Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).

ABSTRACT:

Aim

To present the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial.

Patients and methods

8381 patients with stage I-III HER2 positive breast cancer randomised to chemotherapy plus 1-year of trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib + trastuzumab (L+T). The primary endpoint was disease-free survival (DFS). A secondary analysis examined DFS treatment effects by hormone receptor status, nodal status and chemotherapy timing; time to recurrence; overall survival (OS) and safety (overall and cardiac).

Results

At a median follow-up of 6.9 years, 705 DFS events for L+T versus T were observed. Hazard Ratio (HR) for DFS was 0.86 (95% CI, 0.74-1.00) for L+T versus T and 0.93 (95% CI,

SUBMITTER: Moreno-Aspitia A 

PROVIDER: S-EPMC8103014 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature