HERA update at SA

[Rozebud]

Found this abstract from late last week. Trying to think back to stats, but doesn't the last line on this chart imply the 2 year results are better than the 1 year results?? Or how do we read that? (Go to the actual link to see the chart in readable form.)



http://www.abstracts2view.com/sabcs05/view.php?nu=SABCS05L_371

[11] Trastuzumab (H: Herceptin ) following adjuvant chemotherapy (CT) significantly improves disease-free survival (DFS) in early breast cancer (BC) with HER2 overexpression: the HERA Trial.


Background: The Breast International Group (BIG), in collaboration with Roche, conducted an international, multi-center, randomized, 3-arm trial to compare 1 year of 3 weekly H (8 mg/kg iv day 1; 6 mg/kg iv q 3 weeks thereafter) with observation and 2 years of 3 weekly H with observation in patients with HER2 overexpressing, node-negative (T size > 1 cm) or node-positive BC who had completed at least 4 cycles of an acceptable (neo)adjuvant chemotherapy (CT) regimen. Adjuvant endocrine therapy (mostly tamoxifen) also followed CT for patients with hormone receptor positive disease. Prior to randomization, eligibility criteria included central confirmation of HER2 overexpression (3+) or amplification (FISH+) and a baseline LVEF (echo or MUGA) > 55 % following CT.
Methods: 5090 patients were enrolled from 12/2001 to 4/2005 by 478 institutions from Europe, Canada, South Africa, Israel, the Asia Pacific Region, Japan, and Latin America: median age=49 yrs, node negative=32%, hormone receptor negative=49%, prior anthracyclines (A)=68%, prior A and taxanes=25%.
Results: At a median follow-up of 1 year, 475 events were observed in the database and triggered the first and only interim analysis. The Independent Data Monitoring Committee (IDMC) recommended release of the results for the 1 year H arm (1694 pts; 127 events) versus observation (1693 pts; 220 events), which were presented at ASCO 2005 (see table below). The 2 year H arm also improved DFS compared with observation (p<0.0001). H-treated patients had a higher incidence of NYHA class III-IV CHF (cardiologist confirmed) with LVEF drop at least 10 EF points from baseline to below 50%: 9 (0.5%) with H v. 0 without H. Cardiac deaths were rare: 0 with H v. 1 without H.
Discussion:One year H significantly improves outcome compared with observation. The trial continues to assess 2 years v 1 year of H, and monitor late side effects. Updated results and information on cardiac AEs will be presented.



HERA Study Results - ASCO, May 16, 2005




DFS*

RFS

DDFS**

OS

HR

0.54

0.50

0.51

0.76

95% CI

0.43 - 0.67

0.40 - 0.63

0.40 - 0.66

0.47 - 1.23

p-value

< 0.0001

< 0.0001

< 0.0001

0.26

events

127 v. 220

113 v. 209

98 v. 179

29 v. 37

2-year %

85.8% v. 77.4%

87.2% v. 78.6%

89.7% v. 81.8%

96.0% v. 95.1%



*includes local, regional, distant recurrences, contralateral BC, 2nd malignancies, death without prior event. ** includes distant recurrences, contralateral BC, 2nd malignancies.



Thursday, December 8, 2005 3:00 PM

General Session 2 (1:30 PM-3:30 PM)