6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial
Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of tras...
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| Vydáno v: | The lancet oncology Ročník 14; číslo 8; s. 741 - 748 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
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England
Elsevier Ltd
01.07.2013
Elsevier Limited |
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| ISSN: | 1470-2045, 1474-5488, 1474-5488 |
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| Abstract | Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer.
We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30–90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901.
1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1–51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6–94·9) in the 12-month group and 91·1% (89·7–92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05–1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001).
After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care.
French National Cancer Institute. |
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| AbstractList | Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer.BACKGROUNDSince 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer.We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901.METHODSWe did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901.1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001).FINDINGS1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001).After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care.INTERPRETATIONAfter 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care.French National Cancer Institute.FUNDINGFrench National Cancer Institute. Background: Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer. Methods: We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1.15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901. Findings: 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42.5 months (IQR 30.1-51.6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93.8% (95% CI 92.6-94.9) in the 12-month group and 91.1% (89.7-92.4) in the 6-month group (hazard ratio 1.28, 95% CI 1.05-1.56; p=0.29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5.7%] of 1690 patients vs 32 [1.9%] of 1690 patients, p<0.0001). Interpretation: After 3.5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care. Funding French National Cancer Institute. SummaryBackgroundSince 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer. MethodsWe did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30–90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901. Findings1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1–51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6–94·9) in the 12-month group and 91·1% (89·7–92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05–1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001). InterpretationAfter 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care. FundingFrench National Cancer Institute. Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer. We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901. 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patients vs 32 [1·9%] of 1690 patients, p<0·0001). After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care. French National Cancer Institute. Background Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer. Methods We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1 times 15. Analyses were done in the intention-to-treat population. This study is registered at ClinicalTrials.gov, number NCT00381901. Findings 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42 times 5 months (IQR 30 times 1-51 times 6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93 times 8% (95% CI 92 times 6-94 times 9) in the 12-month group and 91 times 1% (89 times 7-92 times 4) in the 6-month group (hazard ratio 1 times 28, 95% CI 1 times 05-1 times 56; p=0 times 29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5 times 7%] of 1690 patients 32 [1 times 9%] of 1690 patients, p<0 times 0001). Interpretation After 3 times 5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care. Funding French National Cancer Institute. Since 2005, 12 months of adjuvant trastuzumab has been the standard treatment for patients with HER2-positive early-stage breast cancer. However, the optimum duration of treatment has been debated. We did a non-inferiority trial of a shorter exposure of 6 months versus the standard 12 months of trastuzumab for patients with early breast cancer. Methods We did an open-label, randomised, phase 3 trial in 156 centres in France. Patients with HER2-positive early breast cancer who had received at least four cycles of chemotherapy, had breast-axillary surgery, and had received up to 6 months of trastuzumab (administered by intravenous infusions over 30-90 min every 3 weeks; initial loading dose 8 mg/kg; 6 mg/kg thereafter) before randomisation were eligible. Patients were randomly assigned via central randomisation procedure with web-based software to continue trastuzumab for another 6 months (12 months total duration; control group) or to discontinue trastuzumab at 6 months (6 months total duration; experimental group). Randomisation was stratified by concomitant or sequential administration of trastuzumab with chemotherapy, oestrogen-receptor status, and centre using a minimisation algorithm. The primary endpoint was disease-free survival, with a prespecified non-inferiority margin of 1·15. Analyses were done in the intention-to-treat population. This study is registered atClinicalTrials.gov, numberNCT00381901. Findings 1691 patients were randomly assigned to receive 12 months of trastuzumab and 1693 to receive 6 months of trastuzumab; 1690 patients in each group were included in the intention-to-treat analyses. After a median follow-up of 42·5 months (IQR 30·1-51·6), 175 disease-free survival events were noted in the 12-month group and 219 in the 6-month group. 2-year disease-free survival was 93·8% (95% CI 92·6-94·9) in the 12-month group and 91·1% (89·7-92·4) in the 6-month group (hazard ratio 1·28, 95% CI 1·05-1·56; p=0·29). 119 (93%) of the 128 cardiac events (clinical or based on assessment of left ventricular ejection fraction) occurred while patients were receiving trastuzumab. Significantly more patients in the 12-month group experienced a cardiac event than did those in the 6-month group (96 [5·7%] of 1690 patientsvs32 [1·9%] of 1690 patients, p<0·0001). Interpretation After 3·5 years follow-up, we failed to show that 6 months of treatment with trastuzumab was non-inferior to 12 months of trastuzumab. Despite the higher rates of cardiac events, 12 months of adjuvant trastuzmab should remain the standard of care. Funding French National Cancer Institute. |
| Author | Bachelot, Thomas Romieu, Gilles Khayat, David Serin, Daniel Debled, Marc Pierga, Jean-Yves Rios, Maria Espié, Marc Kerbrat, Pierre Fumoleau, Pierre Lortholary, Alain Jacquin, Jean-Philippe Kramar, Andrew Pivot, Xavier Cany, Laurent Catala, Stéphanie Jouannaud, Christelle Tubiana-Mathieu, Nicole Abadie-Lacourtoisie, Sophie Pauporté, Iris |
| Author_xml | – sequence: 1 givenname: Xavier surname: Pivot fullname: Pivot, Xavier email: xavier.pivot@univ-fcomte.fr organization: University Hospital J Minjoz, Besançon, France – sequence: 2 givenname: Gilles surname: Romieu fullname: Romieu, Gilles organization: Centre Val d'Aurelle, Montpellier, France – sequence: 3 givenname: Marc surname: Debled fullname: Debled, Marc organization: Institut Bergonié, Bordeaux, France – sequence: 4 givenname: Jean-Yves surname: Pierga fullname: Pierga, Jean-Yves organization: Institut Curie, Paris, France – sequence: 5 givenname: Pierre surname: Kerbrat fullname: Kerbrat, Pierre organization: Centre Eugene Marquis, Rennes, France – sequence: 6 givenname: Thomas surname: Bachelot fullname: Bachelot, Thomas organization: Centre Léon Bérard, Lyon, France – sequence: 7 givenname: Alain surname: Lortholary fullname: Lortholary, Alain organization: Centre Catherine de Sienne, Nantes, France – sequence: 8 givenname: Marc surname: Espié fullname: Espié, Marc organization: University Hospital Saint-Louis, Paris, France – sequence: 9 givenname: Pierre surname: Fumoleau fullname: Fumoleau, Pierre organization: Centre Georges François Leclerc, Dijon, France – sequence: 10 givenname: Daniel surname: Serin fullname: Serin, Daniel organization: Institut Sainte Catherine, Avignon, France – sequence: 11 givenname: Jean-Philippe surname: Jacquin fullname: Jacquin, Jean-Philippe organization: Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, France – sequence: 12 givenname: Christelle surname: Jouannaud fullname: Jouannaud, Christelle organization: Institut Jean Godinot, Reims, France – sequence: 13 givenname: Maria surname: Rios fullname: Rios, Maria organization: Centre Alexis Vautrin, Vandoeuvre-les-Nancy, France – sequence: 14 givenname: Sophie surname: Abadie-Lacourtoisie fullname: Abadie-Lacourtoisie, Sophie organization: Institut de Cancérologie de la Loire, Angers, France – sequence: 15 givenname: Nicole surname: Tubiana-Mathieu fullname: Tubiana-Mathieu, Nicole organization: University Hospital, Limoges, France – sequence: 16 givenname: Laurent surname: Cany fullname: Cany, Laurent organization: Clinique Francheville, Périgueux, France – sequence: 17 givenname: Stéphanie surname: Catala fullname: Catala, Stéphanie organization: Clinique Saint-Pierre, Perpignan, France – sequence: 18 givenname: David surname: Khayat fullname: Khayat, David organization: University Hospital Pitié Salpêtrière, Paris, France – sequence: 19 givenname: Iris surname: Pauporté fullname: Pauporté, Iris organization: French National Cancer Institute, Boulogne-Billancourt, France – sequence: 20 givenname: Andrew surname: Kramar fullname: Kramar, Andrew organization: Centre Oscar Lambret, Lille, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23764181$$D View this record in MEDLINE/PubMed |
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| CODEN | LANCAO |
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| ContentType | Journal Article |
| Contributor | Soulié, P Demarchi, F Misset, J L Luporsi, E Mignot, L Gligorov, J Bréau, J L Iurisci, I Grossat, N Berton-Rigaud, D Lévy, E Lancry, L Rebattu, P Durand, M Piprot, C Maillart, P Chouahnia, A K Vanneuville, A C Ray-Coquard, I Bons, F Beerblock, C Stein, U Bousquet, G Galotte, M Saintigny, P Guastalla, J P Grenier, J Henry, S Tarpin, C Cuvier, C Capitain, O Girre, V Biron, P Ferrière, J P Bourbouloux, E Guimont, I Roché, H Dupuy-Brousseau, L Trillet-Lenoir, V Uwer, L Hocini, A Durieux, A Delva, R Mayer, F Mouret-Reynier, C Cals, L Le Maignan, C Fabbro, M Durando, X Dillies, A F Extra, J M Chièze, S Villanueva, C Campone, M Tartas, S Rivera, P Van Praagh, I Ferrero, J M Trédan, O Ferrant, E Trager-Maury, S Lavau-Denès, S Bonnefoi, H Diéras, V Madranges, N Vanlemmens, L Weber, B Mauriac, L Valenza, B Servent, V Cottu, P Tresca, P Avenin, D Jouve, M Bonneterre, J Rousseau, F Bougnoux, P Fournel-Fédérico, C Falandry, C Médioni, J Nabholtz, J M Pouessel, D Chaigneau, L Tournigand, C Follana, P Boué, F N'Guyen, T Auclerc, G Vennin, P Chollet, P Raban, N Largillier, R Giacchetti, S Haj |
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| Copyright | 2013 Elsevier Ltd Elsevier Ltd Copyright © 2013 Elsevier Ltd. All rights reserved. Copyright Elsevier Limited Jul 2013 |
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| References | Slamon, Eiermann, Robert (bib3) 2011; 365 Joensuu, Kellokumpu-Lehtinen, Bono (bib4) 2006; 354 Romond, Perez, Bryant, Suman (bib2) 2005; 353 Piaggio, Elbourne, Altman, Pocock, Evans (bib13) 2006; 295 Perez, Suman, Davidson (bib11) 2011; 29 Perez, Romond, Suman (bib8) 2011; 29 Gianni, Dafni, Gelber (bib9) 2011; 12 Piccart-Gebhart, Procter, Leyland-Jones (bib1) 2005; 353 bib7 Spielmann, Roche, Delozier (bib10) 2009; 27 Smith, Procter, Gelber (bib6) 2007; 369 Goldhirsch, Piccart-Gebhart, Procter (bib12) 2012; 72 (bib5) 2006; 25 Goldhirsch (10.1016/S1470-2045(13)70225-0_bib12) 2012; 72 Slamon (10.1016/S1470-2045(13)70225-0_bib3) 2011; 365 Piccart-Gebhart (10.1016/S1470-2045(13)70225-0_bib1) 2005; 353 Spielmann (10.1016/S1470-2045(13)70225-0_bib10) 2009; 27 Joensuu (10.1016/S1470-2045(13)70225-0_bib4) 2006; 354 Perez (10.1016/S1470-2045(13)70225-0_bib8) 2011; 29 Piaggio (10.1016/S1470-2045(13)70225-0_bib13) 2006; 295 Gianni (10.1016/S1470-2045(13)70225-0_bib9) 2011; 12 Romond (10.1016/S1470-2045(13)70225-0_bib2) 2005; 353 (10.1016/S1470-2045(13)70225-0_bib5) 2006; 25 Smith (10.1016/S1470-2045(13)70225-0_bib6) 2007; 369 Perez (10.1016/S1470-2045(13)70225-0_bib11) 2011; 29 23764182 - Lancet Oncol. 2013 Jul;14(8):678-9 |
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San Antonio Breast Cancer Symposium 2012 publication-title: Cancer Res – volume: 27 start-page: 6129 year: 2009 end-page: 6134 ident: bib10 article-title: Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial publication-title: J Clin Oncol – volume: 29 start-page: 3366 year: 2011 end-page: 3373 ident: bib8 article-title: Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31 publication-title: J Clin Oncol – volume: 25 start-page: 1628 year: 2006 end-page: 1638 ident: bib5 article-title: Committee for medicinal products for human use (CHMP) guideline on the choice of the non-inferiority margin publication-title: Stat Med – volume: 353 start-page: 1673 year: 2005 end-page: 1684 ident: bib2 article-title: Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer publication-title: N Engl J Med – volume: 369 start-page: 29 year: 2007 end-page: 36 ident: bib6 article-title: 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial publication-title: Lancet – volume: 353 start-page: 1659 year: 2005 ident: 10.1016/S1470-2045(13)70225-0_bib1 article-title: Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa052306 – volume: 353 start-page: 1673 year: 2005 ident: 10.1016/S1470-2045(13)70225-0_bib2 article-title: Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa052122 – volume: 29 start-page: 4491 year: 2011 ident: 10.1016/S1470-2045(13)70225-0_bib11 article-title: Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer publication-title: J Clin Oncol doi: 10.1200/JCO.2011.36.7045 – volume: 12 start-page: 236 year: 2011 ident: 10.1016/S1470-2045(13)70225-0_bib9 article-title: Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(11)70033-X – volume: 295 start-page: 1152 year: 2006 ident: 10.1016/S1470-2045(13)70225-0_bib13 article-title: Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement publication-title: JAMA doi: 10.1001/jama.295.10.1152 – volume: 369 start-page: 29 year: 2007 ident: 10.1016/S1470-2045(13)70225-0_bib6 article-title: 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(07)60028-2 – volume: 354 start-page: 809 year: 2006 ident: 10.1016/S1470-2045(13)70225-0_bib4 article-title: Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa053028 – volume: 25 start-page: 1628 year: 2006 ident: 10.1016/S1470-2045(13)70225-0_bib5 article-title: Committee for medicinal products for human use (CHMP) guideline on the choice of the non-inferiority margin publication-title: Stat Med doi: 10.1002/sim.2584 – volume: 365 start-page: 1273 year: 2011 ident: 10.1016/S1470-2045(13)70225-0_bib3 article-title: Adjuvant trastuzumab in HER2-positive breast cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa0910383 – volume: 29 start-page: 3366 year: 2011 ident: 10.1016/S1470-2045(13)70225-0_bib8 article-title: Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31 publication-title: J Clin Oncol doi: 10.1200/JCO.2011.35.0868 – volume: 72 issue: 24 suppl year: 2012 ident: 10.1016/S1470-2045(13)70225-0_bib12 article-title: HERA trial: 2 year versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up. 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| Title | 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial |
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