Adjuvant imatinib for high-risk GI stromal tumor: analysis of a randomized trial
PurposeThree 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 bene...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2016
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| In: |
Journal of clinical oncology
Year: 2015, Volume: 34, Issue: 3, Pages: 244-250 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.2015.62.9170 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1200/JCO.2015.62.9170 Verlag, Volltext: https://ascopubs.org/doi/10.1200/JCO.2015.62.9170 
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| Author Notes: | Heikki Joensuu, Mikael Eriksson, Kirsten Sundby Hall, Annette Reichardt, Jörg T. Hartmann, Daniel Pink, Giuliano Ramadori, Peter Hohenberger, Salah-Eddin Al-Batran, Marcus Schlemmer, Sebastian Bauer, Eva Wardelmann, Bengt Nilsson, Harri Sihto, Petri Bono, Raija Kallio, Jouni Junnila, Thor Alvegård, and Peter Reichardt |
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| 245 | 1 | 0 | |a Adjuvant imatinib for high-risk GI stromal tumor |b analysis of a randomized trial |c Heikki Joensuu, Mikael Eriksson, Kirsten Sundby Hall, Annette Reichardt, Jörg T. Hartmann, Daniel Pink, Giuliano Ramadori, Peter Hohenberger, Salah-Eddin Al-Batran, Marcus Schlemmer, Sebastian Bauer, Eva Wardelmann, Bengt Nilsson, Harri Sihto, Petri Bono, Raija Kallio, Jouni Junnila, Thor Alvegård, and Peter Reichardt |
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| 520 | |a PurposeThree 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.Patients and MethodsEligible 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.ResultsA 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 < .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.ConclusionThree 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. | ||
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