One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial
<h3>Context</h3>Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared with placebo.<h3>Objective</h3>To investigate the role of imatinib administration du...
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| Main Authors: | , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
28 March 2012
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| In: |
The journal of the American Medical Association
Year: 2012, Volume: 307, Issue: 12, Pages: 1265-1272 |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2012.347 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1001/jama.2012.347 Verlag, Volltext: https://jamanetwork.com/journals/jama/fullarticle/1105116 
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| Author Notes: | Heikki Joensuu, Mikael Eriksson, Kirsten Sundby Hall, Jörg T. Hartmann, Daniel Pink, Jochen Schütte, Giuliano Ramadori, Peter Hohenberger, Justus Duyster, Salah-Eddin Al-Batran, Marcus Schlemmer, Sebastian Bauer, Eva Wardelmann, Maarit Sarlomo-Rikala, Bengt Nilsson, Harri Sihto, Odd R. Monge, Petri Bono, Raija Kallio, Aki Vehtari, Mika Leinonen, Thor Alvegård, Peter Reichardt |
| Summary: | <h3>Context</h3>Adjuvant imatinib administered for 12 months after surgery has improved recurrence-free survival (RFS) of patients with operable gastrointestinal stromal tumor (GIST) compared with placebo.<h3>Objective</h3>To investigate the role of imatinib administration duration as adjuvant treatment of patients who have a high estimated risk for GIST recurrence after surgery.<h3>Design, Setting, and Patients</h3>Patients with KIT-positive GIST removed at surgery were entered between February 2004 and September 2008 to this randomized, open-label phase 3 study conducted in 24 hospitals in Finland, Germany, Norway, and Sweden. The risk of GIST recurrence was estimated using the modified National Institutes of Health Consensus Criteria.<h3>Intervention</h3>Imatinib, 400 mg per day, orally for either 12 months or 36 months, started within 12 weeks of surgery.<h3>Main Outcome Measures</h3>The primary end point was RFS; the secondary end points included overall survival and treatment safety.<h3>Results</h3>Two hundred patients were allocated to each group. The median follow-up time after randomization was 54 months in December 2010. Diagnosis of GIST was confirmed in 382 of 397 patients (96%) in the intention-to-treat population at a central pathology review. KIT or PDGFRA mutation was detected in 333 of 366 tumors (91%) available for testing. Patients assigned for 36 months of imatinib had longer RFS compared with those assigned for 12 months (hazard ratio [HR], 0.46; 95% CI, 0.32-0.65; P < .001; 5-year RFS, 65.6% vs 47.9%, respectively) and longer overall survival (HR, 0.45; 95% CI, 0.22-0.89; P = .02; 5-year survival, 92.0% vs 81.7%). Imatinib was generally well tolerated, but 12.6% and 25.8% of patients assigned to the 12- and 36-month groups, respectively, discontinued imatinib for a reason other than GIST recurrence.<h3>Conclusion</h3>Compared with 12 months of adjuvant imatinib, 36 months of imatinib improved RFS and overall survival of GIST patients with a high risk of GIST recurrence.<h3>Trial Registration</h3>clinicaltrials.gov Identifier: NCT00116935 |
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| Item Description: | Gesehen am 11.10.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2012.347 |