New Xeloda Combination Allows Patients with Stomach Cancer to Live Significantly Longer

New Xeloda Combination Allows Patients with Stomach Cancer to Live Significantly Longer

June 05, 2006

In Addition, Oral Chemotherapy Xeloda Reduces Treatment Time for Patients

    BASEL, Switzerland, June 5 /Xinhua-PRNewswire/ --
Results of the largest-ever phase III study in advanced
oesophagogastric cancer, the REAL 2 study, reveal that
Xeloda can replace 5-fluorouracil (5-FU) and oxaliplatin
can replace cisplatin for the first-line treatment of
patients with advanced oesophagogastric (oesophagus and
stomach) cancer. The standard treatment for this disease in
the UK and much of Europe is the combination of epirubicin,
cisplatin and 5-FU (known as ECF). In addition, the trial
showed that patients treated with the combination of Xeloda
plus oxaliplatin and epirubicin (known as 'EOX') live
significantly longer, compared to patients treated with
standard ECF chemotherapy. ECF is administered to patients
via an infusion pump connected to their arm -- lasting all
day and night, every day of the week, for the entire
duration of their treatment. Oral Xeloda frees the patient
from this schedule, is more convenient and provides greater
patient autonomy.  

    A second study, presented by lead investigator Prof. Y
K Kang of the Asan Medical Center, Seoul, South Korea,
confirms that Xeloda can also effectively replace the old
standard intravenous 5-FU, in combination with cisplatin,
as first-line therapy for stomach cancer. 

    Xeloda in combination with other chemotherapy drugs is
therefore an effective, safe, simpler and more convenient
treatment option for stomach and oesophageal cancer
patients compared to standard treatments.

    Stomach cancer is the fourth most commonly diagnosed
cancer and the second leading cause of cancer-related
deaths worldwide.(1) In Europe alone, nearly 140,000 people
die from stomach cancer each year.(2) Stomach cancer affects
twice as many men as women and occurs more frequently in
people aged over 55 years.(3) Amongst tumours of the upper
GI tract, oesophagogastric cancer is more common in the
West, whilst stomach cancer is predominant in the East.(4)

    Annie Logan, a patient with stomach cancer, said
"I wasn't prepared for how drastically my life would
change after I'd been diagnosed with stomach cancer -- it
was an absolute shock. The cancer felt like an intruder
inside of me, and it left me very debilitated. The
operation to remove the cancer involved being cut right
across my stomach and it felt like being knitted up inside.
Having now received therapy, I have a positive outlook for
the future, and am able to enjoy spending time with my
family".

    Professor David Cunningham from the Royal Marsden
Hospital, London, and lead investigator of the REAL 2
study, comments "Xeloda can now be considered as a
treatment option for oesophagogastric cancer, replacing
5-FU, as it provides the optimal balance between efficacy,
safety and convenience for patients".  

    Roche is filing for an indication in advanced stomach
cancer with worldwide regulatory authorities, based on the
results of the study presented by Prof. Y K Kang.

    NOTES TO EDITORS:

    About the Studies

    The REAL 2 study is the largest-ever phase III study in
advanced oesophagogastric cancer, and the study by Prof.
Kang is a large international phase III study in advanced
stomach cancer. These remarkable data were unveiled today
as late-breaking abstracts at the American Society of
Clinical Oncology (ASCO) Annual Meeting in Atlanta --
considered the premier educational and scientific event by
the oncology community. 

    1. 'Randomised multicentre phase III study comparing
capecitabine with fluorouracil and oxaliplatin with
cisplatin in patients with advanced oesophagogastric (OG)
cancer: The REAL 2 trial' Cunningham D 
    (Presented at ASCO 2006, 05/06/2006, 11:30a.m.) 

    -- This study was conducted in 1002 advanced
oesophagogastric cancer patients from 61 centres mainly in
the UK.

    -- The chemotherapy regimen ECF (epirubicin, cisplatin
and 5-FU) is considered a standard treatment option for
patients with oesophagogastric cancer in the UK and much of
Europe.

    -- The study aimed to establish the potential use of
Xeloda (X) and oxaliplatin (O) in untreated patients, with
the primary endpoint of overall survival.

    -- Patients were randomised to one of four regimens:
ECF, EOF, ECX or EOX. The primary comparison was overall
survival between the Xeloda and 5-FU containing arms (ECX +
EOX versus ECF + EOF) and the oxaliplatin and cisplatin
containing arms (EOF + EOX versus ECF + ECX). A further
comparison was survival between all four regimens.   

    -- Results: Xeloda was found to be as effective as 5-FU
and oxaliplatin was shown to be as effective as cisplatin
for the 5-FU arms (HR for non-inferiority =0.86, 95% CI;
0.9-0.99 which was highly significant).  Patients on the
oxaliplatin containing arms lived at least as long as those
on the cisplatin arms (HR for non-inferiority =0.92, 95% CI;
0.8-1.1        which was highly significant). Patients who
were treated first-line with Xeloda plus oxaliplatin and
epirubicin (EOX) had a longer overall survival which was
significant when compared to standard ECF (median overall
survival of 11.2 months on EOX versus 9.3 months on EOF,
and 9.9 months on ECF and ECX). The toxicity profile for
the Xeloda and oxaliplatin-containing arms appeared
acceptable. 
    -- Xeloda and oxaliplatin can now replace 5-FU and
cisplatin in triplet regimens used for the first-line
treatment of advanced oesophagogastric cancer.

    2. 'Randomised phase III trial of
capecitabine/cisplatin vs. continuous infusion of
5-FU/cisplatin as first-line therapy in patients with
advanced gastric cancer: efficacy and safety results' Kang
Y.K. 
    (Presented at ASCO 2006, 05/06/2006, 11:45a.m.)

    -- This phase III study was conducted in 316 advanced
gastric cancer patients who were enrolled in 46 centres
across 13 countries.   
    -- The study compared the efficacy and safety of Xeloda
and cisplatin (XP) with intravenous 5-FU and cisplatin (FP);
FP is also a standard treatment of gastric cancer, and
accepted by regulatory agencies as the reference regimen
against which all other regimens should be compared.    
    -- The primary endpoint was non-inferiority in
progression-free survival; patients receiving the XP
combination therapy lived at least as long without the
cancer progressing as those treated with FP (median
progression-free survival 5.6 vs. 5 months, HR= 0.81,
p=<0.001 showing strong evidence of non-inferiority),
with acceptable and similar levels of toxicity.   
    -- XP patients also lived at least as long overall
(10.5 vs. 9.3 months, HR=0.85, p=0.008 showing strong
evidence of non-inferiority).  
    -- XP response rate was superior to FP - this is the
first time that Xeloda has shown superiority to infusional
5-FU rather than bolus 5-FU (overall response rate 41 vs.
29%, p=0.030).
    -- XP reduces the amount of time a patient needs to
visit the clinic by 80% compared to FP (1 day vs. 5 days
per 3 weeks).

    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 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(R)
(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 erythrodysesthaesia).
 
    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 ( http://www.roche.com ).

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

    For more information, please contact:

     Julia Pipe                             
     International Communications Manager
     Tel:    [phone]
     Email:  [e-mail]  

     Peter Dixon
     Shire Health International, New York
     Tel:    [phone]
     Email:  [e-mail]

    Further Information Available from Media Relations
Contacts:

    -- Gastric and oesophageal cancer fact sheet 
    -- Xeloda in stomach cancer fact sheet 
    -- Xeloda fact sheet
    -- Roche in oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_a.pdf

    -- Roche: http://www.roche.com 
    -- Broadcast quality B-roll including doctor, caregiver
and patient interviews is available for download via
http://www.thenewsmarket.com 


    References: 

    1. Ajani, J. Evolving Chemotherapy for Advanced Gastric
Cancer. The Oncologist, Oct. 2005; Vol. 10, Sup. 3, 49-58

    2. Boyle, P & Ferlay, J. Cancer incidence and
mortality in Europe. 2004. Annals of Oncology 2005;
16(3):481-488

    3. Oncology Channel.
http://www.oncologychannel.com/gastriccancer/ . Visited on
15th March 2006

    4. Crew, K & Neugut, A. Epidemiology of gastric
cancer. World J Gastroenterol. 2006 Jan 21; 12(3):354-62

SOURCE  Roche