Landmark Study in The Lancet Oncology Shows Capecitabine (Xeloda(R)) Combination Therapy Reduces Early Breast Cancer Recurrence

This is a third party press release. It will be issued by the Finnish Breast Cancer Group on Wednesday 11 November 2009.

Finland, November 11 - An analysis conducted by the Finnish Breast Cancer Group and published
in The Lancet Oncology shows women at intermediate to high-risk of early
breast cancer recurrence who received capecitabine as part of their
chemotherapy regimen had a 34% reduction in the risk of the disease returning
or death, compared with those taking the chemotherapy combination regimen
without capecitabine.

The pre-planned three-year interim analysis of a randomised, prospective
trial (known as FinXX) compared adjuvant capecitabine in combination with
docetaxel and cyclophosphamide plus epirubicin for the treatment of early
breast cancer with the standard, non-capecitabine regimen (docetaxel,
epirubicin, cyclophosphamide and fluorouracil).[1] The analysis also found that
patients taking the capecitabine-containing regimen were significantly less
likely to have their cancer spread (distant metastasis) to another part of
the body (a 36% reduction in risk was observed). This is the first phase III
randomised trial to report efficacy of capecitabine combination therapy in
the adjuvant treatment of early breast cancer.

"Capecitabine has already been shown to be effective in patients with
advanced breast cancer. In addition, these results from the FinXX study show
that using a capecitabine-containing regimen in the early stages of breast
cancer may offer survival benefits for women, which is a primary goal of
treatment," said Professor Heikki Joensuu, Principal Investigator, Helsinki
University Hospital, Finland. "I am encouraged by this analysis, which
demonstrates that adding capecitabine to the chemotherapy regimen in the
early stages of breast cancer may prevent the cancer coming back," he added.

Breast cancer is the second most common cancer in the world and the most
common cancer among women.[2] There are 1.1 million new cases of female breast
cancer each year worldwide.[2] Despite recent advances, there is still an unmet
need in the treatment and management of early breast cancer with relapse
occurring in approximately 30% of patients, depending on individual risk
factors, even after chemotherapy.[3]

Notes to editors:

About the FinXX study

The study, led by the Finnish Breast Cancer Group, was a large
open-label, two-arm, randomised multicentre phase III study in women with
early breast cancer. 1,500 patients in Finland and Sweden with no distant
metastases who had an intermediate to high risk of recurrence within five
years from the time of diagnosis, were recruited to the study.

    - The primary objective of the study was to compare the
      recurrence-free survival of patients receiving single-agent docetaxel
      (T), followed by cyclophosphamide, epirubicin and 5-FU (CEF) to those
      receiving docetaxel with capecitabine (XT), followed by
      cyclophosphamide, epirubicin and capecitabine (CEX) in the adjuvant
      treatment of early breast cancer.
    - Secondary objectives included the evaluation and comparison
       between the two treatment arms of:
         - Safety profile
         - Overall survival.

    Results to date show that:

    - 54 women in the capecitabine-containing arm had their cancer
      return, or died compared to 80 women in the non-capecitabine
      containing arm of the study.
    - There were fewer deaths among those taking the capecitabine-containing
      combination regimen (a 34% reduction in risk of death was observed in
      this group).
    - 43 women in the capecitabine-containing arm experienced tumour
      growth in another part of their body compared to 72 women in the
      non-capecitabine arm.
    - The study participants need to be followed up for longer in order
      to assess the effect of capecitabine on survival.
    - This analysis is further evidence that capecitabine may have a
      role in early breast cancer treatment.

About The Finnish Breast Cancer Group

The Finnish Breast Cancer Group is a scientific and educational
legitimised society for scientists and specialists who are responsible for
breast cancer diagnostics and treatment in Finland. With 260 members The
Finnish Breast Cancer Group has carried out several clinical trials on
advanced breast cancer and in adjuvant setting on academic basis from 1991.

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References:

1. Significant improvement in recurrence-free survival (RFS) when
capecitabine (X) is integrated into docetaxel (T) 5-FU + epirubicin +
cyclophosphamide (CEF) adjuvant therapy for high-risk early breast cancer
(BC): interim analysis of the FinXX-trial. Presented at the San Antonio
Breast Cancer Symposium, December 2008 (abstract # 82)

2. Kamanger F et al Patterns of cancer incidence, mortality and
prevalence across five continents: defining priorities to reduce cancer
disparities in different geographic regions of the world. J Clin Oncol 2006;
24: 2137 - 2150

3. Olivotto IA, Bajdik CD, Ravdin PM, Speers CH, Coldman AJ, Norris BD,
Davis GJ, Chia SK, Gelmon KA. Population-based validation of the prognostic
model ADJUVANT! for early breast cancer. J Clin Oncol 2005;23:2716-25.

For further information please contact: Finnish Breast Cancer Group, Professor Heikki Joensuu, +358-9-471-73208, Heikki.Joensuu at hus.fi