Roche announced recently its new long-term follow up-data from two large pivotal studies evaluating adjuvant trastuzumab in HER2 positive early-stage breast cancer presented at the CTRC-AACR San Antonio Breast Cancer Symposium. Both studies, N9831 conducted by the North Central Cancer Treatment Group and BCIRGOO6 performed by the Breast Cancer International Research Group consistently showed that -trastuzumab - reduced the risk of the cancer returning by about one third in women with HER2 positive early breast compared to patients receiving chemotherapy alone. In both studies, at least 80% of women receiving one year of trastuzumab were alive free of the disease at five years follow-up.
The trials confirmed trastuzumab's favorable cardiac safety profile at long-term follow-up. In addition, both studies were seeking to answer questions the medical community has been contemplating regarding the best way of giving their patients trastuzumab treatment.
BCIRGOO6 evaluated trastuzumab in combination with anthracycline-based chemotherapy versus an anthracycline free regimen. The study showed that both approaches extended survival without the cancer returning as well as overall survival compared to chemotherapy alone.
Be aware, N983D1 is a US, Phase III randomised, multicentre, open label trial of one year of adjuvant trastuzumab. Patients with HER2-positive early breast cancer were given other chemotherapy alone, trastuzumab following chemotherapy (sequential) or trastuzumab at the same time as chemotherapy (concurrent).
No comments:
Post a Comment