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

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    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.

ots Originaltext: Roche Pharmaceuticals
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