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Survival outcomes of the NeoALTTO study (BIG 1–06): Updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer

European Journal of Cancer Aug 14, 2019

Huober J, Holmes E, Baselga J, et al. - Given that the pathologic complete response (pCR) rate rises significantly with providing lapatinib (L) plus trastuzumab (T) with weekly paclitaxel vs anti–human epidermal growth factor receptor 2 (HER2) agent alone plus paclitaxel, researchers examined the treatment arms L + T vs T and L vs T regarding the event-free survival (EFS) and overall survival (OS). In addition, they investigated the relationship between pCR and EFS/OS both in the whole study population and according to hormone receptor–negative and hormone receptor–positive cohorts after a median follow-up of 6.7 years. They randomly assigned 455 patients with HER2-positive early breast cancer to received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. After surgery, three cycles of fluorouracil, epirubicin and cyclophosphamide were administered to the patients. With L, T and L + T, 6-year EFS rates were 67%, 67% and 74%, respectively; 6-Year OS rates were 82%, 79% and 85%, respectively. In HER2-positive disease, achieving a pCR is important and is correlated with the better long-term outcome with regard to EFS and OS.
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