NEW ORLEANS, Louisiana, June 7 /PRNewswire/ -- - Glivec(R) should not be interrupted in patients with advanced GIST
The French Sarcoma Group today announced results of a multi-center, Phase III trial demonstrating that Glivec(R) (imatinib) interruption in patients with advanced GIST was associated with a high risk of re-progression within the following year. Announced today at ASCO, they confirm that in patients with advanced GIST (gastrointestinal stromal tumor), Glivec(R) should be given until documented progression or intolerance. The data represent 2 years of follow-up from the first continuous vs. intermittent imatinib treatment study in advanced GIST after one year.
“As we look at the benefits of Glivec(R) over long-term use, the results continue to be very impressive,” said Dr. Jean-Yves Blay, lead investigator, Centre LÃ?©on BÃ?©rard, HÃ?´pital Edouard Herriot, and scientific director of the CancÃ?©ropÃ?´le Lyon RhÃ?´ne-Alpes Auvergne, Lyon, France. “By all parameters measured in this study, Glivec(R) interruption was associated with a high risk of re-progression within the following year. It is still too early to be sure of long-term outcomes in Glivec(R)-treated patients, and we do not recommend this strategy outside of a clinical trial, however, when Glivec(R) is given continuously, with the results we have seen to date, there is reason for optimism.”
Clinical Data
The study was conducted in 192 patients in 30 French hospitals to evaluate the impact of Glivec(R) interruption of PFS and OS in GIST patients in CR, PR, or SD 12 months after initiation of Glivec(R). Of the 192 patients recruited, 129 completed the study; 58 received intermittent treatment and 26 received continuous Glivec(R) treatment. The analysis of the first 48 randomized patients demonstrated that none (0%) of the patients receiving continuous Glivec(R) experienced re-progression within 1 year. Further, of the 58 patients receiving intermittent treatment, 40% experienced re-progression. Of this group, >90% have responded positively to the re-introduction of Glivec(R) so far.
Page 2 New Study Finds Interruption of Glivec(R) in Patients with Advanced GIST associated with high-risk of re-progression within following year
Glivec(R), manufactured by Novartis Pharma, AG, is indicated for the treatment of newly diagnosed adult and paediatric patients with Ph+ CML in the EU and Switzerland. Glivec(R) is approved in the US for newly diagnosed adult patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. In addition, Gilvec(R) is already approved in over 80 countries for the treatment of patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Glivec(R) is also approved in the EU, US, Japan and more than 70 other countries for the treatment of patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant GISTs.
Study Funding
This study was made possible by support from Novartis SA, Centr�© L�©on B�©rard (regional cancer center), Canc�©rop�´le Lyon Rh�´ne-Alpes Auvergne and supervised by the Groupe Sarcome Fran�§ais de la F�©d�©ration Nationale des Centres de Lutte Contre le Cancer (French Sarcoma Group of the National Federation of Cancer Centers).
About the Canc�©rop�´le Lyon Rh�´ne-Alpes Auvergne
The Canc�©rop�´le Lyon Rh�´ne-Alpes Auvergne is the result of concerted support from the Minist�¨re de la Recherche (Ministry of Research), the Minist�¨re de la Sant�© (Ministry of Health), the Conseil R�©gional Rh�´ne-Alpes (Regional Counsel of Rh�´ne-Alpes, the Conseil G�©n�©ral du Rh�´ne (General Counsel of the Rh�´ne) and the Grand Lyon (Greater Lyon) with collaboration and support from the scientific, academic and medical communities as well as from the vast private industry in the region. This coalition serves as the fulcrum in uniting the cancer-related community by facilitating the transfer of technology, the development of industry as well as the birth of start-ups all for the benefit of the patient.
Canceropole Lyon Rhone-Alpes
CONTACT: For further information please contact: Dara Brice, Canc�©rop�´leLyon Rh�´ne-Alpes, 60 avenue Rockefeller, 69008 Lyon, France,dbrice@canceropole-lyonrhone