J-Y Blay, C Schiffler, Olivier Bouché, Mehdi Brahmi, F Duffaud, M Toulmonde, B Landi, W Lahlou, D Pannier, E Bompas, F Bertucci, L Chaigneau, O Collard, M Pracht, C Henon, I Ray-Coquard, K Armoun, S Salas, M Spalato-Ceruso, A Adenis, B Verret, N Penel, C Moreau-Bachelard, A Italiano, A Dufresne, S Metzger, S Chabaud, D Perol, A Le Cesne
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引用次数: 0
Abstract
Background: The administration of adjuvant imatinib during three years is indicated after resection of primary localized GIST at high risk of recurrence, but many patients relapse afterwards.
Methods: IMADGIST (NCT02260505) was a multicenter open-label, randomized phase III study evaluating the maintenance of imatinib for 3 more years (6-years arm) compared to Interruption (3-years arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to treat disease-free survival (DFS). Secondary endpoints include overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, safety.
Results: From December 24th 2014 to April 4th 2023; 136 patients aged ≥18, ECOG PS ≤2, with a localized GIST with a R0 or R1 surgery, and a risk of tumor recurrence ≥35% according to NCCN risk classification were randomized in 14 centers. Sixty-five patients were randomized to the 3-Years arm vs. 71 in the 6-Years arm. There were 68 males and females. Primary sites were gastric and small bowel in 60 (44%) and 64 (47%) patients respectively. Respectively 52 (38%) and 71 (52%) of patients had a risk of relapse of 35-70% and >70%.. With a median follow-up of 55 (IQR=46-59) months post randomization, DFS was significantly superior in the 6-Years arm (HR: 0.40 [0.20-0.69], p=0.0008). Time to imatinib resistance, survival, adverse events and quality of life are not different in the 2 arms.
Conclusions: Three additional years of adjuvant imatinib reduces the risk of relapse in patients who have received 3 years of adjuvant imatinib with an acceptable tolerance.
期刊介绍:
Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine.
The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings.
Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.