard D" uniqKey="Gelber R" first="Richard D." last="Gelber">Richard D. Gelber</name></author><author><name sortKey="Coates, Alan S" sort="Coates, Alan S" uniqKey="Coates A" first="Alan S." last="Coates">Alan S. Coates</name></author><author><name sortKey="Thurlimann, Beat" sort="Thurlimann, Beat" uniqKey="Thurlimann B" first="Beat" last="Thürlimann">Beat Thürlimann</name></author></analytic><series><title level="j">The lancet oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P2">Postmenopausal women with hormone receptor-positive early breast cancer have persistent, long-term risk of breast cancer recurrence and death. Therefore, trials evaluating endocrine therapies for this patient population require extended follow-up. We present an update of efficacy outcomes in the Breast International Group (BIG) 1-98 study at 8.1 years median follow-up.</p></sec><sec sec-type="methods" id="S2"><title>Methods</title><p id="P3">BIG 1-98 is a randomized, phase III, double-blind trial of 8010 postmenopausal women with hormone receptor-positive early breast cancer that compares five years of tamoxifen or letrozole monotherapy or sequential treatment with two years of one of these agents followed by three years of the other. The primary efficacy endpoint is disease-free survival (DFS: events comprise invasive breast cancer relapse, second primaries [contralateral breast and non-breast], or death without prior cancer event), and secondary endpoints are overall survival (OS), distant recurrence-free interval (DRFI) and breast cancer-free interval (BCFI). The monotherapy comparison includes patients randomized to tamoxifen × 5 years (n=2459) or letrozole × 5 years (n=2463). In 2005, after significant DFS benefit was reported for letrozole as compared with tamoxifen, a protocol amendment facilitated the crossover to letrozole of patients who were still receiving tamoxifen alone; Cox models and Kaplan-Meier estimates with inverse probability of censoring weighting (IPCW) are used to account for selective crossover to letrozole of 619 patients in the tamoxifen arm. The comparison of sequential treatments to letrozole monotherapy includes patients enrolled in the four-arm option of the trial and randomized to letrozole × 5 years (n=1546), letrozole × 2 years followed by tamoxifen × 3 years (n=1540), or tamoxifen × 2 years followed by letrozole × 3 years (n=1548). All patients have completed study treatment; follow up is continuing for those enrolled in the four-arm option. BIG 1-98 is registered at <bold>clinicaltrials.gov</bold> NCT00004205.</p></sec><sec id="S3"><title>Findings</title><p id="P4">At a median follow-up of 8.7 years from randomization (range 0–12.4), letrozole monotherapy is significantly better than tamoxifen, whether using IPCW or intention-to-treat (ITT) analysis [IPCW: DFS HR 0.82 (95% CI 0.74–0.92), OS HR 0.79 (0.69–0.900, DRFI HR 0.79 (0.68–0.92), BCFI HR 0.80 (0.70–0.92); ITT: DFS HR 0.86 (0.78–0.96), OS HR 0.87 (0.77–0.999), DRFI HR 0.86 (0.74–0.998), BCFI HR 0.86 (0.76–0.98)]. At a median follow-up of 8.0 years from randomization (range 0–11.2), there were no statistically significant differences in any of the four endpoints for either sequence compared with letrozole monotherapy. Eight-year ITT estimates [each with SE ≤ 1.1%] for letrozole monotherapy, letrozole followed by tamoxifen, and tamoxifen followed by letrozole were 78.6%, 77.8%, 77.3% for DFS; 87.5%, 87.7%, 85.9% for OS; 89.9%, 88.7%, 88.1% for DRFI; and 86.1%, 85.3%, 84.3% for BCFI.</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">For postmenopausal women with endocrine-responsive early breast cancer, a reduction in breast cancer recurrence and mortality is obtained by letrozole monotherapy when compared to tamoxifen. Sequential treatments involving tamoxifen and letrozole do not improve outcome compared with letrozole monotherapy, but may represent useful strategies considering individual patient’s risk of recurrence and treatment tolerability: more thromboembolic events, vaginal bleeding, hot flushes and night sweats with tamoxifen, while more vaginal dryness, bone fractures, osteoporosis, arthralgia/myalgia, and higher grade cardiac events with letrozole.</p></sec><sec id="S5"><title>Funding</title><p id="P6">Novartis, United States National Cancer Institute, International Breast Cancer Study Group.</p></sec></div></front></TEI><pmc article-type="research-article" xml:lang="en"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-title-group><journal-title>The lancet oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">22018631</article-id><article-id pub-id-type="pmc">3235950</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(11)70270-4</article-id><article-id pub-id-type="manuscript">NIHMS336020</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Evaluating Letrozole and Tamoxifen Alone and in Sequence for Postmenopausal Women with Steroid Hormone Receptor-Positive Breast Cancer: the BIG 1-98 Randomized Clinical Trial at 8.1 years Median Follow-Up</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Regan</surname><given-names>Meredith M.</given-names></name><degrees>ScD</degrees><aff id="A1">International Breast Cancer Study Group (IBCSG) Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA. Harvard Medical School and Harvard School of Public Health, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Neven</surname><given-names>Patrick</given-names></name><degrees>MD</degrees><aff id="A2">Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Belgium</aff></contrib><contrib contrib-type="author"><name><surname>Giobbie-Hurder</surname><given-names>Anita</given-names></name><degrees>MS</degrees><aff id="A3">IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Goldhirsch</surname><given-names>Aron</given-names></name><degrees>MD</degrees><aff id="A4">European Institute of Oncology, Milan, Italy, and Swiss Center for Breast Health, Sant’Anna Clinics, Lugano-Sorengo, Switzerland</aff></contrib><contrib contrib-type="author"><name><surname>Ejlertsen</surname><given-names>Bent</given-names></name><degrees>MD</degrees><aff id="A5">Danish Breast Cancer Cooperative Group (DBCG), Rigshospitalet, Copenhagen, Denmark</aff></contrib><contrib contrib-type="author"><name><surname>Mauriac</surname><given-names>Louis</given-names></name><degrees>MD</degrees><aff id="A6">Fédération Nationale des Centres de Lutte Contre le Cancer, Institut Bergonié, Bordeaux, France</aff></contrib><contrib contrib-type="author"><name><surname>Forbes</surname><given-names>John F.</given-names></name><degrees>FRACS</degrees><aff id="A7">Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Smith</surname><given-names>Ian</given-names></name><degrees>MD</degrees><aff id="A8">The Royal Marsden Hospital, London, Royal Marsden NHS Trust, Surrey, England, United Kingdom</aff></contrib><contrib contrib-type="author"><name><surname>Láng</surname><given-names>István</given-names></name><degrees>MD</degrees><aff id="A9">National Institute of Oncology, Budapest, Hungary</aff></contrib><contrib contrib-type="author"><name><surname>Wardley</surname><given-names>Andrew</given-names></name><degrees>MD</degrees><aff id="A10">Christie Hospital NHS Trust, South Manchester University Hospital Trust, Manchester, England, United Kingdom</aff></contrib><contrib contrib-type="author"><name><surname>Rabaglio</surname><given-names>Manuela</given-names></name><degrees>MD</degrees><aff id="A11">IBCSG Coordinating Center and Inselspital, Bern, Switzerland</aff></contrib><contrib contrib-type="author"><name><surname>Price</surname><given-names>Karen N.</given-names></name><degrees>BS</degrees><aff id="A12">IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Gelber</surname><given-names>Richard D.</given-names></name><degrees>PhD</degrees><aff id="A13">IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA</aff></contrib><contrib contrib-type="author"><name><surname>Coates</surname><given-names>Alan S.</given-names></name><degrees>MD</degrees><aff id="A14">International Breast Cancer Study Group and University of Sydney, Sydney, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Thürlimann</surname><given-names>Beat</given-names></name><degrees>MD</degrees><aff id="A15">Breast Center, Kantonsspital, St. Gallen and Swiss Group for Clinical Cancer Research (SAKK), Switzerland</aff></contrib></contrib-group><author-notes><corresp id="FN1">Corresponding Author: Dr. Meredith Regan, Dept. of Biostatistics and Computational Biology, Mailstop CLS11007, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215 USA, Tel: +1 617 632-2471, Fax: +1 617 632-2444, <email>mregan@jimmy.harvard.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>23</day><month>11</month><year>2011</year></pub-date><pub-date pub-type="epub"><day>20</day><month>10</month><year>2011</year></pub-date><pub-date pub-type="ppub"><month>11</month><year>2011</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>9</month><year>2012</year></pub-date><volume>12</volume><issue>12</issue><fpage>1101</fpage><lpage>1108</lpage><permissions><copyright-statement>© 2011 Elsevier Ltd. All rights reserved.</copyright-statement><copyright-year>2011</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P2">Postmenopausal women with hormone receptor-positive early breast cancer have persistent, long-term risk of breast cancer recurrence and death. Therefore, trials evaluating endocrine therapies for this patient population require extended follow-up. We present an update of efficacy outcomes in the Breast International Group (BIG) 1-98 study at 8.1 years median follow-up.</p></sec><sec sec-type="methods" id="S2"><title>Methods</title><p id="P3">BIG 1-98 is a randomized, phase III, double-blind trial of 8010 postmenopausal women with hormone receptor-positive early breast cancer that compares five years of tamoxifen or letrozole monotherapy or sequential treatment with two years of one of these agents followed by three years of the other. The primary efficacy endpoint is disease-free survival (DFS: events comprise invasive breast cancer relapse, second primaries [contralateral breast and non-breast], or death without prior cancer event), and secondary endpoints are overall survival (OS), distant recurrence-free interval (DRFI) and breast cancer-free interval (BCFI). The monotherapy comparison includes patients randomized to tamoxifen × 5 years (n=2459) or letrozole × 5 years (n=2463). In 2005, after significant DFS benefit was reported for letrozole as compared with tamoxifen, a protocol amendment facilitated the crossover to letrozole of patients who were still receiving tamoxifen alone; Cox models and Kaplan-Meier estimates with inverse probability of censoring weighting (IPCW) are used to account for selective crossover to letrozole of 619 patients in the tamoxifen arm. The comparison of sequential treatments to letrozole monotherapy includes patients enrolled in the four-arm option of the trial and randomized to letrozole × 5 years (n=1546), letrozole × 2 years followed by tamoxifen × 3 years (n=1540), or tamoxifen × 2 years followed by letrozole × 3 years (n=1548). All patients have completed study treatment; follow up is continuing for those enrolled in the four-arm option. BIG 1-98 is registered at <bold>clinicaltrials.gov</bold> NCT00004205.</p></sec><sec id="S3"><title>Findings</title><p id="P4">At a median follow-up of 8.7 years from randomization (range 0–12.4), letrozole monotherapy is significantly better than tamoxifen, whether using IPCW or intention-to-treat (ITT) analysis [IPCW: DFS HR 0.82 (95% CI 0.74–0.92), OS HR 0.79 (0.69–0.900, DRFI HR 0.79 (0.68–0.92), BCFI HR 0.80 (0.70–0.92); ITT: DFS HR 0.86 (0.78–0.96), OS HR 0.87 (0.77–0.999), DRFI HR 0.86 (0.74–0.998), BCFI HR 0.86 (0.76–0.98)]. At a median follow-up of 8.0 years from randomization (range 0–11.2), there were no statistically significant differences in any of the four endpoints for either sequence compared with letrozole monotherapy. Eight-year ITT estimates [each with SE ≤ 1.1%] for letrozole monotherapy, letrozole followed by tamoxifen, and tamoxifen followed by letrozole were 78.6%, 77.8%, 77.3% for DFS; 87.5%, 87.7%, 85.9% for OS; 89.9%, 88.7%, 88.1% for DRFI; and 86.1%, 85.3%, 84.3% for BCFI.</p></sec><sec id="S4"><title>Interpretation</title><p id="P5">For postmenopausal women with endocrine-responsive early breast cancer, a reduction in breast cancer recurrence and mortality is obtained by letrozole monotherapy when compared to tamoxifen. Sequential treatments involving tamoxifen and letrozole do not improve outcome compared with letrozole monotherapy, but may represent useful strategies considering individual patient’s risk of recurrence and treatment tolerability: more thromboembolic events, vaginal bleeding, hot flushes and night sweats with tamoxifen, while more vaginal dryness, bone fractures, osteoporosis, arthralgia/myalgia, and higher grade cardiac events with letrozole.</p></sec><sec id="S5"><title>Funding</title><p id="P6">Novartis, United States National Cancer Institute, International Breast Cancer Study Group.</p></sec></abstract><kwd-group><kwd>aromatase inhibitor</kwd><kwd>letrozole</kwd><kwd>breast cancer</kwd><kwd>adjuvant therapy</kwd><kwd>endocrine therapy</kwd><kwd>tamoxifen</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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