Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.

@article{citeulike:447454, abstract = {BACKGROUND: Trastuzumab, a recombinant monoclonal antibody against HER2, has clinical activity in advanced breast cancer that overexpresses HER2. We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy. METHODS: This international, multicenter, randomized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy. RESULTS: Data were available for 1694 women randomly assigned to two years of treatment with trastuzumab, 1694 women assigned to one year of trastuzumab, and 1693 women assigned to observation. We report here the results only of treatment with trastuzumab for one year or observation. At the first planned interim analysis (median follow-up of one year), 347 events (recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant disease, or death) were observed: 127 events in the trastuzumab group and 220 in the observation group. The unadjusted hazard ratio for an event in the trastuzumab group, as compared with the observation group, was 0.54 (95 percent confidence interval, 0.43 to 0.67; P<0.0001 by the log-rank test, crossing the interim analysis boundary), representing an absolute benefit in terms of disease-free survival at two years of 8.4 percentage points. Overall survival in the two groups was not significantly different (29 deaths with trastuzumab vs. 37 with observation). Severe cardiotoxicity developed in 0.5 percent of the women who were treated with trastuzumab. CONCLUSIONS: One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer. (ClinicalTrials.gov number, NCT00045032.)}, address = {Medicine Department, Jules Bordet Institute, Blvd. de Waterloo 125, 1000 Brussels, Belgium. martine.piccart@bordet.be}, author = {Piccart-Gebhart, M. J. and Procter, M. and Leyland-Jones, B. and Goldhirsch, A. and Untch, M. and Smith, I. and Gianni, L. and Baselga, J. and Bell, R. and Jackisch, C. and Cameron, D. and Dowsett, M. and Barrios, C. H. and Steger, G. and Huang, C. S. and Andersson, M. and Inbar, M. and Lichinitser, M. and L\'{a}ng, I. and Nitz, U. and Iwata, H. and Thomssen, C. and Lohrisch, C. and Suter, T. M. and R\"{u}schoff, J. and Suto, T. and Greatorex, V. and Ward, C. and Straehle, C. and McFadden, E. and Dolci, M. S. and Gelber, R. D. and }, citeulike-article-id = {447454}, doi = {http://dx.doi.org/10.1056/NEJMoa052306}, issn = {1533-4406}, journal = {N Engl J Med}, keywords = {cancer}, month = {October}, number = {16}, pages = {1659--1672}, posted-at = {2008-07-11 04:30:27}, priority = {2}, title = {Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.}, url = {http://dx.doi.org/10.1056/NEJMoa052306}, volume = {353}, year = {2005} }

TY - JOUR ID - citeulike:447454 L3 - citeulike-article-id:447454 TI - Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. JF - N Engl J Med VL - 353 IS - 16 SP - 1659 EP - 1672 AD - Medicine Department, Jules Bordet Institute, Blvd. de Waterloo 125, 1000 Brussels, Belgium. martine.piccart@bordet.be SN - 1533-4406 N2 - BACKGROUND: Trastuzumab, a recombinant monoclonal antibody against HER2, has clinical activity in advanced breast cancer that overexpresses HER2. We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy. METHODS: This international, multicenter, randomized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy. RESULTS: Data were available for 1694 women randomly assigned to two years of treatment with trastuzumab, 1694 women assigned to one year of trastuzumab, and 1693 women assigned to observation. We report here the results only of treatment with trastuzumab for one year or observation. At the first planned interim analysis (median follow-up of one year), 347 events (recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant disease, or death) were observed: 127 events in the trastuzumab group and 220 in the observation group. The unadjusted hazard ratio for an event in the trastuzumab group, as compared with the observation group, was 0.54 (95 percent confidence interval, 0.43 to 0.67; P<0.0001 by the log-rank test, crossing the interim analysis boundary), representing an absolute benefit in terms of disease-free survival at two years of 8.4 percentage points. Overall survival in the two groups was not significantly different (29 deaths with trastuzumab vs. 37 with observation). Severe cardiotoxicity developed in 0.5 percent of the women who were treated with trastuzumab. CONCLUSIONS: One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer. (ClinicalTrials.gov number, NCT00045032.) KW - cancer AU - Piccart-Gebhart, MJ AU - Procter, M AU - Leyland-Jones, B AU - Goldhirsch, A AU - Untch, M AU - Smith, I AU - Gianni, L AU - Baselga, J AU - Bell, R AU - Jackisch, C AU - Cameron, D AU - Dowsett, M AU - Barrios, CH AU - Steger, G AU - Huang, CS AU - Andersson, M AU - Inbar, M AU - Lichinitser, M AU - Láng, I AU - Nitz, U AU - Iwata, H AU - Thomssen, C AU - Lohrisch, C AU - Suter, TM AU - Rüschoff, J AU - Suto, T AU - Greatorex, V AU - Ward, C AU - Straehle, C AU - McFadden, E AU - Dolci, MS AU - Gelber, RD PY - 2005/10/20/ UR - http://dx.doi.org/10.1056/NEJMoa052306 ER -