New Data Show Elderly Colorectal Cancer Patients Taking Xeloda Live Cancer-Free for Longer

By Roche, PRNE
Wednesday, January 20, 2010

For Non-US, Non-UK Media Only

BASEL, Switzerland, January 21 -

    - Subgroup Analysis From the NO16968 (XELOXA) Study Demonstrates Benefits
      of Xeloda for Patients Over 65 or 70 Years of Age

This update outlines the key data from a subgroup analysis of the pivotal
NO16968 (XELOXA) study, the largest-ever study of patients with stage III
colon cancer, presented at the American Society of Clinical Oncology (ASCO)
Gastrointestinal Cancers Symposium. The data show that:

    - Patients older than 65 and 70 taking Xeloda (capecitabine) with
      oxaliplatin (XELOX) immediately after surgery live disease-free for
      longer compared with those treated with commonly used chemotherapy
      regimen 5-fluorouracil/leucovorin (5-FU/LV).

    - Although overall survival data are currently immature, the analysis
      shows a trend towards superiority for XELOX in patients aged over 65 or

    - The subgroup analysis in patients over 65 or 70 years of age follows on
      from the main study results which were presented at ECCO/ESMO in 2009,
      and showed that patients (aged 18-70 years of age) taking XELOX
      immediately after surgery lived disease-free for longer compared to
      those treated with 5-FU/LV. The trial demonstrated that XELOX offered
      significantly superior disease-free survival (DFS) at 3, 4 and 5 years.

NO16968 (XELOXA) study:

subgroup analysis

Data presented

    - The 3 year disease-free survival (DFS) for patients receiving XELOX is
      maintained in patients aged 65 years or over and was superior to those
      patients receiving 5-FU/LV (68% versus 62%).

    - A superior DFS was also observed in patients 70 years and over who
      received XELOX compared with 5-FU/LV (66% versus 60%).

Overall survival data are currently immature. Currently, OS is 69% for
patients aged 70 years or over treated with XELOX, versus 67% for those
treated with 5-FU/LV (HR=0.94 [95% CI 0.66-1.34]).

    Clinical relevance

    - The efficacy benefits seen with XELOX differ from recent
      studies which have shown that oxaliplatin-containing adjuvant regimens
      do not offer significant efficacy benefits for patients over 65 or 70
      years of age.(1,2)
    - These results show that XELOX provides an effective treatment
      option for all patients with stage III colon cancer, including patients
      aged over 65 or 70. Further analyses of the NO16968 (XELOXA) study are
      ongoing and additional results will be presented at future congresses
      in 2010.
    - These data are important because age is the biggest risk factor
      for the disease with more than 90% of cases diagnosed in individuals
      over the age of 50.(3)
    - Colorectal cancer affects men and women equally. It is the second
      most common cause of death from cancer across all cancer types in men
      and women in Europe(4) and is the third most commonly reported cancer
      in the world, with nearly one million cases occurring annually.(5)

"These results are very exciting and offer new hope to elderly patients
affected by colorectal cancer. They are particularly important as all recent
studies have shown that oxaliplatin-containing regimens do not offer
significant efficacy benefits for patients over 65 or 70 years of age," said
Dr Daniel Haller, Professor of Medicine, University of Pennsylvania. "It
confirms that all patients with stage III colon cancer should be evaluated
for treatment with XELOX regardless of age," he added.

Further Information

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About the NO16968 study

The NO16968 trial (XELOXA) is an open-label, randomised, phase III study
of XELOX (oral Xeloda in combination with intravenous oxaliplatin) versus
5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for patients with
stage III colon cancer who have undergone surgery. It studied the use of
XELOX for six months. The study included 1886 patients and was conducted at
226 study sites across 29 countries. The primary endpoint of the study was to
demonstrate the superiority of XELOX versus 5-FU/LV in terms of disease-free
survival. Secondary endpoints included overall survival, relapse-free
survival, safety profiles and perceived treatment convenience between the
treatment arms.

The trial demonstrated that XELOX offered significantly superior DFS at
3, 4 and 5 years:

                  3-year DFS    4-year DFS    5-year DFS
    XELOX         71.0%         68.4%         66.0%
    5-FU/LV       67%           62.3%         60.0%

    (HR 0.80, p=0.0045)

About Xeloda (capecitabine)

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. Xeloda uniquely activates the
cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells.
Xeloda tablets can be taken by patients in their own home, reducing the
number of hospital or clinic visits.

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

    Metastatic Colorectal Cancer

    - Monotherapy first-line (US , EU and ROW) - 2001

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

    - In combination with oxaliplatin for the treatment of patients with
      advanced or refractory colorectal cancer who are not candidates for
      curative surgery (Japan) - 2009

    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 and ROW)
      - 2007

    Metastatic Breast Cancer

    - Monotherapy first-line in patients with tumours resistant to taxanes
      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

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

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1. McCleary NA et al.Impact of older age on the efficacy of newer
adjuvant therapies in >12,500 patients (pts) with stage II/III colon cancer:
Findings from the ACCENT Database. ASCO 2009 (abstract 4010)

2. Andre et al. J Clin Oncol 2009;27:3109-116

3. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American
Cancer Society, 2007.

4. Ferlay J, Autier P et al. Estimates of the cancer incidence and
mortality in Europe in 2006. Annals of Oncology 18: 581-592, 2007

5. World Health Organization,

    For further information please contact:

    Michelle Marchione
    International Communications Manager, Xeloda

For further information please contact: Michelle Marchione, International Communications Manager, Xeloda, +44-(0)7809-390-658.

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