Date: 2012-03-27
Type of information: Initiation of preclinical development
phase: 3
Announcement: publication of phase III results in the Journal of the American Medical Association (JAMA)
(Joensuu H, et al. One Versus Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor. JAMA. Vol 307, No.12. March 28, 2012.)
Company: Novartis (Switzerland)
Product: Glivec® (imatinib)
Action mechanism:
Disease: Gastrointestinal stromal tumors (GIST)
Therapeutic area: Cancer Oncology
Country:
Trial
details: The SSG Phase III trial is a multicenter, prospective, randomized study for the evaluation of adjuvant treatment with Glivec® of histologically confirmed KIT+ GIST. The trial was conducted by the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO).
The primary endpoint was to compare, within the first five years, recurrence-free survival in patients with a greater than 50% estimated risk of GIST disease recurrence, following diagnosis and treatment with adjuvant Glivec® for either 12 or 36 months. The secondary endpoints included overall survival and treatment safety.
Inclusion criteria for risk of recurrence was defined as tumor diameter >5.0 cm and mitotic count >5/50 high power fields (HPFs); or tumor diameter >10.0 cm; or tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the peritoneal cavity.
Latest
news: 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 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.
Almost all patients experienced side effects while taking Glivec®. Glivec® was generally well tolerated. The proportion of patients who discontinued Glivec® during the assigned treatment period for reasons other than GIST recurrence was 25.8% in the 36-month group and 13% in the 12-month group.
Novartis provided the study drug and supported the study financially. Additional funding was received from the Academy of Finland, Cancer Society of Finland, Sigrid Juselius Foundation and Helsinki University Research Funds.
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.
