First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC).

摘要: 502Background: Pre-specified 5-year analyses of the phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) Trial defined in Amendments 11&12. Methods: From June 2007 to July 2011, 8381 patients (pts) were randomised from 946 sites 44 countries receive either L+T, T→L, L, or T. In due futility L arm was closed and is not included this analysis. The primary end point disease-free survival (DFS). Secondary objectives include treatment comparisons with respect overall (OS), time recurrence (TTR), distant (TDR), cardiac safety tolerability. Primary analysis results study published JCO 2015 34:1034-1042. This updated occurs at a 6.9 yrs median follow up (MFU). Results: All have reached 5-years follow-up. 705 DFS events for L+T vs T been observed. HR 0.86 (95% CI, 0.74-1.00; 6-yr DFS%=85% 82%) 0.93 0.81-1.08; DFS%=84% for...