10-Year Follow-up Analysis of BCIRG-006 Study by TRIO
11.12.2015 16:45 | Business Wire
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
Publication of Clinical Data Demonstrating Low Immunogenicity and Excellent Efficacy of Nuwiq® in Previously Untreated Patients23.8.2017 06:00 | Pressemelding
Octapharma is delighted to announce the publication of interim data from the NuProtect study (GENA-05, NCT01712438), the first clinical data on treatment with Nuwiq® in previously untreated patients (PUPs), on August 16th 2017 as an Early View article in the internationally renowned medical journal Haemophilia. The NuProtect study was initiated in March 2013 to investigate the immunogenicity, efficacy and safety of Nuwiq® in PUPs with severe haemophilia A, who are at the greatest risk of developing inhibitors. The ongoing study has enrolled 110 PUPs of any age or ethnicity who will receive Nuwiq® for up to 100 exposure days (EDs), making it one of the largest studies with a single FVIII product. Patients who previously received any FVIII concentrates or blood products containing FVIII are excluded from the study. The recently published article describes interim results for 6
IBC’s Big Screen to Explore the Future of Camera and Display Technologies and the Business Behind Cinema22.8.2017 16:58 | Pressemelding
IBC today announced the details of its Big Screen programme, taking place in a specially built auditorium designed to IBC’s specifications and featuring the very latest in cinema technology. With the latest Dolby Vision dramatic imaging and Dolby Atmos immersive audio sound installation, the four-day programme examines and demonstrates the hottest topics, themes, and insights surrounding the art, science, and business of cinema - from capture through to exhibition. As well as being the home of the Big Screen programme, the auditorium will screen in Dolby Vision and Dolby Atmos, Baby Driver, the acclaimed Edgar Wright feature from 2017. The programme for 2017, which has been shaped by a committee of global industry professionals, is an insightful examination of the future of cinema. From virtual reality in cinema to laser and camera assessments, visitors will get up to speed
Digi Communications N.V. Announces the Publishing of an Update to the Investigation by the Romanian National Anti-Corruption Directorate22.8.2017 16:38 | Pressemelding
In connection with the investigation triggered by the Romanian National Anti-Corruption Directorate (“DNA”), which we have previously disclosed to the market and to our investors in the initial public offering prospectus dated 26 April 2017, in the supplemental prospectus dated 8 May 2017 (together, the “Prospectus”), as well as in the subsequent public reports, we inform you that, based on the public release no 832/VIII/3 issued on 22 August 2017, the DNA sent to court under the judiciary control Mr. Ioan Bendei (Vice-president of the Board of Directors of RCS & RDS S.A. – the Company’s subsidiary („RCS&RDS”)) in connection with the offences of bribery and accessory to money laundering, as well as RCS&RDS in connection with the offences of bribery and money laundering, INTEGRASOFT S.R.L. (one of RCS&RDS’s subsidiaries in Romania) in connection with the offence of accessory to mon
SailPoint Named a Leader in Cloud-based Identity Governance22.8.2017 14:00 | Pressemelding
SailPoint, the leader in enterprise identity management, was recently named the overall market leader in KuppingerCole’s 2017 “Leadership Compass: Identity as a Service: Cloud-based Provisioning, Access Governance and Federation.” In addition to being named a leader in every category of the report, SailPoint received superior rankings in four of the five evaluation criteria: security, functionality, interoperability and usability. KuppingerCole is an international and independent analyst organization with a strong focus on Information Security and Identity and Access Management. KuppingerCole’s Leadership Compass reports provide an in-depth analysis of the main players in the market, defining each as a follower, challenger or leader. The Leadership Compass Report for IDaaS evaluates leaders in innovation, product features, and market reach for identity-as-a-service offerings tar
Meggitt Training Systems to Exhibit at DSEI 201722.8.2017 14:00 | Pressemelding
Meggitt Training Systems, the leading provider of integrated live-fire and virtual weapons training products and services for armed forces and law enforcement, will participate at Defence and Security Equipment International (DSEI) through the Georgia Department of Economic Development. The military and security industry event will be held September 12-15, 2017 at ExCeL in London, England. “Today’s threats necessitate maximum realism, despite stretched budgets, and that’s what Meggitt provides to government and commercial customers globally,” said Mark Mears, managing director at Meggitt Training Systems, Ltd. “Although proudly based in Georgia, Meggitt Training Systems is part of Meggitt PLC, a UK-headquartered corporation. As such, we particularly look forward to engaging with current and prospective customers at DSEI, the UK’s largest defense and security trade show.” On
Camelbay Real Estate Management NL B.V. Selects Yardi Voyager22.8.2017 13:58 | Pressemelding
Camelbay Real Estate Management NL B.V. will utilise Yardi Voyager® 7S, a browser-agnostic, fully mobile Software-as-a-Service platform, as its accounting and property management platform. Camelbay will use Yardi Voyager to streamline its property management, leasing and accounting processes for its Dutch real estate portfolio, which is predominantly comprised of commercial office assets. “The automation, transparency and fully integrated accounting and property management that Voyager provides will help us manage our daily financial and operational activities more efficiently and enhance our competitive position within the Dutch office market,” said Alon Levy, Director of Camelbay Real Estate Management NL B.V. “We are very pleased to welcome Camelbay as our latest client in the Netherlands,” said Neal Gemassmer, Vice President of International for Yardi.
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom