Trastuzumab Plus Anastrozole Versus Anastrozole Alone for the Treatment of Postmenopausal Women With Human Epidermal Growth Factor Receptor 2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Results From the Randomized Phase III TAnDEM Study
Identifieur interne : 001014 ( Main/Merge ); précédent : 001013; suivant : 001015Trastuzumab Plus Anastrozole Versus Anastrozole Alone for the Treatment of Postmenopausal Women With Human Epidermal Growth Factor Receptor 2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Results From the Randomized Phase III TAnDEM Study
Auteurs : Bella Kaufman [Israël, Canada, Allemagne, Inde, Royaume-Uni, Russie, Suisse] ; John R. Mackey ; Michael R. Clemens ; Poonamalle P. Bapsy ; Ashok Vaid ; Andrew Wardley ; Sergei Tjulandin ; Michaela Jahn ; Michaela Lehle ; Andrea Feyereislova ; Cédric Revil ; Alison JonesSource :
- Journal of clinical oncology [ 0732-183X ] ; 2009.
Descripteurs français
- Pascal (Inist)
- Wicri :
English descriptors
- KwdEn :
Abstract
Purpose TAnDEM is the first randomized phase III study to combine a hormonal agent and trastuzumab without chemotherapy as treatment for human epidermal growth factor receptor 2 (HER2)/ hormone receptor-copositive metastatic breast cancer (MBC). Patients and Methods Postmenopausal women with HER2/hormone receptor-copositive MBC were randomly assigned to anastrozole (1 mg/d orally) with or without trastuzumab (4 mg/kg intravenous infusion on day 1, then 2 mg/kg every week) until progression. The primary end point was progression-free survival (PFS) in the intent-to-treat population. Results Overall, 103 patients received trastuzumab plus anastrozole; 104 received anastrozole alone. Patients in the trastuzumab plus anastrozole arm experienced significant improvements in PFS compared with patients receiving anastrozole alone (hazard ratio = 0.63; 95% CI, 0.47 to 0.84; median PFS, 4.8 v 2.4 months; log-rank P = .0016). In patients with centrally confirmed hormone receptor positivity (n = 150), median PFS was 5.6 and 3.8 months in the trastuzumab plus anastrozole and anastrozole alone arms, respectively (log-rank P = .006). Overall survival in the overall and centrally confirmed hormone receptor-positive populations showed no statistically significant treatment difference; however, 70% of patients in the anastrozole alone arm crossed over to receive trastuzumab after progression on anastrozole alone. Incidence of grade 3 and 4 adverse events was 23% and 5%, respectively, in the trastuzumab plus anastrozole arm, and 15% and 1 %, respectively, in the anastrozole alone arm; one patient in the combination arm experienced New York Heart Association class II congestive heart failure. Conclusion Trastuzumab plus anastrozole improves outcomes for patients with HER2/hormone receptor-copositive MBC compared with anastrozole alone, although adverse events and serious adverse events were more frequent with the combination.
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<author><name sortKey="Mackey, John R" sort="Mackey, John R" uniqKey="Mackey J" first="John R." last="Mackey">John R. Mackey</name>
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<author><name sortKey="Clemens, Michael R" sort="Clemens, Michael R" uniqKey="Clemens M" first="Michael R." last="Clemens">Michael R. Clemens</name>
</author>
<author><name sortKey="Bapsy, Poonamalle P" sort="Bapsy, Poonamalle P" uniqKey="Bapsy P" first="Poonamalle P." last="Bapsy">Poonamalle P. Bapsy</name>
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<author><name sortKey="Vaid, Ashok" sort="Vaid, Ashok" uniqKey="Vaid A" first="Ashok" last="Vaid">Ashok Vaid</name>
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<author><name sortKey="Wardley, Andrew" sort="Wardley, Andrew" uniqKey="Wardley A" first="Andrew" last="Wardley">Andrew Wardley</name>
</author>
<author><name sortKey="Tjulandin, Sergei" sort="Tjulandin, Sergei" uniqKey="Tjulandin S" first="Sergei" last="Tjulandin">Sergei Tjulandin</name>
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<author><name sortKey="Jahn, Michaela" sort="Jahn, Michaela" uniqKey="Jahn M" first="Michaela" last="Jahn">Michaela Jahn</name>
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<author><name sortKey="Lehle, Michaela" sort="Lehle, Michaela" uniqKey="Lehle M" first="Michaela" last="Lehle">Michaela Lehle</name>
</author>
<author><name sortKey="Feyereislova, Andrea" sort="Feyereislova, Andrea" uniqKey="Feyereislova A" first="Andrea" last="Feyereislova">Andrea Feyereislova</name>
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<author><name sortKey="Revil, Cedric" sort="Revil, Cedric" uniqKey="Revil C" first="Cédric" last="Revil">Cédric Revil</name>
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<author><name sortKey="Jones, Alison" sort="Jones, Alison" uniqKey="Jones A" first="Alison" last="Jones">Alison Jones</name>
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<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2009">2009</date>
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<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
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<idno type="ISSN">0732-183X</idno>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Advanced stage</term>
<term>Anastrozole</term>
<term>Antineoplastic agent</term>
<term>Breast cancer</term>
<term>Cancerology</term>
<term>Comparative study</term>
<term>Female</term>
<term>Hormonal receptor</term>
<term>Human</term>
<term>Human Epidermal growth factor Receptor 2</term>
<term>Metastasis</term>
<term>Phase III trial</term>
<term>Postmenopause</term>
<term>Randomization</term>
<term>Trastuzumab</term>
<term>Treatment</term>
<term>Woman</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Anastrozole</term>
<term>Trastuzumab</term>
<term>Etude comparative</term>
<term>Métastase</term>
<term>Traitement</term>
<term>Postménopause</term>
<term>Cancer du sein</term>
<term>Homme</term>
<term>Femelle</term>
<term>Essai clinique phase III</term>
<term>Adulte</term>
<term>Femme</term>
<term>Récepteur hormonal</term>
<term>Stade avancé</term>
<term>Randomisation</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>Récepteur HER2</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Purpose TAnDEM is the first randomized phase III study to combine a hormonal agent and trastuzumab without chemotherapy as treatment for human epidermal growth factor receptor 2 (HER2)/ hormone receptor-copositive metastatic breast cancer (MBC). Patients and Methods Postmenopausal women with HER2/hormone receptor-copositive MBC were randomly assigned to anastrozole (1 mg/d orally) with or without trastuzumab (4 mg/kg intravenous infusion on day 1, then 2 mg/kg every week) until progression. The primary end point was progression-free survival (PFS) in the intent-to-treat population. Results Overall, 103 patients received trastuzumab plus anastrozole; 104 received anastrozole alone. Patients in the trastuzumab plus anastrozole arm experienced significant improvements in PFS compared with patients receiving anastrozole alone (hazard ratio = 0.63; 95% CI, 0.47 to 0.84; median PFS, 4.8 v 2.4 months; log-rank P = .0016). In patients with centrally confirmed hormone receptor positivity (n = 150), median PFS was 5.6 and 3.8 months in the trastuzumab plus anastrozole and anastrozole alone arms, respectively (log-rank P = .006). Overall survival in the overall and centrally confirmed hormone receptor-positive populations showed no statistically significant treatment difference; however, 70% of patients in the anastrozole alone arm crossed over to receive trastuzumab after progression on anastrozole alone. Incidence of grade 3 and 4 adverse events was 23% and 5%, respectively, in the trastuzumab plus anastrozole arm, and 15% and 1 %, respectively, in the anastrozole alone arm; one patient in the combination arm experienced New York Heart Association class II congestive heart failure. Conclusion Trastuzumab plus anastrozole improves outcomes for patients with HER2/hormone receptor-copositive MBC compared with anastrozole alone, although adverse events and serious adverse events were more frequent with the combination.</div>
</front>
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<name sortKey="Kaufman, Bella" sort="Kaufman, Bella" uniqKey="Kaufman B" first="Bella" last="Kaufman">Bella Kaufman</name>
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