Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial.
نویسندگان
چکیده
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.
منابع مشابه
Trastuzumab in early stage breast cancer: a cost-effectiveness analysis for Belgium.
OBJECTIVES Although trastuzumab is traditionally used in metastatic breast cancer treatment, studies reported on the efficacy and safety of trastuzumab in adjuvant setting for the treatment of early stage breast cancer in HER2+ tumors. We estimated the cost-effectiveness and budget impact of reimbursing trastuzumab in this indication from a payer's perspective. METHODS We constructed a health...
متن کاملTrastuzumab duration effects within patient prognostic subgroups in the PHARE trial.
BACKGROUND At 42.5 months of median follow-up, PHARE failed to show that 6 was non-inferior to 12 months of adjuvant trastuzumab. From the results of PHARE, questions remain regarding whether the magnitude of benefit derived from 1 year is sufficient to justify its systematic use for different patient subgroups. METHODS Treatment effects were evaluated according to various tumour characterist...
متن کاملResistance to HER2-targeted therapy
Production and approval of trastuzumab (Herceptin®) for the treatment of metastatic breast cancer (MBC) was a millstone in antibody-based targeted therapy in the cancer treatment. However, despite the early success in the clinical trials, trastuzumab failed to appreciate the initial attraction due to development of resistance to the drug. The majority of patients who benefit from the drug...
متن کاملThe Effects of Different Intervals of Microdermabrasion Sessions on Skin Biophysical Parameters: A Randomized, Assessor-Blind, Within-Patient Trial
Background: Microdermabrasion has recently become a popular procedure among physicians and patients, whereas few studies have assessed the efficacy of different microdermabrasion protocols nowadays applied.The objective of this study was to assess the effects of microdermabrasion, as well as to compare the effects of weekly and biweekly intervals of microdermabrasion sessions on skin biophysica...
متن کاملCost-effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial.
BACKGROUND Routine adjuvant administration of trastuzumab (T) has been implemented in most centers, but its economic impact has not yet been well examined. METHODS A Markov model was constructed based on clinical data of the Herceptin Adjuvant (HERA) and the Finland Herceptin (FinHer) trials. Costs from the perspective of a Swiss health care provider were calculated based on resource use. R...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Annals of oncology : official journal of the European Society for Medical Oncology
دوره 19 6 شماره
صفحات -
تاریخ انتشار 2008