Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial.

BACKGROUND: Trastuzumab (Herceptin(R)) improves disease-free survival (DFS) and overall survival for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess the magnitude of its clinical benefit for subpopulations defined by nodal and steroid hormone receptor status using data from the Herceptin Adjuvant (HERA) study. PATIENTS AND METHODS: HERA is an international multicenter randomized trial comparing 1 or 2 years of trastuzumab treatment with observation after standard chemotherapy in women with HER2-positive breast cancer. In total, 1703 women randomized to 1-year trastuzumab and 1698 women randomized to observation were included in these analyses. Median follow-up was 23.5 months. The primary endpoint was DFS. RESULTS: The overall hazard ratio (HR) for trastuzumab versus observation was 0.64 [95% confidence interval (CI) 0.54-0.76; P < 0.0001], ranging from 0.46 to 0.82 for subgroups. Estimated improvement in 3-year DFS in subgroups ranged from +11.3% to +0.6%. Patients with the best prognosis (those with node-negative disease and tumors 1.1-2.0 cm) had benefit similar to the overall cohort (HR 0.53, 95% CI 0.26-1.07; 3-year DFS improvement +4.6%, 95% CI -4.0% to 13.2%). CONCLUSIONS: Adjuvant trastuzumab therapy reduces the risk of relapse similarly across subgroups defined by nodal status and steroid hormone receptor status, even those at relatively low risk for relapse.

Search for maximal flavor violating scalars in same-charge lepton pairs in pp̄ collisions at s=1.96TeV

Models of maximal flavor violation (MxFV) in elementary particle physics may contain at least one new scalar SU(2) doublet field ΦFV=(η0,η+) that couples the first and third generation quarks (q1, q3) via a Lagrangian term LFV=ξ13ΦFVq1q3. These models have a distinctive signature of same-charge top-quark pairs and evade flavor-changing limits from meson mixing measurements. Data corresponding to 2fb-1 collected by the Collider Dectector at Fermilab II detector in pp̄ collisions at s=1.96TeV are analyzed for evidence of the MxFV signature. For a neutral scalar η0 with mη0=200GeV/c2 and coupling ξ13=1, ∼11 signal events are expected over a background of 2.1±1.8 events. Three events are observed in the data, consistent with background expectations, and limits are set on the coupling ξ13 for mη0=180-300GeV/c2. © 2009 The American Physical Society.