from St. Gallen conference abstract --hera update presented 3 hours ago

[Lani]

no news I've found yet...but the abstract printed before the conference says no news on 1 vs 2 yrs herceptin until 2011 !!!!
The abstract:
Background: Trastuzumab, a recombinant monoclonal antibody against
the HER-2 receptor, has been shown to significantly improve disease-free
and overall sur vival in women with HER-2 positive early breast cancer
when given concurrently with or sequentially after chemotherapy.
Materials and Methods: HERA is an ongoing international, multicen-
ter, randomised phase III trial comparing one or two years of adjuvant
trastuzumab given ever y three weeks with obser vation in 5,102 patients
with HER-2 positive either node-negative (tumour size 􏰸1.0 cm) or node-
positive early breast cancer who had completed locoregional therapy and
had received at least four cycles of standard neoadjuvant or adjuvant
chemotherapy. Central confirmation of HER-2 positivity and LVEF 􏰸55%
after completing chemotherapy and radiotherapy were required prior to
randomisation. The second planned interim analysis of the 1 yr vs 2 yr
trastuzumab comparison in the HERA trial was conducted on October 20,
2008. The Independent Data Monitoring Committee (IDMC) recommended
that the study continue as planned without disclosing data on the 2 yr
trastuzumab group. In the obser vation and the 1 yr trastuzumab groups,
827 disease-free sur vival events (DFS) have been obser ved at a median
follow up of 48.4 months after randomization, and are the subject to the
present update.
Results: After release of the HERA and the combined B31 and N9831
results in 2005, a protocol amendment allowed for eligible obser vation
patients to receive trastuzumab and data were continuously collected. Out
of the 1698 obser vation patients, there were 885 obser vation patients
who crossed over to trastuzumab. These late star ter patients star ted
trastuzumab at a median of 22.8 months (<1−52.7) from randomization.
The updated intent-to-treat (ITT) analysis of DFS confirmed a statistically
significant benefit in favour of the patients who received 1 yr of trastuzumab
following chemotherapy compared with obser vation (p < 0.0001). Additional
analyses to examine the effect of the late star t of trastuzumab in the
obser vation group and the influence of the selective crossover on the
treatment comparison will be presented.
Conclusion: The updated analysis of the HERA trial confirmed the
benefit of delivering adjuvant trastuzumab for 1 yr after chemotherapy in
women with HER2-positive tumors despite the substantive crossover of
obser vation group patients to active treatment. The HERA study is ongoing
and final results including the comparison of 1 yr vs 2 yrs trastuzumab are
expected in 2011.