0000000000001041
AUTHOR
Miguel Angel Climent
Neoadjuvant and adjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer (NOAH): follow-up of a randomised controlled superiority trial with a parallel HER2-negative cohort.
Summary Background In our randomised, controlled, phase 3 trial NeOAdjuvant Herceptin (NOAH) trial in women with HER2-positive locally advanced or inflammatory breast cancer, neoadjuvant trastuzumab significantly improved pathological complete response rate and event-free survival. We report updated results from our primary analysis to establish the long-term benefit of trastuzumab-containing neoadjuvant therapy. Methods We did this multicentre, open-label, randomised trial in women with HER2-positive locally advanced or inflammatory breast cancer. Participants were randomly assigned (1:1), by computer program with a minimisation technique, to receive neoadjuvant chemotherapy alone or with …
Follow-up results of NOAH, a randomized phase III trial evaluating neoadjuvant chemotherapy with trastuzumab (CT+H) followed by adjuvant H versus CT alone, in patients with HER2-positive locally advanced breast cancer.
503 Background: The monoclonal antibody trastuzumab (H) has been shown to improve event-free survival (EFS) and pathologic complete response (pCR) in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without one year of trastuzumab in the primary analysis of the NOAH study (Gianni L, Lancet 2010). Updated EFS and overall survival (OS) results are now presented. Methods: In this international, multicenter, open-label, randomized phase III trial patients with locally advanced or inflammatory breast cancer were randomized 1:1 to receive CT+H followed by adjuvant H versus CT alone. A parallel cohort of 99 comparable patients w…
Estrogen levels in premenopausal (prem) patients (pts) with hormone-receptor positive (HR+) early breast cancer (BC) receiving adjuvant triptorelin (Trip) plus exemestane (E) or tamoxifen (T) in the SOFT trial: SOFT-EST substudy.
585 Background: Optimal endocrine therapy for prem pts with early HR+ BC may depend on complete estrogen suppression with GnRH-A, and is crucial for those receiving concurrent aromatase inhibitors (AI). SOFT-EST is a prospective substudy of the phase III SOFT trial. Aims of SOFT-EST are to describe estradiol (E2), estrone (E1) and estrone sulphate (E1S) during monthly Trip + E or T and to assess if there is a group in E+Trip with suboptimal estrogen suppression (SES). Methods: All pts enrolled in SOFT from selected centers who consented, selected Trip as ovarian function suppression method and were randomized to E+Trip or T+Trip were enrolled in SOFT-EST until reaching the accrual goal (E=9…
Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor–Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy
Purpose To describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin. Patients and Methods Premenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sen…
Bone Turnover Markers and Potential Correlation with Outcomes in Patients with Genitourinary Cancer (Renal and Bladder) and Bone Metastasis (Results of the Tugamo Study)
ABSTRACT Background Levels of bone turnover markers (BTM) might be correlated with outcome in terms of skeletal related events (SRE), disease progression and death. The aim of the study was to determine the possible correlation between BTM, disease progression, SREs and death in patients with genitourinary cancer and bone metastases (BM) treated with zoledronic acid (ZA). Methods Observational, prospective, multicenter study. Patients with genitourinary cancer (prostate, renal, bladder) and BM were included. BTM determined were: carboxiterminal telopeptide of type I collagen (β-CTX) and bone specific alkaline phosphatase (BALP) by ELISA (immunoenzymatic assay, IDS UK), and aminoterminal pro…