Xeloda Meets Primary Endpoint in Multinational Phase III Advanced Colorectal Cancer Study

2006-12-11 11:33 988

- Roche to Approach World-Wide Regulatory Authorities for a New File


BASEL, Switzerland, Dec. 11 /Xinhua-PRNewswire/ -- Roche announced today

that a large, international Phase III study (NO16967) of 627 previously

treated patients with advanced colorectal cancer met its primary endpoint of

progression-free survival. Study results showed that the chemotherapy

combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying

disease progression as the chemotherapy combination FOLFOX-4 (infused 5-

FU/leucovorin plus oxaliplatin).

"This data endorses previous findings that oral Xeloda in combination

with oxaliplatin may provide a new treatment choice for colorectal cancer

patients," said Eduard Holdener, Head of Global Development at Roche." These

data will be used in the submission to worldwide regulatory authorities to

allow patients with colorectal cancer the opportunity to have an effective

and more convenient therapy."

Xeloda is an oral chemotherapy that can be taken at home and as such it

has an important convenience benefit for both patients and doctors compared

to intravenous infusions which require multiple hospital visits. This

targeted cancer medicine is already used in previously untreated colorectal

cancer patients and last year Xeloda received the additional approval for the

treatment of early (adjuvant) colon cancer.

Results from the NO16967 study will be submitted for presentation at

future major medical meetings.

"Our data complement the findings of the NO16966 study, suggesting that

XELOX is a very reasonable treatment option for patients with recurrent

colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor

of Medicine at Vanderbilt University Medical Center and Ingram Professor of

Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that

Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these

two studies provide the strongest evidence yet that Xeloda may be used in

place of IV 5-FU in the treatment of patients with advanced colorectal


In 2004, colorectal cancer was one of the leading cancers and accounted

for 13 percent of all cancers.(1) It is estimated that more than 394,000

people die worldwide from colorectal cancer each year.(2)

About the Study

The NO16967 trial is a large, international phase III trial which

randomized 627 patients from 15 countries world-wide who had previously

received chemotherapy and whose disease had returned or continued to progress.

The primary objective was to answer whether the XELOX regimen (Xeloda

plus oxaliplatin) is as effective as FOLFOX 4 (intravenous bolus and

infusional 5-fluorouracil/leucovorin plus oxaliplatin) in delaying disease

progression or death. The secondary outcomes, to be reviewed included overall

survival, overall response rates, and safety profile.


An abbreviation for a type of combination chemotherapy used to treat

colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.

About Xeloda (capecitabine)

Xeloda is licensed in more than 90 countries worldwide including the EU,

USA, Japan, Australia and Canada and has been shown to be an effective, safe,

simple and convenient oral chemotherapy in treating over 1 million patients

to date.

Roche received marketing authorisation for Xeloda as a first-line

monotherapy (by itself) in the treatment of metastatic colorectal cancer

(colorectal cancer that has spread to other parts of the body) in most

countries (including the EU and USA) in 2001. Xeloda has also been approved

by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration

(FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June

2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with

metastatic breast cancer (breast cancer that has spread to other parts of the

body) and whose disease has progressed following intravenous (i.v.)

chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for

treatment of patients with metastatic breast cancer that is resistant to

other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda is

licensed for the first-line treatment of stomach cancer that has spread, in

South Korea.

The most commonly reported adverse events with Xeloda include diarrhoea,

abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar


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 a supplier of innovative products and services for the early

detection, prevention, diagnosis and treatment of disease, the Group

contributes on a broad range of fronts to improving people’s health and

quality of life. Roche is a world leader in diagnostics, the leading supplier

of medicines for cancer and transplantation and a market leader in virology.

In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss

francs, and the Diagnostics Division posted sales of 8.2 billion Swiss

francs. Roche employs roughly 70,000 people in 150 countries and has R&D

agreements and strategic alliances with numerous partners, including majority

ownership interests in Genentech and Chugai. Additional information about the

Roche Group is available on the Internet ( ).

All trademarks used or mentioned in this release are legally protected.

Additional information

-- Roche in Oncology:

-- Roche Health Kiosk, Cancer:


1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004.

Annals of Oncology 2005; 16:481-488

2. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology. BMJ 2000;


Source: Roche