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Basel, 11 November, 2009

Landmark study in The Lancet Oncology shows Xeloda reduces early breast cancer recurrence

Large, independent phase III randomised study in women with early breast cancer shows that adding Xeloda (capecitabine) to a treatment regimen containing standard agents  allows more women to live cancer-free for longer

This update outlines the pre-planned, three-year interim analysis of adjuvant Xeloda (capecitabine) in combination with docetaxel and cyclophosphamide plus epirubicin in the treatment of patients with intermediate- to high-risk early breast cancer.  FinXX is a randomised, prospective trial conducted by the Finnish Breast Cancer Group and published in The Lancet Oncology (November, 2009 issue).  The data show that:

  • Women at intermediate to high risk of early breast cancer recurrence taking Xeloda as part of their chemotherapy regimen had a 34% reduction in the risk of the cancer returning or death.1
  • Patients receiving the Xeloda-containing regimen were significantly less likely to have their cancer spread to another part of the body (distant metastasis).
  • Although the results are not yet mature, there was a trend towards superior overall survival in patients taking the Xeloda-containing regimen compared to those women receiving only standard agents.  

FinXX Study Interim Analysis

Results to date:

  • 54 women in the Xeloda-containing arm had their cancer return or died, compared to 80 women in the non-Xeloda arm (docetaxel, epirubicin, cyclophosphamide and fluorouracil).
  • The analysis demonstrates a significant (34%) reduction in the risk of cancer recurrence or death for those women taking the Xeloda-containing regimen.
  • 43 women in the Xeloda-containing arm experienced distant metastases compared to 72 women in the non-Xeloda arm.
  • The analysis demonstrates the risk of death from breast cancer is reduced by almost half (49%) for those women taking the Xeloda-containing combination regimen (18 in the Xeloda-arm vs 35 in the non-Xeloda arm).

Clinical Relevance

  • Xeloda-containing regimens may reduce the risk of cancer returning or death, thus allowing more women with early breast cancer to live cancer-free for longer.
  • Women receiving Xeloda-containing regimens may be less likely to experience distant metastases.
  • This analysis is evidence that Xeloda may have a role in early breast cancer treatment.

“Xeloda has already been shown to be effective in patients with advanced breast cancer. These results from the FinXX study show that using a Xeloda-containing regimen in the early stages of breast cancer may also 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 Xeloda to the chemotherapy regimen in the early stages of breast cancer may prevent the cancer coming back,” he added.

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About Xeloda

Xeloda (capecitabine), is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs.2-3  Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells so avoiding damage to healthy cells.  

Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has more than 11 years of proven clinical experience providing an effective and flexible treatment option to more than 1.8 million people with cancer. Xeloda is currently approved in:

Metastatic Breast Cancer

Monotherapy first-line in patients with tumours resistant to other chemotherapy drugs such as paclitaxel and anthracyclines – (US) 1998 and (EU) 2002

In combination with docetaxel in patients whose disease has progressed following iv chemotherapy with anthracyclines – (US) 2001 and (EU) 2002

In patients with inoperable or recurrent breast cancer – (Japan) 2003

Metastatic Colorectal Cancer

Monotherapy first-line (US & EU) – 2001

In combination with any chemotherapy in all lines of treatment with or without Avastin (EU/RoW) – 2008

Adjuvant Colon Cancer

Monotherapy (US & EU) – 2005

Monotherapy (Japan) – 2007

Advanced Gastric Cancer

First-line treatment (South Korea) - 2002

In combination with platinum-based chemotherapy first-line (EU) – 2007

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.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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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. 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.
3. O’Shaughnessy J et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results.  J Clin Oncol 2002; 20:2812-23.