BASEL, Switzerland, January 21 /PRNewswire/ --

- 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 70. - 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 RD. 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:

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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 +44-(0)7809-390-658


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