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) after surgery to remove KIT (CD117)-positive gastrointestinal stromal tumours (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.
Gastrointestinal stromal tumours are a rare, life-threatening cancer of the gastrointestinal tract. The major cause of GIST is an abnormal form of the protein KIT which causes cells to grow uncontrollably and become cancerous.
Patients with GIST are at risk of recurrence following complete resection of primary GIST.
According to data published in JAMA from this international, multicentre, 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.
Based on this data, in February 2012, the European Commission approved an update to the Glivec label to include three years of treatment after surgery for adults with KIT+ GIST.
“This study shows a significant recurrence-free survival benefit in adults with KIT+ GIST from adjuvant treatment with Glivec and provides important evidence to inform the clinical care of these patients after surgery,” said Heikki Joensuu, M.D., Ph.D., Professor, Oncology, University of Helsinki.
“These data are likely to result in a new standard of care for these patients.”