TY - JOUR
T1 - A randomized study of 6 versus 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse
AU - Blay, J. Y.
AU - Schiffler, C.
AU - Bouché, O.
AU - Brahmi, M.
AU - Duffaud, F.
AU - Toulmonde, M.
AU - Landi, B.
AU - Lahlou, W.
AU - Pannier, D.
AU - Bompas, E.
AU - Bertucci, F.
AU - Chaigneau, L.
AU - Collard, O.
AU - Pracht, M.
AU - Henon, C.
AU - Ray-Coquard, I.
AU - Armoun, K.
AU - Salas, S.
AU - Spalato-Ceruso, M.
AU - Adenis, A.
AU - Verret, B.
AU - Penel, N.
AU - Moreau-Bachelard, C.
AU - Italiano, A.
AU - Dufresne, A.
AU - Metzger, S.
AU - Chabaud, S.
AU - Perol, D.
AU - Le Cesne, A.
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/1/1
Y1 - 2024/1/1
N2 - Background: The administration of adjuvant imatinib during 3 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-year arm) compared with interruption (3-year arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to-treat disease-free survival. Secondary endpoints included overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, and safety. Results: From 24 December 2014 to 4 April 2023, 136 patients aged ≥18 years, Eastern Cooperative Oncology Group performance status ≤2, with a localized gastrointestinal stromal tumor with an R0 or R1 surgery, and a risk of tumor recurrence ≥35% according to National Comprehensive Cancer Network (NCCN) risk classification were randomized in 14 centers. Sixty-five patients were randomized to the 3-year arm versus 71 to the 6-year 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%) patients had a risk of relapse of 35%-70% and >70%. With a median follow-up of 55 months (interquartile range 46-59 months) after randomization, disease-free survival was significantly superior in the 6-year arm [hazard ratio: 0.40 (0.20-0.69), P = 0.0008]. Time to imatinib resistance, survival, adverse events, and quality of life were not different in the two 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.
AB - Background: The administration of adjuvant imatinib during 3 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-year arm) compared with interruption (3-year arm) from the day of randomization, conducted in the French Sarcoma Group. The primary endpoint was intent-to-treat disease-free survival. Secondary endpoints included overall survival, time to imatinib resistance, response after imatinib reintroduction at relapse, and safety. Results: From 24 December 2014 to 4 April 2023, 136 patients aged ≥18 years, Eastern Cooperative Oncology Group performance status ≤2, with a localized gastrointestinal stromal tumor with an R0 or R1 surgery, and a risk of tumor recurrence ≥35% according to National Comprehensive Cancer Network (NCCN) risk classification were randomized in 14 centers. Sixty-five patients were randomized to the 3-year arm versus 71 to the 6-year 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%) patients had a risk of relapse of 35%-70% and >70%. With a median follow-up of 55 months (interquartile range 46-59 months) after randomization, disease-free survival was significantly superior in the 6-year arm [hazard ratio: 0.40 (0.20-0.69), P = 0.0008]. Time to imatinib resistance, survival, adverse events, and quality of life were not different in the two 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.
KW - adjuvant therapy
KW - gastrointestinal stromal tumors
KW - imatinib mesylate
KW - randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85205140793&partnerID=8YFLogxK
U2 - 10.1016/j.annonc.2024.08.2343
DO - 10.1016/j.annonc.2024.08.2343
M3 - Article
C2 - 39241959
AN - SCOPUS:85205140793
SN - 0923-7534
JO - Annals of Oncology
JF - Annals of Oncology
ER -