2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial

Ian Smith, Marion Procter, Richard D. Gelber, Sébastien Guillaume, Andrea Feyereislova, Mitch Dowsett, Aron Goldhirsch, Michael Untch, Gabriella Mariani, Jose Baselga, Manfred Kaufmann, David Cameron, Richard Bell, Jonas Bergh, Robert Coleman, Andrew Wardley, Nadia Harbeck, Roberto I. Lopez, Peter Mallmann, Karen GelmonNicholas Wilcken, Erik Wist, Pedro Sánchez Rovira, Martine J. Piccart-Gebhart

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Abstract

Background: Trastuzumab-a humanised monoclonal antibody against HER2-has been shown to improve disease-free survival after chemotherapy in women with HER2-positive early breast cancer. We investigated the drug's effect on overall survival after a median follow-up of 2 years in the Herceptin Adjuvant (HERA) study. Methods: HERA is an international multicentre randomised trial that compared 1 or 2 years of trastuzumab treatment with observation alone after standard neoadjuvant or adjuvant chemotherapy in women with HER2-positive node positive or high-risk node negative breast cancer. 5102 women participated in the trial; we analysed data from 1703 women who had been randomised for treatment with trastuzumab for 1 year and 1698 women from the control group, with median follow-up of 23·5 months (range 0-48 months). The primary endpoint of the trial was disease-free survival. Here, we assess overall survival, a secondary endpoint. Analyses were done on an intent-to-treat basis. This trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings: 97 (5·7%) patients randomised to observation alone and 58 (3·4%) patients randomised to 1 year of treatment with trastuzumab were lost to follow-up. 172 women stopped trastuzumab prematurely. 59 deaths were reported for trastuzumab and 90 in the control group. The unadjusted hazard ratio (HR) for the risk of death with trastuzumab compared with observation alone was 0·66 (95% CI 0·47-0·91; p=0·0115). 218 disease-free survival events were reported with trastuzumab compared with 321 in the control group. The unadjusted HR for the risk of an event with trastuzumab compared with observation alone was 0·64 (0·54-0·76; p

Original languageEnglish
Pages (from-to)29-36
Number of pages8
JournalLancet
Volume369
Issue number9555
DOIs
Publication statusPublished - Jan 6 2007

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Adjuvant Chemotherapy
Randomized Controlled Trials
Breast Neoplasms
Observation
Disease-Free Survival
Control Groups
Trastuzumab
Odds Ratio
Antibodies, Monoclonal, Humanized
Survival
Lost to Follow-Up
Multicenter Studies
Therapeutics
Clinical Trials
Databases
Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Smith, I., Procter, M., Gelber, R. D., Guillaume, S., Feyereislova, A., Dowsett, M., ... Piccart-Gebhart, M. J. (2007). 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet, 369(9555), 29-36. https://doi.org/10.1016/S0140-6736(07)60028-2

2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer : a randomised controlled trial. / Smith, Ian; Procter, Marion; Gelber, Richard D.; Guillaume, Sébastien; Feyereislova, Andrea; Dowsett, Mitch; Goldhirsch, Aron; Untch, Michael; Mariani, Gabriella; Baselga, Jose; Kaufmann, Manfred; Cameron, David; Bell, Richard; Bergh, Jonas; Coleman, Robert; Wardley, Andrew; Harbeck, Nadia; Lopez, Roberto I.; Mallmann, Peter; Gelmon, Karen; Wilcken, Nicholas; Wist, Erik; Sánchez Rovira, Pedro; Piccart-Gebhart, Martine J.

In: Lancet, Vol. 369, No. 9555, 06.01.2007, p. 29-36.

Research output: Contribution to journalArticle

Smith, I, Procter, M, Gelber, RD, Guillaume, S, Feyereislova, A, Dowsett, M, Goldhirsch, A, Untch, M, Mariani, G, Baselga, J, Kaufmann, M, Cameron, D, Bell, R, Bergh, J, Coleman, R, Wardley, A, Harbeck, N, Lopez, RI, Mallmann, P, Gelmon, K, Wilcken, N, Wist, E, Sánchez Rovira, P & Piccart-Gebhart, MJ 2007, '2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial', Lancet, vol. 369, no. 9555, pp. 29-36. https://doi.org/10.1016/S0140-6736(07)60028-2
Smith, Ian ; Procter, Marion ; Gelber, Richard D. ; Guillaume, Sébastien ; Feyereislova, Andrea ; Dowsett, Mitch ; Goldhirsch, Aron ; Untch, Michael ; Mariani, Gabriella ; Baselga, Jose ; Kaufmann, Manfred ; Cameron, David ; Bell, Richard ; Bergh, Jonas ; Coleman, Robert ; Wardley, Andrew ; Harbeck, Nadia ; Lopez, Roberto I. ; Mallmann, Peter ; Gelmon, Karen ; Wilcken, Nicholas ; Wist, Erik ; Sánchez Rovira, Pedro ; Piccart-Gebhart, Martine J. / 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer : a randomised controlled trial. In: Lancet. 2007 ; Vol. 369, No. 9555. pp. 29-36.
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T1 - 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer

T2 - a randomised controlled trial

AU - Smith, Ian

AU - Procter, Marion

AU - Gelber, Richard D.

AU - Guillaume, Sébastien

AU - Feyereislova, Andrea

AU - Dowsett, Mitch

AU - Goldhirsch, Aron

AU - Untch, Michael

AU - Mariani, Gabriella

AU - Baselga, Jose

AU - Kaufmann, Manfred

AU - Cameron, David

AU - Bell, Richard

AU - Bergh, Jonas

AU - Coleman, Robert

AU - Wardley, Andrew

AU - Harbeck, Nadia

AU - Lopez, Roberto I.

AU - Mallmann, Peter

AU - Gelmon, Karen

AU - Wilcken, Nicholas

AU - Wist, Erik

AU - Sánchez Rovira, Pedro

AU - Piccart-Gebhart, Martine J.

PY - 2007/1/6

Y1 - 2007/1/6

N2 - Background: Trastuzumab-a humanised monoclonal antibody against HER2-has been shown to improve disease-free survival after chemotherapy in women with HER2-positive early breast cancer. We investigated the drug's effect on overall survival after a median follow-up of 2 years in the Herceptin Adjuvant (HERA) study. Methods: HERA is an international multicentre randomised trial that compared 1 or 2 years of trastuzumab treatment with observation alone after standard neoadjuvant or adjuvant chemotherapy in women with HER2-positive node positive or high-risk node negative breast cancer. 5102 women participated in the trial; we analysed data from 1703 women who had been randomised for treatment with trastuzumab for 1 year and 1698 women from the control group, with median follow-up of 23·5 months (range 0-48 months). The primary endpoint of the trial was disease-free survival. Here, we assess overall survival, a secondary endpoint. Analyses were done on an intent-to-treat basis. This trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings: 97 (5·7%) patients randomised to observation alone and 58 (3·4%) patients randomised to 1 year of treatment with trastuzumab were lost to follow-up. 172 women stopped trastuzumab prematurely. 59 deaths were reported for trastuzumab and 90 in the control group. The unadjusted hazard ratio (HR) for the risk of death with trastuzumab compared with observation alone was 0·66 (95% CI 0·47-0·91; p=0·0115). 218 disease-free survival events were reported with trastuzumab compared with 321 in the control group. The unadjusted HR for the risk of an event with trastuzumab compared with observation alone was 0·64 (0·54-0·76; p

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