Finland, November 11 /PRNewswire/ --

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

- FinXX, a Large, Phase III Randomised Study in Women With Early Breast Cancer Shows that Adding Capecitabine (Xeloda(R)) to a Treatment Regimen Containing Standard Agents Allows More Women to Live Cancer-Free for Longer

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.

SOURCE The Finnish Breast Cancer Group

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