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Roche Pharmaceuticals

Revolutionary Treatment Avastin Helps People with Advanced Colorectal Cancer Live Longer While Preserving Their Quality of Life

Barcelona, Spain (ots/PRNewswire)

The addition of Avastin(R)
(bevacizumab, rhuMAb-VEGF) to chemotherapy increases the survival of
patients with advanced colorectal cancer while also preserving their
quality of life for longer according to new data presented today at
the 7th World Congress on Gastrointestinal Cancer (WCGC), Barcelona,
Spain.(1) These data are leading experts to conclude that Avastin can
be incorporated into many different chemotherapy regimens commonly
used to treat this severe disease.
"The results from these studies are extremely positive and they
reflect my own personal experience of treating people with Avastin,"
commented Dr Fairooz Kabbinavar, study investigator and Associate
Professor at the UCLA School of Medicine, Los Angeles, USA. "Avastin
helps to preserve a patient's quality of life for longer because it
is not the same as chemotherapy, and does not add to the typical
burden of chemotherapy-related side effects. Avastin is a valuable
treatment option that maximises the benefit we can offer to
patients."
The side effects associated with chemotherapy such as nausea,
vomiting, fatigue and loss of appetite have a severe impact on a
person's quality of life - even the loss of normal, everyday tasks
that most people take for granted. For example, feeling well enough
to climb the stairs or get dressed in the morning,(2) and emotional
and social wellbeing are all part of what constitutes quality of
life.
"Every day is precious to you if you have been diagnosed with
advanced colorectal cancer. And being able to carry on as normal a
life as possible and enjoy time with your family and friends while
undergoing treatment is very important too," explains Jola
Gore-Booth, Chief Executive of leading bowel cancer charity Colon
Cancer Concern (CCC) in the UK and founder of europacolon, a not for
profit organisation in Europe. "The increasing availability of new
treatments, such as Avastin, that offer colorectal cancer patients an
extension of life without a decrease in their quality of life is
another important step forward in the treatment of the disease."
In 2004, colorectal cancer was the second most common form of
cancer in Europe, with 376,400 new cases. Colorectal cancer is also
the second most common cause of death from any cancer in Europe.(3)
It is estimated that over 50 per cent of people diagnosed with
colorectal cancer will die of the disease.(4)
Avastin has now shown benefits in three of the most common types
of cancer - colorectal, lung and breast cancer.(5-7) Avastin is the
only anti-angiogenic agent to report a survival benefit in any of
these cancer types.
About the studies
Two studies investigating Avastin in colorectal cancer were
evaluated for the secondary endpoint of quality of life.
In the Phase III study, 813 patients with previously untreated
colorectal cancer were randomised to receive
irinotecan/5-fluorouracil/leucovorin (IFL) with either placebo or
Avastin.
In the Phase II study, 209 similar patients were randomised to the
chemotherapy regimen 5-fluorouracil/leucovorin and either placebo or
Avastin.
The combination of Avastin and IFL in the Phase III study resulted
in a significant improvement in overall survival and progression-free
survival, with no significant difference in time to deterioration in
quality of life with Avastin and chemotherapy compared to
chemotherapy alone. The results of the Phase II study showed that
patients receiving Avastin in addition to 5-fluorouracil/leucovorin
had a statistically significant longer time to deterioration in
quality of life as measured by FACT-C* total score (p=0.0159) and TOI
score* (p=0.0477), along with a significant increase in
progression-free survival compared to those receiving chemotherapy
alone.(1)
About Avastin
Avastin is the first treatment that inhibits angiogenesis - the
growth of a network of blood vessels that supply nutrients and oxygen
to cancerous tissues. Avastin targets a naturally occurring protein
called VEGF (Vascular Endothelial Growth Factor), a key mediator of
angiogenesis, thus choking off the blood supply that is essential for
the growth of the tumour and its spread throughout the body
(metastasis).
In Europe, Avastin is approved for first-line treatment of
patients with metastatic carcinoma of the colon or rectum in
combination with the chemotherapy regimens of intravenous
5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic
acid/irinotecan. Avastin received fast-track approval by the US Food
and Drug Administration (FDA) and was launched in the US in February
2004.**
In the pivotal Phase III study, the addition of Avastin to
chemotherapy (irinotecan/5-fluorouracil/leucovorin) significantly
extended survival by, on average, five months (20.3 months versus
15.6 months) for people with previously untreated metastatic
colorectal cancer.(7) In a Phase III study with patients who had
previously failed one chemotherapy regimen for their advanced
disease, Avastin was also shown to significantly improve survival, by
an average of approximately two months (12.9 months versus 10.8
months), when added to a widely prescribed oxaliplatin-containing
chemotherapy regimen (oxaliplatin/5-fluorouracil/leucovorin).(8)
People with very advanced colorectal cancer who are too unwell to
tolerate traditional aggressive chemotherapy also benefit from
Avastin. The addition of Avastin to a less aggressive form of
chemotherapy increased progression-free survival by four months,
compared to chemotherapy alone (a 67 per cent increase).(9)
Avastin has also now demonstrated significant clinical benefit in
advanced non-small cell lung cancer (NSCLC) and metastatic breast
cancer. A Phase III trial in patients with previously untreated
advanced NSCLC has shown that adding Avastin to first-line
platinum-based chemotherapy (paclitaxel and carboplatin)
significantly increased median survival from 10.2 months to 12.5
months.(5) In addition, another Phase III study demonstrated that
patients with metastatic breast cancer who were treated with Avastin
and a standard chemotherapy, paclitaxel, had a significant increase
in median progression-free survival to, on average, 11 months,
compared to six months for patients treated with standard
chemotherapy alone, along with a 49 per cent improvement in overall
survival.(6)
Roche and Genentech are pursuing a comprehensive clinical
programme investigating the use of Avastin in advanced colorectal
cancer with other chemotherapies and also expanding into the adjuvant
setting (post operation). As its mechanism may be relevant in a
number of malignant tumours, Roche and Genentech are also
investigating the potential clinical benefit of Avastin in pancreatic
cancer, ovarian cancer, renal cell carcinoma and others.
Approximately 15,000 patients are expected to be enrolled into
clinical trials over the next few years worldwide.
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 2004
sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion
Swiss francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai.
All trademarks used or mentioned in this release are legally
protected.
Further information:
About Roche: www.roche.com
About Genentech: www.gene.com
About cancer: www.health-kiosk.ch
Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e.pdf
To access video clips, in broadcast standard, free of charge,
please go to:
www.thenewsmarket.com
Notes to Editors
*A number of disease specific instruments have been developed to
measure quality of life in patients with colorectal cancer such as
the Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
questionnaire. The FACT-C total score and the Trial Outcome Index
(TOI-C) score were used to measure time-to-deterioration in quality
of life in patients in the studies.
**In the US, Avastin is approved for use in combination with
intravenous 5-fluorouracil-based chemotherapy, for first-line
treatment of patients with metastatic carcinoma of the colon or
rectum.
References:
1. Chawla A, Holmgren E, Nelson B, et al. Impact of bevacizumab
plus 5-FU/LV with or without irinotecan on quality of life in
patients with metastatic colorectal cancer. WCGC June 2005.
2. British Medical Journal website -
http://bmj.bmjjournals.com/cgi/content/full/322/7296/1240. Accessed
May 2005.
3. Boyle P and Ferlay J. Cancer incidence and mortality in Europe,
2004. Annals of Oncology. doi:10.1093/annonc/mdi098.
4. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology.
BMJ 2000; 321:805-808.
5. Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III
Trial of paclitaxel (P) plus carboplatin (C) with or without
bevacizumab (NSC # 704865) in patients with advanced non-squamous
non-small cell lung cancer (NSCLC): An Eastern Cooperative Oncology
Group (ECOG) Trial - E4599. ASCO 2005, Abstract LBA4.
6. Miller KD, Wang M, Gralow J, et al. E2100: a randomised phase
III trial of paclitaxel versus paclitaxel plus bevacizumab as
first-line therapy for locally recurrent or metastatic breast cancer.
Presented at 2005 ASCO Annual Meeting.
7. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus
Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal
Cancer. New England Journal of Medicine 2004; 350(23): 2335-2342.
8. Giantonio BJ, Catalano PJ, Meropol NJ, et al. High-dose
bevacizumab improves survival when combined with FOLFOX4 in
previously treated advanced colorectal cancer: Results from the
Eastern Cooperative Oncology Group(ECOG) study E3200. J Clin Oncol
2005; 23 (June 1 Suppl.) 1s (Abstract 2).
9. Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of
Bevacizumab to Bolus Fluorouracil and Leucovorin in First-Line
Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial.
J Clin Oncol 2005; 23: 3697-705.

Contact:

For further information, please contact: Emma Robinson, Resolute
Communications, Ground Floor, The Blue Building, London, SE1 3LA
+44-(0)-20-7357-8187

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