Adjuvant Imatinib for High-Risk GI Stromal Tumor: Analysis of a Randomized Trial

• DOI: 10.1200/jco.2015.62.9170
• Publication Date: 2015-11-03T03:24:17Z
• Authors: Heikki Joensuu; Mikael Eriksson; Kirsten Sundby Hall; Annette Reichardt; Jörg T. Hartmann; Daniel Pink; Giuliano Ramadori; Peter Hohenberger; Salah-Eddin Al-Ba...; Marcus Schlemmer; Sebastian Bauer; Eva Wardelmann; Bengt Nilsson; Harri Sihto; Petri Bono; Raija Kallio; Jouni Junnila; Thor Alvegård; Peter Reichardt
• Keywords: Imatinib Mesylate; Clinical endpoint; Adjuvant Therapy

Three years of adjuvant imatinib therapy are recommended for patients with GI stromal tumor (GIST) high-risk features, according to survival findings in the Scandinavian Sarcoma Group XVIII/AIO (Arbeitsgemeinschaft Internistische Onkologie) trial. To investigate whether benefits have persisted, we performed second planned analysis trial.Eligible had macroscopically completely excised, KIT-positive GIST a high risk recurrence, as determined by using modified National Institutes Health criteria. After surgery, were randomly assigned receive either 1 or 3 years. The primary objective was recurrence-free (RFS), and secondary objectives included survival.A total 400 entered onto this open-label study between February 4, 2004, September 29, 2008. During median follow-up 90 months, 171 recurrences 69 deaths detected. Patients 3-year group longer RFS than those 1- year group; 5-year 71.1% versus 52.3%, respectively (hazard ratio [HR], 0.60; 95% CI 0.44 0.81; P < .001), 91.9% 85.3% (HR, CI, 0.37 0.97; = .036). survived subset centrally confirmed without macroscopic metastases at entry (93.4% v 86.8%; HR, 0.53; 0.30 0.93; .024). Similar numbers cardiac events cancers recorded groups.Three results imatinib. High rates achievable patient populations GIST.