Navigation Links
Study Confirms That Avastin Significantly Increases Chance of Living Without Disease Progression in Metastatic Breast Cancer
Date:5/31/2008

- Data From Pivotal Phase III AVADO Study Presented at ASCO for the First

Time

BASEL, Switzerland, May 31 /PRNewswire/ -- Avastin (bevacizumab), significantly improves the time patients with metastatic breast cancer live without their disease getting worse ("progression-free survival") when combined with a commonly used chemotherapy called docetaxel (Taxotere), compared with docetaxel alone. These findings were presented for the first time today at the American Society of Clinical Oncology (ASCO) meeting in Chicago. This is the second large phase III trial that met its primary endpoint by showing that Avastin provides a significant improvement in progression-free survival in HER 2 negative metastatic breast cancer patients. This follows the recently published landmark E2100 study (Avastin plus paclitaxel versus paclitaxel alone).

The results of the phase III "Avastin and Docetaxel" ("AVADO", BO17708) study showed that the combination of Avastin and docetaxel resulted in:

-- Up to a 64% increase in a patient's chance of being alive without

disease progression compared to docetaxel alone.

-- Up to two thirds of patients (63%) experiencing major shrinkage of

their tumor, which is unprecedented.

-- No new safety signals related to Avastin. Furthermore, Avastin did not

have a major impact on the known toxicity profile of docetaxel.

Principal investigator for AVADO, Dr. David Miles, medical oncologist, Mount Vernon Hospital, UK said: "This is the second large phase III study to confirm that Avastin extends the time in which patients live without disease progression in combination with a widely used chemotherapy agent. Importantly this study has confirmed that Avastin can be used with taxane-based chemotherapy to provide a meaningful benefit for patients with metastatic breast cancer."

Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg given every three weeks). The AVADO study was not powered to detect a difference in efficacy between the two doses, however, there was a numerical advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These results, and those of the other landmark study (E2100), support use of this dose (5mg/kg/week). Overall survival data are still immature at present and are expected in 2009.

This second large phase III trial follows the recently published E2100 study. Results from E2100 formed the basis of European Commission approval and FDA accelerated approval of Avastin in combination with the widely used chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2 negative) breast cancer in March 2007 and February 2008 respectively. Study E2100 showed that the addition of Avastin to paclitaxel doubled patients' chance of being alive without disease progression compared to paclitaxel alone.

Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally.

About the AVADO study

AVADO is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups;

-- Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel

-- Avastin 15 mg/kg every 3 weeks in combination with docetaxel

-- docetaxel + placebo as control arm

The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms compared to the control arm. Secondary endpoints for the study included response rate, duration of response, time to treatment failure, overall survival, quality of life, safety and tolerability.

Additional information

To access video clips about Avastin, in broadcast standard, free of charge, please go to: http://www.thenewsmarket.com


'/>"/>
SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)
2. International Diabetes Federation Grant Supports Lifestyle Intervention Study to Prevent Type 2 Diabetes in India
3. Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients With Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)
4. ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients
5. InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
6. New England Journal of Medicine Publishes Results From a RELISTOR Phase 3 Clinical Study
7. Grocery Manufacturers Association: Study Signals Progress in Battle Against Obesity
8. New Study Linking High Normal Blood Pressure to Significant Cardiovascular Risk
9. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
10. CellCyte Genetics Signs Collaborative Agreement With Northwestern Universitys Feinberg School of Medicine to Perform Disease Model Outcome Study of CellCytes CCG-TH30 Product Candidate
11. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... RIDGE, Ill. and INDIANAPOLIS ... of students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship ... The 2016 scholarship winners, announced today online at ... to let type 1 diabetes stand in the way ... Diabetes has supported the Foundation,s scholarship program since 2012, ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... today at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra ... authored journal articles published in Emergency Medicine Practice and Pediatric Emergency ...
Breaking Medicine News(10 mins):