Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study
Identifieur interne : 001550 ( PascalFrancis/Corpus ); précédent : 001549; suivant : 001551Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study
Auteurs : Judith M. Bliss ; Lucy S. Kilburn ; Robert E. Coleman ; John F. Forbes ; Alan S. Coates ; Stephen E. Jonas ; Jacek Jassem ; Thierry Delozier ; J Rn Andersen ; Robert Paridaens ; Cornelis J. H. Van De Velde ; Per E. Lonning ; James Morden ; Justine Reise ; Laura Cisar ; Thomas Menschik ; R. Charles CoombesSource :
- Journal of clinical oncology [ 0732-183X ] ; 2012.
Descripteurs français
- Pascal (Inist)
English descriptors
Abstract
Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non-breast cancer-related events have been reported. Exploratory analyses describe breast cancer-free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) -positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.
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Format Inist (serveur)
NO : | PASCAL 12-0121349 INIST |
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ET : | Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study |
AU : | BLISS (Judith M.); KILBURN (Lucy S.); COLEMAN (Robert E.); FORBES (John F.); COATES (Alan S.); JONAS (Stephen E.); JASSEM (Jacek); DELOZIER (Thierry); ANDERSEN (Jørn); PARIDAENS (Robert); DE VELDE (Cornelis J. H. Van); LONNING (Per E.); MORDEN (James); REISE (Justine); CISAR (Laura); MENSCHIK (Thomas); COOMBES (R. Charles) |
AF : | The Institute of Cancer Research/Sutton/Royaume-Uni (1 aut., 2 aut., 13 aut.); Weston Park Hospital/Sheffield/Royaume-Uni (3 aut.); Justine Reise and R. Charles Coombes, Imperial College London/London/Royaume-Uni (14 aut., 17 aut.); University of Newcastle, Newcastle Mater Hospital/Newcastle, New South Wales/Australie (4 aut.); International Breast Cancer Study Group/Bern/Suisse (5 aut.); University of Sydney/Sydney/Australie (5 aut.); US Oncology Research/Houston, TX/Etats-Unis (6 aut.); Medical University of Gdansk/Gdansk/Pologne (7 aut.); Centre Francois Baclesse/Caen/France (8 aut.); Pfizer Oncology Europe/Paris/France (16 aut.); Aarhus University Hospital/Aarhus/Danemark (9 aut.); Universitair Ziekenhuis Gasthuisberg/Leuven/Belgique (10 aut.); Leiden University Medical Centre/Leiden/Pays-Bas (11 aut.); University of Bergen and Haukeland University Hospital/Bergen/Norvège (12 aut.); Pfizer/New York, NY/Etats-Unis (15 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 7; Pp. 709-717; Bibl. 16 ref. |
LA : | Anglais |
EA : | Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non-breast cancer-related events have been reported. Exploratory analyses describe breast cancer-free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) -positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival. |
CC : | 002B04 |
FD : | Exémestane; Pronostic; Long terme; Etude longitudinale; Cancérologie; Anticancéreux |
FG : | Dérivé de l'androstane; Estrogen synthase; Enzyme; Inhibiteur enzyme; Stéroïde; Inhibiteur de l'aromatase |
ED : | Exemestane; Prognosis; Long term; Follow up study; Cancerology; Antineoplastic agent |
EG : | Androstane derivatives; Estrogen synthase; Enzyme; Enzyme inhibitor; Steroid; Aromatase inhibitor |
SD : | Exemestano; Pronóstico; Largo plazo; Estudio longitudinal; Cancerología; Anticanceroso |
LO : | INIST-20094.354000508401810090 |
ID : | 12-0121349 |
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Pascal:12-0121349Le document en format XML
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<front><div type="abstract" xml:lang="en">Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non-breast cancer-related events have been reported. Exploratory analyses describe breast cancer-free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) -positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0>
</fA01>
<fA03 i2="1"><s0>J. clin. oncol.</s0>
</fA03>
<fA05><s2>30</s2>
</fA05>
<fA06><s2>7</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>BLISS (Judith M.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>KILBURN (Lucy S.)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>COLEMAN (Robert E.)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>FORBES (John F.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>COATES (Alan S.)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>JONAS (Stephen E.)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>JASSEM (Jacek)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>DELOZIER (Thierry)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>ANDERSEN (Jørn)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>PARIDAENS (Robert)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>DE VELDE (Cornelis J. H. Van)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>LONNING (Per E.)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>MORDEN (James)</s1>
</fA11>
<fA11 i1="14" i2="1"><s1>REISE (Justine)</s1>
</fA11>
<fA11 i1="15" i2="1"><s1>CISAR (Laura)</s1>
</fA11>
<fA11 i1="16" i2="1"><s1>MENSCHIK (Thomas)</s1>
</fA11>
<fA11 i1="17" i2="1"><s1>COOMBES (R. Charles)</s1>
</fA11>
<fA14 i1="01"><s1>The Institute of Cancer Research</s1>
<s2>Sutton</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Weston Park Hospital</s1>
<s2>Sheffield</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Justine Reise and R. Charles Coombes, Imperial College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
<sZ>17 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>University of Newcastle, Newcastle Mater Hospital</s1>
<s2>Newcastle, New South Wales</s2>
<s3>AUS</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>International Breast Cancer Study Group</s1>
<s2>Bern</s2>
<s3>CHE</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>University of Sydney</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>US Oncology Research</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Medical University of Gdansk</s1>
<s2>Gdansk</s2>
<s3>POL</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Centre Francois Baclesse</s1>
<s2>Caen</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Pfizer Oncology Europe</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="11"><s1>Aarhus University Hospital</s1>
<s2>Aarhus</s2>
<s3>DNK</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Universitair Ziekenhuis Gasthuisberg</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="13"><s1>Leiden University Medical Centre</s1>
<s2>Leiden</s2>
<s3>NLD</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="14"><s1>University of Bergen and Haukeland University Hospital</s1>
<s2>Bergen</s2>
<s3>NOR</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="15"><s1>Pfizer</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</fA14>
<fA20><s1>709-717</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20094</s2>
<s5>354000508401810090</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>16 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0121349</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non-breast cancer-related events have been reported. Exploratory analyses describe breast cancer-free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) -positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B04</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Exémestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Exemestane</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Exemestano</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Pronostic</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Prognosis</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Pronóstico</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Long terme</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Long term</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Largo plazo</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Etude longitudinale</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Follow up study</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Estudio longitudinal</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Cancérologie</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Cancerology</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Cancerología</s0>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Anticancéreux</s0>
<s5>25</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Antineoplastic agent</s0>
<s5>25</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Anticanceroso</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Dérivé de l'androstane</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Androstane derivatives</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Androstano derivado</s0>
<s2>FR</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Estrogen synthase</s0>
<s2>FE</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Enzyme inhibitor</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Inhibidor enzima</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Stéroïde</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Steroid</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Esteroide</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Inhibiteur de l'aromatase</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Aromatase inhibitor</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Inhibidor aromatase</s0>
<s5>41</s5>
</fC07>
<fN21><s1>093</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
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<server><NO>PASCAL 12-0121349 INIST</NO>
<ET>Disease-Related Outcomes With Long-Term Follow-Up: An Updated Analysis of the Intergroup Exemestane Study</ET>
<AU>BLISS (Judith M.); KILBURN (Lucy S.); COLEMAN (Robert E.); FORBES (John F.); COATES (Alan S.); JONAS (Stephen E.); JASSEM (Jacek); DELOZIER (Thierry); ANDERSEN (Jørn); PARIDAENS (Robert); DE VELDE (Cornelis J. H. Van); LONNING (Per E.); MORDEN (James); REISE (Justine); CISAR (Laura); MENSCHIK (Thomas); COOMBES (R. Charles)</AU>
<AF>The Institute of Cancer Research/Sutton/Royaume-Uni (1 aut., 2 aut., 13 aut.); Weston Park Hospital/Sheffield/Royaume-Uni (3 aut.); Justine Reise and R. Charles Coombes, Imperial College London/London/Royaume-Uni (14 aut., 17 aut.); University of Newcastle, Newcastle Mater Hospital/Newcastle, New South Wales/Australie (4 aut.); International Breast Cancer Study Group/Bern/Suisse (5 aut.); University of Sydney/Sydney/Australie (5 aut.); US Oncology Research/Houston, TX/Etats-Unis (6 aut.); Medical University of Gdansk/Gdansk/Pologne (7 aut.); Centre Francois Baclesse/Caen/France (8 aut.); Pfizer Oncology Europe/Paris/France (16 aut.); Aarhus University Hospital/Aarhus/Danemark (9 aut.); Universitair Ziekenhuis Gasthuisberg/Leuven/Belgique (10 aut.); Leiden University Medical Centre/Leiden/Pays-Bas (11 aut.); University of Bergen and Haukeland University Hospital/Bergen/Norvège (12 aut.); Pfizer/New York, NY/Etats-Unis (15 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 7; Pp. 709-717; Bibl. 16 ref.</SO>
<LA>Anglais</LA>
<EA>Purpose Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non-breast cancer-related events have been reported. Exploratory analyses describe breast cancer-free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) -positive and 547 with ER-unknown tumors. Results In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.</EA>
<CC>002B04</CC>
<FD>Exémestane; Pronostic; Long terme; Etude longitudinale; Cancérologie; Anticancéreux</FD>
<FG>Dérivé de l'androstane; Estrogen synthase; Enzyme; Inhibiteur enzyme; Stéroïde; Inhibiteur de l'aromatase</FG>
<ED>Exemestane; Prognosis; Long term; Follow up study; Cancerology; Antineoplastic agent</ED>
<EG>Androstane derivatives; Estrogen synthase; Enzyme; Enzyme inhibitor; Steroid; Aromatase inhibitor</EG>
<SD>Exemestano; Pronóstico; Largo plazo; Estudio longitudinal; Cancerología; Anticanceroso</SD>
<LO>INIST-20094.354000508401810090</LO>
<ID>12-0121349</ID>
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