JAMA publishes Glivec (Novartis) follow up data in GIST - 28-Mar-2012

The Journal of the American Medical Association (JAMA) has published a Phase III study that showed significant survival benefits for patients meeting the study inclusion criteria who received three years of treatment with Glivec (imatinib)from Novartis after surgery to remove KIT (CD117)-positive Gastrointestinal Stromal Tumors (KIT+ GIST) compared to one year of treatment. The study results were first presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) plenary session in June 2011. According to data published in JAMA from this international, multicenter, open-label Phase III clinical trial, at five years, 66% of patients taking Glivec for three years after surgery for KIT+ GIST remained free of recurrence (RFS) compared to 48% who had received Glivec for only one year after surgery (p<0.001; HR 0.46, 95% CI 0.32-0.65). In addition, at five years, 92% of patients taking Glivec for three years after surgery were alive (OS) compared to 82% who had received Glivec for only one year after surgery (p=0.02; HR 0.45, 95% CI 0.22-0.89). Four hundred patients entered the study. Median patient follow-up was 54 months. see Joensuu H, et al. One Versus Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor. JAMA. Vol 307, No.12. March 28, 2012.