10-Year Follow-up Analysis of BCIRG-006 Study by TRIO
Translational Research in Oncology (TRIO), announced today at SABCS the results of the 10-years follow-up analysis of the BCIRG-006 trial which showed sustained significant benefits (in terms of disease-free survival (DFS) and overall survival (OS)) of docetaxel (Taxotere®)-based chemotherapy combined with trastuzumab (Herceptin®) in women with early-stage human epidermal growth factor receptor 2 positive (HER2+) breast cancer. The analysis also showed that this efficacy benefit is very similar in the anthracycline and non-anthracycline based, trastuzumab-containing regimens; however, the non-anthracycline (TCH) regimen was associated with an important improvement in long-term cardiac safety (FDA/EMEA approvals 2008).
The BCIRG-006 trial evaluated three regimens after initial surgery: 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel (AC-T) versus 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel and one year of Herceptin (AC-TH) versus a non-anthracycline regimen of 6 cycles of docetaxel plus carboplatin and one year of trastuzumab (TCH).
The BCIRG-006 study enrolled 3222 patients between April 2001 and March 2004.
With long term follow-up (median 10.3 years), a persistent significant DFS benefit was seen in both trastuzumab-containing arms compared to AC-T: The reduction in the risk of disease recurrence was 28% for AC-TH and 23% for TCH at 10 years of follow-up. A significant OS benefit was also seen in both trastuzumab-containing arms compared to AC-T, with the reduction in the risk of death being 37% for AC-TH and 24% for TCH at 10 years of follow-up. This however came at the cost of a five-fold higher number of congestive heart failure cases in the AC-TH regimen compared to TCH (21 cases vs. 4), with clinically apparent congestive heart failure being observed at a rate of 0.4% in TCH, versus 2.0% in AC-TH and 0.8% in AC-T. In addition, TCH significantly reduced the incidence of sub-clinical loss in cardiac function from 200 cases with AC-TH to 97 cases with TCH.
“These long-term data from the BCIRG-006 study confirm the significant impact of trastuzumab (Herceptin®) in follow-up analyses demonstrating significant improvements in disease-free as well as overall survival after 10 years. The study showed this sustained efficacy benefits for both trastuzumab-based regimens, TCH and AC-TH, after 10 years of follow-up. Since its approval, the only major safety concern with trastuzumab has been its potential impact on cardiac function. The TCH regimen essentially eliminates this safety concern by significantly reducing the incidence of congestive heart failure and/or cardiac dysfunction that is seen when trastuzumab is used with anthracyclines. We are happy that we have a way to use the drug with even better safety,” said Professor Dennis Slamon [Professor and Chief Hematology-Oncology UCLA Los Angeles – TRIO Chair].
The BCIRG-006 study was a phase III, multinational, multicenter study conducted by TRIO (formerly known as BCIRG) and sponsored by Sanofi with additional support from Genentech.
TRIO together with its global network of dedicated investigators is a not-for-profit academic oncology research organization offering full CRO services to conduct its clinical trials. We are dedicated to advancing translational cancer research by bringing innovative and targeted therapeutics to clinical practice. Our mission is to further cancer research through our translational research model involving close linkage between active preclinical and clinical research. TRIO conducts novel clinical trials using designs based scientifically on new and/or novel preclinical studies from the Translational Oncology Research Laboratory (TORL) at UCLA and other academic institutions.
Additional information is available at http://www.trioncology.org
Translational Research in Oncology
Emmanuelle Mekercke or Valerie Bee-Munteanu
Edmonton : (780) 702 0200
Paris : (33) 158 100 909
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Proton OnSite Has Been Awarded a Contract for Approximately USD 1.8 Million and Assumes the Lead Role in the US Government Advanced Water Splitting Benchmarking Project23.10.2017 21:02 | Pressemelding
Proton OnSite (Proton), a wholly owned subsidiary of Nel ASA, Oslo Norway (Nel, OSE:NEL) has been awarded a contract for approximately USD 1.8 million to participate in the US Department of Energy’s (DOE’s) Advanced Water Splitting Benchmarking Project. This is a critical piece of DOE’s HydroGEN Energy Materials Network (EMN) consortium, which was launched to accelerate the discovery and development of materials for low cost hydrogen production, enabling energy storage, resiliency and economic opportunities across sectors. Proton will work with DOE National Laboratories and lead a team to ensure that all experimental results across the water splitting research community are properly vetted, standards are set for comparison, and roadmaps are developed including research priorities and capability needs. Kathy Ayers, Proton’s Vice President of Research and Development, has been named overall project
SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico23.10.2017 17:14 | Pressemelding
SES Networks' high throughput and fibre-like satellite connectivity service, the stratospheric balloons operated by X, Alphabet’s self-described “moonshot factory”, and local telecommunications expertise are playing a key role in restoring 4G/LTE connectivity in disaster-affected Puerto Rico, SES announced today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171023006165/en/ SES Networks Works with Project Loon to Restore Connectivity in Puerto Rico (Photo: Business Wire) The connectivity is powered by Project Loon's targeted cell coverage and SES Networks' O3b FastConnect, a rapidly deployable satellite terminal delivering fibre-like performance. Together with local technology partners, SES Networks and X are providing reliable high-performance connectivity to Puerto Ricans whose lives have been dev
Sagemcom Unveils the Next-Generation Multi-Gigabit Solutions23.10.2017 16:05 | Pressemelding
AFTER THE SUCCESS OF ITS ONE GIGABIT GATEWAY RANGE, SAGEMCOM RELEASES TO THE OPERATORS THE NEXT GENERATION MULTI-GIGABIT GATEWAYS – VDSL 35B / G.FAST / PON, 2.5G/10G PON, DOCSIS 3.1 – INTEGRATING HIGH EFFICIENCY 802.11AX Wi-Fi, IN ADDITION TO NEW SMART HOME CONNECTIVITY SOLUTIONS INCLUDING DISTRIBUTED WI-FI, VOICE CONTROL AND HOME AUTOMATION. The VDSL 35B / G.fast / FTTH / PON universal gateway, F@st 5380, integrates G.fast 212MHz, GPON and 802.11ax Wi-Fi, enabling the operators to deliver Multi-Gigabit end-to-end services, and to meet the growing bandwidth required by the end-users. F@st 5380 benefits from the last innovations of the in-house field proven Sagemcom SWANTM software suite including big data, Wi-Fi distribution, smart diagnostics… The next generation Fiber gateways range includes two products: F@st 5688ax for 10G PON (XGS-PON
Moody’s Analytics Launches the CreditLens™ Platform23.10.2017 15:43 | Pressemelding
Moody’s Analytics has launched the CreditLens platform, our next-generation credit origination and risk monitoring solution. This new platform offers flexibility, configurability, and efficiency to lending institutions striving to establish smarter and leaner loan origination practices. The CreditLens platform reduces time-to-decision while tapping into powerful models and insightful analytics that help lenders manage risk and drive productivity. Lenders gain efficiency from the solution’s automated spreading capability and a flexible model authoring module. They also gain deep insights from built-in Moody’s Analytics Risk Grading features and Business Insights dashboards, which provide a complete view of the lender’s credit relationships. Automation in the platform also reduces errors and preserves data lineage throughout the credit assessment and origination process.
Knopp Biosciences Announces Renewal of NIH Blueprint Grant Award for Advancing KCNQ2 Modulators in Epilepsy23.10.2017 15:11 | Pressemelding
Knopp Biosciences LLC today announced the renewal and expansion of its grant award from the National Institutes of Health Blueprint Neurotherapeutics Network to advance novel treatments for epilepsy. The Phase 2 award under the NIH Small Business Innovation Research (SBIR) program anticipates NIH support of up to $2 million over the next three years of the project, subject to satisfactory completion of milestones. The renewal follows the successful completion of all milestones under a previously awarded Phase 1 grant of $400,000. Knopp is directing its potassium channel activator program to preclinical and clinical development of small-molecule drug candidates against a validated, anti-seizure pharmaceutical target encoded by the KCNQ2 gene. Knopp intends to advance novel, small-molecule KCNQ2 activators in neonatal epileptic encephalopathy, a rare disorder caused by inherit
HCL Technologies Powers Volvo Ocean Race 2017-1823.10.2017 13:02 | Pressemelding
The 2017-18 edition of the Volvo Ocean Race was flagged off at Alicante, Spain, with HCL Technologies as the strategic IT services provider. The leading global IT services company has provided end-to-end infrastructure support as well as connectivity between the Race Village and the Command Centre in Alicante further connecting them to 12 Host Cities on the race route globally. The world's longest and toughest professional sporting event began at Alicante and will finish eight months later at The Hague. At the flag-off, Jordi Neves, Chief Digital Officer, Volvo Ocean Race, said: “Over four decades, Volvo Ocean Race has drawn some of the greatest ever sailors. This edition of the race will be more digitally focused than before, with HCL as the strategic IT services provider. This edition is also special for us as we embark on a major Sustainability Program in partnership wi
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom