LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC)
Abstract Aim: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised phase III adjuvant breast cancer trial comparing 3 oral lapatinib (L)-containing regimens with trastuzumab (T), each given for 1 year. DFS results of L + T and T—> L compared to T, present...
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| creator | Perez, E.A. Holmes, E. De Azambuja, E. Dueck, A. Baselga, J. Viale, G. Zujewski, J.A. Goldhirsch, A. Crescenzo, R. Pritchard, K. Wolff, A.C. Jackisch, C. Láng, I. Untch, M. Smith, I. Boyle, F. Xu, B. Gomez, H.L. Gelber, R.D. Piccart, M. |
| description | Abstract
Aim: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised phase III adjuvant breast cancer trial comparing 3 oral lapatinib (L)-containing regimens with trastuzumab (T), each given for 1 year. DFS results of L + T and T—> L compared to T, presented at ASCO 2014, showed a non-significant DFS benefit. Results of L vs T and key secondary analyses are presented for the first time.
Methods: 8381 patients (pts) were randomised to receive either T (N = 2097), L (N = 2100), T —> L (N = 2091), or L + T (N = 2093) from 2007-2011. Primary comparison of L vs T evaluated non-inferiority at a margin of 1.11 and the futility boundary for this arm was crossed resulting in premature arm closure (Aug 2011). Pts in the L arm who were free of disease recurrence at that time were offered T as adjuvant treatment. Key secondary analyses including DFS by hormone receptor status and CNS endpoints are now presented.
Results: In 4197 pts and at a median follow-up of 4.5 years, 366 (17%) DFS events in the L and 301 (14%) DFS events in the T arms were observed. 1090 (52%) pts in the L arm received at least one T dose. In post-hoc analysis, there was evidence that these pts benefitted from receiving T [hazard ratio (HR) = 0.67; 95% CI 0.49-0.91 from a time-dependent Cox model of DFS]. The non-inferiority HR was 1.34 (95% CI 1.15-1.56) in the ITT population; 1.45 for hormone receptor negative, 1.23 for hormone receptor positive. CNS as first site of metastases occurred in 2% of cases in all arms. AEs of any grade were more common with L than T: diarrhoea (64% vs 20%), rash or erythema (54% vs 20%) and hepatobiliary (25% vs 16%). Any cardiac events were infrequent in both arms, but more common in T compared to L (4.5% vs 1.9%; p |
| doi_str_mv | 10.1093/annonc/mdu438.2 |
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| fullrecord | <record><control><sourceid>oup</sourceid><recordid>TN_cdi_oup_primary_10_1093_annonc_mdu438_2</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/annonc/mdu438.2</oup_id><sourcerecordid>10.1093/annonc/mdu438.2</sourcerecordid><originalsourceid>FETCH-oup_primary_10_1093_annonc_mdu438_23</originalsourceid><addsrcrecordid>eNqVkEtLw0AUhQdRsD7Wbu-yFdJOHk0bXN0kN83IdBJmJkFXofgAxT5o6cL_6Q9yasW9q3MX3_kuHMZufD70eRKOFqvVevU0Wj7vo3A6DE5Yzx_HiTflkX_KejwJQm8yDqNzdrHbvXPO4yRIeuxLpjjJhSE05BWaCEyjW9GihH5emAEIBbYkkFijFUqkgLJSBKjngCoHeqhdUA6aTCOtgar44evSCUEI4XhrK7BaHJSpmEHg8fgOVJbZGfRRSoEqowEoHof53z_M75sWlXVFQjsndzlzSTrw6soIK1oCQi0fIXWAsZAdLBr6lGaDK3b2uvjYvVz_5iW7Lchmpbfeb7rN9m252H52Pu8Ou3XH3brjbl0Q_gv-Bgn_ZTQ</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC)</title><source>EZB Free E-Journals</source><source>Alma/SFX Local Collection</source><creator>Perez, E.A. ; Holmes, E. ; De Azambuja, E. ; Dueck, A. ; Baselga, J. ; Viale, G. ; Zujewski, J.A. ; Goldhirsch, A. ; Crescenzo, R. ; Pritchard, K. ; Wolff, A.C. ; Jackisch, C. ; Láng, I. ; Untch, M. ; Smith, I. ; Boyle, F. ; Xu, B. ; Gomez, H.L. ; Gelber, R.D. ; Piccart, M.</creator><creatorcontrib>Perez, E.A. ; Holmes, E. ; De Azambuja, E. ; Dueck, A. ; Baselga, J. ; Viale, G. ; Zujewski, J.A. ; Goldhirsch, A. ; Crescenzo, R. ; Pritchard, K. ; Wolff, A.C. ; Jackisch, C. ; Láng, I. ; Untch, M. ; Smith, I. ; Boyle, F. ; Xu, B. ; Gomez, H.L. ; Gelber, R.D. ; Piccart, M.</creatorcontrib><description>Abstract
Aim: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised phase III adjuvant breast cancer trial comparing 3 oral lapatinib (L)-containing regimens with trastuzumab (T), each given for 1 year. DFS results of L + T and T—> L compared to T, presented at ASCO 2014, showed a non-significant DFS benefit. Results of L vs T and key secondary analyses are presented for the first time.
Methods: 8381 patients (pts) were randomised to receive either T (N = 2097), L (N = 2100), T —> L (N = 2091), or L + T (N = 2093) from 2007-2011. Primary comparison of L vs T evaluated non-inferiority at a margin of 1.11 and the futility boundary for this arm was crossed resulting in premature arm closure (Aug 2011). Pts in the L arm who were free of disease recurrence at that time were offered T as adjuvant treatment. Key secondary analyses including DFS by hormone receptor status and CNS endpoints are now presented.
Results: In 4197 pts and at a median follow-up of 4.5 years, 366 (17%) DFS events in the L and 301 (14%) DFS events in the T arms were observed. 1090 (52%) pts in the L arm received at least one T dose. In post-hoc analysis, there was evidence that these pts benefitted from receiving T [hazard ratio (HR) = 0.67; 95% CI 0.49-0.91 from a time-dependent Cox model of DFS]. The non-inferiority HR was 1.34 (95% CI 1.15-1.56) in the ITT population; 1.45 for hormone receptor negative, 1.23 for hormone receptor positive. CNS as first site of metastases occurred in 2% of cases in all arms. AEs of any grade were more common with L than T: diarrhoea (64% vs 20%), rash or erythema (54% vs 20%) and hepatobiliary (25% vs 16%). Any cardiac events were infrequent in both arms, but more common in T compared to L (4.5% vs 1.9%; p <0.0005), although the rate of protocol defined primary cardiac events was <1% for all arms.
Conclusions: Overall, L added to T did not statistically improve DFS. L did not appear to decrease the rate of CNS as first site of metastases. T confers a better outcome compared to L in pts with HER2-positive EBC and remains the standard of care. There is evidence of T benefit even when initiated later in the course of follow-up.
Disclosure: E. De Azambuja: Disclosed an advisory role with GSK; honoraria from Roche; research funding from GSK; and travel grants from GSK/Roche; G. Viale: disclosed an advisory role with Roche and Dako; and honoraria from GSK, Roche, and Dako; R. Crescenzo: disclosed compensated employment with GlaxoSmithKline; and stock ownership with Glaxo SmithKline; K. Pritchard: disclosed an advisory role with Roche; honoraria from Roche; research funding from Roche; and expert testimony on behalf of Roche; C. Jackisch: disclosed honoraria from Roche and GSK; F. Boyle: disclosed honoraria from GlaxoSmithKline; and research funding from GlaxoSmithKline; R.D. Gelber: disclosed research funding from GSK and Roche; M. Piccart: disclosed consultancy with PharmaMar; honoraria from Amgen, Astellas, AstraZeneca, Bayer, Eli Lilly, Invivis, MSD, Novartis, Pfizer, Roche-Genentech, Sanofi Aventis, Symphogen, Synthon, and Verastem; research grants from most companies. All other authors have declared no conflicts of interest.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdu438.2</identifier><language>eng</language><publisher>Oxford University Press</publisher><ispartof>Annals of oncology, 2014-09, Vol.25 (suppl_4)</ispartof><rights>European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Perez, E.A.</creatorcontrib><creatorcontrib>Holmes, E.</creatorcontrib><creatorcontrib>De Azambuja, E.</creatorcontrib><creatorcontrib>Dueck, A.</creatorcontrib><creatorcontrib>Baselga, J.</creatorcontrib><creatorcontrib>Viale, G.</creatorcontrib><creatorcontrib>Zujewski, J.A.</creatorcontrib><creatorcontrib>Goldhirsch, A.</creatorcontrib><creatorcontrib>Crescenzo, R.</creatorcontrib><creatorcontrib>Pritchard, K.</creatorcontrib><creatorcontrib>Wolff, A.C.</creatorcontrib><creatorcontrib>Jackisch, C.</creatorcontrib><creatorcontrib>Láng, I.</creatorcontrib><creatorcontrib>Untch, M.</creatorcontrib><creatorcontrib>Smith, I.</creatorcontrib><creatorcontrib>Boyle, F.</creatorcontrib><creatorcontrib>Xu, B.</creatorcontrib><creatorcontrib>Gomez, H.L.</creatorcontrib><creatorcontrib>Gelber, R.D.</creatorcontrib><creatorcontrib>Piccart, M.</creatorcontrib><title>LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC)</title><title>Annals of oncology</title><description>Abstract
Aim: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised phase III adjuvant breast cancer trial comparing 3 oral lapatinib (L)-containing regimens with trastuzumab (T), each given for 1 year. DFS results of L + T and T—> L compared to T, presented at ASCO 2014, showed a non-significant DFS benefit. Results of L vs T and key secondary analyses are presented for the first time.
Methods: 8381 patients (pts) were randomised to receive either T (N = 2097), L (N = 2100), T —> L (N = 2091), or L + T (N = 2093) from 2007-2011. Primary comparison of L vs T evaluated non-inferiority at a margin of 1.11 and the futility boundary for this arm was crossed resulting in premature arm closure (Aug 2011). Pts in the L arm who were free of disease recurrence at that time were offered T as adjuvant treatment. Key secondary analyses including DFS by hormone receptor status and CNS endpoints are now presented.
Results: In 4197 pts and at a median follow-up of 4.5 years, 366 (17%) DFS events in the L and 301 (14%) DFS events in the T arms were observed. 1090 (52%) pts in the L arm received at least one T dose. In post-hoc analysis, there was evidence that these pts benefitted from receiving T [hazard ratio (HR) = 0.67; 95% CI 0.49-0.91 from a time-dependent Cox model of DFS]. The non-inferiority HR was 1.34 (95% CI 1.15-1.56) in the ITT population; 1.45 for hormone receptor negative, 1.23 for hormone receptor positive. CNS as first site of metastases occurred in 2% of cases in all arms. AEs of any grade were more common with L than T: diarrhoea (64% vs 20%), rash or erythema (54% vs 20%) and hepatobiliary (25% vs 16%). Any cardiac events were infrequent in both arms, but more common in T compared to L (4.5% vs 1.9%; p <0.0005), although the rate of protocol defined primary cardiac events was <1% for all arms.
Conclusions: Overall, L added to T did not statistically improve DFS. L did not appear to decrease the rate of CNS as first site of metastases. T confers a better outcome compared to L in pts with HER2-positive EBC and remains the standard of care. There is evidence of T benefit even when initiated later in the course of follow-up.
Disclosure: E. De Azambuja: Disclosed an advisory role with GSK; honoraria from Roche; research funding from GSK; and travel grants from GSK/Roche; G. Viale: disclosed an advisory role with Roche and Dako; and honoraria from GSK, Roche, and Dako; R. Crescenzo: disclosed compensated employment with GlaxoSmithKline; and stock ownership with Glaxo SmithKline; K. Pritchard: disclosed an advisory role with Roche; honoraria from Roche; research funding from Roche; and expert testimony on behalf of Roche; C. Jackisch: disclosed honoraria from Roche and GSK; F. Boyle: disclosed honoraria from GlaxoSmithKline; and research funding from GlaxoSmithKline; R.D. Gelber: disclosed research funding from GSK and Roche; M. Piccart: disclosed consultancy with PharmaMar; honoraria from Amgen, Astellas, AstraZeneca, Bayer, Eli Lilly, Invivis, MSD, Novartis, Pfizer, Roche-Genentech, Sanofi Aventis, Symphogen, Synthon, and Verastem; research grants from most companies. All other authors have declared no conflicts of interest.</description><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid/><recordid>eNqVkEtLw0AUhQdRsD7Wbu-yFdJOHk0bXN0kN83IdBJmJkFXofgAxT5o6cL_6Q9yasW9q3MX3_kuHMZufD70eRKOFqvVevU0Wj7vo3A6DE5Yzx_HiTflkX_KejwJQm8yDqNzdrHbvXPO4yRIeuxLpjjJhSE05BWaCEyjW9GihH5emAEIBbYkkFijFUqkgLJSBKjngCoHeqhdUA6aTCOtgar44evSCUEI4XhrK7BaHJSpmEHg8fgOVJbZGfRRSoEqowEoHof53z_M75sWlXVFQjsndzlzSTrw6soIK1oCQi0fIXWAsZAdLBr6lGaDK3b2uvjYvVz_5iW7Lchmpbfeb7rN9m252H52Pu8Ou3XH3brjbl0Q_gv-Bgn_ZTQ</recordid><startdate>20140901</startdate><enddate>20140901</enddate><creator>Perez, E.A.</creator><creator>Holmes, E.</creator><creator>De Azambuja, E.</creator><creator>Dueck, A.</creator><creator>Baselga, J.</creator><creator>Viale, G.</creator><creator>Zujewski, J.A.</creator><creator>Goldhirsch, A.</creator><creator>Crescenzo, R.</creator><creator>Pritchard, K.</creator><creator>Wolff, A.C.</creator><creator>Jackisch, C.</creator><creator>Láng, I.</creator><creator>Untch, M.</creator><creator>Smith, I.</creator><creator>Boyle, F.</creator><creator>Xu, B.</creator><creator>Gomez, H.L.</creator><creator>Gelber, R.D.</creator><creator>Piccart, M.</creator><general>Oxford University Press</general><scope/></search><sort><creationdate>20140901</creationdate><title>LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC)</title><author>Perez, E.A. ; Holmes, E. ; De Azambuja, E. ; Dueck, A. ; Baselga, J. ; Viale, G. ; Zujewski, J.A. ; Goldhirsch, A. ; Crescenzo, R. ; Pritchard, K. ; Wolff, A.C. ; Jackisch, C. ; Láng, I. ; Untch, M. ; Smith, I. ; Boyle, F. ; Xu, B. ; Gomez, H.L. ; Gelber, R.D. ; Piccart, M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-oup_primary_10_1093_annonc_mdu438_23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Perez, E.A.</creatorcontrib><creatorcontrib>Holmes, E.</creatorcontrib><creatorcontrib>De Azambuja, E.</creatorcontrib><creatorcontrib>Dueck, A.</creatorcontrib><creatorcontrib>Baselga, J.</creatorcontrib><creatorcontrib>Viale, G.</creatorcontrib><creatorcontrib>Zujewski, J.A.</creatorcontrib><creatorcontrib>Goldhirsch, A.</creatorcontrib><creatorcontrib>Crescenzo, R.</creatorcontrib><creatorcontrib>Pritchard, K.</creatorcontrib><creatorcontrib>Wolff, A.C.</creatorcontrib><creatorcontrib>Jackisch, C.</creatorcontrib><creatorcontrib>Láng, I.</creatorcontrib><creatorcontrib>Untch, M.</creatorcontrib><creatorcontrib>Smith, I.</creatorcontrib><creatorcontrib>Boyle, F.</creatorcontrib><creatorcontrib>Xu, B.</creatorcontrib><creatorcontrib>Gomez, H.L.</creatorcontrib><creatorcontrib>Gelber, R.D.</creatorcontrib><creatorcontrib>Piccart, M.</creatorcontrib><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Perez, E.A.</au><au>Holmes, E.</au><au>De Azambuja, E.</au><au>Dueck, A.</au><au>Baselga, J.</au><au>Viale, G.</au><au>Zujewski, J.A.</au><au>Goldhirsch, A.</au><au>Crescenzo, R.</au><au>Pritchard, K.</au><au>Wolff, A.C.</au><au>Jackisch, C.</au><au>Láng, I.</au><au>Untch, M.</au><au>Smith, I.</au><au>Boyle, F.</au><au>Xu, B.</au><au>Gomez, H.L.</au><au>Gelber, R.D.</au><au>Piccart, M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC)</atitle><jtitle>Annals of oncology</jtitle><date>2014-09-01</date><risdate>2014</risdate><volume>25</volume><issue>suppl_4</issue><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Abstract
Aim: The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial is a randomised phase III adjuvant breast cancer trial comparing 3 oral lapatinib (L)-containing regimens with trastuzumab (T), each given for 1 year. DFS results of L + T and T—> L compared to T, presented at ASCO 2014, showed a non-significant DFS benefit. Results of L vs T and key secondary analyses are presented for the first time.
Methods: 8381 patients (pts) were randomised to receive either T (N = 2097), L (N = 2100), T —> L (N = 2091), or L + T (N = 2093) from 2007-2011. Primary comparison of L vs T evaluated non-inferiority at a margin of 1.11 and the futility boundary for this arm was crossed resulting in premature arm closure (Aug 2011). Pts in the L arm who were free of disease recurrence at that time were offered T as adjuvant treatment. Key secondary analyses including DFS by hormone receptor status and CNS endpoints are now presented.
Results: In 4197 pts and at a median follow-up of 4.5 years, 366 (17%) DFS events in the L and 301 (14%) DFS events in the T arms were observed. 1090 (52%) pts in the L arm received at least one T dose. In post-hoc analysis, there was evidence that these pts benefitted from receiving T [hazard ratio (HR) = 0.67; 95% CI 0.49-0.91 from a time-dependent Cox model of DFS]. The non-inferiority HR was 1.34 (95% CI 1.15-1.56) in the ITT population; 1.45 for hormone receptor negative, 1.23 for hormone receptor positive. CNS as first site of metastases occurred in 2% of cases in all arms. AEs of any grade were more common with L than T: diarrhoea (64% vs 20%), rash or erythema (54% vs 20%) and hepatobiliary (25% vs 16%). Any cardiac events were infrequent in both arms, but more common in T compared to L (4.5% vs 1.9%; p <0.0005), although the rate of protocol defined primary cardiac events was <1% for all arms.
Conclusions: Overall, L added to T did not statistically improve DFS. L did not appear to decrease the rate of CNS as first site of metastases. T confers a better outcome compared to L in pts with HER2-positive EBC and remains the standard of care. There is evidence of T benefit even when initiated later in the course of follow-up.
Disclosure: E. De Azambuja: Disclosed an advisory role with GSK; honoraria from Roche; research funding from GSK; and travel grants from GSK/Roche; G. Viale: disclosed an advisory role with Roche and Dako; and honoraria from GSK, Roche, and Dako; R. Crescenzo: disclosed compensated employment with GlaxoSmithKline; and stock ownership with Glaxo SmithKline; K. Pritchard: disclosed an advisory role with Roche; honoraria from Roche; research funding from Roche; and expert testimony on behalf of Roche; C. Jackisch: disclosed honoraria from Roche and GSK; F. Boyle: disclosed honoraria from GlaxoSmithKline; and research funding from GlaxoSmithKline; R.D. Gelber: disclosed research funding from GSK and Roche; M. Piccart: disclosed consultancy with PharmaMar; honoraria from Amgen, Astellas, AstraZeneca, Bayer, Eli Lilly, Invivis, MSD, Novartis, Pfizer, Roche-Genentech, Sanofi Aventis, Symphogen, Synthon, and Verastem; research grants from most companies. All other authors have declared no conflicts of interest.</abstract><pub>Oxford University Press</pub><doi>10.1093/annonc/mdu438.2</doi></addata></record> |
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| title | LBA7DISEASE-FREE SURVIVAL (DFS) IN THE LAPATINIB ALONE ARM AND EXPANDED RESULTS OF THE PHASE III ALTTO TRIAL (BIG 2-06; NCCTG (ALLIANCE) N063D) IN THE ADJUVANT TREATMENT OF HER2-POSITIVE EARLY BREAST CANCER (EBC) |
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