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Investor Update

Basel, 15 December 2008

Xeloda shows strong promise in early breast cancer

Phase III interim analysis data indicate chemotherapy pill Xeloda, already proven in advanced breast cancer, may also reduce recurrence of early breast cancer

Data presented at the San Antonio Breast Cancer Symposium (SABCS) indicate that adding Xeloda to standard chemotherapy allows women treated for early breast cancer to live cancer-free for longer. Interim results from a phase III study with 1500 patients demonstrate that women with early breast cancer taking Xeloda as part of their chemotherapy had a 34% reduction in the risk of the cancer returning (recurrence-free survival, HR: 0.66, p-value: 0.020).1

The trial by the Finnish Breast Cancer Group also showed that patients treated with Xeloda were less likely to have their cancer spread to another part of the body (HR: 0.64, p-value: 0.014). Preliminary results also suggested a trend towards improved survival, although the overall survival data is not mature yet (HR: 0.66, p-value: 0.089).

“We already know that oral Xeloda on its own, or in combination with other chemotherapies, improves survival in patients with advanced breast cancer. The positive results presented today  indicate a new potential role for Xeloda in treating early breast cancer,” said Professor Heikki Joensuu Helsinki University Hospital, Finland. “These data suggest that women taking Xeloda may live longer without their breast cancer coming back.”

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

Xeloda, an oral chemotherapy drug, is a powerful and effective treatment option that has been shown to significantly lengthen survival in women with advanced breast cancer 3,4 and has been approved for the treatment of breast cancer for over 10 years. Xeloda is a precursor of the cancer-killing agent 5-FU (5-fluorouracil) that gets activated directly inside the cancer cells. Furthermore, as Xeloda is a tablet, patients can take it in the comfort of their own home, which offers them the freedom to carry on with their lives as normally as possible.

Notes to editors:
About the study
The study, led by the Finnish Breast Cancer Group, is a large open-label, two-arm, randomised multi-centre phase III study in patients with early breast cancer. Recruitment of 1,500 patients in Finland and Sweden with no distant metastases who have a >25% risk of distant recurrence within 5 years from the time of diagnosis, has now been completed

  • The primary objective of the ongoing study is to compare the recurrence-free survival of patients with early breast cancer receiving adjuvant treatment with either single agent docetaxel, followed by cyclophosphamide, epirubicin and 5-FU (CEF) or with docetaxel and  capecitabine, followed by cyclophosphamide, epirubicin and capecitabine (CEX).
  • Secondary objectives include the evaluation and comparison of safety profile and overall survival between the two treatment arms.

Results to date show:

  • 54 women in the Xeloda treatment arm had their cancer return, or died compared to 80 women in the non-Xeloda containing arm of the study
  • 42 women in the Xeloda treatment arm experienced tumour growth in another part of their body compared to 72 women in the non-Xeloda containing arm of the study
  • Although the results are not yet mature, women in the Xeloda treatment arm of the study showed a trend towards superior overall survival over those women not in the Xeloda treatment arm

About Xeloda

Xeloda is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs.  Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells, thus avoiding damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.

Licensed in more than 100 countries worldwide, Xeloda has been used for more than ten years by clinicians, and has provided an effective and flexible treatment option to over 1.5 million people with cancer. Xeloda is currently approved in:

  • Metastatic Colorectal Cancer
    - Monotherapy 1st line (US & EU) – 2001
    - In combination with any chemotherapy in all lines of treatment with or without Avastin (EU) - 2008
  • Metastatic Breast Cancer
    - Monotherapy for 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
  • Adjuvant Colon Cancer
    - Monotherapy (US & EU) – 2005
    - Monotherapy (Japan) - 2007
  • Advanced Gastric Cancer
    - 1st line treatment - (South Korea) 2002 and (China) 2008
    - In combination with platinum-based chemotherapy 1st line (EU) – 2007
  • Metastatic Pancreatic Cancer
    - In combination with gemcitabine 1st line (South Korea) - 2006

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 one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.  As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life.  Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology.  It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system.  In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs.  Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007.  Worldwide, the Group employs about 80,000 people.  Additional information is available on the Internet at 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. 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. 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.
4. Wardley, A. et al. Evaluation of trastuzumab (Herceptin®), docetaxel and capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 2007 (abstract # 3001-3115