Press Release

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.- 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 LongerPR NewswireFinland, November 11

Finland, November 11 /PRNewswire/ -- 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, prospectivetrial (known as FinXX) compared adjuvant capecitabine in combination withdocetaxel and cyclophosphamide plus epirubicin for the treatment of earlybreast cancer with the standard, non-capecitabine regimen (docetaxel,epirubicin, cyclophosphamide and fluorouracil).[1] The analysis also found thatpatients taking the capecitabine-containing regimen were significantly lesslikely to have their cancer spread (distant metastasis) to another part ofthe body (a 36% reduction in risk was observed). This is the first phase IIIrandomised trial to report efficacy of capecitabine combination therapy inthe adjuvant treatment of early breast cancer.

"Capecitabine has already been shown to be effective in patients withadvanced breast cancer. In addition, these results from the FinXX study showthat using a capecitabine-containing regimen in the early stages of breastcancer may offer survival benefits for women, which is a primary goal oftreatment," said Professor Heikki Joensuu, Principal Investigator, HelsinkiUniversity Hospital, Finland. "I am encouraged by this analysis, whichdemonstrates that adding capecitabine to the chemotherapy regimen in theearly 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 mostcommon cancer among women.[2] There are 1.1 million new cases of female breastcancer each year worldwide.[2] Despite recent advances, there is still an unmetneed in the treatment and management of early breast cancer with relapseoccurring in approximately 30% of patients, depending on individual riskfactors, even after chemotherapy.[3]

Notes to editors:

About the FinXX study

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

  - The primary objective of the study was to compare therecurrence-free survival of patients receiving single-agent docetaxel(T), followed by cyclophosphamide, epirubicin and 5-FU (CEF) to thosereceiving 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 cancerreturn, 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 tumourgrowth in another part of their body compared to 72 women in thenon-capecitabine arm. - The study participants need to be followed up for longer in orderto assess the effect of capecitabine on survival. - This analysis is further evidence that capecitabine may have arole in early breast cancer treatment.

About The Finnish Breast Cancer Group

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

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References:

1. Significant improvement in recurrence-free survival (RFS) whencapecitabine (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 AntonioBreast Cancer Symposium, December 2008 (abstract # 82)

2. Kamanger F et al Patterns of cancer incidence, mortality andprevalence across five continents: defining priorities to reduce cancerdisparities 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 prognosticmodel ADJUVANT! for early breast cancer. J Clin Oncol 2005;23:2716-25.

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