03/06/2006 16:03:01 CET
BASEL, Switzerland, June 3 /PRNewswire/ --
-- Real World Practice Confirms Avastin's Efficacy and Safety in Advanced Colorectal Cancer
New data from 4,000 patients show that Avastin (bevacizumab rhuMAb-VEGF) enables patients with advanced colorectal cancer (CRC) to live longer without progression of their disease.(1) The results also confirm that Avastin is well tolerated.(2) The data, taken from two early access programmes using Avastin in combination with a wide range of chemotherapies, support findings of previous pivotal trials, which demonstrated superior overall survival for Avastin when added to chemotherapy.
These data, which represent the largest data set on Avastin available to date, were presented today at the 2006 American Society of Clinical Oncology (ASCO) Annual Meeting in Atlanta, Georgia.
The BEAT study, conducted in 41 countries across the world, and the BRiTE registry, its US counterpart, are investigating the use of Avastin in advanced CRC in combination with standard chemotherapies including oxaliplatin, irinotecan or 5-FU and/or Xeloda (capecitabine). Outstanding progression-free survival (length of time without the cancer growing) is seen in BRiTE with a median at 10.2 months, independent of the chemotherapy used.(1) This real life experience compares favourably with the data previously seen in pivotal studies of Avastin in CRC in which the addition of Avastin to standard chemotherapies improved survival as well as progression free survival, compared to chemotherapy alone.
"In multiple large, well controlled studies, Avastin has consistently demonstrated significant survival benefits in colorectal cancer," said Dr Mark Kozloff, Clinical Associate, Department of Hematology/Oncology, University of Chicago. "These new data are very important as they confirm that the results shown in earlier randomized trials hold true in the real world setting. Moreover, they demonstrate that Avastin can be used in combination with a wide range of chemotherapy treatments. This is a real advance as it widens treatment options for physicians and patients and bolsters their hope of overcoming the disease."
The BEAT and BRiTE studies also evaluate the safety of Avastin with different chemotherapies in a broad patient population. Results from the studies show that Avastin's safety profile/tolerability is consistent with the safety observations from other studies
In 2002, colorectal cancer was the third most commonly reported cancer with approximately one million new cases worldwide. It is estimated that over 50 percent of people diagnosed with colorectal cancer will die of the disease (3). In the European Union colorectal cancer is the second most common cause of death from any cancer in both men and women (4).
Avastin is the first and only anti-angiogenic agent to have demonstrated improved survival in the three major causes of cancer death: colorectal cancer, NSCLC and breast cancer. In Europe, Avastin was approved in early 2005 for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received approval by the US Food and Drug Administration (FDA) and was launched in the US in February 2004. In addition, filing occurred in the US on April 10, 2006, for use of Avastin in previously untreated advanced non-squamous, non-small cell lung cancer and in Japan on April 21, 2006 for use of Avastin in patients with advanced or recurrent colorectal cancer
About BEAT and BRiTE
BEAT and BRiTE are two phase IV, open label, multi-centre studies of patients with advanced CRC receiving Avastin in addition to first-line chemotherapy.
-- BEAT is a phase IV trial which has enrolled 1927 patients from 41 countries worldwide. Patients are receiving Avastin with chemotherapy; the most common regimens are FOLFOX, CAPOX, FOLFIRI and Xeloda (capecitabine). Efficacy data from the BEAT trial are continuing to be evaluated. Safety data have shown that Avastin related serious adverse events were reported in 9 percent of patients. Gastrointestinal perforation occurred in 1.2 percent and bleeding in 1.3 percent.
-- BRiTE is a large, community based observational registry which has enrolled 1968 patients across the US. Patients are receiving Avastin with chemotherapy, the most common regimens are FOLFOX, FOLFIRI and IFL. Current efficacy data from the BRiTE study show a median progression free survival of 10.2 months. Safety data have reported that serious adverse events were seen in 12 percent of patients. Postoperative bleeding/wound healing complications in 1.2 percent, gastrointestinal perforation occurred in 1.7 percent, bleeding in 1.9 percent and arterial thromboembolic events in 2.1 percent.
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).
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant ie post-operation). The total development programme is expected to include over 25,000 patients worldwide
1 Kozloff M, et al. Efficacy of bevacizumab plus chemotherapy as first-line treatment of patients with metastatic colorectal cancer: Updated results from a large observational registry in the US (BRITE). Presented at ASCO 2006, abstract 3537
2 Berry S, et al. Preliminary safety of bevacizumab with first-line Folfox, Capox, Folfiri and Capecitabine for metastatic colorectal cancer - First B E A Trial. Presented at ASCO 2006, abstract 3534
3 Parkin D et al. Global Cancer Statistics 2002. Cancer J Clin 2005; 55: 74-108
4 Boyle P. Cancer incidence and mortality in Europe, 2004. Annals of Oncology 2005; 16(3): 481-488; doi:10.1093/annonc/mdi098
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-- Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
-- Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs