Navigation Links
Bevacizumab offers no benefit for newly diagnosed glioblastoma, M.D. Anderson-led study finds
Date:6/2/2013

Chicago, IL The angiogenesis inhibitor bevacizumab (Avastin) failed to increase overall survival (OS) or statistically significant progression-free survival (PFS) for glioblastoma patients in the frontline setting, according to research led by researchers at The University of Texas MD Anderson Cancer Center.

The study was presented today on the plenary session of the American Society of Clinical Oncology 2013 Annual Meeting by Mark Gilbert, M.D., professor in MD Anderson's Department of Neuro-Oncology.

Glioblastoma is both the most common and lethal form of brain cancer. More than 12,000 people will be diagnosed with the disease in 2013, with an average survival rate of less than 18 months, said Gilbert.

Bevacizumab works as a monoclonal antibody against VEGF-A, which is produced by glioblastoma to stimulate blood vessel growth. The angiogenesis inhibitor first showed promise in glioblastoma as clinicians reported positive results treating the disease under approved compassionate use. Numerous institutional studies then found similar results: a 35-40 percent objective response rate, or tumor shrinkage, of more than 50 percent, and a six-month PFS rate in the mid-30 percent, said Gilbert. With those findings, in May, 2009, the FDA granted an accelerated registration of bevacizumab in the second line setting.

However, before this trial, no randomized, double-blind studies with the drug in glioblastoma had been conducted.

"Obviously, glioblastoma is a cancer with too few effective therapies," said Gilbert, who also holds the Blanche Bender Professorship in Cancer Research. "When we launched this study, those in the field of brain cancer both the scientific and patient communities -- were excited. Bevacizumab recently received approval in the second-line (recurrent disease) setting, and we knew some physicians were already giving the drug as a frontline therapy -- even with virtually no data to support that decision. It was important from a patient care and regulatory standpoint that we conduct this trial."

The Phase III, international study (RTOG 0825) was a collaboration of three cooperative groups: RTOG, NCCTG and ECOG.

The randomized, double-blind, placebo-controlled study registered 978 and enrolled 637 patients, respectively, all of whom were newly diagnosed with glioblastoma. Participants underwent surgery to resect some or most of the tumor, received the standard of care of chemoradiation with temozolomide, and were randomized to receive either bevacizumab or placebo. The study was designed with two primary endpoints: PFS and OS.

Two distinguishing factors of the study design include: crossover to bevacizumab in the placebo arm at the time of progression, and longitudinal assessment of symptom burden, neurocognitive function and quality of life.

"With the crossover, we could determine the possible overall, or progression free survival benefits that could distinguish the potential benefits of early versus later use of bevacizumab," Gilbert said. "Also, there may be some alternative advantages for delaying progression in the disease. In order to interpret that possible delay in progression, it was important to understand what the quality of the survival of that possible progression free survival interval."

A third distinction: the study was designed to look at the impact of pre-specified molecular markers -- a nine-gene signature expression and MGMT methylation -- to determine if a subgroup that specifically benefited from bevacizumab could be identified.

The researchers found no difference in OS between the bevacizumab and placebo arms, 15.7 and 16.1 months, respectively. PFS did not reach the pre-set level statistical significance -- although longer in those taking bevacizumab upfront (10.7 months), compared to in those receiving placebo (7.3 months).

Bevacizumab was associated with a higher rate of toxicities, including hypertension, bleeding, deep vein thrombosis and pulmonary embolism, and gastrointestinal perforation. Those on the therapy also experienced increase rates of symptom burden and neurocognitive decline, as well decreased quality of life, compared to those on placebo.

When looking at the molecular markers, no subgroup of patients that benefitted from bevacizumab could be identified, said Gilbert.

Despite the disappointing findings, Gilbert stressed that the study did not find that bevacizumab had no place in the management of glioblastoma.

"Ultimately, our study showed that bevacizumab has the same benefit whether given early or late and because of the risk of extra toxicity upfront, its used can be reserved as a later treatment for most patients," said Gilbert.

Complementary studies detailing quality of life, symptom burden and molecular findings will all be presented by MD Anderson faculty at the meeting.


'/>"/>

Contact: Laura Sussman
lsussman@mdanderson.org
832-264-8893
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert

Related medicine news :

1. Study finds glioblastoma patients treated with bevacizumab experience reduced cognitive function and quality of life
2. Time to tumor growth helps predict survival benefit of Bevacizumab for patients with metastatic colorectal cancer
3. TheBeautyPlace.com Offers the Number One Alternative for Sun Damage Prevention
4. hCG Treatments/Diet Doc hCG Diets & Weight Loss Plans Offers Newly Improved hCG Diet Plans Thought To Reduce Menopausal Weight Gain and Its Related Symptoms
5. Spectrum Surgical Offers Pre-Configured Veterinary Dental Packs
6. Inexpensive LAX And Burbank Airport Shuttle Service 800 72-LAXRIDE Offers Car Service To Los Angeles Airport In Style For Less Than A Taxi In A Towncar Or Limousine
7. New Relumins Skin Whitening Line Offers New and Safer Solutions to Battle Melasma
8. LaDainian Tomlinson Preparatory Academy Offers Promo Code for CoreCourseGPA.com Membership
9. Classe Wines Offers Exquisite Special Edition French Wines from Burgundy
10. AMP Futures
11. Cheapest Ninja Trader Broker
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology: