BACKGROUND: Imatinib evaluated as a new treatment option in patients with recurrent or established progressive aggressive fibromatosis/desmoid tumor (AF/DT). PATIENTS AND METHODS: Forty patients with unresectable and progressive symptomatic AF/DT were treated with imatinib (400 mg/day for 1 year) in a Simon's optimal two-stage phase II study (P(0) = 10%, P(1) = 30%, α = 5%, β = 10%). The primary end point was non-progressive at 3 months (RECIST). RESULTS: The study population consisted of 28 women and 12 men, with a mean age of 41 (range 20-72 years). Most of the primary sites were extra-abdominal (24, 54.5%). Familial adenomatous polyposis was observed in six (15%) cases. The median follow-up was 34 months. Imatinib toxicity was similar to that previously reported in literature. Tumor assessment was validated by a central independent radiology committee for 35 patients At 3 months, one (3%) complete and three (9%) partial confirmed responses were observed. The non-progression rates at 3, 6 and 12 months were, respectively, 91%, 80% and 67%. The 2-year progression-free and overall survival rates were 55% and 95%, respectively. Two patients with mesenteric AF/DT died from progressive disease. CONCLUSION: Imatinib is active in the treatment of recurrent and progressive AF/DT, providing objective response and long-term stable disease in a large proportion of patients.
BACKGROUND:Imatinib evaluated as a new treatment option in patients with recurrent or established progressive aggressive fibromatosis/desmoid tumor (AF/DT). PATIENTS AND METHODS: Forty patients with unresectable and progressive symptomatic AF/DT were treated with imatinib (400 mg/day for 1 year) in a Simon's optimal two-stage phase II study (P(0) = 10%, P(1) = 30%, α = 5%, β = 10%). The primary end point was non-progressive at 3 months (RECIST). RESULTS: The study population consisted of 28 women and 12 men, with a mean age of 41 (range 20-72 years). Most of the primary sites were extra-abdominal (24, 54.5%). Familial adenomatous polyposis was observed in six (15%) cases. The median follow-up was 34 months. Imatinibtoxicity was similar to that previously reported in literature. Tumor assessment was validated by a central independent radiology committee for 35 patients At 3 months, one (3%) complete and three (9%) partial confirmed responses were observed. The non-progression rates at 3, 6 and 12 months were, respectively, 91%, 80% and 67%. The 2-year progression-free and overall survival rates were 55% and 95%, respectively. Two patients with mesenteric AF/DT died from progressive disease. CONCLUSION:Imatinib is active in the treatment of recurrent and progressive AF/DT, providing objective response and long-term stable disease in a large proportion of patients.
Authors: Antoine Adenis; Olivier Bouché; François Bertucci; Elsa Kalbacher; Charles Fournier; Philippe Cassier; Olivier Collard; Jacques-Olivier Bay; Antoine Italiano; Christine Chevreau; Stéphanie Clisant; Andrew Kramar; Jean-Yves Blay; Nicolas Penel Journal: Med Oncol Date: 2012-03-24 Impact factor: 3.064
Authors: Jae-Cheol Jo; Yong Sang Hong; Kyu-Pyo Kim; Jae-Lyun Lee; Jeeyun Lee; Young Suk Park; Sun Young Kim; Jin-Sook Ryu; Jong-Seok Lee; Tae Won Kim Journal: Invest New Drugs Date: 2014-01-16 Impact factor: 3.850
Authors: Pooja J Sheth; Spencer Del Moral; Breelyn A Wilky; Jonathan C Trent; Jonathan Cohen; Andrew E Rosenberg; H Thomas Temple; Ty K Subhawong Journal: Skeletal Radiol Date: 2016-08-09 Impact factor: 2.199