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Joensuu, Heikki; Eriksson, Mikael; Sundby Hall, Kirsten; Reichardt, Annette; Hartmann, Jörg T.; Pink, Daniel; Ramadori, Giuliano; Hohenberger, Peter; Al-Batran, Salah-Eddin; Schlemmer, Marcus; Bauer, Sebastian; Wardelmann, Eva; Nilsson, Bengt; Sihto, Harri; Bono, Petri; Kallio, Raija; Junnila, Jouni; Alvegård, Thor; Reichardt, Peter

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

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  • Medientyp: E-Artikel
  • Titel: Adjuvant Imatinib for High-Risk GI Stromal Tumor: Analysis of a Randomized Trial
  • Beteiligte: Joensuu, Heikki; Eriksson, Mikael; Sundby Hall, Kirsten; Reichardt, Annette; Hartmann, Jörg T.; Pink, Daniel; Ramadori, Giuliano; Hohenberger, Peter; Al-Batran, Salah-Eddin; Schlemmer, Marcus; Bauer, Sebastian; Wardelmann, Eva; Nilsson, Bengt; Sihto, Harri; Bono, Petri; Kallio, Raija; Junnila, Jouni; Alvegård, Thor; Reichardt, Peter
  • Erschienen: American Society of Clinical Oncology (ASCO), 2016
  • Erschienen in: Journal of Clinical Oncology, 34 (2016) 3, Seite 244-250
  • Sprache: Englisch
  • DOI: 10.1200/jco.2015.62.9170
  • ISSN: 0732-183X; 1527-7755
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Purpose</jats:title><jats:p> Three years of adjuvant imatinib therapy are recommended for patients with GI stromal tumor (GIST) with high-risk features, according to survival findings in the Scandinavian Sarcoma Group XVIII/AIO (Arbeitsgemeinschaft Internistische Onkologie) trial. To investigate whether the survival benefits have persisted, we performed the second planned analysis of the trial. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Eligible patients had macroscopically completely excised, KIT-positive GIST with a high risk of recurrence, as determined by using the modified National Institutes of Health criteria. After surgery, the patients were randomly assigned to receive imatinib for either 1 or 3 years. The primary objective was recurrence-free survival (RFS), and the secondary objectives included survival. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> A total of 400 patients were entered onto this open-label study between February 4, 2004, and September 29, 2008. During a median follow-up of 90 months, 171 recurrences and 69 deaths were detected. Patients assigned to the 3-year group had longer RFS than those assigned to the 1- year group; 5-year RFS was 71.1% versus 52.3%, respectively (hazard ratio [HR], 0.60; 95% CI 0.44 to 0.81; P &lt; .001), and survival was 91.9% versus 85.3% (HR, 0.60; 95% CI, 0.37 to 0.97; P = .036). Patients in the 3-year group survived longer in the subset with centrally confirmed GIST and without macroscopic metastases at study entry (93.4% v 86.8%; HR, 0.53; 95% CI, 0.30 to 0.93; P = .024). Similar numbers of cardiac events and second cancers were recorded in the groups. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Three years of adjuvant imatinib therapy results in longer survival than 1 year of imatinib. High 5-year survival rates are achievable in patient populations with high-risk GIST. </jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang