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Abstract S5-2: HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up

2012; American Association for Cancer Research; Volume: 72; Issue: 24_Supplement Linguagem: Inglês

10.1158/0008-5472.sabcs12-s5-2

1538-7445

A. Goldhirsch, M.J. Piccart-Gebhart, Marion Procter, Evandro de Azambuja, HA Weber, Michael Untch, Ian Smith, Luca Gianni, C Jackisch, David Cameron, R. Bell, Mitch Dowsett, RD Gelber, Brian Leyland‐Jones, José Baselga,

HER2/EGFR in Cancer Research

Abstract Background: One year (yr) of trastuzumab (T) significantly improves disease-free (DFS) and overall survival (OS) in patients with HER2-positive early breast cancer (EBC) and is considered the standard of care. HERA is the only randomized trial investigating whether longer duration of T can further improve efficacy outcome. Materials and Methods: HERA (BIG 01–01) is an international, multicenter, phase III randomized trial involving 5102 women with HER2-positive EBC. Pts were randomized, after completion of primary therapy [surgery, chemotherapy and radiotherapy as indicated], to T every 3 weeks for 1 yr, 2 years (yrs), or observation. This landmark efficacy analysis compares the outcome of pts randomized to either 2 yrs or 1 yr of T who were disease-free at 1 yr after randomization (N = 1553 for 2 yrs, and N=1552 for 1 yr). The primary endpoint is DFS and secondary endpoints are OS and time to distant recurrence (TTDR). Updated efficacy analyses of the T arms vs. observation at 8-yrs of median follow-up (FU) are also presented. Results: On 12 April 2012 HERA reached the target number of 725 DFS events needed for 80% power to detect a true hazard ratio (HR) of 0.80 for the comparison of 2 yrs vs. 1 yr of T. The unadjusted HR for an event in the 2-yr vs. 1-yr T arms was 0.99 (95% CI 0.85–1.14; p = 0.86). OS in the two arms was comparable [HR=1.05 (95% CI 0.86–1.28; p = 0.63)]. TTDR results were similar. The primary cardiac endpoint* was comparable (1.0% vs. 0.8% for 2-yr and 1-yr arms, respectively), but the secondary cardiac endpoint** was higher in the 2-yr arm (7.2% vs. 4.1%). Importantly, the durable benefit in DFS and OS for both 1 yr and 2 yrs of T compared with observation remains stable at 8 yrs of median FU. Subgroup analyses including by hormone receptor status will be available for the meeting. Conclusions: These results confirm that 1 yr of adjuvant T remains the standard of care for HER2-positive EBC pts. It is also reassuring that the significant improvement in DFS and OS persists over time and that the incidence of cardiac endpoints remains low at a median FU of 8 yrs. * NYHA class III or IV, confirmed by a cardiologist, and LVEF < 50% and ≥ 10% below baseline, OR cardiac death. ** LVEF < 50% and ≥ 10% below baseline confirmed by repeat assessment, excluding patients with a primary cardiac endpoint. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr S5-2.