Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News
SYS-CON.TV

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
Phase 3 Data Published in Lancet Show bendamustine (Levact®) Plus Rituximab Doubles Progression-Free Survival in Patients With Indolent Non-Hodgkin Lymphoma and Mantle Cell Lymphoma Compared With CHOP-R

MECHELEN, Belgium, February 20, 2013 /PRNewswire/ --

NOT INTENDED FOR MEDIA IN THE NETHERLANDS

- Treatment with bendamustine plus rituximab (B-R) doubles progression free survival (PFS) compared with current standard of care CHOP-R (69.5 versus 31.2 months; p<0.0001)

- B-R better tolerated than CHOP-R in study designed to explore simplified regimen as new first-line treatment

- Data adds to growing body of clinical evidence that demonstrates anticancer effect of bendamustine in wide range of lymphoid malignancies

- Bendamustine is currently licensed for use after rituximab, an application has been made on the basis of this data for first line use.

Results from the StiL NHL-1  study published in the Lancet today show that a first-line treatment regimen of bendamustine plus rituximab (B-R) doubles progression-free survival (PFS) compared with the most often used treatment CHOP plus rituximab (CHOP-R), in newly diagnosed patients with indolent non-Hodgkin lymphoma (iNHL) and mantle cell lymphoma (MCL).[1]

Median PFS for patients treated with B-R was 69.5 months, compared with 31.2 months for patients treated with CHOP-R, the most common  chemoimmunotherapy regimen used for the treatments of these diseases (p<0.0001).[1]

The statistically significant PFS benefit was maintained in the B-R group, regardless of age and across all subtypes; follicular lymphoma, MCL and Waldenström's macroglobulinaemia, with the exception of marginal zone lymphoma, which was non-inferior.[1]

The results also represent the first time that a simplified treatment regimen has led to a superior complete response (CR) rate compared to CHOP-R in a randomized trial, with 40% of the B-R group achieving a CR compared with 30.0% for CHOP-R (p=0.021).[1] The B-R group also experienced fewer side effects to those receiving CHOP-R, with serious adverse events occurring in 19% of the B-R group compared with 29% for patients receiving CHOP-R.[1]

Patients receiving B-R experienced less myelosuppression, with severe neutropenia occurring in only 29% of patients compared to 69% with CHOP-R (p<0.0001).[1] Infections, a challenging side effect of chemoimmunotherapy, were also significantly reduced with the B-R regimen (p=0.0025).[1]

A commonly acknowledged side effect of CHOP-R is hair loss; however, hair loss was not reported in a single patient receiving B-R (p<0.0001).[1]

"These results represent a significant breakthrough in cancer treatment for patients with indolent non-Hodgkin lymphoma and mantle cell lymphoma, who in the past have had to endure particularly aggressive and toxic chemotherapy combinations," said Professor Mathias J. Rummel, Head of the Department for Haematology at the University Hospital in Giessen, Germany, who led the study.  "Our study showed bendamustine and rituximab offered a significant improvement in PFS, and that the combination was better tolerated than CHOP-R. This means that the regimen could become the new preferred first-line treatment, capable of extending the time patients battling these malignancies live free of disease."

Professor Fritz Offner, Head of heamatology at the University of Gent in Belgium, states : "The treatment of indolent non Hodgkin lymphoma has come a long way, from an ineffective oral treatment with few side effects to an immuno-chemotherapy with maintenance antibody treatment that results in median PFS above 3 years in patients requiring therapy. This has been obtained so far with chemotherapy that carries significant toxicities, from hair loss to hospital admissions for neutropenic fever and infections.  The current study from the StiL-group represents a major advance in this field : not only does bendamustine have significantly lower toxicities, including no hair loss (which is important for patients continuing to be socially and professionally active during their treatment) but it also comes with a doubling of PFS, unseen with any other chemotherapeutic modification of the standard treatment. This is not only true for the more prevalent follicular NHL but also for other indolent lymphomas usually absent from major phase 3 trials, such as Waldenstrom's macroglobulinemia. It is a big step forward for patients to make cancer care better and less disruptive for daily life."

Non-Hodgkin lymphoma (NHL) is the tenth most common cancer worldwide and figures from 2008 indicate that there are an estimated 356,000 new cases diagnosed every year, comprising two out of five haematological cancers.[2]  Indolent lymphomas represent 40% and MCL 3-10% of all NHL subtypes.[1] The estimated average incidence of NHL in 2008 in the European Union is 10.8 per 100,000, with the highest estimated incidence being for men living in Luxembourg (around 19 cases per 100,000).[2]-[3]   

Bendamustine is currently approved for Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab

containing regimen. Medicinal products should not be used outside their approved indication.

Data from the StiL NHL-1 study have been submitted to regulatory authorities for their consideration of a bendamustine and rituximab combination as a first-line treatment for iNHL and MCL.

-Notes to Editors-

StiL NHL-1 Study Methodology

The StiL NHL-1 study was a prospective, open-label, multi-centre, randomized phase 3 non-inferiority trial, which involved 549 patients aged 18 years or older, with newly diagnosed stage III or IV indolent NHL and MCL.[1]

Patients were stratified according to histological lymphoma subtype and then randomised to receive bendamustine 90mg/m2 on days 1 and 2 of a 4-week cycle or CHOP (3-weekly cycles of cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2 and vincristine 1.4 mg/m2 on day 1, and prednisone 100 mg/day for 5 days) for a maximum of 6 cycles. Patients in both treatment arms received rituximab 375 mg/m2 on day 1 of each cycle.[1]

CHOP-R Treatment Regimen

Rituximab plus chemotherapy, most commonly CHOP-R, is the current first-line standard of care for patients with advanced iNHL, and for elderly patients with MCL.[1]

About Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. For further information please visit: http://www.mundipharma.be

About Bendamustine

In 2008 the US Food and Drug Administration (FDA) approved bendamustine for the treatment of iNHL and chronic lymphocytic leukemia (CLL), and it subsequently received European approval in 2010 for certain types of iNHL, CLL and multiple myeloma.  Bendamustine has marketing authorisations in Germany, France, UK, Italy, Spain, Austria, Switzerland, Sweden, Norway, Finland, Denmark, Poland, Slovakia, Ireland, Cyprus, Iceland, Belgium, The Netherlands, Greece, Slovenia, Portugal, Czech Republic, Romania and Bulgaria (Levact®, Ribomustin®, Ribovact®) where it is marketed by the Mundipharma network of independent associated companies.

Bendamustine is licensed (Levact®, Ribomustin®, Ribovact®) from Astellas Deutschland GmbH.

References

1 Rummel MJ, Niederle N, Maschmeyer G, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. The Lancet, 20 February 2013 (online publication, ahead of print).

2  Non-Hodgkin lymphoma incidence statistics: In the EU and worldwide. Cancer Research UK. Available at http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incide.... Accessed February 2012

3  European Age-Standardised rates calculated by the Cancer Research UK Statistical Information Team, 2011, using data from GLOBOCAN 2008 v1.2, IARC, version 1.2. Available at Non-Hodgkin lymphoma incidence statistics: In the EU and worldwide. Cancer Research UK http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incide.... Accessed February 2012.


About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest AJAXWorld RIA Stories
Are you developing or hosting PHP applications? Are you doing performance sanity checks along your delivery pipeline? No? Not Yet? Then start with a quick check. It only takes 15 minutes and it really pays off. As a developer you can improve your code, and as somebody responsible...
Poorly performing websites, like Twitter’s recent fiasco with Ellen’s selfie, are a constant source of irritation for users. At first you think it’s your computer, or maybe someone on your block is downloading the entire “Game of Thrones” series. But, when nothing changes after r...
Have you seen this error message before “java.sql.Exception: ORA-00060: deadlock detected while waiting for resource”? This is caused when parallel updates require locks on either rows or tables in your database. I recently ran into this exception on an instance of an IBM eComme...
When the agile movement re-cast the roles of the SDLC they did so with small projects as the baseline of their experience. A typical minimal SDLC method includes subject matter experts (those who execute the current workflow activities), a Project Manager, a Business Analyst, a S...
Telerik Controls are great for building modern, rich clients, and web applications often seen at the enterprise level. I just worked with a company that uses these controls in their soon-to-be-released customer-facing SharePoint portal. They ran a small load test that showed that...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021


SYS-CON Featured Whitepapers
ADS BY GOOGLE