Background Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is noninferior to the standard 12-month treatment regarding disease-free survival. Methods This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006-007018-39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140).
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
The aim of this study was to examine the efficacy and toxicity of the epirubicin, carboplatin and 5-fluorouracil (ECarboF) regime in patients aged 70 or less with metastatic prostate cancer resistant to LHRH analogues. The majority of patients had previously received steroids as part of their systemic management and had progressive disease on steroids. In total, 80 patients were treated over a 6-year period, with objective response rates (PSA or radiological) of 45% and median time to relapse of 9.5 months. Median survival of the group was 9.2 months. In all, 32% of patients were alive at 12 months. Grade 3/4 neutropenia occurred in 34% of patients with an 8.7% rate of neutropenic sepsis. Grade 3/4 nonhaematological toxicity occurred in 28% of patients. For a substantial minority of patients with hormone refractory prostate cancer, combination chemotherapy can induce remission of significant duration. While similar responses have been documented for systemic cytotoxic -steroid combinations, the responses in this study are likely to reflect the activity of cytotoxic drugs alone.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.