New Orleans, LA, June 6, 2004 – The French Sarcoma Group today announced results of a multi-center, Phase III trial demonstrating that Glivec® (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® 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® over long-term use, the results continue to be very impressive," said Dr. Jean-Yves Blay, lead investigator, Centre Léon Bérard, Hôpital Edouard Herriot, and scientific director of the Cancéropôle Lyon Rhône-Alpes Auvergne, Lyon, France. "By all parameters measured in this study, Glivec® 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®-treated patients, and we do not recommend this strategy outside of a clinical trial, however, when Glivec® is given continuously, with the results we have seen to date, there is reason for optimism."
The study was conducted in 192 patients in 30 French hospitals to evaluate the impact of Glivec® interruption of PFS and OS in GIST patients in CR, PR, or SD 12 months after initiation of Glivec®. Of the 192 patients recruited, 129 completed the study; 58 received intermittent treatment and 26 received continuous Glivec® treatment. The analysis of the first 48 randomized patients demonstrated that none (0%) of the patients receiving continuous Glivec® 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® so far.
Glivec®, 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® 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® 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® 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.
This study was made possible by support from Novartis SA, Centré Léon Bérard (regional cancer center), Cancéropôle Lyon Rhône-Alpes Auvergne and supervised by the Groupe Sarcome Français de la Fédération Nationale des Centres de Lutte Contre le Cancer (French Sarcoma Group of the National Federation of Cancer Centers).
About the Cancéropôle Lyon Rhône-Alpes Auvergne
The Cancéropôle Lyon Rhône-Alpes Auvergne is the result of concerted support from the Ministère de la Recherche (Ministry of Research), the Ministère de la Santé (Ministry of Health), the Conseil Régional Rhône-Alpes (Regional Counsel of Rhône-Alpes, the Conseil Général du Rhône (General Counsel of the Rhône) 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.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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