Integrated meta-analysis on 6402 patients with early breast cancer receiving neoadjuvant anthracycline-taxane +/- trastuzumab containing chemotherapy.
Authors: G von Minckwitz, M Kaufmann, S Kümmel, P Fasching, W Eiermann, J Blohmer, SD Costa, L Sibylle, V Dietmar, M Untch
Journal: Cancer Research (2009)

Abstract Abstract #79 Background: An integrated meta-analysis on individual data has been performed on 7 prospective neoadjuvant trials containing doxorubicin (A) or epirubicin (E), docetaxel (D) or paclitaxel (P) (with or without trastuzumab (H)) conducted by the German Breast Group and the AGO Breast Group.&amp;#x2028; Methods: Patients (Pts) with operable or locally advanced, non-metastatic breast cancer were included in trials between 1998 and 2002: GeparDo (dose-dense (dd) AD +/- tamoxifen (Tam), N=248), GeparDuo (ddAD+Tam vs AC-D+Tam;N=904), AGO 1 (EP vs ddE-ddP;N=666), Gepartrio-Pilot (DAC+/-vinorelbine/capecitabine(NX);N=284), and between 2003 and 2007: GeparTrio (DACx6 vs DACx8; DACx6 vs DAC-NX;N=2072); Prepare (EC-P vs ddE-ddP-CMF;N=733) and GeparQuattro (EC-D vs EC-DX vs EC-D-X;+H if HER2+),N=1495). Pathological complete response (pCR) is defined as no invasive residuals in the breast and lymphnodes (ypT0/is,ypN0).&amp;#x2028; Results: Overall 1200 (18.7%) out of 6402 pts (13.7% before and 21.2% after 2003) had a pCR at surgery. pCR-rates according to treatment groups were: conventional dosed (N=5007): 20.1% vs dose-dense (N=1395): 13.9% (p&amp;lt;.0001); docetaxel-based (N=5003): 19.9% vs. paclitaxel based (N=1399): 14.4% (p&amp;lt;.0001); HER 2 negative (N=2342): 18.4% vs HER2 pos treated w/o trastuzumab (N=684): 22.6% vs HER2 pos treated with trastuzumab (N=446): 39.9% (p&amp;lt;.0001). pCR rates according to predictive factors were: age &amp;lt; 50 yrs (N=3152): 21.7% vs &amp;gt;= 50 yrs (N=3248): 15.9% (p&amp;lt;.0001); tumor size &amp;lt;= 5cm (N=4763): 20.6% vs &amp;gt; 5cm (N=1358): 14.1% (p&amp;lt;.0001); T-stage 1-3 (N=5611): 16.8% vs T4 (N=735): 12.2% (p=0.0065); node-neg (N=2784): 21.3% vs node-pos (N=3354): 17.2% (p=0.0009); ductal or other (N=5346): 20.5% vs lobular (N=781): 8.6% (p&amp;lt;.0001); grade 1 or 2 (N=3544): 12.2% vs grade 3 (N=2362): 27.1% (p&amp;lt;.0001); hormone receptor (HR) pos (N=3890): 11.3% vs neg (N=1912): 34.6% (p&amp;lt;.0001), HR and HER2 (triple) neg (N=1516): 32.5% vs non-triple neg (w/o pts treated with trastuzumab) (N=2782): 4.0% (p&amp;lt;.0001). Multivariate analysis revealed HR (OR 3.2 (95% CI: 2.7-3.8); p&amp;lt;.0001), grade (OR 1.8 (1.5-2.2); p&amp;lt;.0001), tumor type (OR 1.7 (1.2-2.3); p=0.001), HER2 (OR 2.2 (1.8-2.5); p&amp;lt;.0001), dose dense vs standard therapy (OR 1.3 (1.1-1.7); p=0.0076), age (OR 1.3 (1.2-1.6); p=0.0001), and tumor size (OR 1.5 1.2-1.9); p=0.0006) as significant predictors of pCR. Breast conservation was achieved in 64.8% (65.5% before 2003 and 64.4% after 2003 despite increase in pCR rate). Patients achieving a pCR had a mastectomy in 17.1%.&amp;#x2028; Conclusions: Findings of this meta-analysis might be used to better select patients and treatment for the neoadjuvant approach and development of new strategies to further improve pCR and breast conservation rate. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 79.